Replies to post #29340 on Amarin Corp Plc (AMRN)

[Biobillionair]

Hey STS,

I read this originally as final approval into law, however, the committee's meaning is after we have a positive vote and sent this on to the next ruling. For the final passage of the law they want these issues resolved. Example #1, Seafood Advisory had the same wording as the SPA request,"enactment of this Act".

EXAMPLE:
Seafood Advisory---"The Committee directs FDA to publish final advice to pregnant women on seafood consumption in conjunction with all applicable parties as directed in House Report 112–101 and Senate Report 112–73 by June 30, 2014."...."Finally, FDA shall provide a progress report to the Committee 30 days after the enactment of this Act and every 30 days thereafter until the advisory and seafood risk benefits assessment are published."

Then like a good FDA they complied:June 10, 2014

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm397929.htm

"Seafood Advisory.—The Committee is concerned that after many years, FDA has not published updated advice on seafood consumption for pregnant women, mothers, and children. Seafood is an important part of a healthy diet which contains critical vitamins and nutrients, such as Omega 3s, which are essential during pregnancy to ensure optimal fetal and child development. The Committee directs FDA to publish final advice to pregnant women on seafood consumption in conjunction with all applicable parties as directed in House Report 112–101 and Senate Report 112–73 by June 30, 2014. FDA shall issue its final seafood risk benefits assessment at the same time as the seafood advice. The seafood advice shall be consistent with the latest science and contain a clear and actionable advice that will enable the public, medical, and scientific communities to make informed dietary decisions and recommendations. Finally, FDA shall provide a progress report to the Committee 30 days after the enactment of this Act and every 30 days thereafter until the advisory and seafood risk benefits assessment are published."

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AMARIN'S WORDING:
Amarin's timeframe wording: "Committee directs FDA to report to the Committees on Appropriations of the House and Senate within 60 days of enactment of this Act"


"To ensure agreement over the standard to rescind a SPA, the Committee directs FDA to report to the Committees on Appropriations of the House and Senate within 60 days of enactment of this Act regarding the standard by which FDA would rescind a SPA. Lastly, to ensure agreement over the standard to rescind a SPA, the Committee directs FDA to revise and re-issue, after public comment, its existing guidance regarding SPA agreements to clarify the agency’s interpretation of the statutory standard regarding SPA agreements and the rescission of such agreements.

Example #2
On 6-11, the FDA completed another assignment on time:ANDA Review Prioritization

"Within 45 days of enactment of this Act, the Committee directs FDA"

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM400630.pdf


ANDA Review Prioritization.—In its Generic Drug User Fee Act commitment letter, FDA affirmed that in order to provide more certainty to the generic drug industry, it would expedite the review of Paragraph IV applications that become eligible for approval during the review period and other applications that have the potential to be the first generics to market. Within 45 days of enactment of this Act, the Committee directs FDA to report to the Committee how it has prioritized its abbreviated new drug application review process to ensure first generics are approved on the earliest possible date.

The FDA was requested to get this done after 60 days of enactment of this Act...clock started 5-21-2014.

Hope this clears it up.
BB