Content by Laura Stanley:
By: Bridget C.E. Dooling & Laura E. Stanley | November 2, 2021
This Minnesota Law Review article evaluates two specific flexibilities granted during the COVID-19 pandemic that made it easier for patients to access buprenorphine and methadone. First, the Drug Enforcement Administration (DEA) allowed practitioners to prescribe buprenorphine using telemedicine without first conducting an in-person medical exam. Second, the Substance Abuse and Mental Health Services Administration (SAMHSA) made it easier for patients to have a take-home supply of methadone, reducing many patients’ need to make a daily trip to an opioid treatment program. The White House Office of National Drug Control Policy indicated that extending pandemic flexibilities for treating opioid use disorder is a priority for the Biden Administration, and this Essay provides a roadmap for the executive branch to do so.
While Congress could certainly make the changes permanent through legislation, this Essay provides an independent assessment of whether DEA and SAMHSA have the statutory authority to extend these flexibilities after the COVID-19 public health emergency ends by making changes to their regulations using the notice-and-comment rulemaking process under the Administrative Procedure Act (APA). The main finding is that DEA and SAMHSA have regulatory mechanisms available to extend the flexibilities described above. In addition, the U.S. HHS Secretary’s opioid-specific public health emergency declaration could offer a longer term, but still impermanent, legal pathway to extend these flexibilities beyond the current pandemic.
April 27, 2020 | By: Laura Stanley
This public interest comment assesses the Drug Enforcement Administration's proposed rule and offers four sets of recommendations: a) DEA should immediately begin approving mobile components in response to the coronavirus crisis, while the agency works towards finalizing the proposed rule, b) DEA should revise or remove conditions in the proposed rule that do not decrease the risk of diversion but do increase the burden of expanding mobile components, c) DEA should issue an updated economic analysis, and d) DEA should commit to conducting an evaluation of the mobile NTP program.
April 2, 2020 | By: Laura Stanley
This public interest comment assesses the proposed rule in four main sections: a) FDA should include additional principles aimed at improving the efficacy of food identity standards, b) FDA should alter its proposed approach, which is not to review any existing standards, and instead devote agency resources to conducting retrospective review, c) FDA should alter its existing temporary permit program for food identity standards, and d) FDA should issue a revised economic analysis and rely on that evidence in setting final standards.
October 6, 2021 | By: Laura E. Stanley
The Office of Information and Regulatory Affairs makes regulatory review data on interim-final rules easily accessible. Analyzing interim-final rules that have gone through regulatory review over time can shed light on the success of agency efforts to bypass the notice-and-comment process.
June 30, 2021 | By: Laura E. Stanley
The Drug Enforcement Administration released a final rule that lifts a ban on new methadone vans. The rule is expected to increase access to methadone, an effective treatment for opioid use disorder, in rural and underserved urban areas.
May 19, 2021 | By: Laura E. Stanley
The Department of Health and Human Services recently released guidelines that make it easier to prescribe buprenorphine to patients with opioid use disorder. HHS withdrew an earlier version of the policy to fix legal vulnerabilities and procedural issues.
February 03, 2021 | By: Laura E. Stanley
The Trump administration made a last-minute attempt to provide flexibilities for prescribing buprenorphine to treat opioid use disorder. The Biden administration changed course and decided not to publish the associated guidelines due to legal and policy concerns. Although HHS appears to have the legal authority to provide exemptions from buprenorphine requirements, taking time to ensure flexibilities are legally defensible will promote the uptake of the policies in the long term.
September 23, 2020 | By: Laura Stanley
The Drug Enforcement Administration plans to release a flurry of proposed and final regulations this year, up significantly from previous years. Several of the regulations teed up at the DEA are long-awaited actions that seek to address the ongoing opioid epidemic.
July 13, 2020 | By: Laura Stanley
Executive Order 13891 requires agencies to take actions to promote transparency and public participation in the development of certain guidance documents. Last month, some federal agencies hit a tight deadline set out in the executive order, while other agencies lag behind.
April 29, 2020 | By: Laura Stanley
In 2007, DEA placed a moratorium on approving new mobile narcotic treatment programs. Under a recently proposed rule, DEA would repeal the moratorium and establish requirements for mobile narcotic treatment programs.
April 14, 2020 | By: Laura Stanley -- Originally published by The Regulatory Review
A proposed rule to speed up administrative decision-making could have unintended consequences.
March 9, 2020 | By: Laura Stanley
FDA and USDA proposed a rule in 2005 to establish general principles the agencies could rely on to evaluate food identity standards. The agencies did not finalize the rule, but FDA recently reopened the comment period on the proposal.
April 22, 2021 | By: Bridget C.E. Dooling & Laura E. Stanley
SAMHSA made it easier for patients to receive take-home supplies of methadone and buprenorphine during the pandemic, and it has the legal authority to extend this COVID-19 flexibility.
February 23, 2021 | By: Bridget C.E. Dooling & Laura E. Stanley
This report concludes that DEA and SAMHSA have the legal authority to extend the flexibilities granted during the COVID-19 public health emergency without additional authorization from Congress.
Washington Post, Bring back the methadone vans, by Laura Stanley