PAINKILLER LAW BLOG: FDA’s Best Bad Idea

The FDA recently announced a new “action plan” to deal with the nation’s public health crisis of opioid addiction, overdose and death.  Given that the FDA endorsed dubious science put forth by the pharmaceutical industry in initially blessing opioid prescribing for chronic pain, there are those who’d commend the FDA for its ongoing efforts to deal with the unexpected and deadly epidemic.  To others, however, the FDA’s latest attempt to do something recalls a great line from the Oscar-winning movie ARGO, where a lead CIA analyst tells his very skeptical boss that the plan to evacuate captive Americans from revolutionary Tehran by having them pose as a Canadian film crew is “the best bad idea we have, by far.”

According to its website, The FDA will (1) form new advisory committees to work alongside the committees already formed; (2) require new product warnings on opioid prescription labels; (3) mandate the generation of new data by drug manufacturers on the long term impact of extended release/long acting opioids; and, (4) train more prescribers on pain management and safe prescribing.  The first elements of the plan sound like more bureaucracy and over-reliance on opioid manufacturers to self-police and self-disclose.  The fourth element, however — educating more prescribers on pain management and safe prescribing — is well conceived and absolutely necessary.  Too many doctors, with the endorsement of the FDA, the Federation of State Medical Boards, and the gleeful good wishes of Big Pharma, got into pain management without knowing what they were doing.  Well intentioned physicians got way in over their heads, and still are.  Educating physicians in pain management and safe prescribing is the very least the FDA can now do.

To be what a prescriber really needs, physician education can’t just consist of seminars where everyone gets a copy of his or her state’s opioid prescribing guidelines, and a warning from the DEA speaker on the dais that from now on, things had better be right with one’s prescribing.  Instead, proper prescriber education starts with the guidelines, but doesn’t stop there.  Physicians must be educated that prescribing guidelines are a legal test of a doctor’s medical judgment, and that if law enforcement perceives guideline noncompliance, criminal liability can quickly follow.  Criminal liability, as in prosecution of a doctor for unsafe prescribing and more.

The FDA would do well to include this critical legal-medical component in its education program.  Physicians should demand nothing less.  That way, the FDA’s “best bad idea” would actually bring some good to patient safety and the profession.

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