FDA Boosts Testing of Generic Drugs As Quality Concerns Mount

Amid growing reports that some generic pharmaceuticals do not act in the same manner as brand-name drugs, in some cases causing health issues, the U.S. Food and Drug Administration (FDA) has started a new program to boost testing of these drugs.

The $20 million program, which was launched with little fanfare and was first reported by Bloomberg last week, involves at least a dozen universities and academic centers. It is set to run through 2017.

In the past, only a few million dollars have been allotted annually for testing of generic drugs, FDA Office of Generic Drugs acting director Kathleen Uhl told Bloomberg. But after quality concerns prompted the recent shutdown of several generic drug plants in India, and after a 2012 study found that certain generics of the antidepressant Wellbutrin XL didn’t work the same way as the brand-name version, the FDA is taking more action. 

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Lipitor Generics Found with Impurities

Another study, conducted last year by R. Preston Mason of Boston’s Brigham and Women’s Hospital, found that generic versions of Pfizer’s Lipitor cholesterol-lowering drug manufactured outside of the U.S. contain impurities that inhibit the drug's therapeutic effect. The FDA is currently looking into Mason’s research on the drug.

The FDA believes it is taking an important first step with the new program. “The regulatory science results will provide new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products in all product categories,” FDA spokeswoman Sandy Walsh told Healthline. She added that the funding for the program came from the Generic Drug User Fee Act (GDUFA), legislation legislation that went into effect in 2012.

According to information provided by the FDA, Washington University has been awarded a grant to examine the bioequivalence of bupropion hydrochloride, the generic name for Wellbutrin. The University of Michigan was also awarded two grants related to bupropion, including one that will examine the release patterns of the drug across different doses of the drug.

Another award went to the University of Cincinnati to examine clinical and safety outcomes when patients are switched from Prograf, a drug used to prevent organ rejection after transplant, to tacrolimus, its generic version.

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Subpar Generics Could Have Negative Health Impacts

Harry Lever, a cardiologist with the Cleveland Clinic, says he has observed first-hand what happens when patients are given subpar generics. He has found that some generics made in India do not work as well as those manufactured in other countries, and he routinely switches patients off the Indian drugs.

During a December event at the American Enterprise Institute on Indian drug manufacturing, Lever explained how a patient who was on furosemide, a diuretic used to treat congestive heart failure that is manufactured by Ranbaxy, one of India’s largest drug makers, was experiencing shortness of breath. After the patient was switched to the furosemide made by another manufacturer, the patient felt better.

Lever was in Washington, D.C., in late February, along with Mason and Dinesh Thakur, a former Ranbaxy executive turned whistleblower, to brief congressional staffers on their concerns. Lever told Healthline that the problems with Indian drugs are widespread, especially with generics that are in extended or sustained-release formulation, which are designed to slowly release the drug into the bloodstream.

“When a drug goes generic, there’s no [release of the] patent on release mechanism,” Lever explained. “The generic company then has to come up with its own release mechanism.” This, according to Lever, can lead to problems.

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India Seen As Trouble Spot for Manufacturing Generics

Millions of Americans use generic drugs on a daily basis, and they account for more than 80 percent of all the prescriptions filled in the U.S. However, concerns have been mounting in recent years over the quality and safety of generics as an increasing amount of generic drugs are imported, especially from India, which is the second largest exporter of generic drugs to the U.S. and provides 40 percent of its generics.

The FDA is aware of manufacturing issues in India, given that in the last year it has banned imports made in factories there owned by Ranbaxy, and Wockhardt. All plants where drugs are exported to the U.S. are inspected by FDA officials, though the regularity of such examinations is not as often as facilities in the U.S. In May 2013, Ranbaxy pleaded guilty to charges it manufactured generics that were sub-standard and lied to the FDA about its manufacturing practices, leading to a $500 million fine.

As a means of getting India’s generic manufacturers to shape up, FDA Commissioner Margaret Hamburg went to India earlier this month to meet with generics executives and regulatory counterparts there. In a blog post, Hamburg said that although some companies stated that they were “challenged” by increased FDA inspection activity in India, she wouldn’t budge.

“I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective, and of high quality,” she said. 

However, India seems to be pushing back at the increasing attention that the FDA has been giving to its drug industry.  India’s Drug Controller General, G.N. Singh, recently told Indian business newspaper the Business Standard that “if I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those.”

The U.S. generics industry is on board with the more rigorous testing and applauded Hamburg’s India visit.

“As the industry expands global operations, it is more important than ever for the FDA… to work with its international counterparts in India and across the world,” Generic Pharmaceutical Association president and CEO Ralph Neas said in a statement. “Part of GDUFA is global inspection parity. More can be done so that patients and consumers, regardless of geography, know that when they receive generic medicines that they are receiving the same medicine with the same active ingredients at lower cost."