FDA Seeks Removal of 2 Dozen Generic Drugs
WASHINGTON — In another move aimed at cleaning up the scandal-ridden generic drug industry, the Food and Drug Administration has notified two generic drug companies that it intends to seek the removal of more than two dozen of their drugs from the market because of suspected fraud, The Times has learned.
In letters to the two companies, copies of which were obtained by The Times, the FDA said that it was taking the action because “untrue statements, discrepancies and omissions exist” concerning the production and testing of lots “used to support approval of the applications.”
The companies are Quantum Pharmics Ltd., and Superpharm Corp., both of Long Island, N.Y. The drugs include generic versions of the brand-name sedative Valium and blood pressure products, but numerous other generic versions of the brand-name drugs still remain on the market.
As a first step toward eventual removal, the FDA said it intends to change the “therapeutic equivalence” code for all of these products--a change of rating that essentially alerts pharmacists that these drugs no longer can be substituted for their brand-name equivalents.
A spokesman for Quantum said that the company already has recalled most of these drugs voluntarily. Quantum is owned by American Home Products, a leading manufacturer of brand-name drugs.
“The company itself has been investigating because it appeared that a number of these products were approved on the basis of false information filed by prior management,” before Quantum was acquired by American Home Products, said James Fingeroth, a spokesman for Quantum.
In September, American Home Products temporarily shut down its Quantum operation when allegations first began to surface that the company had falsified data in winning approval for some of its drugs. The FDA was investigating the firm at that time.
Superpharm said in a statement that it has been “cooperating fully” with the ongoing investigation of the industry, and “to our knowledge, there is no evidence that Superpharm . . . intentionally submitted false or misleading data to the FDA.”
The statement added: “As a matter of fundamental corporate policy, Superpharm will only produce products according to the highest pharmaceutical standards.”
The FDA said that its decision does not represent a final determination but that it could no longer “advise the public in good faith that the products are therapeutically equivalent to their listed counterparts. . . .”
The generics industry has been the subject of a growing federal inquiry conducted by the U.S. attorney in Baltimore and by Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee and of its oversight subcommittee.
The scandal began some months ago with revelations that chemists in the FDA’s generics division had accepted bribes from industry officials in return for speeding the approval of generic drugs.
Dingell’s oversight subcommittee has scheduled the last of its planned hearings on the generics industry today with testimony from outgoing FDA Commissioner Frank E. Young.
