FDA Faulted for Scrutiny
Of Medical-Device Makers
By ANNA WILDE MATHEWS
January 29, 2008; Page A2
The Food and Drug Administration can't keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign facilities, according to congressional investigators.
In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found "weaknesses" in the agency's oversight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials' own estimates, overseas makers of the riskiest products, such as pacemakers, were examined only every six years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.
The GAO testimony on medical devices will be a part of the hearing's broader effort to highlight an issue that has turned up in reports and critiques over the past few years: concerns the FDA's resources and technology aren't enough to meet its regulatory responsibilities to oversee drugs, food and other products.
The subcommittee also is expected to discuss a separate, harshly worded report released in November by a group of the FDA's own advisers that warned the agency needs substantial resources to deal with emerging scientific developments.
The report, from a subcommittee of the FDA's outside Science Board that included members and advisers from industry as well as academia, said the agency "cannot even keep up with the advances in science." An appendix to the report said the FDA conducted twice as many inspections of food facilities in 1973 as it did of all facilities -- including food, drugs and medical devices -- in 2006.
The hearing also is expected to focus on the FDA's oversight of food, an issue that has sparked concerns in the wake of recalls. The GAO will testify that the FDA's plan to step up food regulation, unveiled last year, could help, but the agency needs to issue more specifics. The FDA's staff and resources haven't kept up with the food-safety work load, the congressional investigators will say.
An FDA spokeswoman said the agency will comment on the GAO testimony at the House hearing. She said the agency "appreciates the Science Board subcommittee's efforts to draft a report" and will work with the full board on the issue.
Worries about the FDA's funding have been strong enough to spark a lobbying effort, first launched in 2006, that brought together industry and patient groups, as well as former agency officials. The money appropriated for the FDA by Congress for fiscal 2008, which ends Oct. 1, was up a bit more than 9% compared with the year before, according to Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, a group that lobbies for increased agency funding.
The hearing also will highlight safety concerns that have been raised in several hearings by Michigan Democratic Reps. John Dingell and Bart Stupak, who are chairmen of the full Energy and Commerce panel and the Oversight and Investigations Subcommittee, respectively. Mr. Dingell has introduced a bill seeking to bolster inspections of imported food and drugs through new industry fees.
The medical-device testimony will say that FDA officials estimated U.S. makers of the highest-risk products are examined, on average, every three years. Domestic manufacturers of moderate-risk devices get inspected every five years. Both are supposed to be looked at every two years.
In a statement, AdvaMed, a trade group that represents medical-device makers, said the industry "has an excellent safety record" and it supports "additional appropriations for FDA."
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