Life Science Compliance Update

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32 posts from March 2011

March 24, 2011

America Invents Act

America Invents 
Recently, the Senate Judiciary Committee unanimously approved the “America Invents Act” (S. 23), a bill that would overhaul the U.S. patent system by changing it from a first-to-invent to a first-to-file system. The legislation would also give courts more influence in determining patent dispute damages. 

After its passage in Committee, the bill was passed by the Senate on March 8 in a 95-5 vote. This kind of legislation has been considered for several years and has reached the full Senate three times since 2008. According to an analysis by the law firm White & Case, LLP, the bill contains many important provisions affecting the patent process in the United States:

·         Patent System Moves From First-to-Invent System to First-to-File System. The bill would harmonize the US patent system with the rest of the world by switching from a first-to-invent system to a first-to-file system.


·         PTO Given Fee-Setting Authority. The bill would allow the PTO to set patent and trademark fees without Congress's prior approval.


·         End to Fee Diversion. The bill ends diversion of fees collected by the PTO into the general fund. A USPTO Revolving Fund will enable those fees to be used by the PTO for future expenditures.


·         Third Parties May Submit Prior Art During Patent Examination. The bill would allow third parties to submit prior art for consideration during patent examination.


·         Post-Grant Review During First Nine Months After Issue. Post-grant review could be requested on any grounds in the first nine months after a patent issues. The PTO Director would have sole authority to authorize or deny post-grant review.


·         Supplemental Examination Process Provided for Patent Owners to Submit Prior Art and Prevent Its Use in an Inequitable Conduct Defense. The bill creates a new procedure called "supplemental examination," which allows the patent owner to make pre-litigation submissions to the PTO of prior art not disclosed during examination. Such submissions could not then be used to support an inequitable conduct defense.


·         Ban on Tax Strategy Patents. Strategies for reducing, avoiding or deferring tax liability are not eligible for patents.

In the bill’s favor, the patent office is self-financing, and the legislation would not add to the budget deficit. Consequently, David J. Kappos, the director of the patent office and under secretary of commerce for intellectual property, asserted that the America Invents Act “would be an enormous improvement.”


Mr. Kappos noted that, “the current, first-to-invent system does no more than grant an inventor “a lottery ticket,” with the right to defend in court whether he was the first to come up with an idea.” Instead, Mr. Kappos recognized that a first-to-file system “adds transparency and objectivity” in the form of a clear line of priority — that is, who arrived first at the patent office.


In addition, Gary F. Locke, the Secretary of Commerce, which oversees the patent office, told the New York Times that it is “unacceptable and scandalous” that the patent office has a backlog of more than 700,000 unexamined applications. This means that it takes “two years for an inventor to get an initial ruling on one, and a final patent usually takes another year.” Secretary Locke noted that the patent office’s computer systems are out of date and Congress has made a practice of siphoning off the office’s revenue for other uses.”


As the Times noted, the legislation would allow the patent office to set its own fees and make several changes, including charging companies that desire a decision within a year of filing to pay extra to move to the front of the line. Mr. Kappos said he also “wanted to cut fees for independent inventors and small businesses by at least half. Applicants currently pay about $4,000 for a patent.”


Additionally, the Times article explained that “Mr. Kappos disputes the notion that a first-to-file system puts small companies, which might need more time and money to develop a patentable idea, at a disadvantage.” Mr. Kappos “said that the office already offers a $110 provisional application that secures a place in line and gives the applicant time to develop an idea before submitting a full application.”




Consequently, large corporations such as General Electric, Cateprillar, and IBM,

support the bill because the “proposed changes would also help to keep patent disputes out of the court system, which inevitably adds millions of dollars to the cost of maintaining patent protection.”


In addition, the Biotechnology Industry Organization (BIO) commended the Senate for its overwhelming passage of the America Invents Act by a vote of 95-5. BIO noted that, “once enacted into law, it will strengthen and improve our nation’s patent system, spurring innovation and job creation.”


BIO noted in its press release how “patents are often the main assets of small biotech companies, and they rely on this intellectual property to attract investors to fund the lengthy and expensive research and development process necessary to bring breakthrough new therapies and other biotech products to patients and consumers.”


 However, “opponents of the bill maintain that the current system is better structured to “give the little guy an advantage.” Some believe that changing to a first-to-file system, “could cause big companies to overwhelm the patent office with claims on every imaginable innovation, slowing the process further and crowding out small inventors.”



The next step in the process is for the House Judiciary Committee to take up the bill, which is led by Chairman Lamar Smith (R-TX). As for now, the Committee does not have anything scheduled, so it is uncertain when the legislation will be considered.

March 23, 2011

Affordable Care Act One Year Later

Afforable Care Act Signing 
It is hard to imagine that one year ago today President Obama signed into law the Affordable Care Act (ACA), the nation’s most sweeping reform since Medicare was passed in 1965.

 POLITICO ran a number of stories addressing health care reform and the impact that the ACA has had on Americans. Some of the stories were written by notable health care stakeholders, including Health and Human Services (HHS) Secretary Kathleen Sebelius, Senator Ron Wyden (D-OR), Senator Tom Harkin (D-IA), and Representative Steve King (R-IA). Below is a summary of each of these articles, as well as some additional commentary on recent developments in Congress relating to the ACA and health care reform.

Kathleen Sebelius

Ms. Sebelius asserted in her article that Americans “are enjoying new protections, greater freedoms and lower costs,” since the ACA was enacted. She noted how “children are now protected from being turned away by insurers because of a pre-existing condition and seniors enrolled in Medicare now have the freedom to get preventive care — such as mammograms and colonoscopies — for free.”

She also noted that “a Patient’s Bill of Rights is freeing families from some of the worst abuses of insurance companies, including cancelling coverage when you get sick because of a paperwork error.”

With respect to coverage and insurance, she noted that, “the number of small businesses offering coverage to employees is increasing.” Ms. Sebelius also added that the ACA is “demanding transparency and accountability from the insurance industry to bring down premiums.” For example, she noted how HHS has given states almost “$250 million in funding to strengthen their ability to review, revise or reject unreasonable insurance rate hikes.”

In addition, she pointed to “new proposed rules that would force many insurers to justify big increases and post explanations on the Web.” She also recognized that the new rules regarding medical loss ratio, requiring insurers to pay out 80-85 % of premium dollars on health care and quality improvement efforts — rather than marketing and executive bonuses.

In the future, the HHS Secretary noted that in 2014, individuals and small businesses will be able to bring down their health insurance rates through new state-based health insurance exchanges to. In addition, the ACA will give millions of eligible people tax credits, based on need, to help them afford health coverage.

Defending these changes, Ms. Sebelius pointed to data from the Congressional Budget Office (CBO), which showed that a family of four, making $55,000, could save more than $6,000 a year on health insurance in 2014.

Finally, the Secretary acknowledged the ACA’s investment in bringing down costs by investing “in preventive care, and innovative programs aimed at slowing that growth of premiums.” She asserted that new ides to “coordinate care, improve patient safety, and reduce waste, fraud and abuse, will create additional savings for decades to come.”

Interestingly, Ms. Sebelius acknowledged President Obama’s recent remarks at a hearing with governors, providers and patients, where the “president announced his support for legislation that allows states to pursue innovative alternatives to the law, provided they can achieve the same results as the Affordable Care Act — including relief from skyrocketing costs.”

Ultimately, Ms. Sebelius asserted that Americans “can’t afford to take away these benefits, cancel these rights, and return to the days when insurance companies got between you and your doctor.”

Senator Tom Harkin (D-IA)

Mr. Harkin echoed the comments of Secretary Sebelius, and noted that efforts to repeal the ACA are “misguided.” He claimed that “support for health care reform is growing steadily.” However, his article must have missed another POLITICO story that cited a recent survey from the Henry J. Kaiser Family Foundation, which found that 57% of independent voters had an unfavorable view of the law in January, up from 41% in December.

Nevertheless, the focus of his message was to put insurance companies on the hot seat. He noted that if the ACA is repealed, Americans will face discrimination based on pre-existing conditions and access to health insurance for more than 30 million Americans will be lost. Mr. Harkin pointed out that repealing the ACA would also “add hundreds of billions of dollars to the deficit by wiping out the savings in the ACA.”

Mr. Harkin specifically took issue with the provision of the ACA that ends denial of coverage due to pre-existing conditions. This issue is significant because “nearly half of nonelderly Americans have some type of pre-existing condition — like high blood pressure, arthritis or heart disease.” He also championed the ACA’s provisions that ban the practice of canceling policies when people get sick, prohibit insurers from imposing lifetime limits on benefits, and allow parents to keep their children on their policies until age 26.

In response to conservative attacks on the individual mandate, Senator Harkin noted that this provision is just “common sense.” Without this mandate, he noted that people will continue using emergency rooms for treatment and sticking other Americans with the bill—in fact, $1,100 a year to every family’s health insurance premiums comes from uncompensated care.

He noted how Mitt Romney, as governor of Massachusetts, put an individual mandate in his state’s health reform law to eliminate free riders and put everyone in the risk pool, to keep rates down for everyone. Mr. Harkin noted that, “this is the only way people with pre-existing conditions are not denied affordable coverage.”

Ultimately, Senator Harkin urged for continued support of the ACA, to insure that Americans have the freedom to afford a doctor, and so that people do not fear that a major illness will lead to financial ruin. While he admitted that the ACA is not perfect, and is more like “a starter home — suitable for improvement,” he noted that the ACA will replace the current sick care system with a genuine health care system — focused on wellness and prevention, which will reward health care providers for the quality of care they provide, not just the quantity.

As the law is implemented, he asked his colleagues who want to make sensible changes “to bring their tool kits, rather than their sledgehammers, so we can work together to improve the law.”

Senator Ron Wyden (D-OR)

The focus of Senator Wyden’s article was to discuss the bipartisan Empowering States to Innovate Act, which he introduced last year with Senator Scott Brown (R-MA) to advance states’ ability to make changes to the health reform law, has not lacked attention.

Mr. Wyden recognized how there has been too little focus on his bipartisan legislation because there is too much back and forth about whether President Obama is being inflexible (conservatives) or yielding too much (liberals).

In clarifying arguments against his proposed legislation, Mr. Wyden explained how “the legislation would make it easier for states to get waivers for health care reform and Medicaid and allow states to address both in one waiver request.” For example, he noted how a state could use the waiver process to cover Medicaid recipients as part of its new state private insurance exchanges. He further added that, “Wyden-Brown would also lock states into guaranteeing a generous and costly level of benefits.”

According to another article from POLITICO, the State Innovation Waivers will allow states to opt out of key health reform programs, like the mandated purchase of health insurance and building an insurance exchange, if they meet high benchmarks for coverage and affordability. Oregon and Vermont are expected to pursue these waivers and have secured the president’s support on moving their effective date to 2014 from 2017, when they currently kick in.

Consequently, Mr. Wyden noted how the idea of the Waiver for State Innovation provision was first part of his Healthy Americans Act that he introduced in 2006. He recognized then and now that states need “the flexibility to adapt federal health care laws to meet their regional needs,” because health care challenges are different in every part of the country.

Interestingly, Mr. Wyden noted that the provision is currently in the ACA, but wouldn’t take effect until 2017. Accordingly, “Wyden-Brown would allow states to start looking for ways to adapt and improve on the law now — while they are focused on its implementation — rather than years after those decisions and investments have been made.”

Mr. Wyden asserted that, “empowering governors and local lawmakers to improve the law is likely to make reform more successful for all Americans.” As a result, he noted that if states have the ability to invest their time and energy in finding ways to innovate and make health care reform work better, “all Americans would be healthier and more financially secure.”

In addition to innovation waivers, officials at HHS have approved no fewer than 1,040 requests for so-called mini-med waivers. However, the mini-med waivers — which allow people to keep insurance plans that have an annual payout on benefits of less than $750,000 — affect a relatively small group of the privately insured: 2.6 million people.

Moreover, many states over the next year will also seek a reprieve from two of the law’s most wide-reaching provisions: the medical loss ratio and the maintenance-of-effort provision. Last week, the agency granted Maine the country’s first medical-loss-ratio waiver, concluding the new regulation could drive insurers away from the state’s small individual insurance market.

POLITICO noted that HHS is weighing similar requests from New Hampshire, Nevada and Kentucky, and that “officials in a third of the states will ask Washington for waivers that will allow insurance companies to set aside more money for administration costs and profits. And more than half of the states are eying waiver requests to the Medicaid requirement.”

Additionally, more than two dozen Republican governors sent HHS a letter in January asking the secretary to waive the maintenance-of-effort provision, which bars states from dropping Medicaid eligibility before the program’s expansion in 2014.

Ultimately, the administration asserted that, “certain waivers and adjustments are necessary to ensure an orderly transition toward 2014, when most of the major health reform provisions come online.

Representative Steve King (R-IA)

Mr. King’s article primarily focused on amendments and legislation he has proposed in the House that would stop the automatic funding provisions of the ACA. Specifically, the ACA includes provisions, “unprecedented in scope,” which automatically spend $105.5 billion over the next 10 years to implement the law.

However, during the continuing resolution debate on funding the federal government for FY 2011, his amendments to cut off this funding were defeated. While two of his other amendments were adopted, which prevented ACA funds from being used to further the implementation of Obamacare, these provisions did not touch Obamacare’s automatic spending provisions. Accordingly, Mr. King emphasized the need to cut off these automatic spending provisions.

Consequently, he asserted that “if the president refuses to sign a continuing resolution that provides for responsible funding of all government functions except Obamacare, Americans will know that serving them is not his priority. Preserving his signature socialized medicine plan is.”

Accordingly, Mr. King explained how he and Representative Michele Bachmann (R-MN) are circulating a letter to House members for language to be in the FY 11 CR that would shut off both the annual and the automatic appropriations for ObamaCare’s implementation. The proposed language reads:

“Notwithstanding any other provision of law, none of the funds made available by this or any previous Act with respect to any fiscal year may be used to carry out the provisions of Public Law 111-148, Public Law 111-152, or any amendment made by either such Public Law.”

The letter also contains a pledge to vote against any CR that lacks this language and it asks that every member of Congress who supports repealing and defunding Obamacare sign the letter and take this pledge.

Rep. Dan Boren (D-Okla.) 

Representative Dan Boren discussed in his article why he voted against the Affordable Care Act and how just “17% of his constituents supported the law,” according to a survey conducted by Public Policy Polling in his district in March 2010. For Mr. Boren, the most disappointing part about the ACA was that there were many bipartisan issues that Republicans and Democrats agreed on, but instead of working on those issues incrementally, Democrats last year pushed a 2,000 page bill through Congress. He noted that the ACA has “dramatically expanded the federal government’s role in the private sector, placed burdensome mandates on small businesses and individuals and increased taxes during an economic downturn.”

As a result, Mr. Boren’s article discussed how he, along with Rep. Mike Rogers (R-Mich.), have introduced the Health Care Waiver Fairness Act. This legislation will allow every small-business owner or average American the opportunity to apply for a waiver from the new health care law if they so desire. The basics of this bill are that if you like the health care reform law, you can take advantage of it. If you want no part of it, you can opt out.


Given the ongoing debate about repealing the ACA and constant changes in public perception and opinion about the ACA, the landscape for 2012 is shaping up to be a battle over health care reform. While many Americans are in favor of a number of the provisions—insurance for 26 year-olds, support on premiums for moderate-income Americans and better prescription drug coverage for seniors, no limits on pre-existing conditions, no lifetime limits—many Americans are still uncertain about the legislation.

Republicans will likely be running a campaign that attacks the ACA for being irresponsible and insufficient to address the growing health care costs and inefficiencies. While Democrats will emphasize the key provisions that have already taken effect and are helping Americans. Some say that Republican presidential candidates will likely run on repealing the bill, as many new members in the Senate and House did during the November 2010 elections.

There is also the added factor of the federal courts to issue rulings on the individual mandate, and with the Supreme Court leaning conservative right now, a decision from the federal judiciary finding the individual mandate unconstitutional may give Republicans the extra boost needed to win the election. And interestingly, a recent Kaiser Family Foundation poll found that nearly 90% of Republicans and 69% of independents want to repeal it. Even Democrats aren’t crazy about it — 51% want to repeal it, according to the same poll.

Ultimately, to repeal the ACA and change the political landscape of Congress and the implementation of health care reform, Republicans will have to come up with a replacement plan; a way to control rising Medicare costs, while also balancing the important provisions of the ACA that American’s support.

March 22, 2011

America’s Lost Innovation May Mean Lost Lives

The road to discovering a life-saving treatment or medicine is long and filled with obstacles. “For those with life-threatening diseases or painful chronic conditions, time is not on their side. When promising treatments languish waiting for approval in a bog of bureaucracy, the cost must be reckoned in lost lives and diminished quality of life.”

“That’s why it’s so alarming that only 21 new drugs gained FDA approval last year.”

As a recent article noted, this “was a significant decrease from the previous two years, when there were 25 approvals in 2009 and 24 in 2008.”

The article, written by Robert Goldberg, co-founder and vice president of the Center for Medicine in the Public Interest in New York, also recognized that “not only are approvals down, so are applications for approval.” He predicted that this will mean “even further declines in annual approvals down the road.”

But what is so perplexing about the decline in drug approvals is that “science is more cutting edge today and grants for new research — in areas from pediatrics to Alzheimer’s — are at all-time highs.” So then, “how is it possible that approvals and applications are both dropping?”

Goldberg noted that one reason is that “the FDA’s review process, in the view of many in the medical and biopharmaceutical communities, has become increasingly turgid.” For example, he noted how “the FDA now frequently calls for extra clinical trials, requiring detailed safety plans that necessitate additional doctor and patient education, and an extended review period.”

He also noted that, “of the 21 drugs approved in 2010, there were 21 drug makers to take credit. Not a single company earned more than one approval. From Pfizer to Bristol-Myers Squibb to Eli Lilly to Merck — all of which were shut-out for approvals in 2010 — the FDA was an equal opportunity rejecter.”

Unfortunately, Goldberg also noted that the small amount of approvals also takes place in the “development of tools that tailor treatments to our individual needs are drowning in a sea of endless confusion.” He asserted that “tests and medical efforts that can help detect and prevent disease, and eliminate useless or even harmful care are being held up in the name of patient safety.”

Consequently, Goldberg recognized that “government policy writ large has now begun to stifle innovation in pharmaceuticals.” For example, he pointed out how “Obama’s health care plan levies tens of billions in taxes on new medical products through 2019.”

In addition, he acknowledged how “comparative effectiveness studies, required even after FDA approval as a condition for being added to benefits, will delay progress, too.” Even worse, he noted, is that “FDA regulators are beginning to consider the comparative effectiveness of products and as a result are raising the bar for approval.”

Ultimately, Goldberg asserted that “innovation is the result, not of a top-down decision, but by learning from actually using an invention,” and “taking products off the market therefore undermines medical progress in many cases.” Accordingly, Goldberg noted that, “innovation is in a very precarious position” because of the “the FDA’s slow-to-act review process and the Obama health care plan’s disproportionate taxation of pharmaceutical firms.”

The reality is, “most medical innovations come from start-ups with limited capital,” and by FDA and the Obama administration making it harder for these small business, the government is doing the opposite of advancing science and medicine. This regulatory uncertainty has left many asking, “whether developers can bring enough new drugs to market at the pace needed to remain financially viable.”

This is problematic because as Goldberg points, out, “China, India and Singapore are inviting America’s innovators to set up shop overseas.”

Therefore, Goldberg asserted that, “as the world’s leader — by far — in scientific research investment, the United States must change course and must do so immediately” because “not only are we losing innovation, we are losing lives as well.”

FDA Medical Device Innovation Initiative

Innovation report 
Recently, the Food and Drug Administration (FDA) announced the "Medical Device Innovation Initiative," which proposes actions that the Center for Devices and Radiological Health   (CDRH) could take to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science. These actions include:

  • Facilitate the development and regulatory evaluation of innovative medical devices;
  • Strengthen the U.S. research infrastructure and promote high-quality regulatory science; and
  • Prepare for and respond to transformative innovative technologies and scientific breakthroughs.

Much of the emphasis on medical devices comes as the FDA recently overhauled its recommendations and policies regarding the 510(k) approval pathway.

Consequently, FDA last week held a public meeting on the "Innovation Initiative" to solicit public feedback on select actions. Specifically, FDA sought input on a number of identified challenges associated with incentivizing innovation, and the proposed solutions. In addition, the agency requested comments on the Innovation Pathway proposed under the initiative.

According to an article from MassDevice, FDA kicked off the program by choosing a robotic arm being developed by the military as its pilot candidate, granting priority review to a Defense Advanced Research Projects Agency project to create a "brain-controlled, upper-extremity prosthetic." The DARPA team is looking to "restore near-natural arm, hand and finger function to patients suffering from spinal cord injury, stroke or amputation," according to the FDA.

The article noted how the “new regulatory pathway, which is slated to undergo public review before more projects are selected, is the CDRH’s push to boost the development of "pioneering medical devices" that's "designed to encourage cutting-edge technologies among medical device manufacturers."

CDRH Director Jeffrey Shuren noted that, "Each year, millions of American patients benefit from innovative medical devices that reduce suffering and treat previously untreatable conditions." As a result, he asserted that "CDRH's Innovation Initiative will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs."

FDA also noted that on April 7, 2011, it will convene a workshop in Silver Spring, Maryland, on how to create a database of medical device labeling and pictures without revealing any device makers' proprietary information. The aim is a repository of data for the public, researchers, and the medical device industry. It was noted that there “might also be a photo of the device and any acceptable accessories." FDA also anticipated that the repository would not include service and technical manuals, nor would it supply any proprietary information.

In response to FDA’s new Innovation Initiative and public meeting, Sharon Segal, vice president of technology and regulatory affairs for the Advanced Medical Technology Association (AdvaMed), issued a statement commending FDA for giving all stakeholders the opportunity to offer input.

Ms Segal noted that while AdvaMed “supports the goals of the Innovation Initiative, we believe that early and consistent interaction and the focus on a cooperative effort to get safe and effective products developed and reviewed quickly should be available to all innovative products, especially those that currently qualify for expedited review.” Accordingly, she noted that “FDA has a number of tools already available to achieve these objectives and they should be used more broadly and effectively.”

In addition, the statement noted how "FDA already has identified several steps it intends to take to bring greater speed and consistency to the current review process, including greater reviewer training, development of more guidance documents, and streamlining the de novo process.” AdvaMed stated that it “supports these initiatives and believes FDA should continue to focus on these process improvements to help address the unacceptable delays and inconsistencies which have plagued its review process in recent years and have needlessly delayed patient access to life-saving, life-enhancing medical technology." 

March 21, 2011

IOM Report: Leading Health Indicators for Healthy People 2020


Last December, the Department of Health and Human Services (HHS) announced  Healthy People 2020, the nation’s new 10-year goals and objectives for health promotion and disease prevention. HHS acknowledged that the Healthy People initiative “in just the last decade, has either progressed toward or met 71 percent of its Healthy People targets.”  

The 2020 initiative includes a number of new topic areas including: Adolescent Health, Blood Disorders and Blood Safety, Dementias, including Alzheimer’s Disease, and several others.

Additionally, the new initiative includes “myHealthyPeople,” a new challenge for technology application developers. This challenge encourages developers to create easy-to-use applications for professionals who are working with the new national health objectives and state- and community-level health data. The idea is that “myHealthyPeople‟ apps challenge will help spur innovative approaches to information technology that will help communities track their progress using Healthy People objectives and targets as well as develop an agenda for health improvement.”

Consequently, HHS requested that the Institute of Medicine (IOM) evaluate the Healthy People 2020 initiative. In response to this request, the IOM established the Committee on Leading Health Indicators for Healthy People 2020 to develop and recommend 12 indicators and 24 objectives for consideration by HHS for guiding a national health agenda and for consideration for inclusion in Healthy People 2020.


Recently, the Committee released its Letter Report, entitled, “Leading Health Indicators for Healthy People 2020.” In conducting its work, the committee was asked to: 

  • Review current and past health indicators sets, including Healthy People 2010 Leading Health Indicators, the State of the USA (SUSA) indicators, and the Community Health Status Indicators;
  • Give consideration to provisions of the Patient Protection and Affordable Care Act that mandate the establishment of key national indicators and prevention-related measures, goals, and objectives;
  • Define basic principles or purposes for Healthy People 2020 Leading Health Indicators;
  • Develop criteria for selecting Healthy People 2020 Leading Health Indicators. Such criteria should be actionable and reflect the importance of science, evidence, and public health concerns. Development of such criteria should involve consideration of Healthy People 2010 Leading Health Indicators and reflect the Healthy People 2020 framework that includes new issues and topics (e.g., health communication and health information technology);
  •  Choose indicators that, to the extent possible, have annual data sources, with comparable data available at the state and county level; and
  • Identify 24 objectives drawn from Healthy People 2020 and 12 topics under which the selected objectives will be organized.

 During the HHS presentation of the charge to the committee on November 8, 2010, the committee was informed that since only 39 of the 42 Healthy People 2020 topics had written objectives, the committee could propose objectives for the three topics under development.


Those topics are: social determinants of health; health-related quality of life and well-being; and lesbian, gay, bisexual, and transgender health. The committee also received clarification from HHS that the 12 topics selected by the committee did not need to be drawn from the list of 42 topics listed in Healthy People 2020. 

Healthy People 2020

The mission of Healthy People 2020 strives to identify nationwide health improvement priorities. It also looks to increase public awareness and understanding of the determinants of health, disease, and disability and the opportunities for progress. Additionally, it strives to:

  • Provide measurable objectives and goals that are applicable at the national, State, and local levels.
  • Engage multiple sectors to take actions to strengthen policies and improve practices that are driven by the best available evidence and knowledge; and
  • Identify critical research, evaluation, and data collection needs.

IOM Report

The report consists of the committee’s recommendations concerning topics, indicators, and objectives. It then goes into the discussion of the committee process, the framework and the process used to select objectives, and a discussion of the selection of topics and indicators. The report also includes a detailed discussion of each of the selected objectives as well as suggestions for measures that could be used in the three Healthy People topic areas for which no objectives exist: social determinants of health; health-related quality of life and well being; and lesbian, gay, bisexual, and transgender health.


Consequently, the committee developed and recommended 12 indicators and 12 topics, and selected 24 objectives from the Healthy People 2020 objectives that relate to the identified indicators and topics. A list of the objectives with accompanying subobjectives, quantitative goals, and data sources are in the report. Specifically, the committee recommended that the following indicators be used by HHS as the Healthy People 2020 Leading Health Indicators. These indicators are: 

  • Proportion of the population with access to health care services
  • Proportion of the population engaged in healthy behaviors
  • Prevalence and mortality of chronic disease
  • Proportion of the population experiencing a healthy physical environment
  • Proportion of the population experiencing a healthy social environment
  • Proportion of the population that experiences injury
  • Proportion of the population experiencing positive mental health
  • Proportion of healthy births
  • Proportion of the population engaged in responsible sexual behavior
  • Proportion of the population engaged in substance abuse
  • Proportion of the population using tobacco
  • Proportion of the population receiving quality health care services

The committee also recommended the following 24 objectives, selected from the Healthy People 2020 objectives, as important objectives related to these indicators. 

  • Increase educational achievement of adolescents and young adults.
  • Increase the proportion of persons with health insurance.
  • Increase proportion of persons with a usual primary care provider.
  • Increase the proportion of persons who receive appropriate evidence-based clinical preventive services.
  • Reduce the overall cancer death rate.
  • Reduce the number of days the Air Quality Index (AQI) exceeds 100.
  • Increase the proportion of children who are ready for school in all five domains of healthy development: physical development, social emotional development, approaches to learning, language, and cognitive development.
  • Reduce pregnancy rates among adolescent females.
  • Reduce central line-associated bloodstream infections (CLABSI).
  • Improve the health literacy of the population.
  • Reduce coronary heart disease deaths.
  • Reduce the proportion of persons in the population with hypertension.
  • Increase the proportion of sexually active persons who use condoms.
  • Reduce fatal and nonfatal injuries.
  • Reduce the proportion of persons who experience major depressive episodes (MDE).
  • Reduce low birth weight (LBW) and very low birth weight (VLBW).
  • Reduce the proportion of children and adolescents who are considered obese.
  • Reduce consumption of calories from solid fats and added sugars in the population aged 2 years and older.
  • Increase the proportion of adults who meet current Federal physical activity guidelines for aerobic physical activity and for muscle-strengthening activity.
  • Reduce the proportion of persons engaging in binge drinking of alcoholic beverages.
  • Reduce past-month use of illicit substances.
  • Increase the proportion of adults who get sufficient sleep.
  • Reduce tobacco use by adults.
  • Reduce the initiation of tobacco use among children, adolescents, and young adults.


Ultimately, the committee concluded that the indicators and selected objectives in Healthy People 2020 should  prove valuable in eliciting interest and awareness  among the general population; motivating diverse  population groups to engage in activities that will  exert a positive impact on specific indicators and, in  turn, improve the overall health of the nation; and providing feedback on progress toward improving  the status of specific indicators.

The committee also stated that HHS may wish to highlight the indicators and objectives in communications to state and local health departments, use them as a guide for funding priorities in department programs, and use them as priority guides for ongoing departmental  public health data collection and reporting activities.

March 18, 2011

University of Florida Begins New Conflict of Interest Policy

University of Florida College of Medicine 
The University of Florida (UF) recently began implementing a new Conflict of Interest Program to address physician-industry interactions. The conflict of interest (COI) Program is focused on structuring appropriate, principled, transparent relationships with the university’s “valued Industry collaborators.”

According to the policy, industry “relationships are critical to the success of the University’s effort to teach medical students, train residents and fellows, and to provide the best care for our patients.”

However, the University of Florida recognized the changing direction of academic medical centers across the country that are introducing specific measures to maintain the public’s trust in academic medicine. Many of these policies have been enacted or changed largely because of extensive media coverage and intensifying government scrutiny about physician-industry collaboration.

Accordingly, the University of Florida introduced its new Conflict of Interest policy, and recognized that the determination that an individual has a conflict of interest “is a judgment about the situation and not about the professional who happens to be in that situation.”

The policy applies to a broad array of individuals employed by UF, including Faculty, Residents, Fellows, AP, and TEAMS, USPS & OPS (College of Medicine or “COM”).

Under the policy, “Industry” includes, but is not limited to, pharmaceutical, medical device, equipment, biotechnology, service, software, supplies, biomedical investment, and for profit educational companies and foundations sponsored by companies such as drug and device companies

Gifts and Food

  • The policy prohibits accepting gifts of any kind and does not permit industry-purchased food at the College of Medicine.


  • Generally, the policy prohibits samples, but UF faculty may petition the University of Florida Physicians Clinical Safety Committee for a waiver, and demonstrate clear and compelling benefit to patients in need and must provide safeguards for appropriate distribution and control.

Teaching Materials

  • Generally not permitted to directly accept books, instruments, equipment, or teaching aids from Industry
  • Want to encourage Industry and faculty to use the UF Foundation, which is designed to accept grants from Industry
  • Dean’s Office will have oversight and audit function
  • Materials/equipment may be donated to Foundation if properly transferred via a written agreement

CME and Non-CME

  • If CME, must comport to ACCME standards and be processed through the CME office
  • Non-CME educational activities are monitored, evaluated and subject to full disclosure

On-Site Training

  • Industry may provide on‐site training with preapproval from the COM’s CME office or the Industry Academic Relations Committee if non-CME. Industry may also receive on-site training from COM personnel in the safe and proper use of certain medical devices and/or equipment.

Off-Site Events

  • UF faculty may participate in or attend Industry-sponsored conferences and meetings and/or conferences and meetings of tax-exempt organizations funded or sponsored by more than one entity, which may include Industry under certain circumstances.
  • Food/ beverages made available to the entire group are allowed. However, some companies report the provision of food/beverages and your name may appear in an Industry database.
  • Travel expenses may not be paid by Industry unless you are speaking/presenting based on a written agreement.

Speaker’s Bureaus

UF’s College of Medicine defines a “speakers bureau” as any engagement in which you are speaking on behalf of Industry, where the content of the talk is not completely original to you; or the talk is subject to Industry approval; or the attendees of the event are selected by Industry or provided a gift or stipend to attend.

  • Speakers Bureau activities are prohibited.
  • Violations of this prohibition against Speakers Bureau activities will result in disciplinary action.
  • As of January 1, 2011, faculty should not have any active Speakers Bureau relationships with Industry.


  • The professional presentations, books, articles, reports, or other materials, oral or written, of COM personnel must have appropriate authorship attribution.
  • Collaboration with Industry during any phase of manuscript preparation should be appropriately disclosed.


  • Cannot be accepted directly from Industry
  • However, Scholarship and fellowship funds may be provided to the Foundation for education, travel to educational programs, and for other educational purposes.


All faculty and members that fall under this policy must disclose outside activities and financial interests, which is to be reviewed by the department chair or immediate supervisor and forwarded as necessary for authorization. The form must be completed and filed prior to such time as the outside activity or financial interest begins and at the beginning of each fiscal year. They must first be approved by the Chair, the Dean’s Office, and, if applicable, the Office of Research before participating in the outside activity. If a material change in the information presented occurs during the year, a new form must be submitted. All paperwork associated with continuing outside employment/activity must be renewed on a fiscal‐year basis.

  • Outside agreements must reference the individual’s home address and compensation must be paid to them acting in a private capacity.
  • Compensation must reflect Fair Market Value.
  • Reasonable travel expenses may be reimbursed by Industry or other entity.


Many of the rules are fair and balanced.  The prohibition of samples and speakers bureaus is an unfortunate side effect of the endless barrage on freedom of association by the Association American Medical Colleges (AAMC).  It is unfortunate that universities adopt these policies.  Perhaps in several years from now we may see a shift back to allowing samples and physicians to speak on products to other physicians in their community.

March 17, 2011

Physician Payment Sunshine: Special Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests

Public Forum 2 
Within the Affordable Care Act (ACA) is Section 6002, which requires the public reporting of payments or other value transfers made to physicians and teaching hospitals by manufacturers and group purchasing organizations of drugs, devices, biologicals, and medical supplies that are covered by Medicare, Medicaid or the Children’s Health Insurance Program.

Under this provision, known as the Physician Payment Sunshine Act, the Secretary of the U.S. Department of Health and Human Services (HHS) is responsible for establishing procedures for the submission of the information as well as its public availability. Consequently, the Centers for Medicare & Medicaid Services (CMS) recently announced that it is “in the process of identifying and analyzing key processes and requirements to ensure the effective implementation of this provision.”

CMS will be holding a Conference Call Only “Special Open Door Forum on Transparency Reports and Reporting of Physician Ownership or Investment Interests.”

Date: Thursday, March 24, 2011

Time:  2:00PM – 4:00PM EST

Number:  1-800-837-1935

Conference ID: 51513526

CMS noted that it is seeking stakeholder input on a number of topics defined in the statute including:

  • Comments on additional forms and natures of payment and transfer of value to be considered by HHS.
  • Accessibility to and usability of the reported data by consumers.
  • Mechanisms for accurate, efficient, and cost-effective reporting of data.

Specifically CMS is interested in feedback regarding:

Other forms of payment or transfer of value: The legislation lists specific forms of payment or other transfer of value that applicable manufacturers are required to report: Cash or cash equivalent; in-kind items or services; stock, a stock option, or any other ownership interest, dividend, profit, or other return on investment. In addition, the Secretary can define additional forms of payment or other transfers of value to require of manufacturers to report.

  • Should CMS consider additional forms of payment or transfers of value?
  • If so, what additional forms should CMS consider and what additive value do they bring?

Definitions of nature of payment or other transfers of value: The legislation lists 14 specific natures of payment and transfers of value that applicable manufacturers are required to report. These include: consulting fees, compensation for services other than consulting, honoraria, gift, entertainment, food, travel (including specified destinations), education, research, charitable contribution, royalty or license, current or prospective ownership or investment interest, direct compensation for serving as faculty or speaker for a medical education program, and grant. The Secretary can define additional natures of payment or transfers of value.

  •  Should CMS consider additional natures of payment or transfers of value?
  • If so, what additional natures of payment or transfers of value should CMS consider and what additive value do they bring?
  • How narrowly or broadly should CMS define the nature of payments/transfers of value listed in the legislation? For example, what types of consulting should CMS specify (if at all). Please provide examples.

Additional categories of information to report: Beyond the categories listed in the statute, such as forms and nature of payment, the Secretary can determine additional categories of information regarding the payment or other transfer of value to require of the manufacturers to report.

  • Should CMS consider additional categories of information to report?
  • If so, what additional categories should CMS consider requiring and what additive value do they bring?

Ownership or investment interest: The Secretary can determine whether to require additional information regarding physician ownership or investment interest.

  • Should CMS require additional information regarding physician ownership or investment interests?
  • If so, what additional information regarding physician ownership or investment interest should CMS consider and what additive value do they bring?

Average consumer information: What additional types of information should CMS consider reporting to the public beyond forms and natures of payment or transfers of value and physician ownership in applicable manufacturers and group purchasing organizations?

  • What types of background information on industry-physician relationships should CMS consider including?
  • What are best practice approaches for presenting the data in a way that is most understandable by consumers? How can CMS maximize the use of data reported on the website?

Reporting of data: What types of approaches/mechanisms should CMS consider to ensure accurate, efficient, and cost-effective reporting of data?

  • Electronic form: What electronic form should submissions take? What types of electronic forms are currently available that CMS can leverage or use as a model for the purposes of satisfying this requirement? (e.g., electronic forms used by states with sunshine laws)
  • Corrections of reported information. What procedures should CMS establish for the correction of mistakes in the reported data provided by manufacturers?

CMS noted that it will try to provide everyone with the opportunity give feedback during the call; however, participants are also encouraged to submit additional thoughts or feedback following the session to an email address established for this purpose:

Special Open Door Forum Participation Instructions:

**Capacity is limited so dial in early. You may begin dialing into this forum as early as 1:45PM EST. **  Dial 1-800-837-1935 Conference ID 51513526.

An audio recording and transcript of this call will be posted to the Special Open Door Forum website and will be accessible for downloading beginning on or around April 21, 2011.


The Physician Payment Sunshine Act has the potential to bring about a systemic shift in the health care industry, with government taking a larger roll in care of patients. For CME, grants will be reported if they are requested on behalf of a specific physician and/or are given to a teaching hospital.

Many stakeholders in the CME community and healthcare industry have a large interest in ensuring that the reporting requirements under the Sunshine Act are clear, logical, and common sense. We encourage as many people as possible to submit their comments to CMS and to participate in the conference call.

Physician Payment Sunshine: Ohio State Senator Introduces “Payment Disclosure” Duplicative of Federal Law

As the media continues to publish what it calls “investigative journalism” by conducting nothing more than “google” searches of doctors who collaborate and innovate with industry on a database published by ProPublica, states are unfortunately reading these articles without a critical eye.

The media coverage has often portrayed a “vast” problem among doctors and health care practitioners receiving payments from pharmaceutical and medical device manufacturers for training and educating physicians and for consulting about new therapies and devices.

This “tabloid medicine” recently caused two states to consider legislation that would ban such collaboration between physicians and industry. Earlier this week and last week, we covered HB 818, being considered in Maryland, which would prohibit a manufacturer of prescribed products from offering or giving a gift to a health care professional.

Similarly, a bill in the Ohio Senate, Senate Bill 79, sponsored by Sen. Michael Skindell (D), would require pharmaceutical manufacturers to submit annual reports that list “gifts” (including all payments for speaking and consulting) to physicians who are authorized to prescribe drugs. According to an analysis from MedCity News, the bill seems nearly identical to a provision of last year’s health reform law that is scheduled to take effect in 2013. The federal law also applies to medical device makers in addition to drug companies, unlike the Ohio proposal.

In addition, the analysis of the article noted that “under the Ohio proposal, drugmakers would be required to submit to the state an annual report detailing the value, nature and purpose of any gift provided to a doctor in connection with a drug’s promotion. The law wouldn’t apply to gifts valued at less than $25.”

The report would be due on Feb. 1 each year. Violators would be subject to a fine of up to $10,000. All of the following are exempt from disclosure under the proposed legislation:

Any gift, fee, payment, subsidy, or other economic benefit the value of which does not exceed twenty-five dollars;

Sample drugs that are given with the intent that they be distributed to patients;

The payment of reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial conducted in connection with a research study designed to answer specific questions about vaccines, new therapies, or new ways of using known treatments;

Scholarships or other support for medical students, residents, and fellows to attend bona fide educational, scientific, or policy-making conferences of an established professional association if the recipients of the scholarships or other support are selected by the association

Consequently, the bill does not actually provide a definition for "bona fide clinical trial" and "bona fide educational, scientific, or policy-making conference." Instead, it authorizes the Director of the Department of Health to define such terms. 

The Ohio State Medical Association, the trade group representing the state’s doctors, is still studying the proposal and hasn’t taken a position on it, spokesman Jason Koma said. “OSMA supports transparency in this area as long as the responsibility for providing this transparency falls on the pharmaceutical industry — not physicians who are already burdened with far too many administrative hassles,” Koma said.

Most likely, this bill will not be approved because it is extremely redundant and duplicative of the federal Sunshine Act contained in the Affordable Care Act. It should be concerning to those stakeholders in the medical education, research, and continuing medical education (CME) community that the Director will have the power to define the terms mentioned above. This gives complete discretion to an unelected bureaucrat to decide what kind of payments are to be exempt from disclosure for educational value.

Given this kind of uncertainty, it is highly likely that pharmaceutical and device companies will refrain from providing payments for research, clinical trials or education to avoid this uncertain classification.

Ultimately, healthcare stakeholders in Ohio who care about keeping business and innovation in Ohio, advancing medicine and medical technology, and improving patient care, should speak up before it’s too late.

March 16, 2011

FDA Guidance: Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination

Combination therapy is an important treatment modality in many disease settings, including cancer, cardio-vascular disease, and infectious diseases. Recent scientific advances have increased our understanding of the pathophysiological processes that underlie these and other complex diseases.

This increased understanding has provided further impetus for new therapeutic approaches using combinations of drugs directed at multiple therapeutic targets to improve treatment response or minimize development of resistance. In settings in which combination therapy provides significant therapeutic advantages, there is growing interest in the development of combinations of investigational drugs not previously developed for any purpose. 

Because the existing developmental and regulatory paradigm focuses primarily on assessment of the effectiveness and safety of a single new investigational drug acting alone, or in combination with an approved drug, the Food and Drug Administration (FDA) recently published a guidance to industry to assist sponsors in the codevelopment of two or more unmarketed drugs. 

The guidance, entitled “Codevelopment of Two or More Unmarketed Investigational Drugs for Use in Combination,” is intended to describe a high-level, generally applicable approach to codevelopment of two or more unmarketed drugs.  It describes the criteria for determining when codevelopment is an appropriate option, makes recommendations about nonclinical and clinical development strategies, and addresses certain regulatory process issues.  

This guidance is intended to assist sponsors in the codevelopment2 of two or more novel (not previously marketed) drugs to be used in combination to treat a disease or condition. The guidance provides recommendations and advice on how to address certain scientific and regulatory issues that will arise during codevelopment.

It is not intended to apply to development of fixed-dose combinations of already marketed drugs or to development of a single new investigational drug to be used in combination with an approved drug or drugs. The guidance is also not intended to apply to vaccines, gene or cellular therapies, blood products, or medical devices.

Therefore, FDA believes that codevelopment should ordinarily  be reserved for situations that meet the following criteria:    

  • The combination is intended to treat a serious disease or condition.
  • There is a compelling biological rationale for use of the combination (e.g., the agents inhibit distinct targets in the same molecular pathway, provide inhibition of both a primary and compensatory pathway, or inhibit the same target at different binding sites to decrease resistance or allow use of lower doses to minimize toxicity).
  • A preclinical model (in vivo or in vitro) or short-term clinical study on an established biomarker suggests that the combination has substantial activity and provides greater than

FDA recommends that sponsors consult with FDA on the appropriateness of codevelopment before initiation of clinical development of the combination. Additionally, the guidance discusses codevelopment issues in:

-       Phase 1 Trials: Early Human Studies

-       Phase 2 Trials: Proof of Concept Studies

-       Phase 3 Trials: Confirmatory Studies

Early Interaction with FDA

Sponsors are encouraged to communicate as early as possible (e.g., pre-IND meeting) with the appropriate FDA review division when considering codevelopment of innovative combination therapy. Sponsors also are encouraged to consult FDA frequently throughout the development process. We believe such communication will help facilitate development of the combination therapy.  

With respect to Investigation New Drug (IND) submissions and Marketing Applications for codevelopment of drugs, FDA recommended that these decisions be made on a case-by-case basis in consultation with the appropriate review division until the agency has more experience with codevelopment.

Labeling Issues: FDA also anticipates that the content of labeling for the combination and/or the components will be case specific, depending on the nature of the combination, the intended uses of the individual components, the marketing strategy, and other factors. Therefore, FDA does not believe it can

provide generally applicable labeling guidance at this time. Again, we recommend consultation with the appropriate review division.  

Regulatory Process of Codevelopment

Early Interaction with FDA Sponsors are encouraged to communicate as early as possible (e.g., pre-IND meeting) with the appropriate FDA review division when considering codevelopment of innovative combination therapy.  Sponsors also are encouraged to consult FDA frequently throughout the development process.  We believe such communication will help facilitate development of the combination therapy. 


Applicants should develop a pharmacovigilance plan that takes into account the additional postmarket risks presented by initial marketing of two or more previously unapproved drugs for use in combination (compared to risks associated with marketing of a single drug).  Risk will vary, depending on the nature of the combination and how the combination is marketed.  The risk assessment should consider, among other things:

• Potential for use of each drug individually;

• Potential for use of any of the components of the combination in combinations with other drugs; and

• Drugs likely to be co-administered with the combination.

Applicants should discuss their pharmacovigilance plans with the appropriate review division and the Office of Surveillance and Epidemiology. 

March 15, 2011

Governor Patrick to Reconsider Massachusetts Code of Conduct

Governor patrick reconsiders 
A recent article discussed the approach Massachusetts Governor Deval Patrick has taken for engaging business and economic development in his state. The article illustrated his and the state's “choppy history with business development.” For example, Evergreen Solar Inc., a solar-panel manufacturer that the Patrick administration promised $58 million in state aid, decided to shift manufacturing jobs to China and close a new plant at Devens.

Spokeswoman Kimberly Haberlin noted that Governor Patrick and many other members of his administration are engaging in a number of meetings designed to “bring more jobs, more business investment, and more tourism dollars home to the commonwealth.”

However, the article noted that the Governor seems to be sending “mixed messages” to various industries about bringing business to Massachusetts. For example, in 2008, Patrick pushed through a $1 billion Life Sciences Initiative aimed at boosting the Massachusetts biotechnology industry. “He quickly jetted off for San Diego to attend the annual Biotechnology Industry Organization (BIO) conference and promote the new law.”

But he, “then-House Speaker Salvatore DiMasi, and Senate President Therese Murray received a rocky reception because of a separate health care cost-control bill pushed by Murray and later signed into law by Patrick.” The bill, known as the Massachusetts Code of Conduct, “included a ban on gifts of any kind from pharmaceutical manufacturers to doctors, their family members, or their employees.

“That prompted the strange juxtaposition of Patrick arriving at the conference to participate in an industry panel discussion, and shortly be named BIO's "Governor of the Year," while BIO leaders were still cleaning their ink-stained hands after writing letters complaining to members of his delegation.”

BIO itself said to DiMasi "the gift-ban provision threatens research and treatment for patients in the commonwealth.” And GlaxoSmithKline accused the Massachusetts political establishment of harboring "a strong anti-biopharmaceutical streak."

Consequently, the article noted how last fall, “Patrick made two fresh points on the subject during his re-election campaign. He said the ban was never intended to extend to the state's medical device industry, and thus should be narrowed.”

He also said the “state pharmaceutical ban itself was ripe for repeal or modification, since the Obama administration's federal health care overhaul included superseding language.” According to a spokesman, "the Department of Public Health, which oversees these regulations, is currently reviewing the ways in which Massachusetts regulations are impacted by federal law in order to determine whether there are any additional steps that need to be taken." A study done by MIT showed that the Code of Conduct is having significantly negative effects on patient care and medical innovation.

Ultimately, with more and more companies picking up and leaving Massachusetts, and new businesses and other industries deciding to set up their offices in other states, it is becoming clearer to some that the Code of Conduct must go. With the Sunshine Act set to take place in 2013, the reporting requirements under the code will be unnecessary and duplicative. Accordingly, Governor Patrick would be doing a service to the patients, health care practitioners, and entrepreneurs of Massachusetts by urging his legislature to repeal the Code of Conduct.


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