FDA loosens pharmaceutical regs

FDA loosens pharmaceutical regs
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The Food and Drug Administration (FDA) is loosening the regulatory controls for 13 pharmaceutical companies that will receive expedited entry for drugs they are importing into the United States.

As part of an FDA pilot program, these "highly vetted" companies will receive more responsibility for keeping their own supply chains in line so the agency can focus more attention on preventing other, unapproved drugs that are misbranded and adulterated from crossing the border. 


In return for participating in the Secure Supply Chain Pilot Program, these companies will receive expedited entry for up to five drugs that they import into the country.

"We're still going to be looking at them, but we have a greater degree of confidence that their drugs are not going to need to be as thoroughly vetted as others," FDA spokesman Christopher Kelly said.

The FDA plans to reallocate some of the imports surveillance resources that it was using to monitor these companies to focus on catching importers that are trying to sneak higher-risk drugs into the market.

These companies that will be regulating their own supply chains have agreed to comply with requirements from the Food, Drug and Cosmetics Act. They will be required to maintain control of their drugs from the manufacturing process all the way through their entry into the U.S.

The FDA has certified that these companies have procedures in place to deal with problems that could arise, such as recalls and acts of terrorism against the nation's drug supply.

The pilot program will run for two years, during which time the FDA will evaluate its effectiveness. Afterwards, the FDA will consider expanding the program to include more pharmaceutical companies.

"We're still going to keep an eye on everything that's coming in," Kelly said. "We're going to maintain oversight on them. They'll still be under our regulatory guidelines. If a compliance issue comes up, we'll be able to review it immediately. And if there's a serious compliance issue, we can remove them from the program."

The FDA announced the pilot program last August, and said it was looking for a handful of pharmaceutical companies that wanted to participate.

The agency announced Tuesday which companies had been selected for the program. They include AbbVie Inc., Allergan Inc., Astellas U.S. Technologies Inc., Bristol-Myers Squibb Company, Celgene Corporation, GE Healthcare Inc., GlaxoSmithKline LLC, Merk Sharp & Dohme Corporation, Mylan Pharmaceuticals Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., Teva Pharmaceuticals USA Inc. and Watson Laboratories Inc.