Medical Center Pharmacy v. Mukasey, 536 F.3d 383 (5th Cir. 2008), which is only precedent in Texas and Louisiana?
Drugs intended for animals, like human drugs, are also commonly compounded. Indeed, compounding may be more prevalent for animal drugs, since "for significant diseases there are no effective FDA-approved drugs."[13]Jonathan Berman and Michael Sennett Do Compounding Pharmacies "Live in Sin"? The FDA's Assertion of Enforcement Authority Over Pharmacy Compounding, and Two Courts' Efforts to Bless the Practice
Under the Animal Medicinal Drug Use Clarification Act of 1994,[14] veterinarians are allowed to prescribe approved human and animal drugs "off-label"—to treat conditions in animals even in the absence of an FDA finding that the drug is safe and effective for that particular purpose. The FDA interprets this statute as allowing the compounding of animal drugs, and accordingly it promulgated regulations permitting the practice.[15] The regulations, however, permit compounding only from drugs that are in their approved, final form. The regulations do not permit "compounding from bulk drugs." ("Bulk" compounding does not refer to the amount of the drug substance used but means using the chemicals from which a finished product can be manufactured, rather than using final-form medicines.)
The omission of bulk drugs from the animal compounding regulation is significant. There does not appear to be any dispute that compounding from bulk drugs falls squarely within the "traditional" practice of compounding. Indeed, courts have found that it is more difficult, more dangerous, and more expensive to compound from finished products. Finished products typically are mixtures of active and inactive ingredients, and compounding from such a mixture requires a pharmacist to reverse engineer the finished product into its unfinished form, and then determine how to separate and recombine ingredients into the prescribed dosage, formulation, and strength. The FDA, in excluding bulk drugs from the animal drug compounding regulations, did not find that compounding from bulk drugs was unduly dangerous or in any respect inferior to compounding from finished products. The FDA's rationale was that in the 1994 amendments, Congress permitted only off-label uses of approved drugs, and therefore Congress did not authorize the use of bulk products.[16] By contrast, §503A—which focuses on drugs compounded for humans—requires the use of bulk drug substances.
In any event, the FDA takes a firm position against the bulk compounding of animal drugs. The relevant guidance document flatly states that "the compounding of a new animal drug … from bulk drug substances results in an adulterated new animal drug…."
The FDA began cracking down on bulk compounding in the late 1980s. Rather than proceed against the people performing the compounding (largely veterinarians, as well as pharmacies), the FDA obtained injunctions against their suppliers.[17] In doing so, the FDA did not prove that compounding was illegal. Instead, the FDA used a wrinkle in the labeling regulations that effectively made it impossible for wholesalers to lawfully label bulk containers.[18]
In 2010, the FDA brought suit against a Florida pharmacy, Franck's Lab, seeking to enjoin the bulk compounding of animal medications. The FDA took "the bright-line position that any compounding of animal medications from bulk substances violates [the Act], even when conducted by a state-licensed pharmacist for an individual animal patient pursuant to a valid veterinary prescription." The Franck's court found, through undisputed evidence, that compounding from bulk substances pursuant to a veterinary prescription qualifies as "traditional compounding," and that the Franck's litigation was the FDA's first attempt to bar a pharmacy from engaging in bulk compounding for non-food-producing animals. The FDA's position, as paraphrased by the court, was that "state-licensed veterinarians and pharmacists have, with the FDA's blessing, been 'living in sin'…."[19]
The Franck's court, like the Fifth Circuit in Medical Center Pharmacy, took a dim view of the notion that compounding pharmacies across the nation are "living in sin," and found in favor of the pharmacy. But the holdings of the two courts are in conflict. Medical Center Pharmacy held that the compounding of animal drugs is lawful only if performed within the confines permitted by the Animal Medicinal Drug Use Clarification Act. But no statute or regulation expressly authorizes bulk compounding of animal drugs, and as a result, the Franck's court could not decide in the pharmacy's favor without a broader holding. Franck's thus held that Congress had never intended to prohibit traditional compounding, notwithstanding the literal language of the FDCA. To find such a prohibition by implication from the broad scope of the statutory definition of "new animal drugs" would be akin to hiding an elephant in a mouse hole.
Franck's did hold that compounding created "new animal drugs," that the FDA could distinguish between manufacturing and compounding, and that the FDA could regulate the former. But the FDA's authority is restricted to the power to curb abuses. By asserting authority to enjoin a pharmacy from traditional pharmacy compounding in compliance with state law, Franck's held, "the FDA overreaches."
Conclusion
Despite the recent efforts of courts to regularize the federal law of compounding, the law remains very much in flux. Medical Center Pharmacy did not resurrect §503A nationwide. Rather, the case created a circuit split, and the FDA's published position is that it will follow only Medical Center Pharmacy in the Fifth Circuit. The Franck's decision was issued by a district court.....
(November 2011). Although Franck's was appealed, the Eleventh Circuit dismiss the case as moot on a joint motion of the parties.
No comments:
Post a Comment