President Bush today
signed a comprehensive Food and Drug Administration bill that focuses on
prescription drug safety reforms. The
bill holds the prescription drug industry more accountable for the safety of
their products by requiring them to publicly disclose drug safety studies, even
the ones that show their medicines in an unflattering light. It also increases the budget for drug safety
reviews at the Food and Drug Administration.
Statement by U.S. PIRG Consumer Health Care
Advocate Paul Brown:
“This bill is the
right prescription for improving the safety of our medicines. We applaud Congress for passing it and
President Bush for signing it into law.
“It is a huge
victory for consumers over the powerful prescription drug industry, which tried
unsuccessfully to weaken the drug safety disclosure language in the bill.”
The Food and Drug
Administration Amendment Act will:
Prohibit drug makers from hiding unflattering
studies about a drug’s side effects.
It requires drug companies post the results of drug studies on-line
so researchers, doctors and patients have access to complete information.
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.
The “Food and Drug Administration Amendment Act”
last week passed the House 405 to 7 and passed the Senate unanimously. The bill
includes prescription drug user fee reauthorization that provides nearly $400
million of the FDA’s $1.5 billion budget. To avoid layoffs at the FDA, the
president needed to sign the bill before October 1.
