Thursday, July 12, 2007

Drug Safety Bill Easily Passes House

Less controversial than the College Cost Reduction Act of 2007 was the passage of H.R. 2900 a bill To amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. The 403 to 16 vote was lopsided because the legislation, which reauthorizes an FDA program to review and approve new drugs, is a top drug industry priority. Republicans and Democrats alike know who pays the bills.

The bill gives federal health officials more money and power to police the safety of prescription drugs. According to Andrew Bridges of the AP the bill pays for increased enforcement through user fees expected to be $400,000,000 over the next five years. It also contains provisions targeting, and was strongly opposed by the diet supplement industry.

The bill was passed under a suspension of the rules which required a 2/3 vote. That passage on the suspension calendar was even attempted lead Drew Anderson of to conclude that sponsors knew the bill had broad and deep support. The dietary supplement industry didn't have a chance.

According to Bridges the legislation

would require the FDA to review the safety of certain drugs annually for the first three years following approval and then again during the seventh year. It also would require drug ads to include a toll-free number and Web address for consumers to report side effects and would permit only a single outside expert with a potential conflict of interest to be cleared to serve on any agency advisory panel.

Rep. Michael Burgess, R-Texas, criticized the restriction on those outside advisers, noting it's already difficult to find scientists who are experts in some fields. "This irrational standard will only make it harder," said Burgess. Burgess also praised the earlier stripping out of a provision that would have limited drug companies from advertising new drugs directly to consumers. Such a limit had raised free speech concerns.
Since the Senate has already passed similar legislation, the bill now heads for conference and ultimate passage.