Healthy Skepticism Library item: 16228

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Publication type: news

Mundy A
Drug Chief at the FDA Is Accused Of Conflict
The Wall Street Journal 2009 Aug 12
http://online.wsj.com/article/SB125003545637224263.html

Notes:

Corrections & Amplifications

The Food and Drug Administration didn’t find contamination in experimental heparin from Amphastar Pharmaceuticals Inc. that reached patients in clinical trials, but the FDA and Amphastar did find some contamination in raw materials sent to Amphastar from China. This article said that the FDA didn’t find contamination.

Full text:

The inspector general of the Department of Health and Human Services is investigating a conflict-of-interest allegation involving the official in charge of drug approvals at the Food and Drug Administration, the FDA said.

The investigation of Janet Woodcock, the director of the FDA’s Center for Drug Evaluation and Research, stems from an ethics complaint filed by Amphastar Pharmaceuticals Inc., a California company that says it has been delayed in its six-year effort to win approval for a generic version of Lovenox, a multi-billion-dollar blood thinner.

In its complaint, Amphastar alleges that its competitor had special access to Dr. Woodcock at critical times in the prolonged approval process, which is ongoing. Amphastar points out that Dr. Woodcock co-authored a scientific paper with scientists at Momenta Pharmaceuticals Inc. while both companies were battling to win FDA approval of their generic blood thinners.

Amphastar contends that Dr. Woodcock’s collaboration with Momenta is a conflict of interest and has asked that she recuse herself from the entire matter at the FDA.

“The FDA is aware of the situation, takes it seriously, and is looking into the matter,” an agency spokesman said. He said Dr. Woodcock isn’t recusing herself.

The FDA, responding to repeated queries over a week, declined to make Dr. Woodcock available for comment. An HHS official said the department cannot confirm or deny ongoing investigations.

In separate FDA news, the agency on Tuesday said its top medical-device regulator, Daniel Schultz, is resigning, following internal dissent over decisions that his critics said were too friendly to industry.

Both Amphastar and Momenta, which is based in Cambridge, Mass., submitted applications seeking FDA approval of their generic versions of Lovenox heparin sold by Sanofi-Aventis SA. Amphastar applied in 2003, two years before Momenta.

Lovenox, a low-molecular-weight heparin, is a blockbuster biologic drug that brought in $3.5 billion in world-wide sales last year.

On Nov. 2, 2007, the FDA rejected Amphastar’s application, although the agency acknowledged that Amphastar had passed a key hurdle in demonstrating its drug’s chemical equivalence to Lovenox. The FDA told Amphastar that it needed more data to show that the product wouldn’t cause dangerous immune reactions.

Momenta was also asked to submit such data. Both companies said they have complied and are awaiting the FDA’s response.

Amphastar, in letters sent to the FDA in April and June, cited some public contacts and email between Dr. Woodcock and one of Momenta’s founders, Massachusetts Institute of Technology biological engineering professor Ram Sasisekharan, beginning in February 2007. Among those contacts were their attendance at an international medical conference in Thailand in November 2007.

Mainly, however, Amphastar points to Dr. Sasisekharan’s appointment to lead an FDA task force in early 2008, which put him and Momenta in regular contact with the agency. That task force was investigating tainted Chinese-made heparin, a crisis that led to nearly 100 deaths.

Drs. Woodcock and Sasisekharan, along with other Momenta scientists, then co-authored two medical journal articles last year identifying the cause of the contaminated Chinese heparin imports, a finding that won scientific — as well as Wall Street — kudos for Momenta.

It is unusual for FDA officials to co-author journal articles with industry researchers, though the FDA said it encourages publication in journals in collaboration with noted scientists. Dr. Woodcock, who joined the FDA about 20 years ago, has done so only a handful of times in recent years. In addition, this instance occurred in the middle of a drug-approval process.

Dr. Woodcock has held her post since 1994, except for two years as deputy commissioner under George W. Bush.

In April 2008, after the tainted-heparin article was published, an investment report from Morgan Stanley cited Momenta’s FDA connection as a “game-changer,” and Momenta’s stock jumped 17% in a day.

Dr. Sasisekharan didn’t respond to calls or emails seeking comment.

Momenta’s chief executive, Craig Wheeler, said contacts between representatives of his company and Dr. Woodcock were appropriate. He said they were part of an effort to persuade the FDA that it should use a higher standard of equivalence in approving generic versions of Lovenox — a standard that he believes Momenta’s technology enables it to meet.

“I’m not sure why having lower [generic] standards would be in the public interest,” said Mr. Wheeler.

He noted that the FDA’s demand for more information about immune reactions affected Momenta as well as Amphastar, and caused Momenta’s share price to fall nearly 60% on Nov. 6, 2007.

Without addressing the specific case, an FDA spokesman cited “evolving science” as having raised agency concerns about immune-system issues with complex drugs such as Lovenox.

While the tainted-heparin crisis offered rival Momenta a chance to shine, it added to the delays for Amphastar. At the height of the Chinese heparin crisis in 2008, Amphastar learned that one of its Chinese suppliers for the main ingredient used in its experimental heparin had misled the company about where the raw material had been produced, although the FDA didn’t find contamination.

The FDA sent warning letters to two Chinese suppliers of Amphastar in April this year.

Momenta has teamed up with a unit of Swiss drug giant Novartis AG to bring its product to market.

A Novartis spokeswoman said the company was unaware of the ethics complaint filed by Amphastar.