23 July 2009

FDA looks to improve product safety tracking

The Food and Drug Administration does not have the expertise to forecast its own budget needs, according to congressional investigators.

The FDA has a huge mandate, and yet it continues to struggle to fulfill its mission of regulating food, drugs, and other consumer goods that make up nearly a quarter of the U.S. economy.

While lawmakers and consumer advocates have long complained the agency lacks the staff and equipment to accomplish its mission, the Government Accountability Office (GAO) said the agency does not even have “the data to develop a complete and reliable estimate of the resources it needs.”

The GAO places some of the blame on the FDA’s lopsided budget, which dedicates resources to approving new products, but far less to tracking their safety once they have reached the market.

FDA officials acknowledged the problems and said they are working to get a better picture of the agency’s spending and how much additional funding it needs.

“We have to be able to talk about the funds we need, and how we’re using the money, with more detail than FDA has in the past,” said Dr. Joshua Sharfstein, the agency’s deputy commissioner.

The GAO released the report this week. Over the past few years, the FDA jumped from one health crisis to the next, including the recall of the painkiller Vioxx, linked to heart attacks; contaminated blood thinners imported from China, and an investigation into a salmonella outbreak that dragged on for weeks before finding out peppers were the culprit.

The agency’s product review program largely comes from user fees from drug and medical device companies, while funding for safety inspections comes from taxpayer dollars. It is easy to see the dichotomy: Over the last 10 years, funding from private companies jumped nearly 270%, while funds from the U.S. government grew less than 70%.

Currently, the federal government pays for just over 30% of the FDA’s medical products budget. As a result, the FDA is approving more new products but is spending far less to make sure they are safe.

“The approval of new products has increasingly become the beneficiary of the agency’s budget,” according to the GAO report.

Between 2004 and 2008, the agency failed to inspect all U.S. drug manufacturing plants every two years, as required by law. In other areas, such as reviewing reports of negative drug side effects, the FDA could not even say how much money and manpower it spent.

For related information, go to www.isa.org/safety.