House Passes Prescription Drug Safety Reforms; Senate to Follow

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Georgia PIRG Education Fund

The House today passed significant reforms to the Food and Drug Administration’s drug safety review system. Part of a comprehensive FDA bill, the bill was a compromise between Senate and House legislation that passed overwhelmingly earlier this year. The bill, which includes strong consumer protections, will be voted on in the Senate tomorrow.

Statement by U.S. PIRG Consumer Health Care Advocate Paul Brown:

“The drugs in our medicine cabinets will be safer because of today’s Congressional action. The reforms are the type of strong medicine needed to protect all Americans from unsafe drugs.  The drug industry opposed many of these safety reforms, but in the end there were too many headlines about dangerous drugs.  Congress had to act, and we’re pleased they did.  In recent years safety problems with drugs like Vioxx, Paxil and Avandia have made consumers question whether the drugs they are taking to keep themselves healthy are causing more harm than good.  The reforms strengthen the FDA’s drug safety review process, and they hold drug makers more accountable to consumers.  For a number of years, the FDA’s system for reviewing the safety of drugs has been broken.  Today’s action by Congress takes steps to solve our drug safety problems.”  

The Food and Drug Administration Amendment Act will:

  • Make more information about drug studies available to researchers, doctors and patients by posting the results of most clinical trials on-line.  Drug makers will no longer be able to bury unflattering studies about a drug’s side effects.
  • Strengthen conflicts-of-interest rules for scientists who serve on FDA drug safety panels by limiting the number of scientists with financial ties to drug makers by 25 percent over five years.    
  • Grant the FDA the authority to issue fines of up to $10 million for drug makers who fail to complete follow-up safety studies. In the past, drug makers failed to complete drug safety studies nearly 70 percent of the time.
  • Add $225 million from drug industry user fees for follow-up safety studies (post-market drug safety reviews).  This is a significant increase in user fees being dedicated to drug safety.

Congress must pass the Food and Drug Administration Amendment Act by September 30 to avoid layoffs at the FDA.  The bill includes prescription drug user fee reauthorization that provides nearly $400 million of the Food and Drug Administration’s $1.5 billion budget.