May 15, 2007
Senate passes drug-safety bill
The bill reauthorizing PDUFA passed in the Senate 93-1, giving the FDA power to change drug labels and requiring post-market studies for drugs with safety problems.
But the DTC moratorium, an original provision in the bill giving the agency power to restrict consumer advertising for new drugs for the first two years, was removed.
That provision was replaced with a measure that allows the agency to fine companies for ads that are false or misleading when it comes to disclosing a “serious health risk.” Companies can be fined $150,000 per violation initially and $300,000 if they ignore the sanctions and continue running the ad.
The House has yet to vote on a companion measure, but because the bill reauthorizes fees collected from drug firms to speed product review, Congress is expected to pass a version of the legislation by the end of fiscal year 2007, which ends in September.
The bill, S. 1082, or the FDA Revitalization Act, also mandates pre-submission of ads to FDA but not pre-clearance and requires drug makers to register most of their clinical trials, although the legislation gives the FDA 2 1/2 years to develop guidelines for making some, but not all, clinical trial results public.
The bill marks “an important shift in the balance of power” between the FDA and industry, wrote The Wall Street Journal, as the FDA's power to require label changes and new studies currently “isn't clearly delineated.”
Opposition to the DTC moratorium, particularly by Sen. Pat Roberts (R-KS), had threatened to cause a filibuster.
In addition, an amendment offered by Sen. Byron Dorgan (D-ND) authorizing reimportation of drugs could have ensured a presidential veto but was effectively voided by passage of an amendment requiring that FDA ensure the safety and efficacy of any imported drugs.
Sen. Ed Kennedy (D-MA), chief sponsor of the bill, has said he will add language to the bill creating a regulatory pathway for generic biologics, but lawmakers from the House say it may be difficult for such language to move through the House in tandem with the user-fee legislation.