Pioneering Prescription Drug Reform

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 WISPIRG Advocate Bruce Speight:

“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.

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