House Approves Drug Testing Bill, Senate & Prez Expected To Follow
This week, the House of Representatives passed a new bill that gives the FDA the power to require new warning labels on existing prescription drugs, and the power to request "post-approval" studies of medicines as warranted. It also gives the FDA the authority to levy fines as high as $10 million to companies that fail to comply. The bill passed with a 405-7 vote on Wednesday and is expected to be passed by the Senate and approved by the President.
The bill was sparked largely by problems with the anti-inflammatory drug Vioxx, sold by Merck & Co Inc., which was linked to heart attacks and strokes in some patients.
Some other features of the bill:
- It increases the amount that pharmaceutical companies will have to pay to support FDA safety studies—about $87 million more than current levels beginning October 1st of this year;
- It requires pharmaceutical companies to pay $225 million over the next five years to support FDA safety monitoring for drugs that have reached the market;
- It requires drugmakers to place the results of their clinical trials for approved products in a public database;
"House clears FDA drug safety, fee bill" [Reuters]
(Photo: Getty)
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Comments:
I agree that the the inclusion of the phrase:
"It requires drugmakers to place the results of their clinical trials for approved products in a public database" ...is an important step. What's more important is that all of the results of all clinical trials be included in the database. Often times clinical trials can be quite contradictory and expose some of the nasty side effects of a given drug.
So, what concessions to the drug companies were included in the bill? Something that gets passed nearly unanimously like that has to have some concessions, or the drug companies would have lobbied left and right against it.
Vioxx was not a painkiller, its an anti-inflamitory.
The concession is that it looks good but there's the phrase "as warranted" in there. I'm guessing there will be lapses, foot-dragging, and general hemming and hawing on enforcing the post-approval studies.
"It requires drugmakers to place the results of their clinical trials for approved products in a public database"
I like that. We need more of that.