Amarin Corp Plc (AMRN)

[Biobillionair]

Historically, the FDA retaliates....and yes I've suggested this to a few. Whisleblower systems work if you have an overall Law Abiding Leadership....this is not the case. There's an active mechanism of accepting "fees" for influencing policy, the below example is not a one and done incident.



Proof FDA takes Bribes

1) "A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.

The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort""

http://www.washingtonpost.com/business/economy/pharmaceutical-firms-paid-to-attend-meetings-of-panel-that-advises-fda-e-mails-show/2013/10/06/a02a2548-2b80-11e3-b139-029811dbb57f_story_1.html

2) What department?

"FDA officials who regulate painkillers"

Zohydro approval

http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202880Orig1s000ltr.pdfBob A. Rappaport, M.D.

CDER Office of Drug Evaluation 2

3) Who's in charge of CDER Office of Drug Evaluation 2 that accepted "hundreds of thousands" for admission?

Dr. Rosenbrough

Mary Parks

http://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobacco/cder/ucm075128.htm

4) This wasn't a bribe...it's covered under PDUFA law.

No, it's not.

5) Yeh, but the FDA has a published MAPP how to accept Money from Private Stakeholders so they can hear Private Policy Making Decisions.
No, MAPP covers this type of involvement

6) Anyone charged with a crime?
Not yet..

Where does a bribe stop? How many favors do you get? The HELP committee will address this at the Hearing.

BB