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Posted by: Linda Chalat
February 05, 2007

Things may be improving for the average patient, FDA announced last week that changes were being made which were intended to ensure that marketed drugs are as safe as advertised. A significant step is the first effort to do a comprehensive safety assessment of approved drugs 18 months after introduction to the market. And the FDA will collaborate with the Veterans Health Administration to track how real patients fare after taking drugs. . The agency also will create an advisory panel to improve communications on safety concerns.

In both the Vioxx case and the antidepressants, the FDA took years to acknowledge risks that were well documented by researchers, and that threatened the safety of millions of patients. Last September, the Institute of Medicine released a critical report, concluding that the FDA was rife with internal squabbles and hobbled by under-financing, poor management and outdated regulations. The institute, the most important medical advisory organization in the country, suggested that the agency undergo 25 major changes, many of which would require Congressional authorization.

The new efforts will include creation of a database of genetic codes associated with bad drug outcomes, the development of a computer model to identify patients who are most likely to suffer liver injury, and the design of screening tests that would identify patients most at risk of general drug problems.

The announced changes will address some of the problems highlighted by the institute, but does nothing to help the chronic shortage of government money. The FDA has regulatory authority over about a quarter of the American economy. After the Sept. 11 attacks, the agency was asked to increase its efforts to prevent bioterrorism. Yet the FDA budget has remained flat for years.

There are now thousands of drugs in routine use and assessing which of these medicines may have undiscovered side effects will be very costly. The FDA gets about $400 million of its $1.9 billion budget from fees assessed on drug makers. Under a formula negotiated with the drug industry, this money comes with strings attached. One restriction was that the FDA. could use little of the money to track the safety of approved drugs.

That negotiated agreement between the FDA and the pharmaceutical industry expires this year, and the drug companies have agreed to allow more of their money to be used for the planned post-market safety assessments. Whether those fees are enough, whether there should be any strings attached to them and whether that money should be coming from drug makers at all has become the subject of fierce debate.

The new plan promises to return the FDA to its scientific roots. Once home to state-of-the-art laboratories that conducted original studies to assess drug risks, the FDA now looks to drug companies for the actual testing. The FDA labs were largely eliminated in the past decade to free more money for the drug-approval process and the support of a elementary computer program to track side effects of drugs.

But in the past two years, the agency has refocused on the science of drug safety, making itself an active participant in scientific endeavors once left exclusively to drug makers and basic scientists.

FDA Returns to Its Roots

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