[Ip-health] Sanders, other lawmakers urge FDA approval of generic Crestor

Zack Struver zack.struver at keionline.org
Mon Jul 11 13:38:28 PDT 2016


Sanders, other lawmakers urge FDA approval of generic Crestor

JULY 7, 2016

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

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 New York
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

“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.”​

Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428

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