A former Vitarine Pharmaceuticals Inc. official has been charged with three federal false-statement counts tied to substitutions of name-brand drugs for Vitarine's generic products in tests required by the U.S. Food and Drug Administration.
Steven Colton, Vitarine's former vice president and research-development director, was charged Wednesday in a criminal information document, which suggests that he has agreed to plead guilty.
He is scheduled to appear May 13 before Judge John R. Hargrove in U.S. District Court in Baltimore, court officials said.
The criminal information, filed by First Assistant U.S. Attorney Gary P. Jordan, says Colton submitted false statements to the FDA for the generic products verapamil hydrochloride, an angina medication; triamterene hydroclorothiazide, a hypertension medicine; and albuterol sulfate, an asthma medication.
The information document charges that Colton willfully submitted the false applications to the FDA, knowing that name-brand products had been disguised and substituted for Vitarine products in the FDA-required tests.
Colton, who was fired from Vitarine in 1989, now lives in Colorado. He could not be reached for comment on the charges.
He is the 18th defendant to be charged in a continuing, 2-year-old federal investigation of the generic drug industry by prosecutors in the U.S. attorney's office here.
Vitarine, based in Spring Garden, N.Y., was the first generic drug company to be identified as substituting name-brand "innovator" drugs for its own products in bioequivalency testing required by the FDA to show that the generic substitutes met safety and effectiveness standards.
According to information published by the congressional oversight committee chaired by Rep. John D. Dingell, D.-Mich., at least five Vitarine drugs were the subjects of such substitutions. Those drugs included a generic substitute for SmithKline Beecham's Dyazide, a popular hypertension medication.
Dingell, whose committee held hearings on Vitarine's activities in September 1989, has said publicly that Vitarine submitted "numerous ...apparently fraudulent and false statements" to the FDA in support of its Abbreviated New Drug Applications, or ANDAs. Dingell said two other former Vitarine employees and the firm itself are believed to be targets of the federal investigation in addition to Colton, who supervised Vitarine's product formulation and the building of a large generic product inventory.
Vitarine contested FDA attempts to withdraw what Dingell called "tainted" approvals of the company's generic drugs. But the firm withdrew its application for approval of its Dyazide substitute, and the FDA withdrew nine other Vitarine applications.
The FDA also has given the company notice that it will conduct withdrawl hearing on 20 other Vitarine generic drugs.