Hinchey Statement On GAO Report Of FDA's Post-Market Safety Activities     Posted on 4-25-06

 “The FDA has long had an inappropriately cozy relationship with drug companies and the Americans people are paying the price for it,” says Congressman Maurice Hinchey (D-NY).

Washington, DC -- Congressman Maurice Hinchey (D-NY) released the following statement in response to the U.S. Government Accountability Office (GAO) report unveiled today that details a wide array of problems with the FDA's post-market drug safety monitoring.  Hinchey is the author of the FDA Improvement Act (FDAIA), which is a comprehensive reform bill that would create an independent Center for Post-Market Drug Safety & Effectiveness responsible for regulating all approved drugs and related advertisements and promotions.  Among other steps, the FDAIA would also end the financial link and inappropriate relationship between the drug industry and the FDA and eliminate conflicts-of-interest on FDA advisory committees.

"This new GAO report confirms in detail what many of us have long known about the FDA: the agency is too closely tied to the pharmaceutical industry and lacks the authority and funding to adequately monitor the safety of drugs once they hit the market.  The FDA has long had an inappropriately cozy relationship with drug companies and the Americans people are paying the price for it. 

"Currently, the same doctors and scientists at the FDA who approve a drug are in charge of monitoring the safety of that drug once it hits the market.  This creates a situation that makes it nearly impossible for a drug to be pulled from the market or for a label change to move forward.  Additionally, given that drug companies can now bypass doctors and directly market their products to the public, the FDA needs to have a structure in place to deal with this new dynamic in which tens of millions of people are dictating which medicines they take even if a specific drug isn't best for them.

"In May 2005, I introduced the FDA Improvement Act, which addresses a wide array of problems at the FDA, including those related to post-market safety.  Specifically, my bill creates an independent Center for Post-Market Drug Safety & Effectiveness, which would be within the FDA, but would have its director appointed independently by the HHS Secretary.  To address potential conflicts of interest, different doctors and scientists than the ones who approve a drug would monitor its safety post-market.  The Center would be given increased funding and the authority to strengthen the FDA's post-market regulatory functions and abilities.  On a separate but related track, the bill also gives the FDA the authority to mandate label changes on drugs if a post-market problem is discovered.  Currently, the FDA doesn't have the authority to force drug companies to change their labels.  Republicans in Congress twice rejected my attempt to pass legislation last year that would have finally empowered the FDA to mandate label changes.  Hopefully, this new GAO report will encourage them to allow the amendment to pass this year when I offer it again.  Until we create a system of accountability that is free from drug company influence, the American people are not going to be adequately safeguarded from dangerous drugs on the market. 

"At the heart of many of the problems at the FDA is the fact that the agency receives a significant portion of its funding from the drug industry.  As a result, the agency has to negotiate with the drug industry as to how it can spend that money.  Essentially, this system has made drug companies clients of the FDA rather than regulated entities.  This entire structure has to change.  The FDA must be freed of any obligations to the drug companies so it can focus solely on its obligations to protect the health and safety of the American people.  My FDA reform bill addresses all of this.

"It is my sincere hope that this new GAO report will help wake up Congress to the fact that comprehensive FDA reform is long overdue.  I will do everything I can to create a structure and provide the resources needed for the FDA to adequately protect the American people. 

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