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The Prescription Opioid and Heroin Epidemic and the FDA
FDA: ThalidomideFDA: OxyContinFDA: VicodinFDA: ZohydroFDA: AddictionFDA: Big PharmaFDA: Pediatric OxyContin FDA vs. CDC, Dec 2015
FDA vs. CDC, Dec 2015

     Sharon Hertz, M.D., is the Director of the FDA Division of Anesthesia, Analgesia and Addiction Products (DAAAP).  Formerly Deputy Director of DAAAP, she replaced Bob Rappaport, M.D. as Director when he resigned last year.  The Division of Anesthesia, Analgesia, and Addiction Prod,ucts regulates new drug applications for pain medications and has been at the heart of critical FDA decisions regarding prescription opioids. 

     At the Dec. 3, 2015, meeting of the Interagency Parin Research Coordinating Committee (IPRCC), Dr. Hertz, discussing the proposed Draft CDC Guidelines, said, "I think we need to recognize that the CDC wants to substantially limit opioid prescribing. Period."  She also said that the quality of the evidence cited to support the guidelines was 'low to very low and that's a problem.'
     Dr. Tom Frieden, Director of the CDC, has previously discussed both these issues: "Addressing the prescription drug overdose epidemic is one of the CDC's top priorities. Overprescription of opiates for pain is a key driver of this epidemic..
.We know that we don't have ideal evidence, but we also know that we can't wait."

     Dr. Hertz is not correct that the goal of the CDC Guidelines is to "...substantially limit opioid prescibing. Period."  The CDC clearly does want to limit clinically inappropriate overprescribing of opioids, because it is a key driver of an epidemic that has killed 250,000 people.

     And for the Director of DAAAP to express concern about the quality of evidence is disingenuous given the record of the FDA in making decisions without evidence.  Examples:
          (1) Approval of Zohydro ER.  Note Dr. Rappaport's statement (see FDA: Zohydro) in the approval letter for Zohydro ER that "
I find that the overall risk-benefit balance for patients ... falls firmly on the side of approval of this application.” But there was simply no evidence of any kind to support Dr. Rappaport's conclusion. Indeed, Dr. Rappaport's conclusion flew in the face of the 11-2 vote against approval of the FDA-apppointed scientific Advisory Committee. 
          (2) The FDA's decision to institute ER/LA Opioid REMS (Risk Evaluation and Management Strategies), a broad-based, expensive program that would supposedly decrease prescription opioid overdoses for extended-release and long-acting opioids.  There was no evidence and there is no evidence of the efficacy of REMS. 
          (3) The FDA has done no research and cited no research that would inform doctors or patients of the likelihood that a patient starting prescription opioids for chronic pain or acute pain will wind up dependent on opioids or dead from a prescription opioid overdose. How can anyone assess risk without such basic information?  
     At least the CDC is willing to acknowledge when its evidence is weak. 

     Dr. Hertz's position is important and her views are important.  Let us hope her rash comments do not reflect forces at the FDA that intend to continue policies that have contributed to the epidemic of accidental opioid overdose deaths. 
     At the very least, she needs to apologize to the CDC for her willful mischaracterization of their position. 

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