By GARDINER HARRIS
WASHINGTON, Feb. 22 - A generic version of Flonase, a popular allergy spray, was approved for sale by federal drug regulators Wednesday. The generic should be available within days, its maker said.
Flonase is one of the most popular drugs in the world, with $1.14 billion in sales last year. Sales of branded drugs often tumble more than 90 percent within weeks of the introduction of a generic version.
Officials at the Food and Drug Administration held a news conference to announce the generic's approval, the first such gathering for a decision about a generic drug in recent memory. The heightened attention may have been intended to rebut criticism in recent weeks that the agency is falling behind in its review of generic-drug applications.
"The generic-drug program is very important to the F.D.A.," said Gary Buehler, director of the Office of Generic Drugs at the agency.
The Bush administration has proposed no increase in the office's budget of $28 million for 2007, even though the number of generic drug applications more than doubled in the past five years, to 777 last year from 320 in 2001.
The agency now has a backlog of 850 applications for generic drugs, more than twice that of 2002.
Several members of a House appropriations subcommittee suggested last week to Dr. Andrew C. von Eschenbach, the drug agency's acting commissioner, that Congress might add money to his agency's generic-drug budget.
"We may be able to help you out on that," said Representative Jo Ann Emerson, Republican of Missouri.
In a speech on Friday before an audience of generic-drug manufacturers, Dr. Scott Gottlieb, the drug agency's deputy commissioner for medical and scientific affairs, suggested that generic-drug makers should consider paying fees to the agency so it could hire more staff members to reduce the backlog.
Branded-drug makers and medical device companies pay such fees.
But generic-drug makers are resisting the proposals. Kathleen Jaeger, president and chief executive of the Generic Pharmaceutical Association, said the government would have to spend only another $15 million annually to eliminate the backlog of generic-drug applications.
With federal and state governments spending hundreds of billions of dollars on drug purchases annually, such an investment would pay for itself quickly as the government could buy cheaper pills, Ms. Jaeger said. More than half of all prescriptions in the United States are filled with generic drugs, and the sales of such drugs rose 21 percent last year, according to I.M.S. Health, a drug information company.
The generic-drug industry would consider fees if the drug agency would "close unintended loopholes and regulatory abuses" that delay the introduction of generic drugs by months and years, Ms. Jaeger said.
Such action is unlikely, however, because the agency has little control over some delaying factors, including the patenting of many aspects of a drug's manufacture and use.
Flonase is a case in point. GlaxoSmithKline, the British drug giant that makes Flonase, filed two "citizen petitions," each with supplements, asking the agency to consider or reconsider various aspects of the approval process. Other parties filed at least two such petitions.
The agency was required to consider the petitions and to write responses. That took time and delayed the approval, Mr. Buehler said.
Mary Anne Rhyne, a spokeswoman for GlaxoSmithKline, said the company was considering legal action. Ms. Rhyne would not say whether the target of those actions would be the agency or the generic's maker, Roxane Laboratories.
Mark Vincent, a spokesman for Boehringer Ingelheim, which owns Roxane, said the company began shipping the generic version of Flonase on Wednesday.
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