Support, Criticism for Opioid Benefit/Risk Framework Guidance
Collegium Pharmaceutical, a specialty pain management drug company, says it appreciates recent FDA actions related to the opioid crisis. In a comment on an agency draft guidance on considerations for a benefit/risk assessment framework for opioids, the company says it agrees with FDA that an assessment of opioid analgesic drugs should take into account the broader public health impact of such drugs, including consideration of risks related to misuse, abuse, opioid use disorder, accidental exposure, and overdose. “In doing so,” it adds, “it is equally important that the agency take into consideration the legitimate need of millions of Americans for meaningful relief for their moderate to severe pain when alternative treatments are inadequate.”
Collegium also says it would be reasonable for FDA to conclude that new opioid medications that do not provide a meaningful clinical improvement over existing therapies cannot be viewed as sufficiently safe to merit approval.
Pharmaceutical Manufacturing Research Services, a contract drug manufacturer, says it supports FDA efforts in the draft guidance to educate stakeholders on the importance of an opioid’s proposed or prescribed duration of use to the agency’s assessment of the drug’s relative benefits and risks to patients. However, the letter says the draft addresses dosage only in passing and only with regard to overdose risks. It says the document should give dosage levels a more important and explicit role in the benefit/risk calculation. And it asks for further detail on the methods industry should employ and FDA will consider to assess or test opioid risks and benefits before a drug is approved for marketing.
Kaiser Permanente comments it strongly supports FDA efforts to gather more evidence about the relative safety, effectiveness, and public health effects of new opioid products as part of the benefit/risk assessment process. “This information will be extremely valuable for informing treatment decision-making between clinicians and their patients, as well as designing pharmacy benefits that advance patient safety and public health,” it says. Kaiser also encourages the agency to rigorously evaluate submissions for abuse-deterrent formulations and other opioid products with safety features. It says the agency should require manufacturers to include evidence of decreased risk of addiction and misuse in NDAs for products with safety features, as well as post-market studies showing the results and decreased use in the community.
Finally, Public Citizen criticizes the draft as “woefully inadequate because its cursory content is far more focused on the non-specific, generalized factors that FDA itself will consider when reviewing an NDA for an opioid, rather than providing industry with guidance as to what specific benefit and risk information should be sought out and included in future NDAs for opioids.” The advocacy group says the draft fails to specify the need for sponsors to conduct comparative safety and efficacy studies on all new opioids and fails to address the diversion of opioids. It suggests that an agency 2015 guidance on evaluation and labeling of abuse-deterrent opioids “is much more useful because it provides numerous specific, detailed recommendations that companies should follow when designing pre-approval studies to support NDAs for new abuse-deterrent opioids.”