FDA Let Off the Hook for Genzyme Drug Shortage

WASHINGTON (CN) - The Food and Drug Administration need not face claims that it helped create a shortage of a treatment for life-threatening Fabry disease, a federal judge ruled.

Fabry disease is caused by a faulty or missing enzyme needed to metabolize fats, resulting in lipid accumulation in blood vessel walls.

Sanofi-owned Genzyme offers a treatment for the disease called Fabrazyme, but a group of users claimed in a February 2012 complaint that the government had given the drugmaker a pass to create a Fabrazyme shortage.

Genzyme was not named as a defendant to the federal complaint against the FDA, the Department of Health and Human Services, the National Institutes of Health, the Mount Sinai School of Medicine, and top officials in the federal agencies.

The 25 plaintiffs, 13 of whom sued anonymously, claimed that the shortage denied them interstate access to Fabrazyme.

U.S. District Judge Beryl Howell dismissed the action on Thanksgiving Eve, however, noting that it tended "to obfuscate the relevant facts of this matter, as it mixes facts, legal arguments, and political and social theory, often in the same paragraph."

"As the defendants point out '[t]he precise nature of the claims in plaintiffs' ... complaint is often difficult to discern," Howell added.

In the complaint , lead plaintiff Joseph Carik, who has a doctor's prescription for Fabrazyme, claimed that "FDA consent" banned him from interstate access to FDA-approved doses of Fabrazyme during the Genzyme-created drug shortage.

"Plaintiff is instead forcibly injected with a diluted, unregulated, unapproved dose of Fabrazyme because if the plaintiff refuses infusion of the unapproved dose, then the FDA licensee will withdraw any access and not provide future access to the drug until the shortage is over," the complaint stated. "The United States defendants have delegated all medial decisions during the shortage regarding plaintiff's disease, life, and health to the sole discretion and control of a corporation regulated by and through grant of an FDA license."

Judge Howell found, however, that the plaintiffs failed to demonstrate how the federal agency's inaction caused their injuries.

"As the defendants rightfully point out, the actions of private pharmaceutical companies are not fairly attributable to the defendants because '[e]ven extensive regulation by the government does not transform the actions of the regulated entity into those of the government,' ... and because '[m]ere approval of or acquiescence in the initiatives of a private party is not sufficient to justify holding the [government] responsible for those initiatives,'" the 31-page decision states.

Howell noted that the Fabrazyme shortage occurred in 2009 when a viral contamination caused Genzyme to shut down and sanitize its facility. While the manufacturing plant was shut down, the drugmaker strategized with Fabry disease experts to make the best use of the remaining supply of the drug.

The result was a recommendation that doctors prescribe 80 percent of the normal levels of Fabrazyme to patients, which is the equivalent of missing two doses.

The plaintiffs had claimed that the FDA let Genzyme decide whether a patient would be treated during the shortage while diluting the medication without approval.

Though Howell found that the plaintiffs had failed to show an injury, he said he "joins in the defendants' 'utmost sympathy for patients suffering from Fabry disease and vitamin A deficiency' and likewise does 'not question the legitimacy of plaintiffs' desire for access to Fabrazyme and Aquasol A.'"

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