Bloomberg News

Generic Drugs May Get Faster Review Under New Rules

October 04, 2007

Generic drugs, priced 30 to 80 percent less than their brand-name counterparts, may get faster reviews under new policies designed to handle hundreds of backlogged applications, U.S. regulators said.

The Food and Drug Administration said today that it is bolstering its generic-drug program by giving priority to decisions on products that are the first of their kind, and by giving applicants more feedback. The policies, some already in place, were designed to shorten the queue of more than 1,300 drugs awaiting approval.

Lack of resources has prevented the FDA's Office of Generic Drugs from keeping pace with the growing number of applications for copies of medicines whose patents expired or were challenged. Consumer groups and generic-drug makers such as Teva Pharmaceutical Industries Ltd. (TEVA) and Mylan Inc. (MYL:US) say Americans need better access to affordable medicines as health-care costs soar.

``Another initiative in name only simply will not get the job done,'' said Kathleen Jaeger, president of the Generic Pharmaceutical Association, a trade group in Arlington, Virginia. The agency must address ``the core fundamental issues'' blocking drugs from the market, such as brand-name companies' use of so- called citizens' petitions to delay action, she said.

The FDA approved or tentatively cleared a record 682 generic drugs in the fiscal year ended Sept. 30, up more than 30 percent from the prior year, the agency said today in a statement. The backlog of applications awaiting final action has increased as submissions come at a quickening pace, said Gary Buehler, director of the FDA's Office of Generic Drugs.

The agency now takes 16 to 17 months to review an application.

`Working Very Hard'

The Office of Generic Drugs ``is working very hard to address the number of applications that we have,'' Buehler said today in a conference call. Streamlining operations will help ``sustain this increase in productivity'' within the agency's budget, he said.

The new policies include priority reviews for drugs that are the first of their type and aren't subject to litigation. Previously, the agency reviewed applications in the order they were submitted. The FDA is also shifting to electronic data submission and communications and plans to give more feedback to the industry about how applications should be designed.

The agency's proposed budget for the current fiscal year included $5.6 million in additional funds for new staff and more resources to review applications. The FDA also wants to start charging generic companies to review applications, with fees similar to those now paid by brand-name drugmakers. In exchange, the regulators would guarantee timely decisions.

Teva, of Petah Tikva, Israel, is the world's biggest seller of generic drugs, according to data compiled by IMS Health Inc. Sandoz, a unit of Basel, Switzerland-based Novartis AG (NOVN), ranks second, and Canonsburg, Pennsylvania-based Mylan is third.

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

To contact the editor responsible for this story: Robert Simison at rsimison@bloomberg.net.


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  • MYL
    (Mylan Inc/PA)
    • $46.25 USD
    • 0.22
    • 0.48%
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