Not surprsingly, the Senate Health Education Labor and Pensions Committee has passed the Kennedy-Enzi bill, which calls for drugmakers to pay 45 percent more to the FDA to speed reviews of new meds and improve safety monitoring.

The measure, which passed 15-5, would also give the FDA power to ban DTC ads of meds with dangerous side effects for up to two years and force drugmakers to complete studies after their products are on the market.

There’s more: the bill would renew and increase fees, paid by drugmakers, that otherwise would expire on Sept. 30. The FDA says this is needed to avoid staff layoffs and a slowdown in drug reviews. The FDA would also have new powers to fine companies that fail to do post-approval studies and to ban advertising of a new drug to consumers for two years. The safety of new meds would be reviewed 18 months and three years after reaching the market.

“We want the drugs to be as safe as possible,” said US Senator Mike Enzi of Wyoming, the committee’s top Republican, during the meeting. “We also want to be able to get new drugs to market as fast as possible - with the assurance that they will be safe.”

More here…
Reuters;
Bloomberg News.[tags]Drug Safety, DTC Ads, FDA[/tags]