Testing of generic drugs previously has been done only on a spot basis in the United States. 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 past 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, in an interview at the Generic Pharmaceutical Association annual meeting in Orlando. Before this year, “there was a very small research program — $2 or $3 million each year.”
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’s Lipitor cholesterol pill made outside of the United States, said Christopher Kelly, an FDA spokesman. Kelly wouldn’t say when the agency may complete the review.
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 and said it doesn’t have the authority to require post-market studies by generics manufacturers.
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. “We plan to post it soon.”
Among the academic centers to receive grants are Duke University in Durham, N.C., Johns Hopkins University in Baltimore, Brigham and Women’s Hospital in Boston and the universities of Florida, Michigan and Maryland. Researchers are studying how absorption, inactive ingredients and packaging affect generic efficacy, according to a partial list of grantees provided by 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, John Atwater, director for verification services at the nonprofit organization, said in an interview. Companies pay $40,000 for a manufacturing review and $10,000 for three years of testing, although 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 the Feb. 26 congressional briefing 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 in a Feb. 10 telephone interview about the FDA’s inspection efforts in India.
— Bloomberg News