Three Bills Reintroduced Requiring Actions by FDA to Address the Opioid Epidemic

Last week, Senators Joe Manchin (WV) and Mike Braun (IN) reintroduced three pieces of legislation that would require the Food and Drug Administration (FDA) to take steps to address the opioid epidemic. The Ensuring the FDA Fully Examines Clinical Trial Impact and Vitalness before Endorsement (EFFECTIVE) Act would provide FDA with authority to review the public health impacts of opioid approvals and deny new drug applications for opioid analgesics if the product is not clinically superior to other commercially available products. The bill was developed in response to requests by FDA Commissioner Dr. Robert Califf to provide the agency with additional legal authority to implement recommendations outlined by the National Academy of Sciences, Engineering and Medicine in their 2017 report, Pain Management and the Opioid Epidemic. The Changing the Culture of the FDA Act would require the FDA to amend its mission statement to include specific language on the FDA’s responsibility for protecting public health by considering the dangers of addiction and overdose deaths when approving and regulating opioids. The Protecting Americans from Dangerous Opioids Act would require that FDA revoke approval for an opioid drug currently on the market for every new opioid medication approval. The bill also requires that FDA prioritize revoking non-abuse deterrent opioids and consider the public health impact of the drug being on the market.

Articles & Resources


Changing the Culture of the FDA Act

Protecting Americans from Dangerous Opioids Act

DEA Proposed Telemedicine Rules Would Require In-Person Consultations for Long Term Buprenorphine Access

On February 24th, the Drug Enforcement Administration (DEA) announced proposed permanent rules for the prescribing of controlled substances, including the addiction-treatment medication buprenorphine, via telemedicine. The proposed rules would allow prescribers who have never conducted an in-person evaluation of a patient to use telemedicine to prescribe a 30-day supply of buprenorphine for the treatment of opioid use disorder. However, after the public health emergency expires on May 11th, the rule would require in-person consultations for patients who need refills of buprenorphine beyond the 30-day limit. Comments to the rule are due March 31, 2023 here.

Articles & Resources

DEA – DEA Announces Proposed Rules for Permanent Telemedicine Flexibilities

What We Read Last Week

Several articles were published last week pertaining to the opioid epidemic, covering a variety of different components of the topic. Links to relevant articles are provided below.

Big Island Now – Big Island task force, doctor, former opioid addict plead case for Buprenorphine

Congressman Mark Green – Chairman Green Demands Updated Data on Fentanyl Overdose Deaths

FDA – CANCELLED: March 20, 2023: Joint Meeting of the Nonprescription Drugs Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Announcement

Pennsylvania Capital-Star – Addiction treatment may be coming to a pharmacy near you

Senator Rick Scott – Sen. Rick Scott Hosts Roundtable on Fentanyl Crisis with Families, Border and Law Enforcement Leaders, Subject-Matter Experts

STAT – Medicare Part D plans authorized opioid prescriptions for cancer pain — to people without cancer

The New England Journal of Medicine – Buprenorphine versus Methadone for Opioid Use Disorder in Pregnancy

The Washington Post – Why parents should get Narcan and more on teen fentanyl use

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