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The Prescription Opioid and Heroin Epidemic and the FDA
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FDA: Vicodin

     The FDA has consistently been shockingly cavalier as to the damage done by prescription opioids.  
     On Oct. 25, 2013, the FDA upscheduled hydocodone-acetaminophen products from Controlled Substances Schedule III to Schedule II.  Since that time, the FDA has taken credit for that decision as a significant step forward in efforts to deal with the prescription opioid epidemic.   
     In reality, the FDA did everything it could to block upscheduling of hydrocodone-acetaminophen products, and it finally upschedule these drugs because the pressure on it to make appropriate changes in classification had become irresistible. 
     The main reason for the FDA's recalcitrance was that moving these products to Schedule II could create hardships for pain patients.  While this could well be the case, it had nothing to do with the scientific issues involved in determination of controlled substances scheduling.
     Hydrocodone-acetaminophen products were initially placed in Controlled Substances Schedule III by accident, while other opioids were placed in Controlled Substances Schedule II.  Schedule III drugs are easier for doctors to refill and less burdensome for pharmacies.  Doctors can write a 30 day prescription for a Schedule III drug with up to 5 refills and can call in refills to the pharmacy on the phone.  For Schedule II drugs, doctors must write each individual prescription and cannot call in refills.  Tighter regulations apply to pharmacies as well.
     The first serious questioning as to whether hydrocodone-acetaminophen products were properly scheduled occurred in 1999, when Dr. Ronald Dougherty wrote to the DEA about problems he was seeing with addiction to hydrodocodone-acetaminophen products (Norco, Lortab, Vicodin). 
     In 2004, after reviewing the evidence and concluding that hydocodone-acetaminophen was every bit as addictive as other opioids, the DEA petitioned the FDA to change hydrocodone-acetaminophen products from Controlled Substances Schedule III to Schedule II. 
     While the DEA petitioned the FDA for the scheduling change in 2004, it was four years before the FDA responded.  Using questionable logic, the FDA argued that hydrocodone-acetaminophen products were safer than Schedule II products such as Percocet (oxycodone-acetaminophen), and that hydrocodone-acetaminophen products would remain Schedule III.
     In 2009, the DEA, using evidence accumulated since its 2004 submission, again petitioned the FDA that hydrocodone-acetaminophen products were every bit as addictive as other Schedule II drugs and needed to be rescheduled.
     The FDA took no action until Congress passed legislation requiring the FDA to meet on this topic.
     On Jan. 23-24, 2013, the FDA Advisory Committee met to discuss the issue.  The FDA presented preparatory material to the Advisory Committee members.  While the FDA expressed no formal opinion regarding rescheduling, the conclusion from the FDA's presentation would be that the DEA was wrong and that hydrocodone-acetaminophen products could be kept in Schedule III. 
     FDA arguments toward this end bordered on the bizarre.  When we think of the amount of exposure to an addictive substance that leads to addiction, factors include total dosage of the drug, the length of time for which it is taken, and individual differences in vulnerability to addiciton.  The FDA's epidemiologists substituted the number of pills for total dosage, basing this on the hypothesis that each exposure to a unit of the drug constituted an opportunity for addiction to occur.  The FDA was saying that a patient taking a pill containing hydrocodone 5 mg 4 times a day for 6 months had the same risk of addiction as a person taking 50 mg 4 times a day for 6 months.  In making this argument, FDA epidemiologists manipulated fundamental scientific concepts for the sake of politics.  
     The Advisory Committee voted 19-10 to reschedule hydrocodone-acetaminophen combination products to Schedule II. 
     The FDA had been keeping track of this issue for years and had managed to keep these addictive opioid products more readily available by maintaining them in Schedule III from 2004-2013. 
     All the scientific evidence had been reviewed before January, but over the next 9 months the FDA dawdled, apparently trying to determine the potential political fallout of deciding against the 2:1 recommendation of its Advisory Committee.  
     On Oct. 25, 2013, the FDA finally rescheduled hydrocodone-acetaminophen products to Schedule II.  As Dr. Douglas Throckmorton, the Deputy Center Director for Regulatory Programs in the FDA's Center for Drug Evaluation and Research wrote, "While it is useful in the treatment of pain, it has also contributed significantly to the very serious problem of opioid misuse and abuse in the United States." 

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