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The FDA is quietly testing some drugs for generic equivalency

With GDUFA fees, the agency has been able to expand its effort
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Generics make up about 80% of the drugs U.S. consumers use, but there has long been questions about whether some of them work as well as the products they mimic. Now the FDA is finding out.

The agency since last September has been testing some generic products in labs around the country, a program it started without announcement, Bloomberg reports. Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, told the news service that the new fees generic drugmakers are paying are helping to fund the $20 million effort to expand testing.

The new effort follows the agency's finding in 2012 that a generic of Wellbutrin XL, a long-release version of the antidepressant, that was made by Teva Pharmaceutical Industries ($TEVA) did not act like the original. Teva pulled its copies, although testing of other Wellbutrin XL copies found them to be equivalent. Uhl told Bloomberg the results of the testing on the Teva product "triggered pretty substantial changes and requests for additional studies."

In addition to antidepressants, this fiscal year the FDA is looking at immunosuppressants, antiseizure medicines and drugs for treating attention deficit hyperactivity disorder, Bloomberg said. Uhl did not disclose what products are being tested and pointed out that the agency does not have the authority to require generic drugmakers to do postmarket studies. The Generic Pharmaceutical Association did not respond to a request for comment.

An independent study of generic versions of Pfizer's ($PFE) cholesterol-lowering drug Lipitor, done by Preston Mason at Brigham & Women's Hospital, found some of the generics were ineffective because of impurities resulting from the manufacturing. The FDA is reviewing that study and Brigham & Women's Hospital is one of the facilities the FDA has reached out to for testing.

A Congressional hearing is set for Wednesday to hear from Mason and others about what they are finding from foreign-made generics. FDA Commissioner Margaret Hamburg just returned from a week-long trip to India to meet with government and industry officials. Much of those meetings focused on quality drug manufacturing since the agency has in the last 10 months banned products from two plants owned by Indian generic drugmakers Ranbaxy Laboratories and Wockhardt. Analytical testing was part of the problems that led to the bans.

But Tony Mauro, the North American president of Mylan ($MYL), said it is an important issue regardless of where products are made. If questions are raised about the effectiveness of any generic, it reflects on the entire industry. "The industry as a whole always suffers when there's challenges from a quality perspective because this whole industry's foundation is about sameness of the brand," Mauro said.

- read the Bloomberg story

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