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Drug safety bill moves to Conference Committee; send strong bill to the President!

Drug safety legislation moves to Conference Committee; Strongest bill should be sent to the President.

Both houses of Congress have just passed drug safety legislation (S. 1082, HR 2900) that would allow 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.

There are some similarities in both bills, though many provisions in the House version are stronger. We urge lawmakers in conference committee to agree on the strongest bill possible to send to President Bush for signature.

Both measures:

• Give the FDA an additional $225 million in user fees from drug companies over the next five years for safety monitoring.
• Give the FDA more authority in requiring follow up safety studies and changes on a drug’s label.
• FDA and private contractors will monitor huge medical databases from private insurers and Medicare (with a Senate goal of 100 million records by 7/1/12) to work to detect problems with a drug’s safety.
• Give the FDA the authority to pre-view ads up to 45 days prior to dissemination. FDA could require ad to specify serious risks.

Stronger House provisions:

• Would 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.
• Would require the FDA to resolve the issue of the hundreds of requested post-market clinical safety trial studies that have never been started.
• Reviews would be conducted on drugs with indications of safety concerns annually for the first 3 years and then again at 7 years. This is important because only half of all adverse events occur by the 7th year (In general, the Senate bill only requires reviews up to 3 years).
• If drug companies repeatedly fail to perform safety actions, the bill allows for fines up to $50 million. (This is stronger than the Senate version, which caps at $2 million).
• 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, or $300,000 for repeat violations).
• 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.
• Would create a registry of ongoing drug clinical trials, and a second registry would post the results of these trials. (In the Senate, final reporting requirements are not clear).
• The House bill would require experts serving on FDA advisory panels to disclose all financial conflicts of interest. The FDA could grant only one waiver per meeting to a panel member with a conflict of interest. (The Senate bill has no limits).

Stronger Senate provisions:

• Requiring post approval drug safety actions would involve decisions from both the Office of New Drugs and the Office of Drug Safety. (The House bill has no reference to involving the Office of Drug Safety).
• The FDA’s action package for a drug’s approval must be quickly made public with full discussion of points of internal disagreement and protection for dissents by FDA staff. (The House bill has no reference to this).

Posted July 17, 2007