By overwhelming margins, the House and Senate passed this week
significant reforms to the Food and Drug Administration’s drug safety
review system. The centerpiece of the bill includes strong consumer
protections. President Bush has sent mixed signals on whether or not
he will sign the bill, which passed the House 405 to 7 and passed the
Senate unanimously.
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 funding is a significant
increase in user fees being dedicated to drug safety.
President
Bush must sign 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.
