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.
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.
