Appeals Court Says Stem Cells May be Regulated as Drugs, Affirming Low Court's Decision

by jeeg 6. February 2014 20:40

The US District Court of Appeals for the DC Circuit has ruled that a lower court was correct when it ruled that the US Food and Drug Administration (FDA) could legally regulate stem cells as drugs.

Background

In July 2012, the US District Court of DC ruled that FDA may legally regulate stem cell therapies as drug products. The decision was viewed by many as an opening salvo in what was likely to be a lengthy court battle between the agency and a company accused of violating federal regulations.

The company, Colorado-based Regenerative Sciences, was cited by FDA in a 2008 Warning Letter in which the agency claimed the company was in violation of federal law.

FDA maintained that Regenerative's technique of reprocessing a patient's own mesenchymal stem cells violated 21 CFR 1271.1—FDA's human cell, tissue and tissue-based products (HCT/P) regulation—by falling afoul of its "minimal manipulation" provisions and because the resulting stem cells were not "intended for homologous use only."

As it could not be an HCT/P product, it was therefore a drug based on its claims, FDA argued.

Regenerative Sciences filed a lawsuit against FDA in 2010 challenging its characterization of its Regenexx procedure, but the July 2012 decision by the US District Court sided with FDA's interpretation of the regulations as well as its findings with respect to Regenerative Sciences.

"The FDA has acted within the authority granted by section 361 of the Public Health Service Act," the court concluded.

What's a Drug, and What's a Procedure?

The company appealed to the Circuit Court of Appeals for DC, seeking relief from the original decision.

Its argument: The Refenexx procedure is just that—a procedure. FDA has the authority to regulate products, but not the practice of medicine.

That argument has been supported by one of FDA's former associate commissioners, Scott Gottlieb, who wrote in the Wall Street Journal in August 2012 that the court decision would set a dangerous precedent for FDA being able to regulate medical procedures beyond its statutory authority.

"Federal regulators have stretched that definition to the point where a reasonable limit no longer exists," Gottlieb explained. "The constraint that a drug needed to be a ‘thing’ has been read out of the law by FDA, and the district court appears to have accepted that position."

Gottlieb added: "If the FDA's victory is upheld on appeal, then conceivably nothing done as part of clinical practice is beyond the agency's reach … there may be little to prevent the FDA from imposing its drug-approval requirements on any cell-based procedure."

While FDA hasn't shown any willingness to go after other types of procedures, it has gone after other purveyors of stem cell therapies, such as CellTex Therapeutics and Texas Applied Biomedical Services, which both received Warning Letters in October 2012.

New Findings

Unfortunately for Regenerative and its supporters, the appeals court has now confirmed the lower court's findings.

In a 4 February 2014 ruling, the DC District Court of Appeals found that the Regenexx procedure results in a product that is defined as a drug, not an HCT/P under 21 CFR 1271, making the company's products misbranded and adulterated under federal law.

"ppellants’ concerns lack merit," the court explained. "They boil down to the following syllogism: the Federal Food, Drug and Cosmetic Act (FD&C Act) was not intended to infringe on states’ traditional role in regulating the practice of medicine; the Procedure fits Colorado’s statutory definition of the “practice of medicine”; therefore, the FDA’s regulation of the Procedure exceeds the FDA’s authority under the FDCA."

"This syllogism is flawed twice over," the court wrote. FDA was not focused on the procedure, but rather the resulting stem cell mixture, the court observed. FDA made no claims regarding the procedure, it said. "Regenerative's arguments about the practice-of-medicine exemption are therefore wide of the mark," it decided.

Second, the court said that while the FD&C Act was "not intended to regulate the practice of medicine, it was obviously intended to control the availability of drugs for prescribing by physicians.” If the court were to rule in favor of Regenerative, it would be conceding that state laws on the practice of medicine could take precedence over the FD&C Act, thereby creating a patchwork of laws not in keeping with Congress' intent.

Minimal Manipulation Provisions

The court similarly struck down Regenerative's arguments regarding the "minimal manipulation" regulations under 21 CFR 1271.1. It's an interesting section, and we quote in full below:

"As to some of those reasons, such as the government’s claim that culturing MSCs alters the genes and proteins they express, appellants have created genuine issues of fact by submitting expert affidavits arguing that the government’s views are based on scientific studies that are inapplicable to appellants’ culturing process. But appellants give no response to other reasons offered by the government. For example, appellants admit that the culturing process is designed to “determine the growth and biological characteristics of the resulting cell population.” It is also undisputed that, in at least some cases, appellants add substances to the cell culture that affect the differentiation of bone marrow cells. These concessions are fatal to appellants’ attempt to claim refuge under § 1271.10(a)."

Alexander Gaffney, Regulatory Focus

 

 

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2/12/2014 1:16:36 PM #

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