FDA to Require Opioid Blister-Packs-Prescribing Guideline in 2020?

The Food and Drug Administration (FDA) plans to require that prescribed immediate-release opioids may no longer be packaged in plastic bottles but must come in sets of blister packs with durations as short as two days.

Also, FDA will publish a report proposing at least some of the scientific-evidence-based opioid-prescribing guidelines it promised last year by the end of 2019, Commissioner Scott Gottlieb announced on February 26.

That report deadline would likely lead to FDA issuing evidence-based prescribing guidelines in 2020, and possibly sooner for some opioids.

The announcement of the likely blister-pack rule and the timetable for the prescribing guidelines were in of a typically long and detailed (4,130 words) Gottlieb announcement on everything the FDA did in 2018 and plans to do this year to fight the opioid crisis.

The FDA first said last fall that it would write prescribing guidelines. This was after many state legislatures had passed laws, one more stringent than the next, limiting the duration of opioid prescriptions based on political pressures, most without regard to clinical evidence or what was being treated. At the same time, the 2016 Centers for Disease Control (CDC) opioid prescribing guideline was being widely criticized for being too “one-size-fits all” (“Are FDA and CDC at War Over Opioid Regulation?” Orthopedics This Week, October 8, 2018).

The CDC has since announced that it is also doing an evidence-based upgrade of its guidelines.

Gottlieb’s announcement said FDA is “working with stakeholders like the National Academies of Science, Engineering, and Medicine to create a scientific framework for developing evidence-based prescribing guidelines that provide specific recommendations on the proper dosing and dispensing of opioids based on specific clinical indications (like outpatient surgeries).”

What’s missing from that quote (and from his entire statement)? Answer: any mention of the CDC. So yes, unless the CDC has backed down from its announcements, the two agencies are at least competing, if not at war, over who gets to write upcoming opioid prescribing guidelines.

Another war—with various states—seems likely when FDA guidelines come out, probably in 2020. The issue: whose rules will be supreme? For example, what if a New Jersey surgeon closely follows the science-based FDA guideline, but the prescription violates the strict five-day rule former Gov. Chris Christie pushed through the state legislature?

Opioid Blister Packs

Under new authority given to the FDA in the federal SUPPORT Act, passed October 24, 2018, FDA can “require certain packaging be made available for opioids and other drugs that pose a serious risk of abuse or overdose if the FDA determines that such packaging may mitigate such risks,” Gottlieb said.

FDA plans to use that authority in the first half of 2019 “to mandate that certain solid, oral dosage forms of immediate-release formulations of opioid analgesics indicated for treatment of acute pain be made available in short-duration packaging for outpatient dispensing…Our data suggests that for many acute pain indications where opioids are used, a day or two of dispensed drug is the appropriate quantity,” Gottlieb said.

Possible New, Tougher Rules for Future Opioid New Drug Applications

“We’re also taking new steps to consider a framework to allow us to formally evaluate each candidate opioid in the context of how a novel opioid might fit into the overall therapeutic armamentarium…and address the question we’re frequently asked as to whether new opioid drugs should offer some comparative benefit over existing drugs,” Gottlieb said.

“This process could include seeking revisions to statutory authorities to allow us to change the weight we give to meaningful therapeutic differentiation for proposed new opioids, including relative safety or effectiveness advantages over existing treatments.”