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;