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Thursday, August 04, 2016 12:03:48 PM
FACT: ALL IR opioids have THE SAME T-Max “issue”—i.e. fatty meal slows down absorption. So the same safety labeling used by other FDA approved opioids (including Opana IR Oxymorphone) should similarly be sufficient for SequestOx! NAMELY “TAKE ONE HOUR BEFORE A MEAL OR TWO HOURS AFTER A MEAL. TAKE NO MORE THAN 2 PILLS EVERY FOUR HOURS”.
THERE IS NO MEDICAL REASON to make the rules for dealing with the SequestOx T-max situation any different than for any other IR Opioid pain med!!! There is no more chance of over-dose on SequestOx than for any other IR Opioid pain med!! FDA KNOWS THIS! THAT IS WHY FDA IN 2014 TOLD NASRAT THAT LABELING INSTRUCTIONS WERE ALL THAT WAS NEEDED TO DEAL WITH THIS T-MAX ISSUE!
The FDA did a switcheroo at the last minute (after having granted ELTP a $2.5 million fee waiver and after having granted ELTP priority review). THERE WAS NO MEDICAL REASON for this switcheroo! THERE IS NO MEDICAL REASON why full approval was not granted on July 14th!!! It was obviously a politically (and/or financially) motivated decision in order to stall the entrance of SequestOx into the marketplace (or for some other politically motivated reason. FDA director Robert Califf was well known to Congress as a BP lobbyist before his appointment so it seems likely that conflict of interest was involved But additional political reasons also possible).(See No2Kool-Aids posts on this).
However, other political pressures exist to strongly motivate Califf to approve SequestOx because Congress wants ADF opioids to be available to replace non-ADF opioids that are causing so much abuse, death and enormous cost to the American people. Therefore, it is in Califf’s best interests to soon grant approval for SequestOx, which he will do. Our guy Eugene will get this problem resolved just like he’s previously gotten many other difficult problems resolved.
Federal House Health subcommittee members need to know about the stupid FDA decision blocking implementation of this ADF.
Jurisdiction:
Public health and quarantine; hospital construction; mental health; biomedical research and development; health information technology, privacy, and cyber security; public health insurance (Medicare, Medicaid) and private health insurance; medical malpractice and medical malpractice insurance; the regulation of food, drugs, and cosmetics; drug abuse; the Department of Health and Human Services; the National Institutes of Health; the Centers for Disease Control; Indian Health Service; and all aspects of the above-referenced jurisdiction related to the Department of Homeland Security.
Investors start calling representatives and voice your displeasure with the FDA bureaucracy.
Republican Members
Joseph Pitts (Pennsylvania - 16) - Chairman Phone: (202) 225-2411
Brett Guthrie (Kentucky - 02) - Vice Chairman Phone: (202) 225-3501
Ed Whitfield (Kentucky - 01) phone: (202) 225-3115
John Shimkus (Illinois - 15) Phone: (202) 225-5271
Tim Murphy (Pennsylvania - 18) Phone: (202) 225-2301
Michael Burgess (Texas - 26) Phone: (202) 225-7772
Marsha Blackburn (Tennessee - 07) Phone: (202) 225-2811
Cathy McMorris Rodgers (Washington - 05) Phone: (202) 225-2006
Leonard Lance (New Jersey - 07) Phone: (202) 225-5361
Morgan Griffith (Virginia - 09) Phone: (202) 225-3861
Gus Bilirakis (Florida - 12) PHONE: (202) 225-5755
Billy Long (Missouri - 07) Phone: (202) 225-6536
Renee Ellmers (North Carolina - 02) Phone: (202) 225-4531
Larry Bucshon (Indiana - 08) Phone: (202) 225-4636
Susan Brooks (Indiana - 05) Phone: 202-225-2276
Chris Collins (New York - 27) Phone: 202-225-5265
Joe Barton (Texas - 06) - Chairman Emeritus Phone: (202) 225-2002
Fred Upton (Michigan - 06) - Ex Officio Phone: (269) 385-0039
Democratic Members
Gene Green (Texas - 29) - Ranking Member Phone: (202) 225-1688
Eliot Engel (New York - 16) Phone: (202) 225-2464
Lois Capps (California - 24) Phone: (202) 225-3601
Janice Schakowsky (Illinois - 09) Phone: (202) 225-2111
G. K. Butterfield (North Carolina - 01) Phone: (202) 225-3101
Kathy Castor (Florida - 14) Phone: (202) 225-3376
John Sarbanes (Maryland - 03) Phone: (202) 225-4016
Doris Matsui (California - 06) Phone: (202) 225-7163
Ben Lujan (New Mexico - 03) Ph: (202) 225-6190
Kurt Schrader (Oregon - 05) (202) 225-5711
Joseph Kennedy (Massachusetts - 04) phone: 202-225-5931
Tony Cárdenas (California - 29) phone: (202) 225-6131
Frank Pallone (New Jersey - 06) - Ex Officio Phone: (732) 249-8892
https://energycommerce.house.gov/subcommittees/health-114th-congress
Investors start calling Senators and voice your displeasure with the FDA bureaucracy.
Senate subcommittee on health:
Chairman (R)
Patrick J. Toomey (PA) Phone: (202) 224-4254
Chuck Grassley (IA) Phone: 202-224-3744
Pat Roberts (KS) Phone: 202-224-4774
Michael B. Enzi (WY) Phone: (202) 224-3424
Richard Burr (NC) (202) 224-3154
Dan Coats (IN) (202) 224-5623
Dean Heller (NV) Phone: 202-224-6244
Tim Scott (SC) Phone: (202) 224-6121
Ranking Member (D)
Debbie Stabenow (MI) (202) 224-4822
Maria Cantwell (WA) Phone: (202) 224-3441
Robert Menendez (NJ) 202.224.4744
Benjamin L. Cardin (MD) Tel: (202) 224-4524
Sherrod Brown (OH) (202) 224-2315
Mark R. Warner (VA) Phone: 202-224-2023
http://www.finance.senate.gov/about/subcommittees/#health
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