U.S. Atty: GSK plant probe is 'ongoing'

GlaxoSmithKline may have settled with the Department of Justice over poorly made medicines, but the government apparently isn't finished with its probe. Going by comments from U.S. Attorney Carmen Ortiz at a press conference earlier this week, the New York Times suggests that DoJ may be investigating company officials involved in the manufacturing violations.

Asked whether any individuals will be called to account in this case, Ortiz said she shouldn't comment specifically "because the investigation is ongoing," the NYT quotes. She went on to say, "The corporate aspect is finally settled. I would rather not say anything else."

Government officials have been saying that they intend to go after individuals as well as companies that run afoul of the law. They've hinted at the prospect of reviving the Park doctrine, which allows managers to be charged with misdemeanor violations of the Food, Drug and Cosmetic Act, even if there's no evidence that the officials knew what was going on.

In the GSK case, the company agreed to pay $750 million to settle a probe of manufacturing violations at a plant in Cidra, Puerto Rico, from 2001 to 2005. The plant has since been closed. The whistleblower suit that started it all blames an unidentified plant manager for several of the most egregious violations. GSK has said that it regrets the plant's mistakes.

- see the NYT piece
- get more from the Wall Street Journal
- check out the coverage in The Guardian

Suggested Articles

Colorado is making a play for a Japanese CDMO in hopes it will invest about $100 million in an empty AstraZeneca plant in Boulder.

Esperion's Nexletol has had a rough road to approval after safety concerns nearly derailed its quest. But an FDA nod has the drug ready for market.

The FDA approved Lundbeck's Vyepti, formerly known as eptinezumab, as the first IV therapy to prevent migraines in adults.