A U.S. House of Representatives investigative subcommittee has asked SmithKline Beecham for documents that explain its decision to market a popular generic hypertension drug through a company that once sold similar generics for two firms that are under federal investigation in Baltimore.
Rep. John D. Dingell, D-Mich., questioned the decision of SmithKline to sell its own generic substitute in the United States exclusively through Rugby-Darby, one of the country's largest generic-drug distributors.
SmithKline is the originator of brand-name Dyazide, a hypertension drug that once was the largest-selling medicine of its kind.
Dingell, chairman of the House Oversight and Investigations Subcommittee, requested the records in a letter to Henry Wendt, SmithKline's chairman. Committee sources released the Jan. 2 letter yesterday.
Rugby-Darby sold Dyazide substitutes for Bolar Pharmaceutical Co. and Vitarine until the U.S. Food and Drug Administration discredited them and ordered the generic drugs removed from the marketplace.
Bolar and Vitarine both are under investigation by federal prosecutors in Baltimore on suspicion of product-switching and other corruption in bioequivalency tests required by the FDA.
Dingell said in a recent congressional summary of FDA-related corruption probes that Chelsea Labs, Rugby-Darby's manufacturing subsidiary, also is believed to be under federal investigation.
Chelsea Labs has voluntarily withdrawn approval applications to the FDA on at least two generic drugs, and is the manufacturer of 21 other products that the FDA is seeking to ban from the marketplace, according to Dingell's summary.
The congressman's letter to Wendt said the subcommittee is interested both in SmithKline's decision to produce a generic version of its own Dyazide and its choice of Rugby-Darby as the exclusive distributor.
NTC A subcommittee source said yesterday that SmithKline's decision to market its own generic Dyazide substitute is "anti-competitive" because it gives the company a monopoly on the hypertension drug and "the ability to continue to control the price." The source said the price of Dyazide has tripled in the last few years because SmithKline controlled its manufacture.
The source also said Dingell is interested in probing SmithKline's choice of distributors because Rugby-Darby "was right in the middle of the scandal" involving Bolar and Vitarine.
Dingell told Wendt the subcommittee "has information that SmithKline distributes abroad a better, or at least different and .. easier-to-copy formulation of Dyazide than it does in the United States."
The effect of that marketing practice, Dingell said, "has been to discourage other firms from developing and manufacturing a generic version of what was once the largest-selling hypertension drug in this country."