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NCPD Files Amicus Brief to Eliminate FDA Regulatory Scheme That Endangers Public Safety

Posted on: Wednesday, 20 June 2007, 21:03 CDT

WASHINGTON, June 20 /PRNewswire-USNewswire/ -- The National Coalition of Pharmaceutical Distributors (NCPD), which represents independent distributors of pharmaceuticals and healthcare products, announced today that it has filed an amicus curiae brief in support of maintaining access to these products to all healthcare providers. The litigation is an appeal (07-0453-CV) by the U.S. Food and Drug Administration (FDA) of a ruling made last December in the U.S. Eastern District (New York) Court, which enjoined the implementation of an FDA regulatory framework governing the distribution of prescription pharmaceuticals in the U.S. Had that framework been allowed to go into effect, it would have arbitrarily limited access to healthcare products to a small number of so-called "authorized distributors" (ADs), destroyed the livelihoods of thousands of small, family-run businesses that support pharmacies and healthcare patients across the country, and preserved a serious loophole in the supply chain through which subpotent, unsafe, and counterfeit drugs could enter.

View amicus here: http://www.ncpdusa.org/pdf/NCPD_Amicus_Brief_Final_2nd_Circuit_053107.pdf

Tortuous regulatory history

The rules that FDA sought to impose last December have a tortuous regulatory history stretching all the way back to the second Reagan Administration, when the Prescription Drug Marketing Act (PDMA) of 1988 was signed. That law has many elements pertaining to how pharmaceuticals are marketed and distributed which are already in effect. But it also contains two elements, the "pedigree" and the concept of the "authorized distributor" (AD) that have yet to be reconciled. A pedigree is a record (either paper or electronic) that identifies where a product comes from and who is selling it. An AD is defined (by Sec. 21 CFR 203.50 of the law, as revised) as someone who receives pharmaceutical product directly from the manufacturer. Under FDA's regulations, which were to have gone into effect in December, an AD is exempt from providing a pedigree to any of its customers. Equally significant is the fact that an AD who purchased prescription drugs from a non-manufacturer source would not be required to disclose that to future customers. Thus, that non-manufacturer product would not be tracked at all. This AD exemption allows ADs to hide behind their AD status, and creates a gaping hole in the supply chain. Indeed, in the past it has been this exact "AD loophole" through which counterfeits have entered the U.S. drug supply.

"This litigation is occurring at the very time when the U.S. Congress is drafting new legislation that would do away with the arbitrary and unfair regulation that FDA seeks to impose, and which the Court has enjoined it from imposing," says Gene Alley, Vice President of NCPD. "We support the parties that brought the original lawsuit against FDA, and we will continue to work with Congress to correct this injustice."

NCPD members are, by and large, non-AD distributors that are obligated to purchase most of their products from ADs, who are among the largest corporations in America. NCPD members serve office-based physicians, pharmacies and hospitals, and other sectors in the United States not well served by the ADs.

"This unfair and irrational regulatory scheme would have been the death knell for thousands of distributors," says Alley, "because they would not have been able to obtain products to sell legally. One of the more bizarre aspects of this scheme is that an AD could sell a drug to one of us, but if we had to return it back to that same AD, we could not, because we didn't have the pedigree from the AD. That's just one example of how arbitrary and unfair this scheme would be."

RxUSA Wholesale, joined by several other small, independent distributors, filed suit in federal court last fall to prevent the imposition of the new FDA regulation. Judge Joanna Seybert agreed with the plaintiffs in her ruling: "This entire regulatory scheme and the anomalous result that would occur if the Rule went into effect appear arbitrary." She added that, "this rule may drastically change how prescription drugs are distributed in this country and ultimately affect the cost to the consumer."

Current litigation

FDA has filed an appeal of the injunction, which will be heard in the Second Circuit Court (U.S.) at a date to be determined. NCPD has filed an amicus curiae brief in support of the appellees, RxUSA Wholesale and others. In the brief, NCPD makes the several points, including:

-- The district court applied the proper legal standards to the evidence, recognizing the FDA rule does nothing to further patient safety -- FDA's position would create a "drug tracking" system in which nothing is tracked & would eliminate the only prescription drug wholesalers, which are currently providing pedigrees -- The injunction enjoins a regulatory scheme, which can only impair, not improve, patient safety. -- There is no valid reason to treat ADs and non-AD distributors differently -- It is wrong to assume that drugs supplied by ADs are "presumptively" safe, while those from non-AD distributors require additional documentation -- FDA recognized the "irrationality" of the current pedigree rules (now under injunction) in earlier deliberations Why this is important

Until the appeal is heard and a ruling issued, an existing system of providing pedigree documentation will continue to be in force, so patient safety will remain at a relatively high level. NCPD members meet state and federal regulations throughout the country for how they handle drug distribution.

FDA has repeatedly asked Congress for new legislation. Congress has listened; new legislation is under consideration in both houses of Congress (S. 242 and HR 380) that would do away with the arbitrary exemption of ADs and require all manufacturers and all distributors to provide pedigree documentation. "NCPD is strongly in support of this regulatory structure," says Alley. "The U.S. pharmaceutical supply chain will be secured only by having all participants involved and accountable at all levels."

The possibility remains, however, that FDA's current discriminatory scheme could be imposed, even if the Congressional legislation is passed and signed into law. The current bills would go into effect in 2010, leaving a gap between today and that date. During the intervening years, NCPD members and other small, independent distributors would be driven out of business by the FDA regulation, if it is imposed.

"We think that FDA should recognize the intent of Congress in the current legislation, and at least postpone any further action until the bills are finalized as law," says Alley. "The current injunction is our only legal recourse during this interim."

About NCPD

The National Coalition of Pharmaceutical Distributors represents and promotes the value of small and independent pharmaceutical distributors with respect to legislatures, regulatory organizations, manufacturers, dispensers, and the community at large through rigorous advocacy in order to preserve the businesses of its members, to ensure distribution system efficiency and to uphold public safety.

National Coalition of Pharmaceutical Distributors

CONTACT: Nora Bradley of the National Coalition of PharmaceuticalDistributors, +1-619-956-4235, nora.bradley@ncpdusa.org

Web site: http://www.ncpdusa.org/

Source: PRNewswire-USNewswire

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