AstraZeneca ($AZN) took another shot at stopping generic Seroquel--and lost, at least so far. It was something of a shutting-the-barn-door-after-the-horse-flees move, because Teva ($TEVA) and Mylan ($MYL) had already started shipping their versions. But AstraZeneca filed for a temporary restraining order, alleging that FDA had acted improperly in approving 10 Seroquel generics.
No can do, said U.S. District Judge Beryl Howell. The judge denied AstraZeneca's TRO, just as another judge nixed the drugmaker's bid for a preliminary injunction. But unlike the previous judge, Howell took the FDA to task. The agency was less than forthcoming with information about its generic approvals and about its denial of AstraZeneca's two citizen petitions seeking to block those approvals, Howell said. And withholding that information seems to have been a "tactical decision" to keep the drugmaker from "seeking judicial review of FDA's legal position."
"The consequences of the FDA's tactics of 'hiding the ball' ... are two-fold," Howell wrote, as quoted by FDA Law Blog. One, consideration of AstraZeneca's legal points was delayed and the opportunity to review those issues last week was lost. Two, yet another judge had to spend time looking at the case.
Now, Howell doesn't necessarily think AstraZeneca's case is strong. When she denied the TRO last night, she wrote that the company hadn't demonstrated that it was likely to succeed on the merits. The court must give "deference" to the FDA's interpretations of its own governing statute, namely the Food, Drug and Cosmetic Act, the judge said.
- read the FDA Law Blog post