Drug safety legislation in US House
Lawmakers in the US House will soon vote on a strong drug safety bill, HR 2900, that allows the FDA to enforce labeling changes, complete safety studies, and more quickly take action to protect the public if a drug proves unsafe. The bill would also give the FDA the authority to impose meaningful fines on drug companies that fail to comply with safety measures.

Many of the reforms included in this legislation are stronger than what the Senate passed last month. HR 2900 will soon go to the House floor for a vote.

The House measure includes:
Additional funding for safety: The bill would give the FDA an additional $225 million in user fees from drug companies over the next five years for safety monitoring; this is also included in the Senate bill.
A stronger, more transparent FDA: Like the Senate’s bill, S.1082, the House bill would give the FDA more authority in requiring follow up safety studies and changes on a drug’s label. The bill would also make public any office of drug safety consultations with the Office of New Drugs so that consumers and outside researchers can see where areas of controversy are.

More effective safety monitoring: This legislation would also require the FDA to regularly review the adverse event reports for data that could point to a drug’s safety problems and to resolve the issue of the hundreds of requested post-market clinical trial studies that have never been started.

Safety reviews: Reviews to be conducted on drugs with indications of safety concerns annually for the first 3 years, and then again at 7 years (important because only half of all adverse events occur by the 7th year).

Tougher fines on drug companies: If drug companies fail to perform safety actions, the House bill allows for fines up to $50 million. This is stronger than the Senate version, which caps at $2 million.

Fines for misleading ads: The House bill authorizes fines of $250,000 for running a false or misleading consumer-directed advertisement for a prescription drug, with a $500,000 fine per day for subsequent offenses. This is stronger than the Senate bill which allows a maximum fine of $150,000. (Language in the House bill that would have given the FDA authority to ban advertisements for drugs with severe side effect for up to three years was ultimately rejected.)

A quick 800# in drug ads for reporting side effects: Drug ads will carry a message encouraging consumers to report adverse drug reactions to FDA's MedWatch on the Internet or through a toll-free number.

More transparency on drug research: The House bill would create two publicly accessible databases. The first would include a registry of ongoing drug clinical trials, and the second would post the results of these trials.The exact details of what and how data has to be reported are still being negotiated. In the Senate, final reporting requirements are not clear. This is a major unresolved area.

Limits on conflict of interest in advisory committees: The House bill would require experts serving on FDA advisory panels to disclose all financial conflicts of interest. The FDA could grant one waiver per meeting to a panel member with a conflict of interest. Experts with conflicts of interest without waivers could present information to the panels, but are not allowed to vote.

June 22, 2007