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Pink Sheet – US FDA May Change Opioid Labeling To Limit Dispensing By Indication

Pink Sheet – US FDA May Change Opioid Labeling To Limit Dispensing By Indication

Executive Summary

Commissioner Gottlieb says FDA is looking to work with provider groups to set dosage based on indication; Patrick Kennedy is calling on CMS to provide reimbursement for opioid addiction treatment.


US FDA Commissioner Scott Gottlieb said that “perhaps the biggest role” the agency can play in responding to the opioid crisis is by reducing overall exposure to opioids. FDA may be able to do so, he said, by encouraging more controlled dispensing so three to seven doses are dispensed rather than 30.


Gottlieb suggested that the agency could work with provider groups to build into opioid labeling what the appropriate dispensing should be for different indications. For example, he said the agency could work with the Dental Association to develop labeling specifying that any dental procedure shouldn’t require more than a five- to seven-day supply of opioids.


“That could be used as a way to regulate dispensing at the pharmacy counter,” he said. “We are going to look at how to use our regulatory tool box more creatively to address these goals.”


Gottlieb said the agency would issue a Federal Notice soon articulating its thinking on the topic. He noted the agency’s opioid labeling plans in response to a question at Research America’s National Health Research Forum in Washington, DC Sept. 7.


His talk at the meeting focused on the policies that FDA is developing for preclinical development of products involving new technology platforms. (Also see “Gene Therapy Platforms May Require Less Preclinical Data, Gottlieb Says” – Pink Sheet, 7 Sep, 2017.)

FDA Looks To ‘Pilot’ With Payers

Gottlieb also alluded to the agency’s interactions with payers at a Sept. 13 meeting sponsored by Friends of Cancer Research. He said the agency is seeking their advice on two topics: how the agency can respond to the opioid crisis and how it can address drug pricing.

“Could we pilot new educational opportunities that might later be incorporated into a REMS?” – FDA’s Gottlieb

In an interview after his talk, Gottlieb said he has asked payers to suggest “where we might be able to collaborate with the supply chain and provide systems to try to effect some of our regulatory goals in opioids.”


These conversations “are aimed at looking for ways that we might be able to pilot certain regulatory approaches, where we might work collaboratively with providers,” he said. “For example, if we have certain guidance and labeling, could we do things in collaboration, even on a voluntary basis, to limit dispensing? Could we pilot new educational opportunities that might later be incorporated into a REMS [Risk Evaluation and Mitigation Strategy]?”


“I think we need to take the opportunity to look at ways that we can do things on a small scale before we do them on a large scale and work with some of these provider systems that might be more forward-leaning that want to collaborate with us,” Gottlieb added. He noted that the agency has just begun this initiative and has met with CVS Health Corp.

Kennedy Calling For CMS Reimbursement

In a panel at the Research America forum, former Rep. Patrick Kennedy, a member of the President’s Commission on Combating Drug Addiction and the Opioid Crisis, asserted that FDA could help by expediting access to long-acting buprenorphine. He said the president’s report would include this recommendation. (See sidebar.)


Indivior PLC announced in May that it had submitted a new drug application to FDA for approval of its once-monthly injectable buprenorphine, RBP-6000, for the treatment of moderate to severe opioid use disorder. Indivior said in an analyst call earlier this month that the drug, which has priority review status at FDA, is on schedule for a US launch in the first quarter of 2018. (Also see “Indivior To Appeal US Suboxone Setback, Flags Follow-On Drug RBP-6000” – Pink Sheet, 2 Sep, 2017.)


Buprenorphine has been available as a pill or a film for treatment of opioid dependence and last year, FDA approved the first buprenorphine implant.


Kennedy, who noted that he is an opioid addict and has been sober for four years, spoke passionately about the need for medical-assisted treatment for addiction. He said he had taken Suboxone (buprenorphine/naloxone) to cope with his addiction while serving in Congress.


Kennedy also criticized the Centers for Medicare and Medicaid Services for its reimbursement policy. He noted that he would be meeting with CMS officials the following day and would ask them why the agency is not reimbursing for treatment of substance use disorder as they do for other illnesses. He said he would recommend that they bump up billing codes used for Medicare payment, particularly the collaborative coordinated care codes.


“Reimbursement for substance use disorder is criminally low,” Kennedy said. “CMS doesn’t reimburse for it” and big insurers follow their lead.


Kennedy also pointed to the lack of health care providers providing medication assisted treatment, saying only 10% of providers do so. He asserted that the American Medical Association “should have a moral responsibility to ask all of their members to write [prescriptions] for medication assisted treatment.”…