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Michael Phelan
Michael Phelan
Attorney • (866) 249-3164

Strenghten the FDA

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Back in the early 1990's, Newt Gingrich trumpeted his plan to eliminate the FDA and allow the food and drug industries to self-regulate. Time has revealed this to be a dangerously naive plan.

From Peter Pan peanut butter to vegetables, we've seen in just the last few years multiple examples of food contaminated with disease-causing bacteria. Foodborne illnesses are a continuing problem in this country. The American Society for Microbiology (ASM) analyzes the labs that are supposed to detect the presence of pathogens in food. The ASM recently concluded a fourteen year analysis of 40,000 food laboratories, which revealed that food laboratories are doing a poor job of detecting common disease-causing bacteria such as E. coli, Salmonella, Listeria, and Campylobacter.

The FDA is uniquely qualified to tackle this problem, and, indeed, has proposed as part of the Food Safety Modernization Act standardized methods of preventing bacterial exposure. The problem is that the FDA is in charge of food safety, cosmetic safety, drug safety, and medical device safety. The agency simply does not have enough staff and resources to handle its mission. Politicians who say otherwise put at risk the public health.

The enormity of the FDA's task and the importance of its public health role are further illustrated by the recent spate of contaminated drugs produced by compounding pharmacies. Compounding pharmacies produce sterile drugs that are typically injected or infused into the body. These drugs must be made under highly sanitary conditions. Unsanitary conditions at the New England Compounding Center resulted in a meningitis outbreak, which was linked to 53 deaths and 733 illnesses. This caused the FDA to inspect compounding labs across the country. The FDA reported last month that it uncovered safety problems at 30 of the compounding pharmacies inspected.

In a blog post to the FDA's website, FDA Commissioner Margaret Hamburg noted that four of the 30 pharmacies initially refused to admit the agency's inspectors. In two cases the agency had to return with search warrants and U.S. marshals to complete the inspections.

"These challenges and others highlight the need for clearer authorities for FDA to efficiently protect public health," Hamburg stated.

Hamburg has asked Congress to pass new laws giving the FDA explicit oversight over large compounding pharmacies. Under the proposal, large compounders would have to register with the FDA and undergo regular inspections, similar to pharmaceutical manufacturers. But the FDA proposal has faced pushback from some members of Congress, particularly House Republicans, who have been investigating whether the FDA could have prevented the meningitis outbreak using its existing powers.

It's 1994 all over again, and the House Republicans are trying to resurrect the Contract With America. The ideas that didn't work then, will not work now, e.g., denying ordinary citizens their Seventh Amendment rights to trial by jury, and weakening the FDA.