FDA launches project to cut quality control lapses at drugmakers

Print 14 January 2015
Toni Clarke / Reuters

(Reuters) - The U.S. Food and Drug Administration launched an initiative on Monday aimed at reducing lapses in quality control at pharmaceutical manufacturing facilities.

Dr. Janet Woodcock, head of the FDA's pharmaceuticals division, said at a news conference that the project, some 10 years in the making, is designed to establish consistent quality standards for all drugs, whether brand name or generic.

The FDA has established an Office of Pharmaceutical Quality that will be responsible for some 10,000 decisions a year and manage the process.

Drugs currently being evaluated for approval will remain with their existing review team at the FDA. New applications will be filed with the new office beginning immediately, Woodcock said.

Under the new structure, drug companies can expect a more integrated review and greater communication with the agency, she said.

The FDA will propose a set of quality metrics for drugmakers. After a public comment period the agency will produce a final rule. Woodcock was not able to give any time-frame for when that might be.

Between 2013 and 2014, the number of drug recalls fell by 20 percent, and the Class I recalls, the most dangerous to public health, fell by 30 percent, according to Todd Harris, vice president of recalls at recall-manager Stericycle Inc.

Still, the absolute numbers remain eye-catching.

The average annual number of recalled units between 2010 and 2012 was 225 million, Harris said. The number between 2013 and 2014 was roughly 70 million units.

"While we can't say explicitly the cause of the downward trend, what we do know is that there is a trend of increasing regulatory scrutiny, which may cause manufacturers to adhere to stricter quality guidelines," Harris said.

Over the past year the FDA banned numerous generic drugs from India, citing quality control problems ranging from data manipulation to sanitation. India supplies roughly 40 percent of generic and over-the-counter drugs used in the United States.

Brand name drug companies have not immune either. Johnson & Johnson, for example, has been forced to recall dozens of products over the past few years, ranging from artificial hips to children's Tylenol.

Up until now, Woodcock said, the FDA has only had a general sense of the state of manufacturing quality at the country's drugmakers. Now, she said, the FDA will have quantitative information.

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