Letter to Congress about Drug Safety and FDA

March 14, 2007

To Chairman Kennedy, Senator Enzi, Chairman Dingell, and Congressman Barton, and Members of the HELP and Energy and Commerce Committees:

The Enhancing Drug Safety and Innovation Act of 2007 is an important effort to respond to the inadequacy of current prescription drug safeguards at the Food and Drug Administration; the damage that has been done by the approval, marketing and use of unsafe drugs; and the ongoing threat this poses to consumer health in the United States.

As organizations representing consumers, scientists, and public health officials who are concerned about drug safety, we are eager to see drug safety initiatives such as this one move forward. However, the current version of this bill does not include the provisions necessary to prevent another Vioxx, Accutane, or Ketek from reaching the market and harming patients and their families. The bill needs to be strengthened to protect consumers from the dangers of unreported drug risks and to safeguard against future drug safety disasters.

Though every drug carries some risk, it is the job of the FDA and the policymakers who oversee the agency to ensure that FDA-approved drugs offer more benefit than risk for an identified group of consumers, that the agency knows as much as possible about the risks of approved drugs, and that the agency takes the steps needed to ensure that consumers are made aware of those risks. If after this legislation passes another parent has to bury a child because of unreported drug risks (such as increased risk of suicide), then we failed as patient and consumer advocates, and you failed as lawmakers to protect the health and safety of your constituents.

To achieve these goals, the Enhancing Drug Safety and Innovation Act must be strengthened in six critical areas.

It needs to establish:

Meaningful penalties for companies that violate safety requirements
The FDA must have the authority to issue meaningful fines or sanctions when drug companies fail to do post-market studies. The range of fines established in the bill would not be even a slap on the wrist if applied to a blockbuster drug with sales in the billions. If drug companies do not conduct required post-market studies, then their new products should not be approved based on their track record of failing to do previous safety studies. Or, if companies fail to do post-market safety studies, their products should be pulled from the market.

Improved mechanisms for information transparency
The legislation must go further in providing the public with access to information from clinical trials, requiring registration of all clinical trials and opening all data from Phase II and Phase III clinical trials to health care providers and patients and unfettered access to FDA reviews of these studies.

Improved balance in the relationship between the Office of Surveillance and Epidemiology and the Office of New Drugs
To ensure that drug safety concerns are given appropriate consideration by the FDA, there must be an explicit structure to facilitate consultation between the Office of Surveillance and Epidemiology and the Office of New Drugs as equals, with the Office of Surveillance and Epidemiology having independent regulatory authority, and neither office subordinate to the other. Under current circumstances, the OSE lacks the resources, personnel and authority to realize that goal, and this legislation does not create the necessary balance. The OSE also needs a greater commitment of resources so it can access and analyze data from the Center for Medicare and Medicaid Services, the VA, NIH, DoD and other large health care databases to proactively look for drug effect patterns that indicate safety concerns.

Expanded requirements for efficacy data prior to approval and stronger requirements for safety data after approval
The FDA must require (not "may" require) post-market safety clinical trials and comparative clinical trials in Phase II trials so doctors and the public will have a better understanding of the drugs efficacy compared to what is currently on the market.

Increased protections for consumers from over-marketing of new and unproven drugs
To ensure that companies do not misuse the opportunity of a new product launch to over-market new drugs, there should be a two-year delay between product approval and the start of any Direct-to-Consumer advertising. This will create a window of time during which the FDA can monitor real-world use of new products before advertising campaigns expand use to markets far greater, less healthy and more diverse than those studied in clinical trials. Additionally, the FDA must have increased resources and staff to review all DTC ads before they are viewed by the public.

A system to ensure that the FDA gets the best advice from expert advisors by expanding recruitment of independent scientists and doctors to serve on advisory committees and banning service by scientists with conflicts of interest
The FDA relies on outside expert advisors to guide its decisions on a range of critical issues. Common sense dictates that physicians or scientists who are on a company's payroll or receive funding in the form of honoraria, grants, consulting fees, or other mechanisms, or have stock in the company (not including mutual funds or similar accounts) are not objective or disinterested parties. The FDA must expand efforts to recruit independent advisors and stop appointing advisory committee members whose conflicts of interest create a bias in favor of products under consideration. Advisory committees also need to be better balanced, with experts who focus on drug safety data, and bio-statisticians need to play a more prominent role regarding whether the product is proven safe or effective.

We also have strong concerns about conflicts of interest stemming from industry funding for the Reagan-Udall Institute, and scientists who would serve on the Board of the Institute. If Congress is not able to appropriate full funding for the Institute, it should not create the Institute.

In the interests of the public health and of re-establishing scientific integrity at the FDA, we strongly urge the Senate HELP Committee to amend the Enhancing Drug Safety and Innovation Act of 2007 to reflect the recommendations outlined here. We also urge the Committee to incorporate more suggestions from the recent IOM report on drug safety, the report by the Union of Concerned Scientists, the report on FDA Advisory Committees by the National Research Center for Women & Families, and the drug safety bill introduced by Senators Grassley and Dodd.

In addition, we urge the Senate HELP Committee and House Energy and Commerce Committee to make sure that any drug safety legislation increases resources for safety reviews and surveillance, before and after FDA approval decisions are made. The current user fee law (PDUFA) restricts almost all user fees for use in speeding the review of products, permitting only a minuscule percentage to be used for the review of safety data. We remain very concerned that the current PDUFA system undermines the safety of the approval process and post-market surveillance for prescription drugs, as well as the efficient functioning of the FDA. Rather than rushing a five-year reauthorization of PDUFA through the Congress, we urge the Congress to pass a one-year extension with essential improvements in order to provide sufficient funding and time for more substantial improvements to the legislation.

We share your concerns about the weakened safeguards at the FDA, and believe that these recommendations will result in stronger legislation that will truly protect the American people from unsafe medications.

Sincerely,

Breast Cancer Action
Center for Medical Consumers
Center for Science in the Public Interest
Government Accountability Project
The Medicare Rights Center
National Research Center for Women & Families
National Women's Health Network
Our Bodies Ourselves
Title II Community AIDS National Network
Union of Concerned Scientists
U.S. PIRG
WoodyMatters