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rug makers generally don’t complain when regulators widen the market for their medicines. But AstraZeneca filed a lawsuit on Monday claiming the US Food and Drug Administration is on the verge of illegally broadening the indication for its best-selling Crestor cholesterol pill, and the move would unfairly allow generic competition.

The argument, which the company also made late last month in a citizen’s petition, hinges on the interpretation of federal law governing product labeling. Depending upon the outcome, AstraZeneca may either maintain a monopoly on Crestor for another seven years or face lower-cost rivals to a key revenue stream when the Crestor patent expires on July 8.

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

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This is where things get tricky.

Several generic companies are lined up to sell a version of Crestor. AstraZeneca argues that a generic must include all pediatric labeling information approved for the corresponding brand-name drug. The company filed its lawsuit over concerns that the FDA will, instead, rely on a decision it made last year allowing generic companies to exclude certain information, so long as a safety risk is not created. The case involved Otsuka Pharmaceuticals, which was trying to prevent generic versions of the Abilify antipsychotic.

In both its petition and its lawsuit, AstraZeneca maintained that the FDA’s interpretation in that case was “unlawful” and would, in fact, pose a safety risk if applied to Crestor. How so? 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 the generic labeling would not contain the same information.

By allowing generic drug makers to market their lower-cost versions without the corresponding product labeling information, “there are substantial risks that doctors would over- or undertreat pediatric HoFH patients if [a] generic version omitted” the Crestor labeling information, according to the citizen’s petition the company filed with the agency.

Moreover, AstraZeneca maintained that it faces “an imminent risk” of harm to revenues and market share if generic versions can be sold without all of the Crestor labeling. Crestor has been the company’s biggest-selling product, generating $5 billion in sales last year out of a total of $23.6 billion, according to its annual report, and more than half of Crestor sales are made in the United States

Even though the FDA has not yet responded to the citizen’s petition, AstraZeneca probably filed the lawsuit now “because they want to try to avoid having to put the genie back into the bottle if FDA approves [generic versions of Crestor] on July 8 and manufacturers launch” their pills,” said Kurt Karst of Hyman Phelps & McNamara, who quarterbacks the FDA  Law Blog. An AstraZeneca spokeswoman confirmed this is the strategy.

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Some see the legal filings, however, mostly as a maneuver to protect sales, especially since the company only began testing Crestor for children with HoFH in 2014, according to its citizen’s petition. Critics contend AstraZeneca viewed the rare disease as an opportunity to reap the benefits of the marketing exclusivity conferred by the Orphan Drug Act.

“It’s not about finding a way to treat children who have rare diseases, it’s a way to extend [the] life of a brand-name drug,” said Walid Gellad, an associate professor of medicine and health policy at the University of Pittsburgh. “AstraZeneca — and society — would be better off putting the money being spent on the lawsuit into researching new drugs.”

The AstraZeneca spokeswoman wrote us that the drug maker “believes federal law entitles the company to an additional exclusivity period of seven years for Crestor in the US.”

In a paper issued last fall in the American Journal of Clinical Oncology, a team of researchers argued that drug makers are exploiting loopholes in the Orphan Drug Act that allow them to widen the market for such drugs and distorting the original purpose of the law.

Gellad also noted that existing Crestor patients may suffer if lower-cost generics are prevented from becoming available. He pointed to a new study in JAMA Internal Medicine showing that a six-month delay in the availability of generic versions of the Lipitor cholesterol pill prevented consumers from benefiting from lower out-of-pocket payments.

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  • Crestor, ha sido el único medicamentó que me ha favorecido para mantener mis lípido estable. He probado con otras medicamentos y he tenidos efectos secundarios y agudos. Soy paciente de fibrilación atrial y estos van combinados con anti arrítmicos e hipertensión y anticoagulante. Lamentablemente para estar en salud uno de lo más importante es el Crestor y obviamente hacer una dieta. Me encantaría que me dijeran si hay ayuda al paciente para poder comprarlos a ustedes con un costo más bajo una vez que mi cubierta de mi plan médico sobrepase el límite. Vivo en Puerto Rico, y aquí los deducible son sumamente costoso. Necesito que me ayuden, una vez más gracias Les hago llegar mi E-mail. Eirr13@gmail.com , Mi nombre es Elena Reyes, 1-787-309-8926. Bonito dia.

  • Ed, I would suggest an additional strategy by AZ for filing the lawsuit. The review date on the Citizen Petition is June 21st and there is no way, except in a health emergency that FDA would rule within the 17 day window between review and the ANDA approval date of July 8th. The FDA, in my experience, given the backlog on the docket takes 6-12 months and so would be perfectly justified in letting the petition lapse. AZ simply waited too long to start their pediatric trials. Lawsuits don’t get resolved too quickly either. If the suit approach doesn’t pan out third arrow in the AZ quiver will be to seek a restraining order against the generic companies with pending approvals preventing them from shipping generic Crestor from their plants while the lawsuit is pending. The best part is when the lawsuit fails the generic companies can seek treble damages. That will set AZ back a billion or more. Next two weeks should be interesting. Keep us posted.
    PV1

    • Hi Pharmvet1,

      The scenario you suggest could well happen and, if it did, it would certainly be interesting. The company asked for an expedited briefing schedule to beat the July 8 deadline, but… Even then, it just buys time.

      Thanks for stopping by,
      ed

  • Here is how this will be legally resolved. The generic companies don’t care about pediatric HoFH labeling. The court will allow AZ to keep seven year exclusivity for rye indication but with generic label carve out to say “not been studied in patients under 18. This is a desperation move. In addition thus would be a claim with no sales because all of these kids would be put on a combination of a generic statin and a PCSK9 inhibitor.

  • The assumption that MDs are not able to make simple math in deciding the dosage is all considered not so far fetched!

    • The real question is how has AZ sold $5 billion worth of pills into genericized market.

  • This soinds like Flonase all over again. I would urge AZ’s lawyers to look carefully at the abuse-of-process rulings in that case. Flonase had to pay hundreds of millions in damages for filing a phony Citizens Petition – and that is exactly what AZ did here. They will be laughed out of court, and end up paying through the nose for their arrogance. That junk doesn’t work anyway.

    • we have had enough of these drug companies, hope they loose big. they are stuffing the exec’s pockets with cash, not their research budgets

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