Judge Tosses Drug Company Compounding Suit

By Walter F. Roche Jr.

A federal judge has dismissed a suit filed by a Woburn, Mass. pharmaceutical firm which had charged a competitor with violating a federal law by illegally copying one of its drug products.
In a five-page ruling Senior Judge Rya Zobel ruled that it was up to the U.S. Food and Drug Administration, not the courts, to determine if Edge Pharma LLC illegally copied Firvang, an antibiotic drug produced by Azurity Pharmaceutical.
In a footnote to her decision Zobel suggested Azurity could file an administrative complaint with the FDA and, if the agency concurred with the allegation, Azurity would then have standing to seek court intervention.
At issue in the suit are provisions of a 2013 federal law passed following the deadly 2012 fungal meningitis outbreak caused by a now defunct Massachusetts drug compounding firm.
Edge, under the provisions of that statute, was designated by the FDA as a drug outsourcer, authorized to compound large volumes of specified drugs without patient specific prescriptions.
But the Azurity suit charged that Edge was in violation of another provision of federal law barring compounders from mass producing a drug that is essentially a copy of another FDA approved drug, Firvang.
Zobel, who presided over a massive civil case stemming from the outbreak, concluded that it was not up to her to resolve matters relating to such "thorny questions."
"It would be inappropriate for the court to resolve plaintiff's Lanham Act claim," Zobel wrote, adding that Congress has expressly delegated that authority to the FDA.
She added that to resolve the issue the court itself might ultimately have to rely on the FDA.
"The FDA itself has not determined that defendant is violating the requirements the plaintiff is identifying in its complaint," Zobel added. She did note, however, that the FDA had identified "compliance issues" in an inspection of Edge's Colchester, VT. facilities.
Contact: wfrochejr999@gmail.com