FDA Deskbook: A Compliance and Enforcement Guide provides a comprehensive description of the complexities of compliance under the FDC Act and practical suggestions on how FDA-regulated entities can avoid being the subject of an enforcement action by the federal government. The book proposes best practice tips, including how to deal with FDA inspections, alternatives to conducting internal investigations, and potential defense strategies for use in enforcement proceedings.
Highlights of the new release include:
- Other Authorities Governing FDA-Regulated Entities: Reviews the CMS authority, granted under the Inflation Reduction Act of 2022, to negotiate the selling price of a select number of high expenditure single-source Medicare Part B and Part D drugs and biologics (see section 4:5.3[E]).
- Over-the-Counter Drugs: Outlines the June 2022 FDA-issued proposed rule addressing “Additional Conditions of Nonprescription Use” (ACNU) and several new concepts and requirements for this category of Rx-to-OTC drug (see section 5:5.6).
- Controlled Substances: Coverage of the U.S. Supreme Court decision imposing a new requirement necessary to prove a criminal violation for prescribing controlled substances (see section 17:4.1), and a review of DEA enforcement actions, including for failure to maintain complete and accurate records (see section 17:4.2); dispensing for a non-legitimate purpose (see section 17:4.3); failure to report suspicious orders (see section 17:4.4); National Prescription Opioid Litigation (see section 17:4.5); and state prescription opioid litigation (see section 17:4.6).
- Health Care Fraud and Abuse Laws: Reviews OIG guidance on patient assistance programs (see section 19:4.1[C][1]).
- FDA Inspections: New discussion covers the effect of the COVID-19 pandemic, and related emergency declarations, on FDA inspections, both domestically and internationally (see section 21:1.2). For related information on how the pandemic has impacted the drug approval process, read the PLI Chronicle article, Expediting the Drug Approval Process: Formulating Regulatory Responses to Critical Societal Health Issues While Preserving Scientific Standards.
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