Aug 20 A federal judge has issued a temporary
restraining order against the U.S. Food and Drug
Administration's decision to allow the sale of generic versions
of the Hospira Inc sedative Precedex.
Hospira filed a lawsuit in U.S. District Court in Maryland
on Tuesday asking for a temporary restraining order against the
FDA, saying the agency's decision to allow generic Precedex went
against its own rules.
The FDA said Monday that drugmakers could sell generic
Precedex as long as the label left out information about uses of
the drug covered by Hospira's patent, which covers "intensive
care unit sedation."
U.S. District Judge Jarrod Hazel said in his order on
Tuesday that Hospira was likely to win its suit because the
FDA's decision was "at odds with relevant authority" and
"tantamount to a change of the rules."
The judge said that allowing such a change could cause
people to lose faith in the process for approving drugs.
Mylan Inc, a drug company that had already won FDA
approval to make generic Precedex, joined the lawsuit on the
FDA's side on Tuesday, arguing that it would be harmed by a
temporary restraining order.
However, Judge Hazel found that any harm to Mylan or other
generic drugmakers "would pale in comparison" to the harm
Hospira would suffer without the restraining order. Hospira said
in its lawsuit that it would lose "tens of millions of dollars"
if the FDA's decision was not overturned.
Precedex accounted for 11 percent of Hospira's global net
sales of $4.1 billion in 2013, according to the company's most
recent annual report.
Sandoz Inc, the generic arm of Swiss drugmaker Novartis
AG, was set to start selling generic Precedex in
December under a settlement of patent litigation with Hospira.
According to court papers, Sandoz expected to have an exclusive
right to sell the generic drug for six months.
Sandoz intervened in Hospira's suit against the FDA on
Tuesday, arguing that it would be wrongly deprived of the
six-month exclusivity period if the FDA's decision was allowed
An FDA representative declined to comment. Mylan, Hospira
and Sandoz did not immediately return requests for comment.
The case is Hospira v. Burwell, U.S. District Court,
District of Maryland, No. 8:14-cv-02662.
(Reporting by Brendan Pierson; Editing by Ted Botha and Dan