An Epic FDA Blunder - Dropping the ANCHOR on Vascepa, says the EPA Drug Initiative
Why You Need to Care and How You Can Make a Difference
NEW YORK, Nov. 18, 2013 /PRNewswire-USNewswire/ -- We are a group of citizens who are deeply concerned by the review conducted by the US Food and Drug Administration (FDA) in relation to a drug called "Vascepa." Vascepa is a purified and semi-synthetic form of ethyl eicosapentaenoic acid (EPA) and sponsored by Amarin Corp, and is used for lipid management, closely associated with the risk of cardiovascular disease.
The decision by the FDA to rescind a Special Protocol Assessment, which is a binding contract, is unprecedented. It sets a troubling precedence and could have important negative consequences for the FDA and the pharmaceutical industry.
In our view, the decision is a major mistake, and the public has the right to be concerned, as the evidence to date suggests that:
- The FDA has used flawed, selective and inconsistent scientific data.
- The FDA has violated its own policies and procedures and/or adopted inconsistent application of them.
- The decisions and actions are inconsistent or questionable based upon the views of other leading expert groups.
- A number of other irregularities may be indicative of antitrust violations.
- Despite the "cruel and unusual" manner in which the Amarin/Vascepa application has been handled, a number of drug applications submitted by other companies for the same indication have been approved in the recently following days and/or the FDA has signaled its intent to reduce the "burden of proof" required for approval.
- The decision is hugely unfair to Amarin, a small company that has diligently met all the requirements of the FDA and has borne significant costs associated with another clinical trial called REDUCE-IT. The results of REDUCE-IT will be of benefit to all citizens of the world but may not be available until 2017. Not only is Amarin's revenue generating capacity now severely compromised for several years but to compound the injustice, other major pharmaceutical companies, with pipelines at various stages, may effectively get a "free pass" to a large and much coveted market at Amarin's expense. Surely, this is not the American way?
- More importantly, cardiovascular disease is now approaching an arguably epidemic scale and the costs, not just for treatment, are huge. The American public is being denied a drug with an abundance of good scientific evidence that it is of great potential benefit and could save lives.
It is impractical or impossible to provide all of the details to the matters of which we speak in this Press Release. We are a small group taking on a massive problem. Expanded discussions of the preceding and other important issues and observations, including ways in which you can help, may be found on our website at:
Please visit it frequently for more detailed information and updates, and ways that consumers and the media can be more informed to help this cause. Please discuss this with your friends and colleagues to spread the word. In conclusion, we urgently need your assistance to get the FDA to reconsider their position prior to an upcoming (Type A) meeting between the FDA and Amarin. This meeting will take place right after the Thanksgiving Holiday. Date TBA! Also please continue advocating thereafter… The final decision on the Vascepa application (sNDA) is scheduled on or before December 20th (PDUFA date).
You may contact us directly by email at: [email protected]
Also a petition link:
http://www.thepetitionsite.com/176/817/515/urge-the-fda-to-approve-vascepa-for-mixed-dyslipidemia/
SOURCE The EPA Drug Initiative
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