Some researchers contend that because of quality and manufacturing shortcomings, at least some generic drugs made outside the U.S. don't work as well as the branded drugs they copy. A congressional hearing Wednesday will hear what they have to say, but the FDA is already looking deeper into equivalency with a $20 million program that has been underway for months.
The agency has been testing some generic products in labs around the country, a program it started without announcement, Bloomberg reports. Kathleen Uhl, acting director of the FDA's Office of Generic Drugs, told the news service that the agency had been able to expand a very limited program with the new fees generic drugmakers are now kicking into the FDA.
For years, some doctors have contended they were not getting similar results in their patients when they moved them to certain generic drugs. The most prominent case involved a generic of Wellbutrin XL, a long-release version of the antidepressant that was manufactured for Teva Pharmaceutical Industries ($TEVA) by Impax Laboratories. Teva defended its product for years but finally pulled it from the market in 2012 when the FDA contended testing found it did not act like the original. Uhl told Bloomberg the Teva findings "triggered pretty substantial changes and requests for additional studies."
In addition to antidepressants, the FDA is looking at immunosuppressants, antiseizure medicines and drugs for treating attention deficit hyperactivity disorder this fiscal year, Bloomberg said. Uhl did not disclose what products are being tested and pointed out that the agency does not have the authority to require makers of generics to do postmarket studies. The Generic Pharmaceutical Association did not respond to a request for comment.
Preston Mason, a researcher at Brigham & Women's Hospital, conducted an independent study of generic versions of Pfizer's ($PFE) cholesterol-lowering drug Lipitor. Published last year, it 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. Ranbaxy Laboratories, the Indian company that has had a lot of problems with the FDA, released the first generic version of that drug, but many other companies now make it.
At the congressional hearing on Wednesday, Mason and others will voice their opinion of foreign-made generics. FDA Commissioner Margaret Hamburg just returned from a trip to meet with government and industry officials in India, a country that now produces about 40% of the generics and over-the-counter drugs U.S. consumers use. Much of those meetings focused on quality-drug manufacturing, since in the last 10 months the FDA has banned products from two plants owned by Ranbaxy and two owned by Wockhardt. Problems with analytical testing partly contributed to the agency's decision.
- read the Bloomberg story