FDA: Speed Generics To Market

November 2, 2007
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ALLEGAN — The U.S. Food and Drug Administration is trying to hasten the review and approval of generic drugs so a greater number and variety of high-quality generics can be made available to consumers and health care providers. 

The FDA’s Generic Initiative for Value and Efficiency effort, announced last month, is aimed at modernizing and streamlining the generic drug approval process so lower-cost copies of brand-name drugs can get to the marketplace faster.

The GIVE plan is a compilation of initiatives. The FDA is adding to its current staff of 215 generic drug reviewers and placing heavier emphasis on the use of electronic programs for handling drug submissions. Among other things, the FDA also revised the review order for certain applications: Now, “first generic” products that have no blocking patents or exclusivity protections are identified at the time of submission for expedited review.

Sandy Walsh, public affairs specialist with the FDA Office of Public Affairs, said the FDA has been piloting some parts of GIVE for a year now, and that has led to an increase in generic approvals. The agency approved or tentatively approved a record 682 generic drug products in fiscal 2007, up 33 percent over the year before. According to the agency, the number of abbreviated new drug applications submitted has increased dramatically over the last three to four years, resulting in a growing list of pending applications.

Expedited approvals would be good news for Perrigo Co., the world’s largest manufacturer and distributor of over-the-counter pharmaceutical products for the store-brand market and the only global company with a mix of generic OTC drugs, prescription pharmaceuticals, nutritional products and active pharmaceutical ingredients. 

“More and more generic applications have been coming in, and the FDA has limited resources,” said Ernest Schenk, manager of investor relations for Perrigo. “But they have been looking at ways to improve efficiency and get more throughput, and we’re supportive of what they’re doing. They’re addressing some of the issues, they understand the problems and they have taken some steps. We hope they can make some strides, because it will help us.”

Walsh said that as of Aug. 31, there were 1,311 generic drug applications pending, half of which are currently blocked by patents or exclusivities that need to expire before they can go through the approval process. More than 60 percent of the pending applications have undergone at least one review in the Office of Generic Drugs and are awaiting response to identified deficiencies, she said. It usually takes about 17 months for an application to be approved.

Walsh would not say how many new drug reviewers will be hired in all, only that it will be an ongoing effort. The FDA’s Office of Generic Drugs recently installed a Document Filing System that allows the agency to sign off and file internal documents electronically, which should improve the agency’s efficiency in handling, storing and retrieving documents, she said.

“We are also encouraging ANDA (Abbreviated New Drug Application) sponsors to submit their applications electronically,” Walsh added. “The industry is finally realizing that this is a much more efficient way for FDA to process their applications, and we are seeing many more submitted in this format.”

Generic drugs now account for 63 percent of all prescriptions dispensed in the United States. In 2006, the average retail price of a brand-name drug was $111.02, while the average price of a generic drug was a considerably less $32.23, according to the National Association of Chain Drug Stores.

The Generic Pharmaceutical Association isn’t so sure this latest FDA effort will necessarily streamline the approval process. The association’s president and CEO, Kathleen Jaeger, said that for years the FDA has “tinkered around the edges” with programs and initiatives designed to increase efficiency in the approval system, but she said those efforts have yielded little in the way of significant results.

While the association shares the goal of increasing efficiency, Jaeger said, another initiative “in name only” will not get the job done. She said there are serious legislative and regulatory issues that must be addressed to yield a real increase in the number of affordable generics brought to market.

“What consumers need is for the FDA to address the core fundamental issues that are blocking timely consumer access to affordable generics,” Jaeger remarked. “These core issues have been around for more than a decade and include the citizen petition process, scientific consults, enhanced communication, more inspection resources, accountability and structure of the Office of Generic Drug program.”

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