Federal Times:

Federal Times: "Lawmakers Worry FDA Bill Adds Too Much Work"

Lawmakers worry FDA bill adds too much work By GREGG CARLSTROM May 15, 2008 A bipartisan group of legislators is concerned that a draft bill overhauling the Food and Drug Administration could cripple the agency by imposing a vast new workload. The Food and Drug Administration Globalization Act would require the agency to perform more frequent inspections of companies that produce food, drugs and medical devices. The legislation, not yet introduced, is a response to recent regulatory failures at the agency, which failed to catch contamination of the blood-thinning drug heparin imported from China, among other lapses. Congress would pay for the new mandates by increasing user fees on those companies. Food and drug companies already pay substantial fees: A company that produces medical devices, for example, pays a $1,700 annual registration fee for each manufacturing plant. The draft bill would up that fee to $2,000. A discussion draft of the bill, written by House Energy and Commerce Committee leaders, was discussed Wednesday at a hearing of the subcommittee on health. Legislators said the user fees, and some of the inspection requirements, could be counterproductive. “User fees may seem like the only option,” said Rep. Nathan Deal, R-Ga. “But they raise some questions about the relationship between the regulatory [agency] and the industry being regulated.” And there are two serious concerns about what the bill would do to FDA’s workload. First, it would require more intensive inspections of medical devices. Right now, FDA inspectors look at the finished product; the legislation expands those inspections to any company that produces part of a medical device. Legislators are worried that would force FDA to oversee an entire supply chain. “Right now, they’re inspected as finished products,” said Rep. Anna Eshoo, D-Calif. “Under this act, each firm that makes every bolt, every circuit board, would be inspected. The number of facilities would be insurmountable.” Second, the bill calls on FDA to set up a permanent “foreign inspectorate.” Those employees would be responsible for inspecting foreign facilities, under the same twice-annual timetable that governs domestic inspections. But the FDA — which complains of chronic underfunding — says it doesn’t have the resources for full-time foreign inspectors without a big boost in appropriations. “Simply calling for more inspections is not the solution,” said Stephen Sundlof, director of FDA’s Center for Food Safety and Applied Nutrition. “FDA is pursuing the use of voluntary third-party certification to verify compliance with requirements.” Sundlof was referring to a program authorized by Congress in 2002, which allows FDA to authorize third-party organizations to perform safety inspections. But the agency has only approved 16 organizations, and those organizations have conducted a total of just four inspections at foreign manufacturers. Legislators also quizzed the FDA on its limited authority to block imported drugs from entering the market. Before blocking an import, “we have to establish at the port of entry that there is a problem,” Sundlof said. But companies now can refuse to be inspected. The proposed legislation would change that, blocking food and drugs from companies that don’t agree to regular FDA inspections. Criticisms of the bill aside, lawmakers and experts agreed the FDA needs a fix. “The FDA has not kept up with the globalization of the industry it regulates,” said Marcia Crosse, director of health issues at the Government Accountability Office. A GAO report released last week found a growing backlog of medical device inspections. The FDA inspects domestic manufacturers of high-risk devices, like pacemakers, once every three years; medium-risk devices, including syringes and hearing aids, every five. Inspections of foreign manufacturers occur even less frequently: six years for high-risk devices, and 27 years for medium-risk. FDA is slowly improving the scope of its overseas inspection program: The agency inspected 289 foreign device manufacturers last year, compared with 219 in 2006. But FDA officials say they need more money and personnel to reach the goal of biannual inspections. GAO’s report on medical devices mirrors another study released last year, which found the FDA had performed inspections at just 1,500 of the nation’s 5,000 drug manufacturers since 2002.

Did You Know?

  • The FDA oversees 80 percent of the nation''s food supply, but only recieves 20 percent of food safety funding?
  • HACCP (Harzard Analysis and Critical Control Point) was originally developed for NASA to ensure the safety of food for consumption in space?
  • The FDA''s entire budget is actually less than the budget for the school system in Montgomory County, MD, where FDA resides?
  • Some in Congress would impose "User Fees" on Food Companies as a way to increase FDA''s budget. Such "fees" are really just new taxes on food and would undoubtedly be passed through to the consumer by way of higher food prices.
  • Current customs law already requires the importers of finished, packaged products, seafood, and some bulk foods to include country of origin labeling on the package. Beginning in 2008, fresh fruits and vegetables imported into the U.S. will also need to display their country of origin.

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