Biotech Values

[DewDiligence]

Amphastar is still whining that the FDA’s Janet Woodcock is
biased in MNTA’s favor. This article from Thursday’s LA Times
covers no new ground other than to announce that Amphastar is
appealing the FDA’s rejection of its conflict-of-interest complaint.
Please see #msg-28748329 and #msg-40421675 for background.

http://www.latimes.com/business/la-fi-fda21-2010jan21,0,1243757.story

›Amphastar Pharmaceuticals files new appeal in FDA conflict-of-interest case

The drug maker is seeking to market a generic version of the blood thinner heparin. Its complaint shows the maneuvering that can break out when billions of dollars in profits are at stake.

By Andrew Zajac
January 21, 2010

A new appeal in a conflict-of-interest controversy involving the Food and Drug Administration's handling of the deadly heparin contamination crisis of 2008 has shed more light on the convoluted and costly maneuvering that can break out when billions of dollars in profits are at stake.

The latest round began last week when Amphastar Pharmaceuticals Inc. of Rancho Cucamonga said it would appeal the FDA's rejection of a complaint. The privately held drug maker alleged that Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, had a conflict of interest.

Amphastar contended that Woodcock's conflict should have barred her from taking part in FDA deliberations over applications by Amphastar and another drug maker to market generic versions of heparin, a widely used blood thinner.

At first glance, Woodcock's alleged miscue -- the basis of the conflict allegations -- may not seem obvious. It springs from her role in ending a crisis in which contaminated heparin was sickening and sometimes killing users. The crisis spread panic among patients and sparked a storm of criticism of the FDA.

Woodcock and her aides responded by creating a task force charged with finding the source of the problem, and Woodcock, who became a member of the medical detective team, co-wrote a scientific paper that identified a contaminant as the culprit.

But Amphastar points out that Woodcock's collaborators in the article included scientists from Momenta Pharmaceuticals Inc. of Cambridge, Mass., which is Amphastar's rival in the race to market a highly lucrative generic form of heparin.

At the time of the crisis, Amphastar and Momenta had competing drug applications under review by Woodcock's office.

But what appears to worry Amphastar -- and raises a corner of the curtain on drug industry's arcane maneuvering -- is not just that the FDA, perhaps influenced by Woodcock, might oppose the company's application to market generic heparin. It's that Amphastar, which filed its application two years earlier than Momenta, might see both applications approved at the same time – meaning that Amphastar would not get the head start it says it deserves. [LOL re the notion that Amphastar “deserves” to be approved first just because they made the first submission—that’s not how the FDA works!]

The Momenta application was submitted in a partnership with Sandoz, a unit of giant Swiss drug maker Novartis.

If the two competitors started even, Amphastar fears that Momenta, with the marketing power of Novartis behind it, could surpass the California firm on what is potentially a financial blockbuster.

On the conflict-of-interest complaint, FDA spokeswoman Karen Riley said the FDA pulled together the team of experts, including Woodcock, under emergency conditions.

"People were dying. We had to find an answer," Riley said.

Momenta Chief Executive Craig Wheeler said Tuesday that his company simply pitched in when asked to help. "From my perspective, this is one of the best examples of unbiased collaboration between FDA, business and academia in a public health emergency," Wheeler said.

Both then and now, Momenta and Amphastar were seeking to market a generic version of Lovenox, the brand name for the drug made by Sanofi Aventis U.S.

Sanofi reported 2008 sales of $4.4 billion for Lovenox, making it the 10th best-selling drug in the world, according to industry research firm IMS Health Inc. [What’s of consequence to MNTA investors are Lovenox sales in the US, which are running at an annualized rate of about $2.6B (#msg-43119870).]

What creates the potential conflict and should require Woodcock to recuse herself from future consideration of the competing applications, Amphastar's lawyers said, was that the successful search for the contaminant might make Woodcock biased in favor of the firm whose scientists helped her solve the mystery.

The FDA tied at least three deaths directly to the tainted heparin, and the drug's maker, Baxter International Inc. of Deerfield, Ill., faces a wave of lawsuits alleging that the corrupted medication is responsible for scores of other injuries and fatalities.

Amphastar lawyer Jason Shandell said Momenta scientists' work on the task force helped Woodcock manage the political and public relations fallout from the heparin crisis, in effect indebting her to the company.

Bioethicists said evaluating the merits of a complaint like Amphastar's was difficult because of a lack of information about how the FDA weighs possible conflicts based on appearance and about Woodcock's role in the drug evaluation process.

"What's needed is transparency. I'd like more information on what their thinking was," Dr. Wylie Burke, chair of the department of bioethics and humanities at the University of Washington School of Public Health, said about the FDA.

Josephine Johnston of the Hastings Center, a nonprofit bioethics think tank, said, "Whether [Woodcock has] actually been influenced, it doesn't look good. Appearances matter a great deal if we're supposed to trust a process. FDA review is a classic example of a process that relies on trust."

In its complaint, Amphastar also cited lobbying of Woodcock by Momenta scientists in 2007 for more stringent evaluation standards for generic versions of drugs like heparin, which the company said it had technology to produce.

Wheeler characterized the contacts as "nothing out of the norm . . . pressing their point at the agency."‹