Opinion ID: 736503
Heading Depth: 3
Heading Rank: 2

Heading: Generic Dyazide

Text: 6 In 1987, Bolar submitted an ANDA to the FDA in an attempt to obtain approval to market triamterene-hydrochlorothiazide, the generic version of the name-brand drug Dyazide used to treat hypertension. To gain approval, FDA regulations required the submission of a bioequivalence study. See 21 C.F.R. § 314.94(a)(7) (1996). Accordingly, in January 1987, the FDA instructed Bolar to supply samples of both generic Dyazide and name-brand Dyazide for bioequivalency testing at Pharmakinetic Laboratories in Baltimore, Maryland. Because Bolar had experienced difficulty in maintaining the stability of its generic Dyazide, Jacob Rivers, Bolar's vicepresident, substituted brand-name Dyazide in Bolar capsules for the FDA to test. As a result, the FDA, believing that it was testing Bolar's generic Dyazide, tested name-brand Dyazide against itself. Not surprisingly, the FDA approved Bolar's ANDA for generic Dyazide in August 1987, and sales began immediately. 7 In June 1989, Pharmakinetic Laboratories informed Shulman that it had discovered the fraudulent substitution in the bioequivalence study. Immediately, Shulman began aggressively campaigning to cover up the facts about the bioequivalence study's false samples. He flew to Baltimore with Rivers and met with Pharmakinetic Laboratories' chief scientific officer, Mark Perkal, in an attempt to conceal the fraudulent study. After Perkal stated that he had to consult with his rabbi in New York City before taking such serious action, Shulman, Rivers, and Perkal flew to New York where Perkal met with his rabbi and ultimately agreed to participate in the cover-up. The next day, Shulman had samples of the name-brand Dyazide used in the bioequivalence study removed from Pharmakinetic Laboratories' offices, and had them replaced with samples of Bolar-manufactured product. FDA investigators arrived at Pharmakinetic Laboratories two days later. 8 Despite Shulman's herculean efforts, the elaborate cover-up unraveled in January 1990. At that time, Bolar stopped selling generic Dyazide. During the time Bolar sold generic Dyazide, the company earned approximately $142 million in gross sales of the drug. From June 1989, the date Shulman admits he learned that the FDA approval had been fraudulently obtained, until January 1990 when Bolar stopped selling the drug, the company earned approximately $34 million in generic Dyazide sales.