PAINKILLER LAW: FDA and I Call For Abuse-Deterrent Drug Agents

The FDA today called upon pharmaceutical researchers to develop formulations of opioids that would bring pain relief while reducing the possibility of addiction. The FDA refers to “abuse-deterrent” drug agents in the chemical sense. I join the FDA in calling for abuse-deterrent drug agents, only the kind of agents I’m talking about wear badges, drive fast in unmarked cars, and show up heavily armed.

The FDA should be commended for its balanced approach, in which it seeks both the development of less addictive drugs, and the need to get real pain relief to patients. What concerns me is that in investigating healthcare providers who write Schedule II-V prescriptions, typically law enforcement agents including the DEA and state Medical Boards emphasize “case clearing” over balance, hard and fast over nuance, and black and white over shades of gray. Whereas the FDA’s January 9 statement expresses its extreme concern “about the inappropriate use of prescription opioids,” the FDA doesn’t define “inappropriate.” Left to the determination of the DEA, which has been accused of being late to the party on addressing prescription drug abuse, and left to state Medical Boards, which have been accused of bailing on the party altogether, the definition of “inappropriate” could be bent, twisted, contorted, and most dangerously, broadened to encompass practices and procedures which a better informed or more detached observer would never contemplate. But when the warrant is signed or the cuffs slapped on, it’s too late for a healthcare provider to say, “Let’s slow down, back up, look at this from the beginning, and then discuss.”

That is why every healthcare provider, risk manager, medical group manager and professional needs to know the black-letter federal and state law of Schedule II-V prescriptions, and the nuances and subtleties of how the law is interpreted, what influences and impacts the agencies charged with “cracking down” on supposedly corrupt providers, and what you can do now, today, to ensure patient safety and the protection of your practice. This is why PAINKILLER LAW exists. Don’t let yourself fall victim to the subjective and loosey-goosey way law enforcement agencies and Medical Boards are defining “inappropriate,” “overprescribing,” “gross negligence,” or other concepts whose interpretation could be fraught with peril for even the most honest and ethical MD, osteopath, or physician’s assistant. Let us help you verify, achieve and maintain full compliance with the laws that well-intentioned but hopelessly biased drug agents are ever more aggressively attempting to enforce.

PAINKILLER LAW – It’s good preventative medicine.

info@painkillerlaw.com 213.293.3737 MEISTER LAW OFFICES

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