Category: Corporate Compliance

FDA Finalizes Two Guidance Documents Regarding Medical Product Communications

The U.S. Food and Drug Administration (FDA) released two final guidances yesterday regarding medical communications: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities — Questions and Answers (Payor Communications Guidance) and Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers (Medical Products Communications Guidance). These guidances […]

Two Enacted State Laws Permit Truthful Off-Label Promotion

Earlier this month, Tennessee House Bill 2220 (substituted for Senate Bill 2361) (Tennessee Law) was enacted, which provides, “A pharmaceutical manufacturer or its representatives may engage in the truthful promotion of off-label uses.” The Tennessee Law is effective July 1, 2018. This law follows on the heels of “The Free […]

OIG Releases December Work Plan Items; Focus on Opioid Prescribing Continues

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The December updates include 6 new Work Plan items: Status Update on States’ Efforts on Medicaid-Provider Enrollment. OIG will follow-up on a previous review to determine the extent to […]

OIG Releases November Work Plan Items; Focus on Opioid Prescribing and Telemedicine

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The November updates include 4 new Work Plan items: Opioids in Medicaid: Concerns about Extreme Use and Questionable Prescribing in Selected States. Focusing on the opioid public health […]

OIG Releases October Work Plan Items; Includes Opioid REMS and Specialty Drug Coverage and Medicare Reimbursement

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The October updates include 5 new Work Plan items: Secretary Price’s Use of Chartered Aircraft for Federal Travel. OIG is reviewing Secretary Price’s use of chartered aircraft for Federal travel […]

California Governor Considers Drug Price Reporting Bill and Ban on Discounts and Rebates for Branded Pharmaceutical Products

The California State Legislature sent two new pharmaceutical pricing measures, S.B. 17 and A.B. 265, to Governor Jerry Brown on September 13th. S.B. 17 would impose new reporting requirements on pharmaceutical manufacturers related to certain price increases of some already marketed drugs and the introduction of new drugs onto the […]

OIG Releases September Work Plan Items; Includes Part D Sponsor Reporting of Rebates and Price Concessions to Medicare

As we recently announced, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The September updates include 9 new Work Plan items: Federal Marketplace Enrollment Systems. OIG will assess operational readiness, internal controls, and IT security in preparation for the fifth open enrollment period. […]