FDA Commissioner Scott Gottlieb Outlines Plan for Battling Opioid Crisis

In the first weeks of his tenure as FDA commissioner, Scott Gottlieb, MD, is taking action on the issue he had vowed to make his “highest initial priority:” fighting the opioid abuse epidemic and stopping the waves of overdoses across the nation.

In the first weeks of his tenure as FDA commissioner, Scott Gottlieb, MD, is taking action on the issue he had vowed to make his “highest initial priority:” fighting the opioid abuse epidemic and stopping the waves of overdoses across the nation.

In an open letter published on the FDA Voice blog, Gottlieb outlines his plans for the FDA to step up its role in preventing and curtailing opioid abuse. For instance, he writes that the agency has the authority and moral obligation to ensure opioids are prescribed appropriately to patients who truly need them.

A major step is the creation of an Opioid Policy Steering Committee, comprised of the FDA’s experienced career faculty members who will be tasked with brainstorming and investigating any potential steps the agency can implement. There will likely be several approaches on the table, as Gottlieb has encouraged the committee members to “go in whatever direction the scientific and public health considerations lead.” This direction will find its inital guide in the answers to the following questions:

  1. In what circumstances should the FDA require mandatory education for prescribers that includes information on appropriate prescribing guidelines, patient risk identification, and addiction treatment resources?
  2. How can the FDA ensure that the prescribing of opioids is appropriate for each patient’s clinical circumstances, such as by writing prescriptions for only the amount of days needed according to the medical indication? Can the FDA and provider organizations collaborate on standards and guidelines for opioid prescribing in various clinical settings?
  3. When evaluating applications for the approval of new opioid medications, is the FDA adequately scrutinizing each drug’s potential for abuse? If not, can the approval process and marketing regulations be modified to include abuse and addiction risk as a factor?

Gottlieb’s letter cited statistics on the scope of the opioid crisis, and its staggering costs, to demonstrate the need for urgent and decisive action. For instance, a survey of heroin users in treatment found that for 3 out of 4, their addiction had started with prescription opioid drugs. Furthermore, the risk of continuing to use opioids for over 1 year is 6% for patients prescribed a 1-day supply of opioids, but 35% for those prescribed a 30-day supply.

In addition to the recommendations of the Steering Committee and other FDA officials, the agency is reaching out to the public for suggestions on tackling the crisis.

“I look forward to working closely with my FDA colleagues as we quickly move forward, capitalizing on good work that has already been done, and expanding those efforts in novel directions,” Gottlieb concluded.

The opioid crisis has been a prominent concern for the FDA and its new leader. In Gottlieb’s Senate confirmation hearing, he described it as a “staggering human tragedy that will require dramatic action.” After being sworn in as commissioner, Gottlieb’s speech to FDA staff indicated he would take immediate action to develop a multifaceted strategy that would define the agency’s role in mitigating the epidemic.