BALTIMORE, JUNE 13 -- Two more defendants have been sentenced to jail terms in the ongoing bribery and fraud investigation of the Food and Drug Administration and the lucrative generic-drug industry it regulates.
Jan T. Sturm, 35, of Columbia, a former FDA consumer safety officer, was ordered jailed for 60 days and fined $5,000 after pleading guilty to accepting an illicit $20,000 gratuity from American Therapeutics Inc. for helping expedite approval of an antidepressant drug in 1986.
Mohammed Azeem, 41, a generic-drug consultant from Dix Hills, N.Y., was ordered confined to a federal halfway house for six months after pleading guilty to racketeering-related charges and giving a $2,000 illegal gratuity to an FDA employee on behalf of American Therapeutics.
The two men were sentenced here last week by U.S. District Judge John R. Hargrove.
A total of 13 defendants -- four FDA employees, five generic-drug industry executives, three pharmaceutical companies and one consultant -- have pleaded guilty in the two-year investigation by federal prosecutors and the inspector general's office of the Department of Health and Human Services.
All but three have been sentenced, several with jail terms up to a year.
First Assistant U.S. Attorney Gary P. Jordan said the investigation is continuing. Investigators said the probe, paralleling one by a House Energy and Commerce subcommittee, is expected to generate more charges.
Investigators said they are now looking into a broad range of fraud allegations, including product substitution and falsification of documents by generic-drug companies dealing with the FDA.
Generic drugs are discount versions of brand-name products whose exclusive marketing patents have expired, making them available for copying.
This has created a hotly competitive atmosphere conducive to corruption, investigators said, with companies rushing to get their generics approved and marketed.
According to court documents, Sturm accepted $20,000 in cash from former American Therapeutics president Raju V. Vegesna after providing the company with insider information to accelerate approval of its antidepressant drug Trazodone Hydrochloride in 1986.
Azeem, court papers said, gave thousands of dollars in cash to at least five FDA employees on behalf of Vegesna. Some of the employees accepted the money, according to the statement. Azeem, owner of Pharmagen Consultant Inc. of Dix Hills, also pleaded guilty to a racketeering charge in connection with an around-the-world trip he arranged on behalf of Vegesna for a former FDA chief review chemist, Charles Y. Chang.
Chang, Vegesna and American Therapeutics have pleaded guilty in the case.