WH, Congressional Leadership Talk Opioid Epidemic

Officials from the Trump Administration met with leaders on Capitol Hill to discuss the steps taken to address the opioid epidemic since it was declared a public health emergency in October. The First Lady delivered opening remarks at the summit, followed by three administration panel discussions moderated by Kellyanne Conway. Secretary of the Department of Health and Human Services (HHS) Alex Azar, Department of Veterans Affairs (VA) Secretary David Shulkin, and Housing and Urban Development Secretary Ben Carson discussed prevention and treatment. Azar specifically expressed support for improving access to non-opioid pain therapies, while Carson discussed how communities can support those suffering from addiction through housing policy. Newly appointed acting director of the Office of National Drug Control Policy (ONDCP) Jim Carroll participated in a question and answer period about the Administration’s efforts to control the crisis. Attorney General Jeff Sessions, Department of Homeland Security Kirstjen Nielson, and Deputy Secretary of State John Sullivan discussed law enforcement and interdiction. Sessions indicated that he plans to review with the Drug Enforcement Administration (DEA) whether changes are needed to current opioid production quotas. President Trump also made an appearance at the event, calling for stronger penalties for drug dealers. He noted that he is considering the possibility of suing opioid manufacturers. The President stated that the White House will release an opioid policy over the next three weeks. The Administration’s emergency declaration was renewed in January and will expire on April 23.

During a separate event last week, FDA Commissioner Scott Gottlieb called for a national electronic prescribing platform and interoperable prescription drug management programs (PDMPs) to help combat the epidemic. According to Gottlieb, the agency is also considering whether it could use risk evaluation and mitigation strategies (REMS) to educate doctors about responsible prescribing.

In related news, the Government Accountability Office (GAO) announced plans to open an investigation into the White House’s response to the opioid crisis. The investigation was requested by Senate Democrats. The GAO will review the actions taken by the administration to address the crisis since the president’s emergency declaration last October.

W&M Requests Information on Opioids

The House Ways and Means Committee is requesting information from insurers, pharmacy benefit managers (PBMs), and health care providers and prescribers about how to better protect Medicare beneficiaries from opioid dependence and overdose. The Committee is currently drafting its own bipartisan opioid-related legislation, and is looking to leverage Medicare to combat opioid abuse and addiction. The lawmakers request feedback by March 15 related to overprescribing, data tracking, communication and education, and expanding treatment options in Medicare.

FDA Looks to Speed Rare Disease Treatment Development

Commissioner of Food and Drugs Scott Gottlieb announced steps his agency plans to take to expedited drug development for rare diseases. The announcement was made on the 11th annual rare disease day last week. The FDA is looking to simplify the form a drug company files for an orphan drug designation, and to establish an online tutorial to help companies navigate this process. The agency has also entered into a memorandum of understanding with the National Organization for Rare Disorders (NORD) to conduct outreach with FDA’s staff.

Legislators Release CARA

A bipartisan group of eight senators released follow up legislation to the Comprehensive Addiction and Recovery Act (CARA), which was signed into law in 2016. The bill, dubbed “CARA 2.0,” would establish an initial three-day prescribing limit on opioids for acute pain. It would also strengthen services to promote recovery, such as an initiative aimed at young support services. The bill would require physicians and pharmacists to use their prescription drug monitoring program (PDMP) before prescribing or dispensing opioids. To increase the availability of treatment, CARA 2.0 would allow states to waive the number of patients a physician can treat with buprenorphine. It would increase penalties for opioid manufacturers who fail to report suspicious orders. The bill authorizes $1 billion in additional funding, which includes $10 million for a national education campaign, $300 million to expand access to medication assisted treatment (MAT), $200 million to build a national infrastructure for recovery support services, and $300 million for expanding first responder training and access to naloxone. The two-year budget deal passed in February included $6 billion for the opioid crisis for fiscal years 2018 and 2019. The bill is sponsored by Sens. Rob Portman (R-Ohio), Sheldon Whitehouse (D-R.I.), Amy Klobuchar (D-Minn.), Dan Sullivan (R-Alaska), Maggie Hassan (D-N.H.), Bill Cassidy (R-La.), Shelley Moore Capito (R-W.V.), and Maria Cantwell (D-Wash.).

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