House OKs bill to improve drug safety

By ANDREW BRIDGES, Associated Press WriterWed Jul 11, 9:05 PM ET
Seeking to avoid another Vioxx debacle, the House voted overwhelmingly Wednesday to give federal health officials more money and power to police the safety of prescription drugs.
The House approved 403-16 a bill giving the Food and Drug Administration nearly $400 million, collected as fees from the drug industry, to spend on drug safety over the next five years. The Senate already has approved similar legislation.
Both bills would give the agency the ability to require drug companies to do follow-up studies on certain medicines.
"It's become increasingly clear FDA needs more of two things: It needs more resources and more authority, particularly in the area of postmarketing surveillance," said Rep. Henry Waxman, D-Calif.
The House version 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.
The FDA was criticized for being too slow to respond once serious problems were linked to the painkiller Vioxx. Merck & Co. Inc. voluntarily withdrew the drug in 2004 after research showed it doubled the risk of heart attacks and strokes.
The legislation's underlying purpose is to renew, through 2012, a program that has the drug industry pay fees to the agency to defray the cost of reviewing new medicines. In the wake of the Vioxx withdrawal and subsequent problems with other drugs, lawmakers seized on the legislation to overhaul how the FDA handles the safety of the drugs it regulates. The bill gathers together other legislation as well, including the reauthorization of a medical device industry user fee program.
The House bill also would give the FDA authority to require further studies of drugs after they're already on the market — and require pharmaceutical companies to submit timetables for their completion. The FDA also could order label changes to a drug or restrict its use or distribution.
Both the House and Senate bills require the FDA to increase its active surveillance of emerging problems with drugs. The bills call for the mining of large health care databases for signs of unanticipated drug side effects.
Rep. John Dingell, D-Mich., said the goal there was "reducing the likelihood of another Vioxx situation, when reported adverse effects went unheard."
The House and Senate are expected to resolve the differences between the versions in coming weeks.
The Senate earlier voided — and the House didn't include at all — a provision that would have allowed consumers to buy cheaper prescription drugs from abroad. The White House has threatened to veto the FDA bill if it contains such a provision.
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The House bill is H.R. 2900
For bill information: http://thomas.loc.gov/