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FDA Advisory Panel Recommends New Restrictions on Hydrocodone Products

This is a follow-up to an earlier post.

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 recommendation. Additionally, many sources pointed out that the recommendation did face some criticism, particularly from pain patient advocacy groups.

The CBS Evening News reported that “an FDA advisory panel” has “recommended new restrictions on prescriptions and refills” of products containing hydrocodone.

ABC World News 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 reports 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,” such as “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 reports, 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 reports, “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.”

The Wall Street Journal points out that the FDA has previously rejected prior requests by the Drug Enforcement Administration to reclassify products containing hydrocodone.

CNN reports that “pain patient advocacy groups and pharmaceutical companies, among others, fear that reclassification will make it harder for patients to get medications they need.”Bloomberg News also covers the story.

In continuing coverage, The Hill reports in its “Regwatch” blog that Reps. Vern Buchanan (R-FL) and Edward Markey (D-MA) wrote to Food and Drug Administration Commissioner Dr. Margaret Hamburg “urging her to move painkillers containing hydrocodone, such as Vicodin [acetaminophen and hydrocodone], from a Schedule III to a Schedule II drug. … ‘Prescription drug abuse is wreaking havoc on countless families and communities across our nation,’ Buchanan and Markey wrote, adding that the drugs ‘are now the most widely prescribed painkillers in the country, with more than 131 million prescriptions for hydrocodone written in 2010 alone.’” The two Congressional Members said there are planning to “reintroduce a bill called the Pill Mill Crackdown Act next week, which also aims to make the medications harder to get.”

WebMD adds that an FDA panel of experts on Friday, “voted 17 to 10 in favor of reclassifying” hydrocodone compounds from Schedule III to Schedule II. However, the “change must be approved by the FDA and the DEA to take effect.”

Medscape publishes comments from the FDA panelists. Those who were in favor of the change included Elaine Morrato, DrPH, from the University of Colorado School of Public Health, who said, “For me, the most persuasive argument was that rescheduling is a signal to the public as well as to the medical profession about the abuse potential, and it rights a misperception that hydrocodone combination products are safer options than class IIs when it comes to long-term risk of abuse.” In contrast, committee members opposed to the reclassification, such as Melinda Moore, a physician assistant from Webster, Texas, said there “were poor data to support the change.” Moore also said that she was against rescheduling because she was concerned about the “inability to call in prescriptions for the hydrocodone combination” for patients in rural areas.

From the American Association for Justice news release.

Bob Kraft

I am a Dallas, Texas lawyer who has had the privilege of helping thousands of clients since 1971 in the areas of Personal Injury law and Social Security Disability.

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The title of this blog reflects my attitude toward those government agencies and insurance companies that routinely mistreat injured or disabled people. As a Dallas, Texas lawyer, I've spent more than 45 years trying to help those poor folk, and I have been frustrated daily by the actions of the people on the other side of their claims. (Sorry if I offended you...)

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