Drug Maker Sues FDA on Denial of Heparin Imports
One of the losing competitors in the bid to make a generic version of a multibillion-dollar-a-year form of heparin filed suit Monday against the Food and Drug Administration, saying the agency improperly held up imports of its raw heparin product this year.
The action by Amphastar Pharmaceuticals Inc. brings into federal court a bitter dispute over the FDA's handling of the battle to sell generic forms of Lovenox, a blood thinner that brought Sanofi-Aventis SA about $4 billion in 2009.
On July 23, the FDA approved a generic from Momenta Pharmaceuticals Inc. and partner Sandoz, part of Novartis AG. Amphastar has accused the FDA of bias toward Momenta. FDA officials have said there hasn't been any favoritism.
The Amphastar suit, filed in U.S. District Court in Washington, D.C., accuses the FDA of "unlawful detention of two shipments of raw materials" needed to make Amphastar's version of the drug.
Amphastar said its FDA application can't be completed unless it gets the shipments. It said the FDA allowed one shipment through Los Angeles International Airport from China in mid-May, but notified Amphastar unexpectedly that the permit was a mistake on July 22, the day before Momenta's application was approved.
An FDA spokeswoman said the agency doesn't comment on pending litigation.
Amphastar filed its application to make generic Lovenox in 2003. Teva Pharmaceutical Industries Ltd. followed the same year, and the Momenta-Sandoz partnership filed two years later.
In 2009, Amphastar, frustrated at the delay, alleged in a series of letters that the FDA had been showing bias towards Momenta, citing, among other things, contacts between Momenta's top scientist and the FDA's chief drug regulator.
The FDA said this year that the agency cleared the drug chief of financial conflict-of-interest allegations.
Amphastar said its shipment troubles "are part of a broader pattern of arbitrary, capricious and vindictive behavior" by the FDA that includes more than a dozen inspections "designed to harass Amphastar."
Momenta has already sold $292 million of its generic Lovenox, also called enoxaparin, according to analyst Simos Simeonidis of Rodman & Renshaw LLC, an investment bank. He said the company could reap $400 million this quarter as it fills initial orders for the drug. "By any definition, it's a blockbuster," he said.
The FDA has been applying tighter standards to heparin-related imports since the crisis in 2008, when contaminated Chinese heparin products were linked to more than 80 U.S. deaths and hundreds of other serious complications. Much of the U.S. heparin ingredient supply comes from China's pig farms, which provide the animal intestines needed to make the ingredients.
Amphastar said its imported heparin product presents "no threat whatsoever to the drug-consuming public" because that heparin is not intended for consumers. It is to be used for its generic Lovenox application, the company said.
(The Wall Street Journal)
