Policy and Medicine

Senate Aging Committee Hearing: Rising Drug Prices

  

Today (Wednesday March 17, 2010), at 2:30 p.m., the Senate Special Committee on Aging will be holding a hearing in the Senate Dirksen Building, room 562. The title of the hearing is: "Seniors Feeling the Squeeze: Rising Drug Prices and the Part D Program." Committee Member Senator Bill Nelson (D-FL) will be chairing the hearing.

 

To view the hearing on line click here to see the webcast.

The hearing stems from six letters that were sent to the following pharmaceutical companies (click each to read the letter): AstraZeneca, Pfizer, Lilly, GlaxoSmithKline, Novartis and Sanofi-Aventis. The letters were sent because the Committee wants to know why there are “large discrepancies” between the prices charged for medicine in the US and other industrialized countries. For example, the letters state that Americans spend an average of $878 a person on drugs per year, compared with $446 a person in other industrialized countries, and then cite specific examples of differences in price, such as drugs costing up to four times more in the US.

The letters note that AstraZeneca’s Nexium costs $3.91 in the US compared with $1.32 in the UK and 88 cents in Germany. Pfizer’s Lipitor costs $2.82 in the US versus 71 cents in New Zealand. The committee cites IMS Health to make the comparisons.

Interestingly, although Senator Kohl (D-WI) believes there are “large discrepancies,” he also acknowledges that “drug quality should not be sacrificed for cost.” Despite his belief, his letters assert that “the difference in prices can’t be explained by differences in production or manufacturing.” As a result he asks each company to:

• Explain the discrepancies in prices;    
• Detail the cost increases for the drugs mentioned in the letters over the last ten years in each country;  
• Explain why drug prices in countries such as Ireland and the Philippines are being reduced, while the same drug costs in the U.S. continue to climb;    
• Explain why U.S. drug prices are not competitive when compared to prices in other industrialized countries;  
• Describe how much and what percentage of the research budge is comprised of U.S. federal funds;
• Detail what their profit margins and distribution costs in each of the countries listed is, and what percentage of overall profit for the drug(s) listed are from the U.S.;       
• Tell the number of employees in every country and what the percentage of operation in the U.S. is;    
• List how much money was spent on marketing each of these drug(s) in each country, and how much was spent directly on marketing to physicians; and  
• Tell whether the company manufactures free samples of the mentioned drug(s) in each country, and if so, how much money was spent making and distributing such samples.

Although the hearing is being held today, Senator Kohl asked that the companies respond by April 5, 2010. We will have a write up and summary of the hearing later.

 

 

Congressional Hearing on Drug Safety: an Update from the FDA

Last week, The House Committee on Energy and Commerce, Subcommittee on Health held a hearing on “Drug Safety: An Update from the Food and Drug Administration.” Many of the members of the Committee were present to hear the testimony of Joshua M. Sharfstein, M.D., Principal Deputy Commissioner, Food and Drug Administration (FDA).

Chairman of the Subcommittee, Congressman Pallone (D-NJ) opened the hearing by noting that in 2006 a series of safety problems with several approved drugs prompted the Institute of Medicine (IOM) and the Government Accountability Office (GAO) to examine the FDA’s post-market surveillance system. After conducting their review, IOM and GAO concluded that FDA needed more resources and more legal authority to better protect Americans from unsafe drugs.

These resources and legal authority came in the form the Food and Drug Administration Amendments Act of 2007 (FDAAA), which strengthened FDA’s post-market drug safety oversight. This legislation gave FDA the ability, for the first time, to require manufacturers to conduct post-market drug safety studies, and to make safety related changes to drug labels. Additionally, FDAAA gave the agency the ability to require a Risk Evaluation Mitigation Strategy (REMS) for drugs and biologics to ensure that the benefits of a drug or biologic outweigh its risks. FDAAA also provided FDA with certain tools related to drug advertising, such as requiring manufacturers to submit television advertisements to the agency for review prior to launching those ads. Lastly, FDAAA gave the agency enforcement tools, including the authority to impose civil monetary penalties for certain violations of the Federal Food, Drug, and Cosmetic Act with respect to drugs.

Since the amendments, FDA has required that sponsors conduct around 200 post-marketing studies or trials, and FDA has used its new authorities to require safety label changes in individual or classes of drugs 32 times since March 25, 2008.

Hearing

Members of the Committee asked for updates on REMS, and discussed why the FDA needs more authorities and more resources to do a better job policing the safety of imported products. Committee members also seemed to use the hearing to announce legislation, such as Representative Dingell’s (D-MI) Drug Administration Globalization Act of 2009 (H.R. 759), and Representative Buyer’s (R-IN) Safeguarding America’s Pharmaceuticals Act. This legislation, which is co-sponsored by Representative Matheson (D-UT) seeks to stop counterfeit, adulterated, or misbranded medicines from entering into this country.

Sharfstein’s testimony focused on two important issues: import safety and the implementation of the drug safety authorities in FDAAA

Testimony

Sharfstein began his testimony by noting that today there are an estimated 20 million shipments of FDA-regulated imports coming into the country each year. This breaks down to 40 percent of drugs being imported and 80 percent of pharmaceutical ingredients in drugs coming from foreign sources. This kind of growth has made it extremely complex, and as a result, Sharfstein stated that “FDA must adopt a new approach— one that addresses product safety by preventing problems at every point along the global supply chain, from the raw ingredient through production and distribution, all the way to U.S. consumers.”

Part of this new approach includes FDA seeking better controls at the point of production, and moving from an approach based on reacting to problems to one that proactively prevents such problems from ever occurring. Besides having various permanent FDA offices in countries like China, India, Costa Rica, and Mexico City, to name a few, FDA also has more than 30 agreements with foreign counterparts to share inspection reports and other nonpublic information that can help the FDA make better decisions about the safety of foreign products.

Another way FDA is addressing product safety is by working with industry to help them strengthen the safety of their supply chains. Sharfstein acknowledged how “some companies today already do a terrific job” demonstrating that safety, quality, and compliance with international and U.S. standards are built into every component of every product and every step of the production process. He also noted how some companies he has met with “react with incredible swiftness to questions about the integrity of their supply chain.” It is also important to recognize that these companies have a vital interest in ensuring confidence in the safety and quality of their products and their brand.

Although companies are moving in the right direct, Sharfstein explained that FDA needs additional tools to move oversight capabilities into the 21st century, and the agency needs to access regulatory information quickly, hold all parties responsible for the quality of products in the supply chain, and have reasonable and reliable options for enforcement. These new tools are important not only to ensure safety, but to make sure that regulations are not unduly burdensome on patient access to the drug.

REMS are crucial because they are designed to provide critical information to clinicians without unduly restricting access to the drugs, and they are also essential for maintaining patient access to important medications. Since 2007, 80 to 90 REMS have been approved. As a result, Sharfstein noted that “it is important to work with drug manufacturing companies to see what works best before moving forward,” and also to find to fast track the REMS process.

One issue affecting the REMS process was filling positions because of the current conflict of interest laws. Representative Shimkus asked if Congress needs to relax these laws so FDA has the most qualified expertise. In response, Sharfstein stated that this issue requires a balance “the agency needs to receive the best advice.”

FDA is planning to hold a public meeting to hear from prescribers, pharmacists, distributors, and payers about their roles in implementing REMS and from patient groups about the effects of REMS on access to needed products.

Sharfstein further added that the agency does not have adequate resources to prevent another problem like Heparin, and does not have enough resources to oversee all of the pharmaceutical drugs entering the country. The agency is also facing a back log for generic drug applications because have a different application and review process. Additionally, Sharfstein asserted that the FDA would like to receive more applications so more Americans can have access to these life saving drugs.

Sharfstein also discussed the Sentinel System, which was launched in May 2008 to enable the FDA to actively gather information about the postmarket safety and performance of its regulated products. He also talked about the FDA issuing a guidance in the near future for establishing a unique identification for prescription drug packages to help secure America’s drug supply. Sharfstein also discussed FDA’s new Safe Use Initiative, a program that will help with preventable harm by working with hospitals, nurses, and patient groups to recognize and mitigate risks.

Conclusion

As Representative Shimkus and Sharfstein both agreed, companies that take the risk of producing these life saving drugs should have an exclusive right to market the drugs for a period of time. Ensuring such protections in coordination with the new authority FDA have been given will allow new treatments and innovations to continue. Moreover, the authority to require REMS provides FDA a very useful set of tools that can be used to reduce the risks of marketed products, while allowing patients to benefit from lifesaving and other beneficial treatments that could not be safely marketed without a risk management program. The progress that FDA has made thus far should only be enhanced by more resources and funding to continue the agency’s ability to allow patients to benefit from these innovations.

 

GAO Recommends the FDA to Strengthen Investigation Oversight

Within the Food and Drug Administration (FDA) is the Office of Criminal Investigations (OCI), which investigates individuals and companies external to FDA. In addition, FDA also has the authority to investigate allegations of FDA employee misconduct through internal investigations conducted by the Office of Internal Affairs (OIA), a distinct office within OCI. Over the last decade (1999 to 2008), the Government Accountability Office (GAO) was asked to examine three particular areas within these offices:

-    oversight of OCI investigations;

-    oversight of OIA investigations; and   

-    funding, staffing, and workload for OCI.

In order to carry out this study, GAO interviewed agency officials, reviewed FDA documents including those describing its investigative policies, and examined FDA data on OCI resources and workload, from fiscal years 1999 to 2008. The final report, which was recently issued, is titled “Improved Monitoring and Development of Performance Measures Needed to Strengthen Oversight of Criminal and Misconduct Investigations.” The report found that:

- FDA's funding for OCI generally increased annually between fiscal years 1999 and 2008 ($19 million in fiscal year 1999 to over $41 million in fiscal year 2008, a 73% increase);

- FDA’s staffing for OCI increased by about 40 percent during this period, from about 165 full-time equivalent employees to over 230;

- OCI's investigative workload also increased 27 percent over this 10-year period;

- the number of cases that OCI’s criminal investigators actively worked at the end of a fiscal year increased by 66 percent, from 655 to 1087; and

- Of the 24 total office assessments that should have been completed by August 2009, only 7, or about 30 percent, were completed and one office had not been assessed in over 10 years;

One of the issues that GAO found was that although OCI has policies to guide its investigations of individuals and companies external to FDA, FDA’s oversight of OCI’s criminal investigations is limited. In particular, FDA has not ensured OCI’s compliance with investigative policies and procedures within prescribed time frames. Additionally, the report found FDA lacks performance measures that could enhance its oversight of OCI by allowing it to assess OCI’s overall success. For example, there is no requirement for OCI to report regularly on specific topics to FDA senior-level offices as part of the formal reporting relationship, leaving the OCI Director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.

According to the OCI Director, some of these issues occur because of limited resources and logistical issues, which have prevented FDA from assessing field office compliance with OCI’s investigative policies and procedures every 3 years. Another reason why OCI has little control over the outcome of cases is because investigations priorities often affect staffing and resources within a U.S. Attorney’s Office and may indirectly affect the ability of the office to proceed on every matter presented for prosecution.

 

Discussion

 

In response to the report, Senator Charles Grassley (R-IA), noted that the “report has made a difference already by securing a much needed commitment from the Commissioner to make the FDA’s investigative unit live up to its significant responsibilities.”  He added further that there was “no excuse for the fact that this division’s failures have gone unchecked for years, and having the FDA leadership focused on fixing what’s broken is the first, very important step needed.”

 

One nuance to the report is that OCI’s investigative load increased over the time frame studied. Although staffing and funding were also increased, the GAO did not comment on the ability for additional funds and staff to address the increased case load. It is unlikely however, that staffing and funding was enough since the OCI Director cited “limited resources” as one of the reasons why investigations were not continued and conducted.

 

The commitment Senator Grassley was referring to came from a letter written by FDA Commissioner Hamburg, who asserted that the agency is currently developing meaningful performance measures for OCI, in response to GAOs recommendations. Dr. Hamburg also noted that the agency is “implementing other significant efforts that address the issues in GAO’s report to enhance coordination, communication and strategic alignment of public health priorities between OCI and other Agency components.” She also indicated that a new committee was formed in August 2009 with members from various health agencies (e.g. CMS, HHS, etc.) to address regulatory priorities and activities.

 

With regards to the issues found in GAO’s report, Dr. Hamburg asserted that OCI is conducting outreach to the Centers and District Offices to better educate them about OCI’s role and responsibilities. She also addressed the fact that FDA is now developing criteria to include in its revised policies for consideration in selection of misdemeanor prosecution cases to hold “responsible corporate officials accountable.”

 

Recommendations

GAO concluded its report with the following three recommendations:

· To ensure OCI's compliance with investigative policies the Secretary of Health and Human Services (HHS) should instruct the Commissioner of FDA to have regular assessments of OCI's field offices conducted in accordance with its existing policy.

· To ensure OIA's compliance with investigative policies, the Secretary of HHS should instruct the Commissioner of FDA to establish a review procedure for the assessment of OIA's compliance with its investigative policies.

· To assess whether OCI's criminal investigative program is achieving its desired results, the Secretary of HHS should instruct the Commissioner of FDA to establish performance measures and assess program results against them. 

 

Conclusion

While it seems clear that FDA has already begun implementing such changes and addressing the concerns of GAO, paying attention to the problems the OCI Director spoke of are equally important.  

Prosecuting company officials and increasing the use of disbarment or disqualification can have a chilling and negative effect on developing new and innovative technologies and treatments.

Prosecutions for headlines should be avoided when OCI specifically noted that a problem with these investigations is that as the number of cases increases, the number of resources are limited (staff and funding). As a result, before any extreme measures are implemented, FDA should consider what increasing more resources to OCI would do to ensure better compliance with GAOs recommendations and which of those recommendations will actually keep us safer.

MedPAC to Discuss New Funding Priorities for Graduate Medical Education

Expanding on their June 2009 Report “Medical education in the United States:

Supporting long-term delivery system reforms” The Medicare Payment Advisory Council (MedPAC) a non partisan governmental advisory council to congress is meeting on Thursday March 4^th at 3:45pm to discuss the role of Medicare funding of graduate medical education.  The session titled “Restructuring Medical Education Financing: Principles and Priorities” will be addressing both direct and indirect funding models and overall restructuring of funding GME through Medicare. 

 

According to MedPAC staff, they are not recommending changing the total amount Medicare gives to GME, just alternative structures for implantation of the funding.

 

The format for MedPAC meetings is the staff presents the current system, reasons for change and proposed changes.  After that the panel discusses potential changes to the slide presentation.  At end from 5:55pm – 6:00pm the public can provide brief input (5 minutes).  The public can also submit comments  up to one week after the meeting via the Web to MedPAC.

Date: Thursday March 4^th

Time: 3:45pm – 6:00pm

Location:   Ronald Reagan Building,

The International Trade Center,

1300 Pennsylvania Avenue, N.W.,

Washington, DC.

 

 

About MedPAC

Link to March 4^th Meeting Agenda

Meeting Brief:  Restructuring Medical Education Financing: Principles and Priorities

MedPAC Members

To Send Comments:  Click here  

MedPAC June 2009 Report: “Medical education in the United States:

Supporting long-term delivery system reforms”

 

AMA Calling For End of Temporary Fix to Medicare Payments

 

This week, in response to the proposed 21% cut to Medicare reimbursement rates set to take effect on March 1, James Rohack, president of the American Medical Association (AMA), informed the organizations 250,000 members  about their options – which include completely opting out of a Medicare contract.

 

Although CNN noted that Congress has at the last minute blocked those cuts from happening in seven of the last 8 years, Rohack and the AMA are no longer supporting any further "temporary fixes." In fact, the AMA wants the current law to be repealed and a new formula used "that more accurately reflects the cost of providing care" in determining Medicare reimbursement rates.

 

A permanent doc fix, which would correct this problem, is not part of any of the health care reform packages before congress including those previously endorsed by the AMA. 

In preparing for the proposed cut, the AMA's Web site is providing information to doctors about how they can help their patients find other doctors if they decide to no longer accept Medicare. Additionally, members have asked the AMA to produce pamphlets with the same information that could be handed out to their patients.

 

One example that highlights the problem of Medicare reimbursement rates is Dr. Edward Kornel, a neurosurgeon based in White Plains, N.Y., who stopped seeing Medicare patients two years ago, along with his two colleagues who stopped in the past six months. While Dr. Kornel, who's been in practice for 27 years, said he had always accepted Medicare patients in the past, he was losing money.

 

He told CNN that when he looked at his income from reimbursements, he was losing money every time he took care of a Medicare patient." He further added that the reimbursement rates were not covering his costs. Specifically, “while Medicare patients accounted for about 20% of his total patient load, they were generating less than 5% of his income.” Dr. Kornel said that he would have to do “300 operations in one year just to break even." In addition, the American Association of Neurological Surgeons (AANS), to which Kormel belongs, has “warned that Medicare patients would likely get less access to doctors if Medicare payment cuts continue.”

 

Despite Dr. Kornel’s experience, the “Center for Medicare and Medicaid Services (CMS) said that its own data, and other industry reports, show only a small percentage of beneficiaries unable to get physician access.” Such data are disputed however by the fact that a survey of AANS’s 3,400 members showed 65% was referring their Medicare patients to other doctors. In fact, about 60% said they were reducing the number of Medicare patients in their practice, something AANS President Dr. Troy Tippet noted painted a “bleak path.”

 

Also echoing similar concerns was Dr. Priscilla Arnold, an ophthalmologist based in Bettendorf, Iowa, and past president of the American Society of Cataract and Refractive Surgery. Dr. Arnold told CNN that each year she is forced to “realistically evaluate” if she can continue to see all her patients. She also noted that the numbers from CMS did not account for doctors who are reducing the number of Medicare patients. As a result, if the cut is not changed, “many doctors in her specialty won't be able to sustain their practices.”  

The concerns of these doctors should be echoed to your representatives and government officials before it’s too late. As Dr. Kornel asserted, "If doctors drop Medicare patients, people will be forced to go to clinics where it's hard to get appointments, the waits are long and you get far less attention than you would otherwise get." In order to avoid this potential “disaster” Congress needs to listen to patients and doctors before they have nowhere to go.

Letters from Grassley: Questions WebMD Advertising Model

Keeping up with his busy letter-sending schedule last week, Senator Charles Grassley (R-IA) sent a letter to the WebMD Health Corporation CEO regarding an advertisement. Mr. Grassley’s concern comes over a television ad that “encourages viewers to take a depression screening test.” Since the advertisement is sponsored by EliLily, Senator Grassley is concerned about the independence between “WebMD and industry since many people access WebMD seeing it as an independent, objective medical resource.”

As a result, he requested that WebMD answer the following questions no later than March 4, 2010.

1)    Copies of all communications regarding the creation of the WebMD depression screening test;

2)    Copies of all contracts regarding the creation of the WebMD depression screening test; and

3)    Any communications between WebMD and Eli Lilly and/or other pharmaceutical companies regarding the creation of the WebMD depression screening test.

4)    Explain your policies on disclosure of outside income by your top  executives, board of directors and physicians; and

5)    Provide the disclosures of outside income filed with your organization by your top executives, board of directors and physicians January 2008 to the present.

 

Senator Grassley also requested “an accounting of industry funding that pharmaceutical, and medical device companies, foundations established by these companies, or the insurance industry have provided to WebMD Health Corporation, from January 2008 to the present. He asked that the data come in the form of a chart detailing annual amounts of industry funding, the (1) year; (2) name of company; (3) amount of funding; and (4) reason(s) that the funding was provided.

Although some believe that because EliLilly produces Cymbalta to treat depression, and there are ads on WebMD about the drug, a WebMD spokeswoman told “Dow Jones the company believes their internal process ensures their editorial independence in their programs.” Patients going onto WebMD are looking for answers, just like any patient going to a doctor. Seeing one ad or taking a test does not suggest this is the only treatment a patient will consider.

WebMD is a valuable resource to millions of patients, and providing information about common drugs and illnesses, and ways to treat them are an important way in improving health. While proper disclosure of funding and content is warranted, discouraging other drugs and treatments from the website would only harm patients, and give them less resources to keep them healthy, which will only crowd our waiting and emergency rooms more.

President Obama’s Health Care Summit: Republican Alternatives

While health care reform has been on the backburner since the election of Republic Senator Scott Brown (R-MA) ended the Democrats supermajority, President Obama is hoping to work with Republicans to save the health care bill.

This Thursday February 25, lawmakers from both parties are scheduled to go to Blair House, across the street from the White House, for a televised clash of health policy ideas. According to the New York Times, the White House planned this meeting as a “strategy to intensify its push to engage Congressional Republicans in policy negotiations, and to share the burden of governing and put more scrutiny on Republican initiatives.”

Mr. Obama challenged Republicans to attend the meeting with their plans for lowering the cost of health insurance and expanding coverage to more than 30 million uninsured Americans. Republican leaders said they welcomed the opportunity and called on Democrats to start the debate from scratch, which the president said he would not do.

Republicans are planning to propose making health insurance more widely available and affordable, by emphasizing tax incentives and state innovations, with no new federal mandates and only a modest expansion of the federal safety net. Some of the Republican goals for health care reform include:

- Not requiring employers to provide insurance.

 

- Opposing the Democrats’ call for a big expansion of Medicaid  

- Allow insurance companies to sell policies across state lines

 

- Offer federal money as a reward to states that achieve specified reductions in premiums or in the number of people without insurance.  

- Offer federal money to states to establish and expand high-risk pools, for people with chronic illnesses who cannot find private insurance at an affordable price.

 

- Changes in state medical malpractice

 

- Expand the use of health savings accounts, to cover routine expenses for people who enroll in high-deductible health plans.

 

- Expand the role of private insurance companies in Medicare.

 

- Help small businesses band together and buy insurance through trade associations and professional societies.

Some Republicans, like Senator Tom Coburn of Oklahoma and Representative Paul D. Ryan of Wisconsin, would replace the tax-free treatment of health benefits with a refundable tax credit for the purchase of insurance. They would also encourage the use of state health insurance exchanges.

Republicans and Democrats agree on the need to emphasize wellness and preventive health programs; to provide more transparency for price and quality data on doctors and hospitals; and to speed the approval of lower-cost generic versions of high-cost biotechnology medicines. Both parties also agree to require insurers to let dependent children stay on their parents’ policies through age 25 or 26, and to offer tax credits for two years to businesses with 25 or fewer employees to help them buy coverage.

Senator Lamar Alexander of Tennessee, the No. 3 Republican in the Senate, said Republicans favored “a step-by-step approach” focused on lowering health costs for families and businesses.

Senator Judd Gregg of New Hampshire, the senior Republican on the Budget Committee, suggested that there are two plans that could serve as a basis for compromise: a proposal that he developed called “Coverage, Prevention, Reform” — C.P.R., for short — and a bill put forward by Senators Ron Wyden, Democrat of Oregon, and Bob Bennett, Republican of Utah. His own plan is described in an op-ed piece on Yahoo with further details provided on his Web site (pdf), and Mr. Wyden and Mr. Bennett’s bill would end the tax exclusion for employer-provided health benefits and provide more choice and flexibility for consumers (pdf), including those who already have insurance.

Most media report that it is not clear that Republicans and the White House are willing to negotiate seriously with each other, and Mr. Obama has rejected Republican demands that he start from scratch in developing health care legislation. With the meeting shortly approaching, and Congress getting ready for mid-term elections, this may be the last full effort to keep the health care debate alive.

After Thursday’s summit we will know more.

Senate Finance Committee Staff Report On GlaxoSmithKline and The Diabetes Drug Avandia – Links to Original Documents

Today the New York Times published some of the findings of a report conducted by the Senate Finance Committee Staff on the Diabetes Drug Avandia that was scheduled to be released on Monday.

The report is critical of GlaxoSmithKline’s internal procedures.  It is also critical of the FDA’s procedures on adjudicating drug safety issues.

We will be providing a full analysis in the coming days.

Subsequently the report and supporting documents were released today by the Senate Finance Committee. 

Bellow are the links to the relevant documents:

Grassley, Baucus release committee report on Avandia 2/20/10

Full Staff Report on GlaxoSmithKline and the Diabetes Drug Avandia 2/20/10

Senators’ letter to the FDA with attachments 2/20/10

Letters from Grassley: FDA to Clarify Policies on Medical Devices

This week, Senator Charles Grassley (R-IA), ranking member of the Senate Finance Committee, issued a press release asking the Food and Drug Administration (FDA) for accounting of its work to clarify approval status for medical devices.

In his letter, he specifically asked the FDA for an update on the implementation of new guidelines for medical device makers on when they need to file new information with the agency and seek clearance for the marketing and use of modified devices under the 510(k) system, the agency’s less stringent process for reviewing most medical devices.

His questions also concerned FDA’s requirements for manufacturers to report changes made to FDA-approved devices.

 

According to his letter, the cause for his concern came from “serious allegations that an annuloplasty ring used in heart valve repair was being implanted in patients even though the device was allegedly not cleared for marketing by the FDA.” Although today, that device, the Myxo dETlogix Annuloplasty Ring (dETlogix ring), has since been cleared by the FDA, Mr. Grassley was concerned about how the product was being  implanted for more than two years on patients at Northwestern Memorial Hospital before a 510(k) was submitted to the Agency.

 

Accordingly, Senator Grassley wanted to know of the status of FDA’s revisions to the Agency’s guidance entitled, “Deciding When to Submit a 510(k) for a Change to an Existing Device,” since four months had passed without any response to his initial letter. He also cited information regarding device registration information listed on the FDA’s website and asked the following questions:

 

1)   Would a manufacturer be required to update its device listings even if it changed only the name of an existing device?

 

2)   Would the manufacturer also be required to update its listings if it made a modification to a device that did not require submission of a new 510(k) but marketed that device under a different name?

 

3)   If the answer to either question is no, please explain why not. Please also explain how patients and their doctors would obtain information about the status of a device other than from the manufacturer itself.

 

4)    FDA concluded that Edwards Lifesciences’ dETlogix ring did require a new 510(k). However, even if a new 510(k) had not been required, was the company required to list that device with the FDA?

 

He asked FDA Commissioner Margaret Hamberg to respond no later than March 2, 2010. We will follow up on this article with their response, and changes made to the guidance.

 

Northwestern University HSPP Policy Manual

Northwestern University to Senator Grassley’s September 30, 2009 letter

When Congress Comes Calling: The Unique Rights and Wrongs of Responding to Congressional Committee Investigations - Live Webcast

On Friday, February 19, 2010, the Washington Legal Foundation (WLF) is hosting a web seminar series titled “When Congress Comes Calling: The Unique Rights and Wrongs of Responding to Congressional Committee Investigations.”

You can register and attend the live webcast at: http://www.wlf.org/communicating/webseminar_detail.asp?id=199,

The program will start at 10:00 a.m. and last until 11:00 a.m. EST.

This interactive online program, will highlight the unique challenges that targets of congressional inquires face and how to survive them, based on the experience of a Capitol Hill Veteran, John F. Sopko, of Akin Gump Strauss Hauer & Feld, LLP, who was also the Former Chief Counsel for Oversight & Investigations of the House Committee on Energy and Commerce.

To submit questions before, during or after the seminar send them to interactive@wlf.org. Questions will be answered during the webcast.