Policy & Compliance

Expert Analysis

• A Potential Shift In FDA's Approach To Drug Trial Design

  

  Recent guidance released by the U.S. Food and Drug Administration clarifying how Bayesian approaches — which combine prior knowledge with new data — may be used in clinical trials reflects the agency's continued interest in innovative trial designs that may accelerate drug approvals, say attorneys at Alston & Bird.

• What FDA Guidance Means For Future Of Health Software

  

  Two significant final guidance documents released by the U.S. Food and Drug Administration last month reflect a targeted effort to ease innovation friction around specific areas, including singular clinical decision support recommendations and sensor-based wearables, while maintaining established regulatory boundaries, say attorneys at Covington.

• How State FCA Activity May Affect Civil Fraud Enforcement

  

  A growing trend of state attorneys general enforcing their False Claims Act analogues independently of the U.S. Department of Justice carries potential repercussions for civil fraud enforcement and qui tam litigation considerations, say Li Yu at Bernstein Litowitz, Ellen London at London & Naor and Gwen Stamper at Vogel Slade.

• Wage-Based H-1B Rule Amplifies Lottery Risks For Law Firms

  

  Under the wage-based H-1B lottery rule taking effect Feb. 27, law firms planning to hire noncitizen law graduates awaiting bar admission should consider their options, as the work performed by such candidates may sit at the intersection of multiple occupational classifications with differing chances of success, says Jun Li at Reid & Wise.

• Assessing Compliance Risks Around TrumpRx Participation

  

  As there are novel compliance obligations and potential political opposition related to the new TrumpRx online drug platform, companies intending to participate on the site should consider the pressure points that are likely to draw enforcement scrutiny, say attorneys at Sheppard.

• Predicting Actual Impact From CDC's New Vaccine Guidance

  

  Recent federal changes to the childhood immunization schedule, reducing the number of vaccine recommendations from 18 to 11, do not automatically create enforceable obligations for parents, schools or healthcare providers, but may spur litigation and other downstream effects on school policies and state guidelines, says Mehdi Sinaki at Michelman & Robinson.

• What Rescheduling Means For Cannabis Labels, Marketing

  

  The proposed reclassification of cannabis is expected to bring heightened scrutiny of labeling, advertising and marketing from the U.S. Food and Drug Administration and the Federal Trade Commission, but the brands that tighten evidence, standardize operations and professionalize marketing controls now will see fewer surprises and better outcomes, say attorneys at Wilson Elser.

• What's At Stake In Possible Circuit Split On Medicaid Rule

  

  A recent Eleventh Circuit decision, reviving Florida's lawsuit against a federal rule that reduces Medicaid funding based on agreements between hospitals, sets up a potential circuit split with the Fifth Circuit, with important ramifications for states looking to private administrators to run provider tax programs, say Liz Goodman, Karuna Seshasai and Rebecca Pitt at FTI Consulting.

• Courts' Rare Quash Of DOJ Subpoenas Has Lessons For Cos.

  

  In a rare move, three federal courts recently quashed or partially quashed expansive U.S. Department of Justice administrative subpoenas issued to providers of gender-affirming care, demonstrating that courts will scrutinize purpose, cabin statutory authority and acknowledge the profound privacy burdens of overbroad government demands for sensitive records, say attorneys at ArentFox Schiff.

• Remote Patient Monitoring Is At Regulatory Inflection Point

  

  With remote patient monitoring at the center of new federal pilot programs and a recent report from the U.S. Department of Health and Human Services' Office of Inspector General examining Medicare billing for those services, it is clear that balancing innovation and risk will be a central challenge ahead for digital health stakeholders, say attorneys at Morgan Lewis.

• Utah's AI Prescription Renewal Pilot Could Inform Policy

  

  Utah recently became the first state to approve an artificial intelligence system for autonomously renewing certain prescription medicines, providing a test case for how regulators may be able to draw boundaries between administrative automation and medical judgment, say Jashaswi Ghosh at Holon Law Partners and Bryant Godfrey at Foley Hoag.

• Ramped Up Psychedelic Production Carries Opportunity, Risk

  

  Kimberly Chew at Husch Blackwell discusses the key legal implications of the U.S. Drug Enforcement Administration's recent dramatic increases in the production quotas for a range of psychedelic substances, offering guidance on compliance, risk management and strategic opportunities for practitioners navigating this rapidly evolving landscape.

• New Biotech Nat'l Security Controls May Have Blunted Impact

  

  While the newly enacted federal prohibition against contracting with certain biotechnology providers associated with countries of concern may have consequences on U.S. companies' ability to develop drugs, the restrictions may prove to be less problematic for the industry than the significant publicity around their passage would suggest, say attorneys at Wilson Sonsini.