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Priorities, staffing impede oversight

By John Diedrich and Ben Poston, Milwaukee Journal Sentinel –

MILWAUKEE — The U.S. Food and Drug Administration is required to inspect drugmakers every two years, but the Milwaukee Journal Sentinel found more than a thousand drug firms that have not been inspected for five years or more.

Examining inspection data since 1999, the newspaper found a similar pattern with medical device makers, but Congress does not require the agency to inspect those firms every two years. There is no set time period on when device makers should be inspected.

FDA officials did not dispute the newspaper’s findings, but said not all drug plants deserve the same oversight.

David Elder, director of the FDA’s Office of Regional Operations, said the agency would focus on a prescription drugmaker over firms that repackage drugs or those that test materials for quality.

“We cover the industry as well as we can with the available resources,” said Elder. “I don’t think there is a large gap in our areas of coverage that has a public health impact.”

The agency uses a risk-based approach to decide which locations to inspect. The FDA says it considers type of product, previous violations and recalls, along with the time since the last inspection in deciding which locations to inspect.

“If a company has a decent compliance history and no changes in ownership, they might not have been (inspected),” Elder said, “We have to look at the risk factors. As we look at all different firms, if we get into one of those (not inspected for years), we are not getting into another location. We have to allocate our resources the best we can to address the risk.”

The agency’s number of inspectors has climbed in recent years but is still not enough to get to all plants, officials said.

Industry observers say the agency tends to target large operations while sometimes missing smaller ones.

“Industry has proven time and time again we are no angels and there is a segment that will do whatever they can to increase profits,” said Scott Sutton, a microbiologist who runs a consulting firm and advises cosmetic and drug firms.

“There is a strong sense that many ethical companies are being held to very high standards of documentation practice, which may have minimal effect on the finished product, while other manufacturing facilities are going unchecked.”

FDA gets to even fewer cosmetic firms. The agency inspects about 115 cosmetic firms a year, in the United States and overseas, the Journal Sentinel’s analysis shows. FDA has authority over plants that produce products brought into the U.S.

The agency doesn’t know how many cosmetic firms there are because registration is voluntary. The FDA estimates there are 1,150 domestic cosmetic firms, plus an unknown number overseas. Industry observers suggest the number could be closer to 5,000 in the U.S. alone.

Elder said the risk is lower with cosmetics, and the law does not require specific manufacturing standards as it does with drugs, devices and food. The law also does not require cosmetic companies to tell the FDA of a serious illness or injury suspected of being caused by their product.

Along with other groups, the Personal Care Products Council, which represents the cosmetics industry, has lobbied to create tougher standards, among others. Congress did not act on a bill to do so in 2009.

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