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Senate Passes Drug-Safety Reforms to Prevent Future Vioxx-type,Disasters; House Urged to Act on Strong Drug Safety Bill

the FDA to fine companies ($150,000 per violation) for ads that are false or misleading when it comes to disclosing a "serious health risk." With new drugs, serious health risks often aren't clear until a drug has been on the market for years and used by millions, which is why having the DTC moratorium option is critical for safety.

"While it's important FDA has the power to hold a drug company's feet to the fire when it comes to misleading ads, we'd urge the House to support restrictions on massive ad campaigns for those new drugs with early danger indications," Vaughan said. "There is nothing in the First Amendment that guarantees drug companies can push medications with health risks on the public. When a company can make more than a million dollars a day in drug sales, a $150,000 fine for running a misleading advertisement won't have much impact."

HR 1561, introduced by Reps. Waxman and Markey, contains many of the Senate provisions, but makes more clinical trial results available more quickly, and allows for a three-year advertising moratorium on new drugs with safety issues. It is unclear whether that bill will move alone or be attached to a broader drug-user fee renewal measure like the Senate version.

"The House bill has some stronger safety measures that would close loopholes the drug industry could exploit when it comes to making risk information public," Vaughan said.

In the Senate bill, an amendment offered by Sen. Grassley (R-Iowa), to give the FDA's drug safety office a higher profile by giving it joint decision-making with the Office of New Drugs over drugs on the market lost by just one vote. CU supported the amendment because those in the FDA responsible for safety "are often overwhelmed, ignored, or even told to be quiet."

The Senate also approved amendments that would:

* Impose higher fines on companies that fail to comply with risk mitigation strategies, such as performing post-market safety studies. "We
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