02/22/2014
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A program that is testing medicines made domestically and overseas reflects a new emphasis by the Food and Drug Administration on the quality of copycat drugs.
The Food and Drug Administration has begun the nation's first widespread testing program for generic drugs, which make up almost 80 percent of U.S. prescriptions.
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. Neither the Creighton University Medical Center nor the University of Nebraska Medical Center is part of the testing.
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.
While the agency long wanted to test generics, “we didn't have money for that,” said Kathleen Uhl, acting director of the FDA's Office of Generic Drugs.
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, Uhl said.
The FDA is reviewing a 2013 study by a Boston-based researcher that found widespread impurities in copies of Pfizer Inc.'s Lipitor cholesterol pill made outside of the U.S., said Christopher Kelly, an FDA spokesman. Kelly wouldn't say when the agency may complete the review.
As late as this week, the agency said generics generally meet “rigorous standards” for quality, purity and potency, though it acknowledged reports that some people may experience an undesired effect when switching from some brand-name drugs to generic versions.
The FDA didn't specify which medicines.
The new program by academic centers wasn't publicized because “it took us a bit of time to compile all of the various awards into one list,” said Sandy Walsh, an FDA spokeswoman.
Among the academic centers to receive grants are Duke University in Durham, North Carolina, Johns Hopkins University in Baltimore, Brigham & Women's Hospital in Boston and the universities of Florida, Michigan and Maryland.
Researchers are studying how absorption, inactive ingredients and packaging affect generics, according to the FDA.
Other, more limited, testing efforts do exist. The U.S. Pharmacopeial Convention, based in Rockville, Md., has programs run mainly in India and China that ensure ingredients are made properly and that test product purity, said John Atwater, director for verification services at the nonprofit organization.
Companies pay $40,000 for a review and $10,000 for three years of testing, though consumers have no way of knowing which drugmakers take advantage of the programs, he said.
Medical professionals have become increasingly vocal about their concerns about the quality of drugs made overseas.
Harry Lever, a Cleveland Clinic cardiologist, has said he will tell lawmakers in congressional briefings Wednesday that generic medicines made by India-based companies for heart failure often don't work the way they should, opening questions about the FDA's ability to keep track of that country's growing copycat-drug business.
“It's like taking a platoon to fight a huge army,” Lever said about FDA's inspection efforts in India.
Tony Mauro, the North American president of Mylan Inc., the largest U.S. generic-drug manufacturer, said problems with quality have a negative effect on all generic-drug makers, no matter where they're located.
“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.
The FDA's new widespread testing program follows a 2012 agency finding that copies of Wellbutrin XL, an antidepressant, didn't work as well as the original. The agency's research led Teva Pharmaceutical Industries Ltd. to withdraw its version from the market in 2012.
The Lipitor study being reviewed by the FDA was done by Preston Mason at Brigham & Women's Hospital.
The research found that some copies of the cholesterol drug produced overseas were rendered ineffective as a result of manufacturing impurities.
The FDA also is creating an Office of Pharmaceutical Quality to improve the agency's scrutiny of brand name and over-the-counter drugs, along with generics.
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