Tuesday, March 29, 2016

New FDA Rules Put Onus On Doctors To Curb Opioid Abuse - Law360

New FDA Rules Put Onus On Doctors To Curb Opioid Abuse - Law360

by Sindu Sindhar

Law360, New York (March 28, 2016, 10:39 PM ET) -- The U.S. Food and Drug Administration's latest efforts to address what public health officials consider an epidemic of opioid abuse put the onus squarely on doctors to limit prescriptions of the controversial painkillers, in what some attorneys say is a tacit acknowledgment of the agency's difficulty in policing what drugmakers and pharmaceutical sales representatives actually tell doctors about opioids.

The FDA last week announced that it is requiring stronger warnings on immediate-release opioids, to alert doctors and patients to their risks for "risks of misuse, abuse, addiction, overdose and death," according to the agency. The stronger warnings also include a so-called boxed or black box warning, meant to alert patients to the most serious side effects, highlighting the risks of taking opioids during pregnancy. Prolonged use of immediate-release opioids — which can be taken up to six times a day — during pregnancy can result in children born with potentially fatal opioid withdrawal, the agency said. The agency had previously required such warnings for extended-release opioids, which pack higher doses than their immediate-release counterparts, and can be taken only up to twice a day.

The move followed a similarly prescriber-focused approach by the U.S. Centers for Disease Control and Prevention, which cautioned doctors to limit prescribing opioids for shorter durations of up to three days. One of the striking features of the FDA's approach here is that it doesn't really ramp up the agency's scrutiny of how drugmakers discuss opioids with doctors, attorneys say.

Black box warnings typically require drugmakers to highlight these labeled risks to doctors when promoting them, but in practice, the agency has few means to supervise what pharmaceutical sales representatives are telling prescribers about their opioids, attorneys say. Significantly, the FDA has not even required opioid drugmakers to send out so-called "Dear Doctor" letters, which the agency usually tells pharmaceutical companies to send to doctors to inform them of new safety issues.

"I don’t think [the new rules] are toothless with respect to changing prescribing habits," said Pete Kaufman of Panish Shea & Boyle LLP. "However, if it's intended to affect manufacturers' advertising practices or the way they market to physicians, I doubt it will be all that effective."

The agency did not indicate why it chose not to require drugmakers to send out letters to doctors alerting them of changes, but spokeswoman Sarah Peddicord told Law360 on Monday that the agency has worked to inform doctors about the new warnings through a number of means.

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