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by
Bridget Johnson

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October 25, 2013 - 2:15 pm

The Food and Drug Administration has forwarded a recommendation to the Department of Health and Human Services to reclassify hydrocodone combo drugs such as Vicodin as a Schedule II controlled substance.

After HHS forwards its expected approval to the Drug Enforcement Administration, that would put the common prescription pain reliever in the same category as cocaine, amphetamines, opium and morphine.

Janet Woodcock, M.D., director for the FDA Center for Drug Evaluation and Research said the decision came about because of the government’s concern “about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”

“While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” Woodstock said.

“Going forward, the agency will continue working with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.”

No Schedule II prescription can be refilled without another written prescription from the doctor.

Currently, hydrocodone compounds such as Vicodin and Tylenol 3 can be filled with a written or phone prescription and refilled up to five times.

Sen. Joe Manchin (D-W.Va.) had been pressing for the reclassification because of hydrocodone abuse “that has ravaged West Virginia and our country.”

“Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities,” said Manchin, noting he’d been informed by Health and Human Services Secretary Kathleen Sebelius about the change. “…I am also extremely grateful that the Food and Drug Administration has finally implemented its own advisory committee’s recommendations to reclassify these addictive drugs. The agency has just saved hundreds of thousands of lives.”

Back in 2012, Manchin first introduced an amendment to the Food and Drug Administration Safety and Innovation Act to reschedule hydrocodone. It passed by unanimous consent but was pulled out in the version passed by the House.

Last year, five pharmacy groups sent a letter to Manchin and his supporters opposing the reclassification: the American Pharmacists Association, the Food Marketing Institute, the International Academy of Compounding Pharmacists, the National Association of Chain Drug Stores, and the National Community Pharmacists Association.

“Moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse,” they wrote.

The American Society of Consultant Pharmacists has said such a proposal would “make it difficult for long-term care (LTC) residents to receive adequate pain treatment in a timely manner by exacerbating existing barriers to pain medication access.”

Bridget Johnson is a career journalist whose news articles and opinion columns have run in dozens of news outlets across the globe. Bridget first came to Washington to be online editor at The Hill, where she wrote The World from The Hill column on foreign policy. Previously she was an opinion writer and editorial board member at the Rocky Mountain News and nation/world news columnist at the Los Angeles Daily News. She has contributed to USA Today, The Wall Street Journal, National Review Online, Politico and more, and has myriad television and radio credits as a commentator. Bridget is Washington Editor for PJ Media.

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All Comments   (5)
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Naturally the people making mega-profits from the opioids would be against new restrictions because the over-prescription of these very addictive and dangerous drugs is worth billions. I'm old enough to remember when pain was accepted as a natural part of human existence and people learned to live with minor and even major pain. Then came the '60s when drugs became a fashionable accessory to a hip lifestyle, which led us to the drug-drenched world we live in now. No one can stand even the most miniscule pain without reaching for something to make it go away, which is just another aspect of the erosion of our national character. The elderly especially are over-prescribed these drugs leading to people not just sitting around in a stupor all day, but falling and creating more pain to be alleviated by yet more drugs. These drugs are poison to all, from the elderly to experimenting, addicted children.
42 weeks ago
42 weeks ago Link To Comment
"I'm old enough to remember when pain was accepted as a natural part of human existence and people learned to live with minor and even major pain. "

Yes, remember the good old days when patients were just given a slug of whiskey before having a limb amputated? And the fun times before antibiotics?

Jaysus. Just because once upon a time we were more accustomed to suffering and dying for lack of medical treatments doesn't mean it was a GOOD thing.
42 weeks ago
42 weeks ago Link To Comment
Beware of politicians with so-called "good" intentions. Low IQ Joe Manchin is clueless of the unintended consequences from such legislation.
42 weeks ago
42 weeks ago Link To Comment
exile...I think you're on to something there.
42 weeks ago
42 weeks ago Link To Comment
why don't we ban all narcotics as prescription meds and then legalize them for recreational use?
no more prescription drug abuse! problem solved.

42 weeks ago
42 weeks ago Link To Comment
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