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Firm Admits Giving FDA Wrong Drug : Other Company's Product Submitted for Generic Test

June 30, 1989|From Reuters

WASHINGTON — A New York drug company acknowledged today that it gained federal approval to market a popular generic high blood pressure drug by submitting another firm's product for government testing.

Vitarine Pharmaceuticals Inc. of Springfield Gardens, N.Y., has informed the Food and Drug Administration that it gained agency approval for a copycat version of the blood pressure drug Dyazide by putting the brand name version of the drug in its capsules and submitting these for FDA evaluation, Roger W. Jordan, Vitarine chief executive officer, told Reuters.

"We have brought this matter to the attention of the Food and Drug Administration and we're actively investigating the matter to determine the facts and the circumstances," Jordan said, adding that the firm was cooperating fully with the FDA.

Product Compared to Itself

"The FDA's approval of Vitarine's generic version was based on a study in which SmithKline Beckman's product was compared to itself," charged Rep. John D. Dingell (D-Mich.), who chairs the House Energy and Commerce Committee's investigations subcommittee, which has been investigating the FDA's generic drug approval procedures.

Dingell, in a letter to FDA Commissioner Frank Young, said the disclosure "raises serious concerns" about procedures at the federal drug safety agency.

He said the subcommittee was aware of four other cases in which Vitarine had passed off other firms' products as its own for FDA testing, though he said none of these was now on the market.

The brand-name version of Dyazide is made by SmithKline Beckman Corp. of Philadelphia, which had no immediate comment.

The drug safety agency said it was probing the matter and would have no other comment at this time.

'Ongoing Investigation'

"The FDA is in the middle of an ongoing investigation of Vitarine and it would be improper to comment any further at this point," agency spokesman Jeff Nesbit said.

Vitarine's Jordan said the substitution had been done without his knowledge.

"We're going into every nook and cranny to determine the facts and circumstances, and whatever we find we're turning over to the FDA right away," he said in a telephone interview.

Off-brand versions of Dyazide, sold by several drug companies, make it the largest-selling U.S. generic drug. The drug combines a chemical that fights high blood pressure with another compound that rids the body of excess fluids.

Industry estimates put U.S. sales of both the generic and brand-name versions of Dyazide at over $300 million a year.

Licensing Procedure

Generic drugs are copycat versions of well-known, brand-name prescription drugs that are marketed after the original maker's patent protection has expired.

Before a generic version of a drug can be sold, it must go through a special FDA licensing procedure intended to speed it onto the market to promote industry price competition.

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