FDA tightens standards to prove generics can be swapped

FDA tightens standards to prove generics can be swapped

October 31st, 2011 // 11:59 am @

Generic-drug makers such as Mylan Inc. will have to meet tighter standards to prove their blood- thinners and anti-seizure treatments work as well brand-name products, U.S. regulators said.

The Food and Drug Administration, responding to complaints that some copies don’t work as well as the originals, is writing guidelines for limits companies must follow that include how fast active ingredients are absorbed in the bloodstream.

The FDA is outlining its plans to companies after patients and employees of generic-drug makers complained to regulators that some of the medicines don’t work as well as the originals.

Regulators are focusing on so-called narrow therapeutic index drugs made by companies such as Mylan, Hospira Inc. and Novartis AG’ Sandoz unit, in Basel, Switzerland. They include the blood-thinner warfarin, digoxin for heart failure and anti- seizure medication phenytoin.

“Ideally, they should start using them now,” said Lawrence Yu, deputy director for science and chemistry in the agency’s Office of Generic Drugs, in an interview about the new standards.

Generic drugs accounted for 78 percent of all U.S. prescriptions in 2010 and saved $158 billion over brand-name counterparts, according to IMS Health, a market research company. More prescriptions are filled with lower-cost generic versions of medicines as insurers try to cut costs and name-brand drugs lose patent protection.

“While it’s onerous, I think it’s something that if FDA didn’t think they needed it, I don’t think they’d impose tighter standards,” said David Rosen, co-chair of the life sciences industry team at Foley & Lardner LLP.

Though most manufacturers already comply with the standards, consumers are wary of swapping brand-name medicines for generics, Yu said.

“There’s a skepticism out there,” Yu said. “This will improve the public confidence in the quality, safety, efficacy and most importantly the switchability of new products.”

Brand-name drugs stay on the market an average of 12.8 years before facing generic competition. By the end of their first year, some generics can capture almost 60 percent of market share.

Equivalency studies can cost as much $500,000 and typically require testing on 24 people, Rosen said. Evaluations to meet the stricter standards could involve as many as 60 people, he said. Companies with approved products may have to retest them to meet the tighter standards, though it’s unclear how many will be affected, Yu said.

The Generic Pharmaceutical Association, the industry’s Washington lobby group, will work with the FDA to develop the guidelines, said David Belian, a spokesman. Nina Devlin, a spokeswoman for Mylan, the biggest U.S. generic-drug company, wouldn’t comment.

The FDA has traditionally approved a generic drug if the rate of absorption of its active ingredient is as low as 80 percent or as high as 125 percent the rate of the brand-name drug. The agency is now requiring a rate between 90 percent and 111 percent from narrow therapeutic index drugs, Yu said.

A generic drug’s potency will also have to fall within 95 percent and 105 percent of the original, Yu said. Currently, drugs can fall within a range of 90 percent to 110 percent.

The FDA plans to release guidelines on the stricter standards, Yu said, declining to say when.

Anti-seizure medications face scrutiny from the FDA and the National Institutes of Health after patient and health providers criticized the generic versions’ effectiveness treating epilepsy and questioned whether some treatments could allow breakthrough seizures.

Generic nervous-system medications, which include anti-seizure drugs, generated $250 billion in health-care savings from 1999 to 2008, the most of any class of drugs, according to the generic-drug industry lobby group.

A Consumer Reports poll of 1,226 adults in June showed 39 percent of respondents had concerns or misconceptions about generics while 21 percent thought the copies weren’t as effective as brand-name products. Twenty-one percent didn’t trust generics as much as brand-name drugs and 14 percent said they didn’t think the products were as safe.

Pharmacists “hope that FDA tightening the standards does in fact help alleviate some consumer skepticism about generics,” said Chrissy Kopple, a spokeswoman for the National Association of Chain Drug Stores, a trade group.

Rosen, who served as the senior generic drug official at the FDA in the 1980s, expects the agency to impose the tighter guidelines on approved drugs that don’t meet the criteria when companies make routine manufacturing or packaging changes.

“People change lots of things about a product as they come up,” he said.

A new equivalency study would require several months to test the product against the original version, Rosen said.

The FDA held an advisory panel meeting July 26 on the issue during which patients and providers spoke about generic drugs that didn’t work.

The FDA could not provide the cost to review each generic application because it varies based on where manufacturing facilities are located and the complexity of the application, Sandy Walsh, a spokeswoman, said in an e-mail.


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