In a pointed letter, US Senator Bernie Sanders and several other lawmakers urged the US Food and Drug Administration on Thursday to approve generic versions of the best-selling Crestor cholesterol pill. And they maintained that a successful legal challenge by AstraZeneca, which last week sued the agency to thwart lower-cost competition, would be “disastrous” for consumers.
At issue is a controversial maneuver that AstraZeneca is employing to maintain a monopoly on its Crestor franchise through 2023. In a lawsuit filed last week, the drug maker accused the FDA of illegally interpreting federal law governing product labeling. The company wants to prevent the agency from broadening the indication for Crestor, which otherwise faces generic competition after its patent expires on Friday.
The letter to the FDA, which was also signed by Elijah Cummings, a Maryland congressman and harsh critic of pharmaceutical pricing, comes as the drug maker and the FDA squared off in federal court on Thursday. AstraZeneca is seeking a restraining order to prevent lower-cost generic versions of Crestor from becoming available as early as Friday.
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Ed, we know that lips are loose in Pharma. Watson has the first approval for generic Crestor. Maybe somebody will leak the news before it’s official. Perhaps a trip up to Parsippany might be worth it. Might be a away to get the scoop.
Tomorrow (July 8) is the date when FDA may approve the many tentatively approved ANDA’s for generic Crestor. I suspect FDA will approve the ANDAs and simultaneously respond to the CP’s. At that point, or perhaps even later tonight after FDA gives AZ 24 hours notice, there will be a new lawsuit challenging the ANDA approvals and the CP denials and requesting a TRO and a Preliminary Injunction.
If the 24 hour notice applies to the first ANDA then the delivery trucks have already left Watson. Sometimes these situations literally boil down to a TRO with FDA marshals (who are licensed to carry side arms) physical preventing the trucks from unloading.