FDA Must Reform Critical Public Health Areas, DeLauro Says

FDA Must Reform Critical Public Health Areas, DeLauro Says

Drug Ads, Medical Devices, Breast Implants, Just a Few of Key Areas

WASHINGTON, D.C. - In a letter to FDA Acting Commissioner Dr. Andrew von Eschenbach, Congresswoman Rosa L. DeLauro (Conn.-3) today said the Food and Drug Administration (FDA) must reform critical public health areas. DeLauro urged the acting commissioner to review and improve direct-to consumer drug advertising, strengthen oversight of newly introduced medical devices, approve Plan B, examine whistleblower's allegations over the safety of breast implants, and work to prevent conflicts-of-interest on FDA advisory panels.

DeLauro is ranking member of the House Agriculture Appropriations Committee, with jurisdiction over the FDA budget.

"Drug advertising, medical devices, and breast implants over just a few of the key areas where FDA has strong regulatory authority," said DeLauro. "The public health hinges on strong oversight of these issues. With new leadership at this agency, there is an opportunity for Dr. von Eschenbach to evaluate each area and make necessary improvements to restore public confidence in the FDA."

The full text of the letter follows.

November 2, 2005

Dr. Andrew von Eschenbach,
U. S. Food and Drug Administration
5600 Fishers Lane
Rockville MD 20857-0001

Dear Dr. von Eschenbach,

I want to welcome you to your new appointment as Acting Commissioner of the Food and Drug Administration. I have enjoyed working with you in the past and look forward to further collaboration on issues under FDA's jurisdiction. As you know, I recently became the Ranking Member on the Committee on Appropriations, Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Subcommittee. As such, I have concerns on a range of issues, including direct-to-consumer advertising; the approval process for drugs and medical devices; Plan B emergency contraception; breast implants; and conflict of interest issues surrounding FDA's advisory committee. All of these issues have serious implications for the public health and will require your close attention as Commissioner.

Direct-to-Consumer-Advertising

I have become increasingly concerned with aggressive advertising campaigns by drug companies that result in the general public serving as a large-scale post-market study on drug's safety. In many cases, the rush to promote drugs has superseded doctors' abilities to gather objective information about the drug. Since 1997, the pharmaceutical industry has steadily increased its advertising budget, with approximately $4 billion being spent annually on direct-to-consumer advertising of specific prescription drugs. Drugs that are promoted directly to consumers are among the best selling drugs, and sales for these drugs have increased at a faster rate than drugs not heavily advertised to consumers. In addition, consumers are more likely to request and receive from their doctor a prescription for a particular drug they have seen advertised. The promotion of Vioxx is but one example. FDA scientists have estimated that over 50,000 patients may have died from Vioxx side effects that may well have been diminished had promotion been delayed. As the nation's top drug regulator, I urge you to make reviewing and improving this relatively new process a priority during your tenure at FDA.

Medical devices

The need for FDA to improve the safeguards for medical devices has also become clear in recent months. At present, doctors and patients rely on safety information from the FDA for the medical devices they use. According to the agency's own estimates, problems with medical devices cause 300,000 deaths and injuries annually. The FDA frequently approves implanted medical devices based on only short-term safety data, contingent on the companies continuing safety studies after approval. However, this adds to the risks for consumers; the FDA has acknowledged the need for improved oversight of newly introduced devices, since most of the follow-up studies manufacturers were supposed to submit were not submitted or not completed as required.

With approximately 80,000 medical devices marketed in the United States, and 60 percent of all devices considered to be high risk, the FDA must improve its pre-market approval process as well as its post-market surveillance of these devices. A report by the Institute of Medicine released in July found that the Center for Devices and Radiological Health (CDRH) failed to effectively monitor the safety of medical devices. I urge you to focus attention and resources in this critical area.

Plan B emergency contraception (EC)

As you know, I was very concerned with then-Commissioner Crawford's announcement on August 26, 2005 to further delay the FDA's decision on over-the-counter sales of Plan B emergency contraception (EC). The effectiveness and safety of Plan B has well been established. The Advisory Panel and FDA's professional and scientific staff concluded that EC meets standard criteria for over-the-counter use: low-toxicity; no potential for overdose or addiction; no teratogenicity (i.e., is not harmful to an existing pregnancy); no need for medical screening; self-identification of the need; uniform dosage; and no significant drug interactions. In fact, experts estimate that wider access to EC would prevent 1.7 million unintended pregnancies and 800,000 abortions each year - a goal all of us share.

In my view, this decision does not reflect valid scientific or regulatory concerns, but ideology. As such, I am very concerned that FDA's global reputation for scientific excellence may be at risk. The public depends on FDA to make its decisions upon sound science and to develop science-based policies that protect the nation's health. FDA's continued delay and postponement on Plan B comes at the expense of women's reproductive health throughout the country. For these reasons, I ask that you approve this product or proceed with the rulemaking process without further delay.

In addition, given the recent changes in leadership at the FDA's Office of Women's Health, I would like your assurances that the Office will continue to carry out all its existing programs and areas of responsibilities. These include research, outreach, policy, and the demographic database project. All of these areas are essential and identified by Congressional directive.

Breast Implants

It has come to my attention that prior to your taking over the leadership of the FDA, the agency sent letters of approval to two silicone gel breast implant manufacturers, Mentor and Inamed. I have serious concerns regarding the adequacy of the safety data provided by these manufacturers, especially for breast cancer patients using implants for reconstruction, and urge you to conduct a thorough examination of the data before moving forward with a final decision.

It is my understanding that a major rationale for approving silicone gel breast implants is to provide a choice for breast cancer patients after a mastectomy. There is also concern over the long-term health effects of leaking silicone. However, both the Inamed and Mentor applications lacked relevant safety data. For example, Inamed's application included fewer than 30 reconstruction patients who underwent MRIs to determine if their implants had ruptured or were leaking. In the case of Mentor, the FDA advisory panel recommended its product for approval because the company provided a long-term study of women who had their silicone implants for approximately 10 years. That study ("The Sharpe/Collis study") included 100 patients - none of them breast cancer reconstruction patients. Especially troubling was the fact that neither company provided an analysis of safety data for women of color with breast implants; such an analysis is important because African American women are particularly susceptible to autoimmune diseases.

In addition, an engineer who recently left Mentor has raised several alarming questions about the integrity of the company's safety data. The engineer claims that the rupture rate for Mentor textured silicone gel breast implants is considerably higher than what the company has reported to the FDA. The engineer further reported that the patch on every Mentor silicone gel breast implant "bleeds" silicone into a woman's body because it is not made of the same kind of "low bleed" silicone that the company uses for the rest of the breast implant shell.

I have been assured that the engineer has contacted an FDA compliance officer regarding these concerns. In addition, the National Research Center for Women & Families brought these allegations to the attention of Dr. Susan Wood this past August, when she was serving as Director of FDA's Office of Women's Health; in turn, Dr. Wood immediately notified the Director of the Center for Devices and Radiologic Health, Dr. Daniel Schultz. Particularly in light of safety data concerns, I urge you to take the whistleblower's allegations seriously by carefully investigating them before any final decision is made.

Conflicts-of-Interest on FDA Advisory Committees

Finally, I want to bring to you attention the issue of conflict of interest on advisory panels. As you know, the FDA has long relied on outside advisory panels to provide recommendations on the safety and effectiveness of drugs and medical devices. However, I am concerned with the integrity of these advisory panels and the fact that many of the scientists who serve on these panels have financial conflicts-of-interest that may bias their recommendations, or at minimum, reinforce that perception. For example, 10 of 32 scientists on the FDA's Cox-2 advisory panel had ties to manufacturers of the drugs. Without their votes, two of the three drugs in that class would have been rejected by the panel instead of receiving narrow support.

Other agencies, such as the National Institutes of Health, have regularly found fully qualified professional advisors who give the agency the best, unbiased advice possible and free of conflict or any appearance thereof. When it comes to advising the FDA, even the perception of influence by the pharmaceutical industry or other regulated industries can prove damaging to public trust and protecting the public health. As such, I urge you to stop this practice.

All of these issues precede you, but I know you bring a wealth of scientific and medical expertise to each of these challenges, as well as a new commitment to restoring the FDA's reputation as one of the most respected regulatory agencies in the world. And I trust that under your leadership they will receive the attention they require and the public deserves.

Thank you for your attention. I appreciate your careful consideration and look forward to your response.

Sincerely,

Rosa L. DeLauro
Member of Congress

http://www.house.gov/delauro/press/2005/November/FDA_reform_letter_11_02_05.html