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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.


Here’s the back story: In May, the drug maker won FDA approval to sell Crestor to treat children with a genetic disorder called homozygous familial hypercholesterolemia or HoFH, which causes very high cholesterol. Thanks to the Orphan Drug Act, the company was awarded an extra seven years of marketing exclusivity, but only for treating this particular rare, or orphan, disease.

Several generic companies are ready to sell versions of Crestor, but AstraZeneca argues their drugs must include all pediatric labeling information approved for its own pill. The company filed its lawsuit over concerns the FDA will, instead, rely on a decision it made last year in which generics were allowed to exclude certain information, so long as a safety risk is not created. That case involved Otsuka Pharmaceuticals, which was trying to prevent generic versions of the Abilify antipsychotic.


In its lawsuit, AstraZeneca insisted the FDA’s interpretation in that case was “unlawful” and actually posed a safety risk. The drug maker contended that any generic label could be dangerous, because a doctor may still prescribe a generic for HoFH, but choose an incorrect dose, since generic labeling would not contain the same information as the Crestor labeling.

The lawmakers, however, wrote FDA Commissioner Dr. Robert Califf to say that AstraZeneca has “already enjoyed 12 years of market exclusivity for Crestor with revenues over $16 billion from Crestor in the last three years alone. Those exclusivity periods have now come to an end. Any additional regulatory exclusivity AstraZeneca has obtained under the Orphan Drug Act does not cover all uses, especially those no longer protected by patents or exclusivities.

“Pharmaceutical companies should not be permitted to block millions of patients from accessing lower cost generic equivalents at the last minute just so they can maximize their profits,” they concluded. “This would be a disastrous anticompetitive, anticonsumer result.”

And the US Justice Department defended the FDA interpretation of the law and argued the company is merely concerned with profits. “This case is a transparent and manifestly premature attempt by one of the world’s largest drug companies — AstraZeneca Pharmaceuticals — to block generic competition. This case is not about the medical needs of a small population of pediatric patients with a rare disease,” the Justice Department wrote in court papers.

“It is about AstraZeneca’s profit-driven desire to substantially extend its virtual monopoly on one of the world’s most popular medicines based on utter speculation about what the [FDA] might — or might not — do and when it might – or might not — do it. … AstraZeneca brings this lawsuit as the latest in a long line of cases in which the manufacturer of a brand name blockbuster drug product has attempted to stave off generic competition by whatever means it can dream up.”

To be sure, Crestor is a big seller. The cholesterol pill, which was first approved in 2003, generated $5 billion in sales last year out of a total of $23.6 billion, according to the company’s annual reports, and more than half of Crestor sales are made in the United States. If the FDA were to permit generic versions of the drug to be marketed, AstraZeneca would face an “irrevocable loss of approximately $400 million” by December, the company wrote in court papers.

The Justice Department, however, countered that a temporary restraining order is not warranted, because “whatever economic losses AstraZeneca might incur during the brief period before the case is decided … would comprise a miniscule percentage of its $24.7 billion annual revenues, and would not threaten or even seriously injure its business.”

  • 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.

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