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Office of National Drug Control Policy Says Congress Should Mandate Painkiller Safety Training

USA Today reports, “To halt prescription drug abuse, the nation’s fast-growing drug problem, Congress must require special training for doctors and other health care workers before they are allowed to prescribe powerful drugs such as OxyContin,” ONDCP Director Gil Kerlikowske said Tuesday.

The Wall Street Journal reports the Food and Drug Administration said Tuesday that it will require pharmaceutical companies to produce new educational tools about their opioid painkillers in an effort to reduce prescription drug abuse. Department of Health and Human Services Assistant Secretary Howard Koh said at a briefing, “This growing public-health crisis is suffocating our society.”

USA Today reports, “American Medical Association President Cecil Wilson said his organization supports the intent of the drug abuse prevention plan but is concerned ‘that a key element of this strategy that relies on industry to develop educational materials and initiatives to train prescribers could in the future become a mandatory part of the DEA registration process for prescribing controlled substances.’”

Bloomberg News reported, “Pfizer Inc. (PFE), Johnson & Johnson (JNJ) and Endo Pharmaceuticals Holdings Inc. (ENDP) will have to train doctors before they can give patients extended-release painkillers under a US plan aimed at reducing prescription drug abuse.” The Food and Drug Administration said on Tuesday that “sixteen companies that make 25 pain patches and pills must create a program to teach medical professionals when these drugs should be used to combat pain and how to recognize signs that the treatments are being misused.”

HealthDay reported, “The new Risk Evaluation and Mitigation Strategy (REMS) is part of a larger multi-agency initiative announced Tuesday by the White House to reduce overall prescription drug abuse in the” US. “‘This new REMS will provide tools to doctors and other prescribers for appropriate pain management to reduce risks and at the same time preserve access for patients and appropriate management of pain for those suffering from moderate to severe pain,’ said Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the” FDA. “For now, the initiative will be limited to extended-release and long-acting products, which, Woodcock said, ‘have a much greater risk than immediate-release because they contain more medicine.’”

Modern Healthcare reports, “President Barack Obama’s administration also will push for enactment of as-yet-unintroduced legislation to require physician participation in opioid prescribing training. And Gil Kerlikowske, director of National Drug Control Policy, said he is confident that Congress would enact such a measure promptly based on the previous passage of other recent measures focused in part on opioid-abuse control.” But, “if Congress does not enact a law requiring mandatory physician participation in such training, the FDA could aim to tighten control on opioid prescribing through restricted formularies.”

The Hill “Healthwatch” blog reported, “As a first step, the FDA sent letters to opioid manufacturers on Tuesday requiring that they provide a plan for training prescribers and educating patients about the safe use, storage and disposal of opioids. They have 120 days to respond, setting in place a regulatory process that officials hope to have in place within 12 months. ‘We have determined that a Medication Guide and a Communication Plan are not sufficient to mitigate the serious risks,’ the letters state. ‘Your (strategy) must include tools to manage these risks’”

On its website, CNN reports, “‘Unintentional drug overdose is a growing epidemic in the US and is now the leading cause of injury death in 17 states,’ said Dr. Thomas Frieden, director of the Centers for Disease Control and Prevention. ‘There are effective and emerging strategies out there to address this problem. Support for this action plan will help us implement those strategies which will go a long way to save lives and reduce the tremendous burden this problem has on our healthcare system and our society.’”

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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