Buchanan Ingersoll & Rooney Submits REMS Industry Consortium’s Comments to FDA on Issues Critical to Industry
Newark, New Jersey (August 2023) - Linda Pissott Reig, shareholder in the firm’s FDA/Biotech and Life Sciences practice groups, submitted comments to the Food and Drug Administration’s public docket on “Changes to Third-Party Vendors for Risk Evaluation and Mitigation Strategies.” 88 Fed. Reg. 17578 (Mar. 23, 2023) in her role as lead Buchanan legal advisor and strategic partner to the REMS industry Consortium (RIC).
Risk Evaluation and Mitigation Strategies (REMS) are additional safeguards that FDA mandates for certain specified prescription medicines to enable patient access to those medicines, while mitigating potential significant safety risks. RIC is a consortium of entities that are working together to address issues relating to REMS. RIC was initially established by six brand and generic pharmaceutical and biopharmaceutical companies (Amneal, Bristol Myers Squibb, The Janssen Pharmaceutical Companies of Johnson & Johnson, Jazz Pharmaceuticals, Mylan and Teva).
Less than two years after the official launch of RIC in early 2022, RIC is now comprised of thirty-four member organizations (twenty-five drug companies and nine industry partners). RIC members seek to promote the RIC mission of fostering “collaboration and innovation to advance patient safety, appropriate access, and best practices in REMS-related drug and biologic risk management.”
Buchanan has been a strategic partner and legal counsel to the RIC since its inception in the Fall 2021. Various Buchanan lawyers have been instrumental in the establishment of the RIC as a 501(c)(6) non-profit entity, and in guiding strategic planning initiatives. Law firm attorneys in addition to Reig who are supporting the consortium include Carrie Amezcua (Antitrust), Richard DiStefano (Corporate), Trisha Klan (FDA/Biotech/Life Sciences), Stanley Marciniak, III (Corporate), Natalie Oehlers (FDA/Biotech/Life Sciences), Jason Parish (Antitrust), Duane Stewart (Trademark/Copyright), and Marc Tepper (Insurance). On the administrative side, Buchanan’s Steven “Stevo” Anthos is the lead liaison with the consortium management company, and Allison Evans is the lead Buchanan liaison responsible for overseeing RIC marketing efforts. Caitlan McCafferty has recently undertaken the role as Buchanan’s primary liaison with respect to overseeing consortium management efforts involving media outreach.
Earlier this year, Reig participated with eleven industry representatives in a kick-off meeting of RIC leaders and FDA (held at FDA headquarters in Rockville, Maryland). She also served as a presenter in multiple sessions at the two-day RIC Annual Meeting held in March 2023.
Most recently, Reig, Oehlers and Klan worked closely with RIC leaders and members to compile detailed feedback about each of the topics that FDA had identified in its solicitation for comments regarding the use of service providers to design and implement REMS programs. (The FDA solicitation for comments arises from a provision in the Food & Drug Administration Omnibus Reform Act (FDORA) that was adopted by Congress in late December of 2022.) Its area of primary focus is the identification of “factors that generally should be considered by the Secretary of the Health and Human Services when reviewing modification requests from sponsors of drugs subject to Risk Evaluation and Mitigation Strategies (“REMS”) related to changes in third-party vendors engaged by sponsors to aid in the implementation and management of the strategies.”
The full text of the RIC Comments are available here.