Baltimore-based PharmaKinetics Laboratories Inc. pleaded guilty today to obstructing a federal generic drug investigation, and was fined $200,000 by the judge who accepted the plea.
Mark B. Perkal, a PharmaKinetics founder and the firm's former executive vice president, also pleaded guilty to an obstruction charge today at a separate hearing in U.S. District Court in Baltimore.
Perkal and defense attorney William A. McDaniel Jr. said in court that two senior Bolar Pharmaceutical Co. officials threatened Perkal's life and the lives of his family if he did not help them cover up a Bolar drug-switching scheme during investigations that led to the criminal charges.
Perkal freely admitted his guilt in court, but said he will call witnesses at his sentencing hearing Oct. 8 to testify that he participated in Bolar's scheme "under duress."
McDaniel later refused to identify the Bolar officials and refused to let Perkal answer questions about the alleged threats. "We don't have any comment about the case," the lawyer said sharply.
First Assistant U.S. Attorney Gary P. Jordan, who has guided more than 20 criminal cases tied to corruption in the generic drug industry and the U.S. Food and Drug Administration, also refused to identify the Bolar officials who allegedly threatened Perkal.
PharmaKinetics and Perkal pleaded guilty to obstructing an FDA investigation in 1989 by letting Bolar officials switch "retained samples" of drugs that the research service company tested for Bolar in the latter's quest for FDA marketing approvals two years earlier.
Lawrence G. McDade, a Justice Department prosecutor, told Judge John R. Hargrove today that PharmaKinetics had performed bioequivalency tests for Bolar on Triamterene Hydrochlorothiazide, a highly profitable generic hypertension drug that the FDA approved for public sales.
McDade said Bolar officials had substituted name-brand Dyazide the tested capsules to assure the approval.
In June 1989, a few days before FDA investigators came to PharmaKinetics to get retained samples of Bolar's products, the two senior Bolar officials came to Perkal and told him they had substituted the name-brand Dyazide for their own product in 1987, McDade said.
The Bolar officials asked Perkal to let them substitute their own product for the name-brand drug before the FDA investigators collected the samples.
Perkal at first refused, but agreed to let them make the switch after he and the insistent Bolar officials met with Perkal's rabbi in New York. The rabbi, who McDade did not name, allegedly told Perkal that if he agreed to the request he should minimize his involvement.
Perkal allowed one of the Bolar officials to switch the products the next day. He later lied about his knowledge of the product-switching to FDA investigators, officials of his own company, a congressional committee and federal investigators who were working with a grand jury here, McDade said.
Robert Plotkin, PharmaKinetics' defense attorney, told Hargrove in a separate hearing that Perkal participated in Bolar's cover-up without the knowledge of other company officials. "The [scientific] integrity of PharmaKinetics was not compromised," Plotkin said.
Jordan said PharmaKinetics should not be unduly penalized. He said the federal investigations of Bolar's product-switching were thwarted" for more than a year by Perkal's actions.