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26 posts from January 2011

January 31, 2011

Florida Court Overturns Affordable Care Act – The Whole Thing, On the Road to the Supreme Court.

Train skidding 
Today, United States District Judge Roger Vinson ruled that the entire health care overhaul is unconstitutional, but he stopped short of ordering the federal government to stop implementing it. Specifically, Judge Vinson wrote in his 78-page opinion that “Congress overstepped its legal bounds when it included the provision requiring nearly all Americans to buy insurance” and that “Congress has no right to require Americans to purchase a product.”


The impact of this decision will likely catapult the issue to the Supreme Court given another recent decision in the United States District Court for the Eastern District of Virginia. That opinion, issued last year by Judge Henry E. Hudson found that the individual mandate, requiring almost every citizen to obtain health insurance, was unconstitutional. Despite her efforts, Judge Vinson denied a motion by Pam Bondi, Florida's attorney general, to immediately halt implementation of the healthcare reform act. 

The U.S. Department of Justice said it plans to appeal the decision. It is also considering whether it needs to ask for a stay, which would temporarily stop the judicial order issued by the court or in other words, suspend the case. In addition, Senate Majority Whip Dick Durbin (D-Ill.) has called a hearing on the constitutionality of the law to be held on Wednesday before the full Judiciary Committee.


Shortly after the Affordable Care Act (ACA) passed and was signed into law last March, former Florida Attorney General Bill McCollum filed a lawsuit in the U.S. District Court for the Northern District of Florida, asserting that a number of provisions were unconstitutional. Shortly after, attorney generals or governors of 26 other states joined the suit, as well as the National Federation of Independent Businesses (NFIB). The other states are: Alabama, Alaska, Arizona, Colorado, Georgia, Indiana, Idaho, Iowa, Kansas, Louisiana, Maine, Michigan, Mississippi, Nebraska, Nevada, North Dakota, Ohio, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Washington, Wisconsin and Wyoming.

Those who support the individual mandate assert that it “is pivotal to delivering key insurance industry reforms in the law, such as a ban on denying patients over pre-existing conditions. It’s due to go into effect in 2014,” according to POLITICO. Supporters also assert that Congress has the right to regulate the insurance market because it is unique— “it’s fair to assume that every single person will need health care at one point in his or her life.” They claim that if people are not insured, “their costs will have to get picked up by other consumers, driving up rates for everyone and putting them in the insurance market whether they plan to or not.”


In addition to the individual mandate, the states and NFIB argued that the “law’s mandatory expansion of the Medicaid program commandeered the states into federal service.” Judge Vinson however ruled with the federal government on this point, “arguing that the states can leave Medicaid at any time.”


Judge Vinson asserted in his opinion that “Because the individual mandate is unconstitutional and not severable, the entire Act must be declared void.” Nevertheless, he recognized the difficulty in making his decision because of the “indeterminable implications” it will have.


With respect to the issue of the individual mandate, the key legal question was whether the Constitution’s Commerce Clause gives Congress the power to regulate the decision to buy insurance. The states and NFIB argued during oral arguments in December that the Congress has no constitutional right to force Americans buy insurance coverage. They said that while Congress is authorized to regulate activity, they could not regulate inactivity— or not buying insurance. Judge Hudson in Virginia, as argued by Virginia Attorney General Ken Cuccinelli, accepted this argument. Likewise, Judge Vinson found that Congress had overstepped its powers. 



The opponents of health reform are “likely to hail the ruling as another sign of the law’s imperfections.” While dozens of other cases challenging the law are pending or have been thrown out, only four judges have ruled on whether the requirement to buy insurance is constitutional. Two judges, both appointed by Republican presidents, have struck down the law or its main provision (the individual mandate). Two other judges appointed by Democrats have upheld the legislation as constitutional.

The U.S. 4th Fourth Circuit Court of Appeals in Richmond, Va., has agreed to expedite its review of the Virginia case, scheduling hearings for May. The next step for Judge Vinson’s decision will be an appeal to the U.S. 11th Circuit Court of Appeals. 

The Senate Judiciary Committee hearing on Wednesday will likely involve some of the main strategies and arguments that Republicans and Democrats will use in the upcoming battles in the Court of Appeals and ultimately the Supreme Court. The hearing might also present an opportunity for Senators to bring into the record information that may later be used by appellate judges in making their ultimate decision on the issue, although the legal authority of Senate hearings is very low.

Ultimately, the decision may come down to one vote once it reaches the Supreme Court, which presently leans more conservatively. Unless there are significant changes or details that occur on appeal, it seems more likely than not that the Affordable Care Act, or at least the individual mandate is on a track to be heard at the Supreme Court.

ProPublica Intimidates Denver Area Hospitals and Medical Schools

The latest victim to fall to the irresponsible and questionable journalistic practices of the Pew funded ProPublica was the University of Colorado, Denver, and its affiliated teaching hospitals. After discovering “extensive ties between its faculty and pharmaceutical companies,” the University is apparently “overhauling its conflict of interest policies.”

 According to a story released by ProPublica, Dr. Richard Krugman, vice chancellor for health affairs, said at a meeting of the faculty senate that “he hoped members would soon consider a policy to clearly ban faculty from delivering talks for drug companies. Apparently, Dr. Krugman believes that without such a rule, “the school faces a loss of public trust, damage to its reputation and the specter of it physicians parroting industry-designed materials.” 

ProPublica identified 13 UC Denver physicians whom drug companies reported paying to deliver promotional talks. 

Of course, both Dr. Krugman and ProPublica failed to acknowledge that the Food and Drug Administration (FDA) regulate promotional or commercial events, which require companies who hire speakers to control the content of such presentations so that individuals do not speak about unapproved uses of products. They both also fail to recognize the educational value many doctors find in attending such commercial events and the significant benefit patients would receive from doctors learning about new treatments, clinical data, and therapies. 

What is perplexing about Dr. Krugman’s comments is that on the one hand, he wants the University " to increase their relationships with industry around drug discovery,” but on the other hand, he doesn’t want “to be involved with speakers bureaus because he believes they are primarily marketing.” This paradox is problematic because part of the drug discovery process is educating physicians about the new drugs, discoveries, and clinical data so they are aware of what options they have available to treat their patients.

Who does Dr. Krugman want to teach doctors about these new discoveries so that patients will receive the benefits, companies will earn back what they invested, and the cycle of finding new therapies and improving old or current ones can continue?

Solutions, a health policy news website run by UC Denver's School of Public Affairs, first reported on the faculty meeting, noting that an internal review at the medical school found that 46 full-time faculty members had been paid by drug companies for speaking or consulting. Only four had sought permission from the school to do the work, as required by a 2008 policy. Krugman attributed the lack of preapproval to a misinterpretation of the policy. 

Until the policy review is complete, “Krugman said he would not approve new speaking contracts. Arrangements previously approved could remain in place until the new policy takes effect.”

According to an article from The Denver Post, National Jewish and Denver Health are also reviewing and tightening ethics rules at their institutions. National Jewish spokesman William Allstetter told the paper that the payments "raise questions in the public mind.” He said that “both the ethics committee and senior management at the hospital want to make sure policies address potential or perceived conflicts of interest.”

Perhaps the most disturbing comments that arose from this story however came from Dr. Krugman, who told the Denver Post that working with industry is a problem "If even the perception is out there that someone, because of their relationship with a company, is changing what could be their objective practice of medicine.” However, when he asked if there were “actual harms to patients,” he admitted, “I don’t know.”

How can the University of Colorado and its affiliated hospitals be considering policies to ban physician-industry collaboration to “protect the public” when they do not even know whether such relationships actually harm patients? Do patients and the public understand that if doctors are not educated through commercial events or drug representatives or if they do not attend continuing medical education (CME), their doctors may not be able to treat them with the best standard of care?

Interestingly, in Colorado, doctors are also required to report relationships worth more than $5,000 to a state database, kept by the Board of Medical Examiners. While some of the drug- company disclosures from ProPublica that were checked against the state database showed some “holes,” Chris Lines, spokesman for the state Department of Regulatory Agencies overseeing the Board of Medical Examiners, said that 90 percent of physicians are complying. Mr. Lines said that the Department does not “see a crisis.”

Ultimately, what these stories highlight is more “Tabloid Medicine” from ProPublica. Dr. Krugman wants to slow innovation and collaboration in Denver because he thinks there is a “perception” of wrong, rather than any evidence of actual harm. This approach is counterproductive and it will only drive out the underpaid academics that presently practice in these hospitals. Moreover, as Dr. Krugman himself admitted, the medical school “does not have the resources to investigate all the private-company relationships among its 2,250 doctors.”

Any overhaul of the ethics policies will likely require more staff, more paperwork, more resources, and more money. This means either they will waste their time since they don’t have adequate resources, or they will end up taking resources and money from research and health services that could be going to truly helping patients. Until anyone can show harm done to patients from physician-industry collaboration, whether through promotional speaking, research, or consulting, policies at hospitals and academic medical centers must not go too far to stifle innovation.

If the mission of hospitals and academic medical centers is to improve public health and maintain trust from the public, there should be as much transparency about any proposed changes to ethics guidelines as there is for industry payments. The last thing patients need are policies that would create obstacles for physicians and faculty to collaborate with industry, which would lead to fewer educated physicians with less experience and exposure to breakthroughs in medicine.

January 28, 2011

FDA Seeks Input on Transparency Initiative

 Town Hall Meeting

In June 2009, Food and Drug Administration (FDA) Commissioner Dr. Margaret Hamburg launched FDA’s Transparency Initiative to help fulfill President Obama’s commitment to openness in government and the U.S. Department of Health and Human Services (HHS) goal of making transparency a priority.

To carry out the Transparency Initiative, Commissioner Hamburg formed an internal Transparency Task Force, chaired by outgoing FDA Deputy Commissioner Joshua Sharfstein, MD, to develop recommendations for enhancing transparency of FDA’s operations and decision-making processes. Last week, the Task Force released its report entitled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.”

Transparency Initiative

Since its creation, the Task Force held two public meetings, launched an online blog, held listening sessions with members of regulated industry, and opened a docket to which comments could be submitted. The Task Force is proceeding with the Transparency Initiative in three phases.  

Phase 1: FDA Basics for Industry: The goal for this Web site is to save many companies time and resources in understanding how to work with the agency. This resource now includes (1) 158 questions and answers about FDA and the products that the Agency regulates, (2) nine short videos that explain various agency activities, and (3) conversations with fourteen agency officials about the work of their Offices.

FDA also established an online program performance program, FDA-TRACK, with monthly metrics on more than 100 FDA offices, and proposed for discussion a series of steps to provide more public understanding of FDA decision-making and promote innovation. 

Phase 2: Public disclosure: The second phase relates to FDA’s proactive disclosure of information the agency has in its possession, and how to make information about agency activities and decision-making more transparent, useful, and understandable to the public, while appropriately protecting confidential information. On May 19, 2010, the Task Force released a report containing 21 draft proposals about expanding the disclosure of information by FDA while maintaining confidentiality for trade secrets and individually identifiable patient information. The Task Force is reviewing the comments received and will recommend specific proposals to the Commissioner for consideration. 

Phase 3: Transparency to regulated industry: The Task Force held listening sessions and solicited comments about ways to improve transparency to regulated industry. The Task Force received public comments from small and large companies requesting transparency about the standards and expectations to which their products are held, the process for soliciting guidance from the agency, and the progress of regulatory efforts at the agency. 

Executive Summary

From the public comments, the Task Force put together 19 action items and five draft proposals to address ways that FDA can become more transparent to regulated industry in order to foster a more efficient and cost-effective regulatory process. The report groups the action items and draft proposals into five categories:

-      Communicating Information About Agency Procedures

-      Product Application Review Process

-      Guidance Development

-      Regulations Development

-      Import Process

Better communication:  Six action items commit the agency to improving communication to industry about agency procedures:

-      FDA Basics for Industry, noted above, which will provide basic information online about the regulatory process governing FDA-regulated products, and include information that is frequently requested by industry.

-      FDA will update the agency organizational charts and senior leadership personnel changes on the FDA Web site on at least a quarterly basis and ensure detailed organizational charts are consistent across the agency.

-      FDA will provide links to the processes available for industry to submit general regulatory questions to each Center.

-      FDA will also aim to respond to general questions about an existing policy, regulation, or the regulatory process that are submitted via email, whenever practicable, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time for response.

-      FDA will finalize the “Strategic Priorities FY 2011-2015” by March 2011.

-      FDA will post on the FDA Web site slide presentations that are delivered by FDA employees to external audiences at events sponsored by, or co-sponsored by, the agency.

A More Transparent Review Process:  Four action items focus on improving transparency during the product application review process:

-      FDA will compile all FDA Center guidance and standard operating procedures on FDA employees meeting with sponsors about product applications on the web-based resource, FDA Basics for Industry.

-      FDA will describe the types of notifications the agency provides to industry with respect to the product application review process. FDA will provide an overview of the processes used to strive for consistency of product application review.

-      FDA will also communicate general expectations about the circumstances, if any, under which it is appropriate to use secure email between FDA and a manufacturer when there is a question involving the manufacturer’s product.

-      FDA will explain how a sponsor is informed about whether the review of its product application is on track to meet the target date for FDA action on the application. FDA is also willing to hold further discussions with industry about application tracking systems, and explore the feasibility of implementing such a system at FDA.

Guidance and Regulations:  Two action items focus on greater transparency around the guidance development process and two action items focus on transparency of the regulations development process: 

-      Commissioner Hamburg has formed a cross-agency workgroup to identify the best practices for improving the agency’s work on guidance.

-      FDA will describe the ways in which interested individuals can provide input to the agency about guidance development.  Links that provide industry with a list of guidance documents that have been withdrawn during the past year as well as possible topics for future guidance development or revision also will be made accessible in one location on the FDA Web site.

-      After FDA issues a final rule, FDA will conduct outreach to the affected stakeholders as part of implementing the final rule if the rule imposes substantial new obligations.

-      FDA will also work with the Department of Health and Human Services (HHS) and the Office of Management and Budget (OMB) to improve the accuracy of the timetables included in the agency’s regulatory agenda published as part of the Unified Agenda.

Communications with Importers:  Five action items focus on improving transparency to the importing community:

-      FDA will provide contact information for points of contact within each District to whom to direct questions about the import regulatory process.

-      FDA will allow the public to receive email notifications when an Import Alert is posted on the FDA Web site, or an existing Import Alert is updated.

-      As part of the agency’s efforts to implement the forthcoming Strategic Import Plan, FDA will develop and execute a project to promote more uniform processes and procedures across districts, when appropriate.  This project will be tracked on FDA-TRACK, the FDA’s agency-wide performance management system.

-      FDA will aim to respond to general questions about the import process, within 5 business days or acknowledge receipt of the inquiry and provide an estimated time for response. The Division of Import Operations and Policy in the Office of Regulatory Affairs will compile a list of answers to questions frequently asked by industry and post this information on the FDA Web site.

-      FDA will work with U.S. Customs and Border Protection to explore developing a process by which brokers and filers can correct inadvertent data errors submitted about imported products and FDA should post that process online.

Draft Proposals

In addition to the above steps, FDA is requesting comments on five draft proposals to improve transparency to regulated industry, including:

-      Disclosing, for certain high priority guidance documents in development, a timeline from the start of the agency’s work on the draft guidance to publication of the final guidance

-      Posting on the FDA Web site a list of presentations given by FDA employees to external audiences

-      Informing submitters if an appeal request will be reviewed by the FDA Commissioner and when a decision may be expected

-      Reviewing existing procedures to evaluate importers, or third parties working on behalf of importers, who file information electronically about products offered for import, and

-      Initiating a planning process to develop a web-based system that provides information about importing requirements.


The outcome of these proposals and the implementation of the action items are significant, as many companies struggle with the difficult regulatory process and landscape at the FDA. For example, FDA approved only 21 new drug approvals in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007, according to an analysis by the Wall Street Journal.

While FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals," companies often face obstacles with getting timely responses and information about drug approvals, marketing, new indications, and various other parts of the drug approval process. Nevertheless, this report, along with the FDA Transparency Initiative, seems to be a step in the right direction, especially considering the large role industry seems to be playing in working with the agency.

As FDA continues to provide more resources to guide companies about the regulatory and drug approval process, investors can continue funding such projects and research and development budgets can be tailored accordingly to focus on new diseases, orphan drugs, and other therapeutic areas. This increased level of communication and reliability on timelines will lead to better treatments for patients that will reach them in a timely manner.


FDA is soliciting public comment on the five draft proposals at until March 6, 2011 (docket number FDA-2009-N-0247). After considering public comment on the draft proposals, the Task Force will recommend specific proposals to Commissioner Hamburg for consideration. FDA will begin to implement the 19 action items in the report in 2011.



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