Replies to post #110774 on Amarin Corp Plc (AMRN)

[Biobillionair]

The FDA has to put the Amarin/Vascepa issues to bed or NOTHING else gets done at the agency. Amarin's NCE and FIRST AMENDMENT cases should have never existed; a really bad piss poor run agency invented these issues when they failed to follow current FDA regulation. Why the FDA failed to follow this regulation should be investigated and the individuals prosecuted to the fullest extend of the law. FDA "officials" defending incorrect regulations should be admonished and allowed to keep current positions with the obvious you will not get a 3rd chance speech.

BB

[Biobillionair]

Here's a quote from Gottlieb that might have the markets recoiling tomorrow:

However, FDA estimates that more than 1,000 prescription drug products have never gone through the approval process and remain on the market. Few, if any, of these unapproved prescription drug products are likely to be exempt from statutory approval requirements.
The lack of evidence demonstrating that unapproved prescription drugs are safe and effective, as well as the lack of a review to ensure that the drugs’ labeling include accurate and complete information, is a significant public health concern. These unapproved new drugs have not undergone the rigorous FDA drug review process, which helps ensure that new drug products are safe and effective, manufactured according to Federal quality standards, and bear labeling that conveys accurate, clear and complete information to health care professionals and patients regarding the drugs’ risks, benefits and safe use. Many healthcare providers are unaware that some of the drugs they prescribe are unapproved.

Why the hell is the agency focusing on Vascepa when they should be refocus on these 1000 other drugs not proven? Did Congress grandfather in poison?!