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Web petition calls on FDA to reconsider Amarin drug
By Lee Howard
November 19, 2013
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Website makes case for Vascepa approval
An online petition urging the U.S. Food and Drug Administration to consider approving Amarin Corp. plc's application for expanded use of its new heart medication Vascepa has garnered more than 1,000 electronic signatures.
Responding to an FDA panel's recommendation last month against allowing the marketing of Vascepa in conjunction with cholesterol-lowering statins such as Lipitor, an organization calling itself The EPA Drug Initiative issued a press release Monday stating its intention to take on the committee's "flawed scientific reasoning."
The group's site includes pro-Amarin articles and a link to the petition, whose author is listed as Madi Matusow.
Calling itself an ad hoc group of physicians, patients and concerned citizens, the pro-Amarin group offered a laundry list of reasons to support Vascepa's expanded labeling, including its view that Americans will be denied an effective and possibly life-saving heart drug at a time of escalating need.
"The decision is hugely unfair to Amarin," the release said.
Amarin, an Irish company with U.S. headquarters in Bedminster, N.J., has its research-and-development hub in Groton. The company announced last month that it would be laying off more than 100 people - half its worldwide staff - in anticipation that the FDA would not approve widening the market for Vascepa when it meets next month.
The fish-oil pill, which competes with GlaxoSmithKline's drug Lovaza, already has been approved for patients with very high levels of blood fat.
To see the petition and related articles, visit www.epadruginitiative.com. The group's email is contactus@epadruginitiative.com.
A request sent by email to the group seeking more information about the campaign elicited no response Monday.
l.howard@theday.com
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