Bill overhauls way FDA approves drugs

Against the backdrop of growing concerns about the safety of drugs and the methods used to test them — recall the dramatic Merck’s withdrawal of its painkiller Vioxx three years ago — the Food and Drug Administration (FDA) is undergoing the most comprehensive overhaul in a decade. A bill to give the FDA more power passed both houses of Congress with large majorities and the president is expected to sign it into law. Forbes’s Matthew Herper reports that the bill is a victory for advocates of higher standards for making sure that drug side effects are known and promptly dealt with. Before Vioxx was pulled, some of the changes being made would be unimaginable. Until now, the claims drug companies such as Merck (NYSE: MRK) and Pfizer (NYSE: PFE) made about their medicines were, to a degree, negotiated. Labeling discussions between Merck and the FDA dragged on, and as a result, the agency will now be able to dictate what claims companies can make with much more force.

Another change: The FDA will be able to force drug makers to do clinical trials even after a medicine is approved and fine them if they do not follow through. Before this change, many big clinical trials regulators asked for were not finished. There will also be more money to study side effects of new medicines post-approval. Companies will pay more in fees when they submit drug applications, increasing the amount of money the FDA gets from industry by 25 percent to $400 million. One of the far-reaching changes may be a new requirement demanding that the drug companies list all of their clinical trials in a registry maintained by the National Institutes of Health (NIH) accessible to anyone with an Internet browser. After the studies finish, the results will also have to be posted. This will expose drug companies to new levels of scrutiny about the safety of their medicines.

Quite a few changes were left out of the bill. The Union of Concerned Scientists worried that it did not do enough to deal with the financial conflicts of FDA advisers. Pharmaceutical companies had at one point hoped that the bill would contain language which helped protect products that had been vetted by the FDA from product liability suits. The bill also does not contain a mechanism for approving cheaper copycat versions of biotech protein drugs such as insulin and human growth hormone. The main reason is the complex safety issues involved in manufacturing proteins, a more challenging task than manufacturing simpler chemicals such as those used in pills like Vioxx and Lipitor.

Herper writes that the bill may make the process of drug approval more expensive for the drug makers, but that “the changes will strengthen the FDA, renewing the public’s shaken faith in the safety of medicines. Drug makers could wish for nothing more.”