Ed Silverman

The Ranbaxy whistleblower and the scheme to fool the FDA

Earlier this week, the feds finally reached closure with Ranbaxy Laboratories with a $500 million deal to settle criminal and civil charges for a serious and widespread manufacturing ruse. The generic drugmaker was charged with using raw chemicals from unapproved sources, fabricating in-house test data to meet FDA standards and concealing these activities from FDA inspectors by falsifying records (back story).

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China changes patent laws to get cheap drugs

In a step that is likely to unnerve global drugmakers, China has overhauled parts of its intellectual property law to allow its domestic pharmaceutical industry to make low-cost versions of medicines under patent protection, Reuters reports. The amended Chinese patent law allows Beijing to issue compulsory licenses to eligible companies to produce generic versions of patented drugs during state emergencies, unusual circumstances or in the public interest.

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