The $20 million effort, coming as concerns grow over the quality of products from abroad, started in September without any public notice. At least a dozen academic centers are involved in a testing program that will run through 2017, agency officials confirmed. The research this year will focus on heart drugs, ADHD treatments, immunosuppressants, anti-seizure medicines, and antidepressants. Results aren’t yet available.
Testing of generic drugs previously has been done only on an occasional basis in the U.S. The program, testing medicines made domestically and overseas, reflects a new emphasis by the FDA on the quality of copycat drugs. The agency has banned the import of treatments made at four India-based plants over the last nine months, and the FDA chief visited that country last week to talk with government officials and companies there.
New fees collected from the generics industry to fund FDA reviews, approved by Congress in 2012, enabled the agency to put more broad-based testing into action.
Ranbaxy, based in Gurgaon, India, was allowed by the FDA to sell the first generic copies of Lipitor in 2011. Wockhardt, based in Mumbai, controlled about 26 percent of the U.S. market for the generic version of the Toprol-XL, known as metoprolol, to treat high blood pressure and heart failure prior to a ban on its Chikalthana plant that makes the pill, according to Needham & Co.
Hamburg said the FDA didn’t see the need to recall the medicines sold at four banned plants in India.
“Our goal is to prevent problems from occurring when we see situations that may represent an imminent problem,” Hamburg said yesterday on a conference call about her trip to India. “We monitor adverse event reports very carefully and use that information for our decision-making.”
The FDA also is creating a new Office of Pharmaceutical Quality to improve the agency’s scrutiny of brand name, generic and over-the-counter drugs. The agency is talking with the industry to develop data that may signal which manufacturing plants are straying from standards and need inspection, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.