Biotech Values

[ghmm]

FDA Clears Imports By California Company After Dispute

I guess the FDA is trying to politely say you don't have a chance with your current application but the company is too stubborn to accept that.

By Alicia Mundy
Of THE WALL STREET JOURNAL


A California biotechnology company that sued the Food and Drug Administration
over a stalled drug application has won a concession from the agency that gives
the company access to imported drugs necessary for the approval process.

Amphastar Pharmaceuticals Inc. said it received a letter from the FDA Monday
saying the agency will release shipments of unfinished heparin sent from China
that have been held at the Los Angeles airport for almost six months. The drug
will be used in Amphastar's application to make a generic form of a
rapid-acting heparin, a blood thinner, that is worth several billion dollars.

Last week, Amphastar asked U.S. District Court in Washington, D.C., for a
preliminary injunction to force the FDA to permit the imports. Amphastar has
argued that because the heparin product will be used for the company's
research, not in treating patients, the drug qualifies for an exemption to a
drug import rule.

The FDA letter confirmed that, but noted that Amphastar faces other issues
before its application is complete.

The Amphastar import battle is a skirmish in a larger war over the right to
sell a generic form of the blockbuster heparin Lovenox, involving three
companies in a competition closely watched by Wall Street.

In late July, the FDA approved an application from Boston-based Momenta
Pharmaceuticals Inc. to make the drug.

That prompted a federal suit from Amphastar alleging longstanding FDA bias
towards Momenta. Teva Pharmaceutical Industries Ltd., the world's largest maker
of generics by sales, also is seeking to sell a generic version of Lovenox and
has complained to the FDA about its approval process.

The FDA says its process is fair, and Momenta says its technology is superior
to that of its rivals.

The FDA's decision Monday to release Amphastar's imports came as Congress was
releasing a report that accuses the agency of creating the appearance of bias
toward Momenta.

"Agency officials ran the risk of undermining public confidence in the
integrity of FDA's operations," including heparin-related drug approvals, said
the report by the congressional watchdog, the Government Accountability Office.

The GAO said the FDA accepted months of free scientific analysis from Momenta
in 2008, during a crisis over contaminated imported Chinese heparin, while
Momenta had a pending heparin product application before the agency.

Also this month, the scientific journal Nature Biotechnology criticized the
FDA over what it called an appearance of favoritism toward Momenta.

An editorial in the journal noted that Janet Woodcock, the director of the
FDA's drug division, co-authored an article in 2008 in Nature Biotechnology
with Momenta scientists about the tainted heparin imports.

"It was inappropriate for Woodcock to author a paper with a company filing
products for review" at the drug division she leads, said the Nature
Biotechnology editorial.

The FDA declined to comment on the editorial or make Dr. Woodcock available
for comment.

Momenta has said it volunteered its work and laboratory to contribute to
public health, not to gain favor with the FDA. The FDA has said its approval of
Momenta's proposed generic drug was not related to Momenta's free work.

In an interview, Nature Biotechnology editor Andrew Marshall credited the FDA
with helping stop deaths and injuries from tainted heparin, but added that the
appearance of favoritism is a serious issue for the FDA.

"Companies need to know it's a level playing field," he said.


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11-10-10 1237ET

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