FDA's broad plan for dealing with opioid medicines could eliminate at least one roadblock to Robert Califf's confirmation as FDA commissioner.

On Feb. 4, Califf, currently FDA deputy commissioner for medical products and tobacco, and other agency officials announced a plan "to reassess the agency's approach to opioid medications." The agency said the plan will focus on policies aimed at reversing the epidemic, while still providing patients in pain access to effective relief.

"We are determined to help defeat this epidemic through a science-based and continuously evolving approach," Califf said in a release. "This plan contains real measures this agency can take to make a difference in the lives of so many people who are struggling under the weight of this terrible crisis."

FDA repeatedly has stated these twin goals as it faced criticism for its handling of opioid products. The long-simmering political tension came to a head when Sens. Ed Markey, D-MA, and Joe Manchin, D-WV, said separately they would hold up Califf's confirmation until FDA adjusted its approval standards ([A#05160201009]).

Other senators also have pledged to block his nomination on other grounds, including Alaska Republican Lisa Murkowski, who was angered over FDA approval of genetically modified salmon.

However, while the agency's evaluation of its opioid drug reviews could help appease Manchin, Markey and Murkowski, Vermont independent Bernie Sanders, also a candidate for the Democrat presidential nomination, might not be swayed.

Sanders has demanded President Obama withdraw the nomination, questioning Califf's ties to the pharmaceutical industry and his commitment to lowering drug prices.

Outside Guidance Sought

FDA said one cornerstone of the plan is for the agency to obtain guidance from outside experts on pain management and abuse. The agency asked the National Academy of Medicine to develop a framework for review, approval and monitoring of opioids.

As part of the plan, the agency will convene an expert advisory committee before approving any new drug application for an opioid that does not have abuse-deterrent properties. It also will consult with its Pediatric Advisory Committee to make recommendations on a framework for pediatric opioid labeling.

FDA faced a barrage of opposition in 2014 when it approved Zogenix Inc.'s Zohydro (extended-release hydrocodone) against the recommendation of its Anesthetic and Analgesic Drug Products Advisory Committee. Members of Congress, state attorneys general and consumer groups called for the agency to retract the approval of the drug, which lacked abuse-deterrent technology ([A#00140407011]).

FDA also is revising immediate-release opioid labeling to include additional warnings and safety information that incorporate elements similar to those in labeling for extended-release/long-acting (ER/LA) opioid analgesics.

House Energy & Commerce Committee leaders had requested that FDA eliminate the discrepancy in the labeling of immediate-release and ER/LA opioids ([A#14150709004]).

Energy & Commerce ranking member Frank Pallone, D-NJ, issued a statement commending FDA for the plan, particularly the stronger labeling requirements and strengthening of postmarketing requirements.

The plan further calls for FDA to:

re-examine the risk-benefit paradigm for opioids and consider their wider public health effects;
update Risk Evaluation and Mitigation Strategy requirements for opioids after considering advisory committee recommendations and review of existing requirements;
expand access to, and encourage the development of, abuse-deterrent formulations of opioid products;
improve access to naloxone and medication-assisted treatment options for patients with opioid use disorders; and
support better pain management options, including alternative treatments.

The agency noted it also is strengthening requirements for drug companies to generate post-market data on the long-term impact of using ER/LA opioids.

FDA said its plan also supports the Centers for Disease Control and Prevention's current work on guidelines for prescribing opioids for the treatment of chronic pain outside of end of life care. CDC's draft guidelines for primary care providers treating patients in outpatient settings would limit the dosage and duration of opioid use ([A#14150928007]).

FDA Opioid Action Plan Could Help Clear Califf Nomination Roadblock

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