And the lone holdout was……Vermont’s Bernie Sanders (yes, that’s him to the right).

The bill would expand the FDA’s ability to monitor drugs for side effects, and to take quicker action to better protect the public if problems arise. “This is breakthrough legislation,” said Sen. Ted Kennedy, the Democrat from Massachusetts, who co-sponsored the bill.’

The bill, which still must be approved by the House, follows a series of high profile cases in the past several years involving FDA-approved painkillers, antibiotics and antidepressants that turned out to have unexpected and, in some instances, deadly side effects.

A key provision would require the FDA to review the safety of some potentially risky drugs at 18 months and at three years after approval, and to conduct regular surveillance of large public and private medical databases to better track possibly harmful side effects.

The legislation also would empower the agency to require drugmakers to conduct postmarket studies of new meds, and set deadlines for revision of drug warning labels when problems occur. User fees paid by drugmakers would also increase, but there would be new performance goals to measure the approval of new drugs, a key issue for the pharmaceutical industry. Although Public Citizen’s Peter Lurie fumed to The Washington Post that it’s a “total conflict of interest” for industry to “dictate” the speed at which reviews will be made.

The bill effectively blocks lower-priced drug imports, a key victory for drugmakers concerned that such a move could lead to an increase of counterfeit meds and also undercut their profits. And their is some added oversight on DTC ads, but lawmakers deleted a provision that would have given the FDA discretion to ban some ads on potentially risky new drugs for up to two years.

Drugmakers expressed pleasure. Typical was Ian Spatz, Merck’s vp for health policy, who described the bill as “common sense” that will restore the FDA to its “gold standard” reputation.

One amendment, by the way, increases civil monetary penalties to $250,000 from $10,000, and would apply when companies don’t to comply with FDA directives, such as label changes, post-approval studies, and communicating info about newly identified risks. The penalty doubles for every 30-day period of non-compliance after that, up to $2 million.

However, another amendment that would allow just one scientist with a conflict of interest to serve on an FDA advisory committee was defeated, 47-47. Under Senate rules, a tie is a defeat. The bill now moves to the House, where companion legislation sponsored by Henry Waxman and Ed Markey has similar language. As GoozNews notes, several representatives have indicated “strong interest in authoring a total ban on scientists with conflicts.”

Posted by Robert Cohen of The Star-Ledger of New Jersey

[tags]Drug Safety, DTC Advertising, PDUFA[/tags]