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Alexander: Draft Legislation Would Require Dispensing Opioids in Short-Term Blister Packs, Help FDA Stop Illegal Fentanyl at Borders

Seeks input to improve legislation before Senate health committee markup of opioids bills at end of April

NASHVILLE, March 26, 2018 — Senate health committee Chairman Lamar Alexander (R-Tenn.) today released two discussion drafts of legislation to improve the Food and Drug Administration’s (FDA) ability to address the opioid crisis.

“The Senate health committee has held six bipartisan hearings so far this Congress on nearly every aspect of the opioids crisis, to inform legislation to better help states and communities on the front lines,” Alexander said. “I want to ensure that the Food and Drug Administration has every tool it needs to fight the opioid crisis, and the draft legislation released today will take the next step towards making that possible.”

Alexander continued: “The first proposal would require drug manufacturers to package certain opioids in a set dose, like a blister pack, which will make it simpler for doctors to write prescriptions for smaller numbers of opioids. It would also encourage manufacturers to provide a safe way to dispose of leftover opioids along with the prescription a patient picks up—to prevent unused opioids from ending up in the wrong hands.  A second proposal would ensure FDA can spend the $94 million included in the omnibus bill Congress passed last week to upgrade detection technology, laboratory capacity, and import facilities to better identify illegal drugs, including synthetic opioids such as fentanyl, at the border.” 

Improving FDA authorities to address the opioid crisis

First, to help limit overprescribing, this legislation would give the Food and Drug Administration (FDA) the authority to require drug manufacturers to package certain opioids in blister packs, allowing for a set dose – for example, a 7 day supply. 

  • This would make it simpler for a doctor to write a prescription for a smaller number of opioids, easier for pharmacists to fill, and will help to prevent overprescribing and diversion of unused medicine, for example, preventing unused medicines from being sold or abused.

Second, to prevent unneeded or unused opioids from falling into the wrong hands, this legislation would encourage manufactures to provide a safe way to dispose the leftover drugs along with the packaging.

  • If a mom receives a 30 day opioid supply after knee surgery, but only takes 15 days’ worth, this would make it easier for her to safely dispose of the unneeded opioids to prevent her child from finding them and using the remaining opioids.  

Text of the discussion draft is available here

Improve coordination between the Food and Drug Administration (FDA) and Customs Border Protection (CBP)

To improve ability to find and seize illegal drugs, such as fentanyl, at the border, this legislation would:

  • Ensure FDA and CBP detection technology and testing equipment used at the border is interoperable and allows near-real-time data sharing for faster and smarter detection of new substances coming across the border, such as synthetic fentanyl.
  • Make available additional trained canine units, including trained canine officers, are available at import facilities to increase detection and screening capabilities.
  • Upgrade FDA facilities and provide appropriate equipment, laboratory capacity, and physical infrastructure improvements, which may include security upgrades, to improve capacity to examine and detect illegal opioids at import sites, such as International Mail Facilities.
  • Require a progress report within six months on the implementation of these new authorities, including progress made towards near-real-time information sharing and the interoperability of technology used at the import sites.

Text of the discussion draft is available here

The Senate health committee has held a series of six bipartisan hearing so far this Congress to examine ways the federal government can be a better partner for states on the front lines of the opioid crisis.

On October 5, 2017, the Senate health committee held the first hearing of the series which focused on the federal response to the opioid crisis, and on November 30, 2017, the committee heard from witnesses representing states, communities, and providers on what they are doing and what, if any, new authorities they need from the federal government to fight the crisis. On January 9, 2018, the committee heard from author Sam Quinones, who has extensively researched and written about the opioid crisis. On February 8, 2018, the committee held a hearing to look the effects the opioid crisis has on children and families. On February 27, 2018, the committee held a hearing on the role technology and data play in responding to the crisis. On March 8, the committee heard from some of the nation’s governors about how they are coming up with innovative solutions and leading the fight against the unique problems their states face in the midst of the opioid crisis.