Opioid addiction is winning and America is losing. It’s unclear which side the FDA is on.

The FDA and its leadership talk a big game about combating the opioid crisis. These promises aren’t reflected in their actions.

We’re calling on the FDA to WAKE UP and do its part to stop opioid-related deaths.

THE PROBLEM

THE SOLUTION

Repressing recovery

The FDA claims to be dedicated to advancing recovery treatment, even going so far as to issue guidance for the industry on developing certain innovative recovery drugs and fast-tracking their development. But this is far from reality. This exact kind of drug—a drug they fast tracked—is being shelved by the FDA for two years not because it doesn’t work—the FDA said it is “safe and effective” and granted it tentative approval in December 2018—but because of a narrow and subjective interpretation of “exclusivity.” Innovation and approving recovery medications are nice, but they mean nothing if we can’t use these life-saving tools.

THE SOLUTION

Prioritize recovery innovation

  • Until the trend in opioid-related deaths declines, recovery medications should go to the front of the review line.
  • Given the urgent need for new and innovative recovery medications, loosen exclusivity rules for these types of drugs.
  • Put Brixadi, a recovery medication that was tentatively approved but shelved because of an exclusivity ruling, on the market. In the future, utilize the FDA’s full discretion (as allowed by law) to interpret regulations for recovery medications given the Administration’s stated desire for more patient-centered drug development and the unmet medical need in the midst of a public health crisis.

THE PROBLEM

Pills before people

Today’s opioid crisis was directly caused by inappropriate use of and access to dangerous opioid pain medications. This crisis has killed hundreds of thousands of people and cost billions of dollars. The FDA likes to say they’re serious about helping to address this crisis, but they’d rather spend their time approving new and more dangerous opioid painkillers—21 in the last 10 years—than accelerating innovations in recovery medications, the gold standard of care for opioid use disorder. Today, there are 8 times more opioid painkillers (106) available than recovery medications (13).

THE SOLUTION

Be a better watchdog

  • Just as the White House Opioid Commission recommended, establish guidelines for post-market surveillance related to diversion, addiction, and other adverse consequences of controlled substances.
  • Develop a plan to address the shortcomings of the opioid risk evaluation and mitigation strategies (REMS) and the lack of uniform opioid prescriber education.

THE PROBLEM

Black box bureaucracy

How does the FDA actually work? Who sits on advisory committees and the Exclusivity Board — and are they qualified to make decisions that have the potential to turn the tide on the opioid crisis (for better or for worse)? Do they understand patient needs or the greater context of this public health emergency? Clearly not. There’s a complete lack of transparency into the inner workings of the FDA and it’s about time someone held them accountable.

THE SOLUTION

Be transparent and accountable

  • Publish who sits on the Exclusivity Board and the process they use to make decisions.
  • Include opioid experts on advisory committees and insist that the Chair of the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) attend all opioid-related committee meetings.
    • The AADPAC Chair was not in attendance during the discussion and vote regarding Dsuvia, one of the most potent opioids on the market, which was approved in 2018 amid outcry from advocates, providers, and policymakers.
  • Mandate that the Drug Safety and Risk Management Advisory Committee (DSaRM) be invited to all opioid-related advisory committee hearings with at least one person attending.
    • During 2016 and 2017, in all 11 instances when AADPAC discussed a specific opioid or opioid issues generally, the full DSaRM was invited as a co-committee.
    • In 2018, DSaRM was only present in 6 of 9 instances. They were not in attendance for the Dsuvia discussion and vote.