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Sunday, February 10, 2013

FDA panel begins hearing on hydrocodone.


ABC World News (1/24, story 5, 2:15, Sawyer, 7.43M) reported, "Now, to the crackdown on the epidemic use of prescription pain killers in America. Consider this, the US, just 4.5% of the world's population, consumes 99% of the world's hydrocodone." ABC (Kerley) added, "The Drug Enforcement Administration can't win the battle, and is pleading to make it harder" to get prescription drugs containing hydrocodone. Special Agent Robert Hill of the DEA Pharmaceutical Investigations Section was shown saying, "If it [hydrocodone] has more restrictive manners tied to it, it could help reduce the abuse potential." Kerley added that there is some concern that if hydrocodone is "classified as a more dangerous drug, that could drive up costs" for drug makers and healthcare providers, and patients "would have to make more visits to the doctor for refills, spending more in co-pays."
        Bloomberg News (1/25, Edney) reports that an FDA advisory panel began its two-day meeting Thursday to contemplate the DEA's request that the agency consider tightening prescribing and other rules on hydrocodone drug products. For one, the Drug Safety and Risk Management Advisory Committee is "debating the DEA's request to limit prescriptions of hydrocodone combination pills and cough suppressants to a 90-day supply instead of the current five refills within six months. The proposal also would strip physician assistants and nurse practitioners of their authority to prescribe the products." In addition, the DEA has asked the agency to move hydrocodone-combination products - such as Vicodin (acetaminophen and hydrocodone) - from the schedule III designation to the highly regulated schedule II class under which narcotics - such as OxyContin (oxycodone) and pure hydrocodone - fall.
        HealthDay (1/25, Gardner) notes that advocates of a "move to Schedule II status point to tragic deaths and suicides that have been the result of misuse of these prescription drugs" whereas opponents have expressed concern "that tightening access to the drugs would mean that people who really need them to ease pain will not be able to get them." Meanwhile, an FDA spokesperson "said the advisory panel would most likely vote on the issue Friday afternoon."


FDA Advisory Panel Recommends New Restrictions On Hydrocodone Products.

An FDA advisory panel's recommendation regarding hydrocodone restrictions received a substantial amount of coverage in print, online, and on two of last night's national news broadcasts. Some sources pointed out that the FDA was likely to adopt the recommendations. Additionally, many sources pointed out that the recommendations did face some criticism, particularly from pain patient advocacy groups.
        The CBS Evening News (1/25, story 9, 0:15, Pelley) reported that "an FDA advisory panel" has "recommended new restrictions on prescriptions and refills" of products containing hydrocodone.
        ABC World News (1/25, story 8, 0:30, Sawyer) reported, "The FDA is expected to follow the recommendation making it more difficult to get those drugs prescribed because of all the abuse."
        The Los Angeles Times Share to FacebookShare to Twitter (1/26, Girion) reported that the panel "recommended Friday that the agency reclassify hydrocodone...as a Schedule II narcotic, placing it in the same category as other widely abused medications, including OxyContin and fentanyl." Should the agency approve "the change, patients would be able to get fewer hydrocodone pills at one time, and there would be more restrictions on refills. In addition, pharmacies would have to follow stricter procedures for handling and storing the drug."
        The New York Times Share to FacebookShare to Twitter (1/26, Tavernise, Subscription Publication) reported, however, that "at 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse." Still, the Times points out that "the drug agency is likely to follow" the recommendation.
        The AP Share to FacebookShare to Twitter (1/25) reported, "FDA officials closed the meeting by acknowledging the difficulty of combating hydrocodone abuse, while keeping the drugs available for patients who legitimately need them." Douglas Throckmorton, the agency's deputy director for regulatory programs, said, "There is an unquestioned epidemic of opioid abuse, overdose and death in this country, an epidemic we need to address as a society."

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