GMP disregard costs GSK $750M

The word is now out: Pharma whistleblower suits pay big. Just ask Cheryl Eckard, a former QA manager at GlaxoSmithKline who helped prosecutors build their case against the drug giant's Puerto Rican subsidiary for making and selling adulterated drugs. Her cut of the settlement is $96 million.

The Justice Department fined GSK $150 million, the largest fine ever imposed on a manufacturer of adulterated drugs, says the New York Times. The fine dispatches criminal charges.

But GSK is on the hook for another $600 million in civil penalties. By virtue of the adulteration, the drugs were not what GSK represented them to be to state and federal payers. The drug giant therefore submitted false claims to government healthcare programs.

The adulterated drugs--Kytril, Bactroban, Paxil CR and Avandamet--were manufactured between 2001 and 2005 by SB Pharmco Puerto Rico, a GSK subsidiary. The adulteration results from violation of the most basic tenets of the Food, Drug and Cosmetic Act. The act says a drug is adulterated when the facilities and methods used in making it do not conform to current good manufacturing practices.

The manufacturing plant in Cidra is now closed. It "suffered from longstanding problems of product mix-ups," the DoJ says. Tablets of one drug type and strength were commingled with tablets of another drug type and strength in the same bottle.

The medications themselves had various defects. Among them are too much or too little API and finished-product contamination. In the case of extended-release Paxil, two-layer tablets had split. The splitting may have resulted in the distribution of some anti-depressant tablets having no therapeutic effect and others having no controlled-release mechanism.

- see the article
- here's the DoJ announcement