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DEA Publishes Long-Anticipated Proposed Rulemaking Proposing to Place Tramadol in Schedule IV
…the medical and non-medical use and abuse of tramadol. Data shows that tramadol has less abuse potential than several narcotics currently controlled in Schedule II. As evaluated by both HHS…
Stormy Weather Ahead: Adheris Challenges HHS’s Final Rule on HIPAA/HITECH Act, May Provide Further Insight into Supreme Court’s Decision in Sorrell
By Jeffrey N. Wasserstein & Alexander J. Varond – Several months ago, when HHS released the final HITECH rule, we noted that several of the provisions represented a sea change…
The Nuts and Bolts of Preparing For and Managing DEA Cyclic Inspections: What Every Registrant Should Know
…investigators inspect the overall security system and individual components thereof to ensure that all components meet specifications and are operational. The investigators test the alarm system by activating a number…
Failure to File Adverse Event Reports Results in Criminal Pleas for Medical Device Company and Quality Manager
…to conduct postmarket studies to allow FDA to better understand how duodenoscopes are reprocessed in real-world settings; in March of this year, FDA issued Warning Letters to all U.S. duodenoscope…
Main Street Family Pharmacy Compounder Pleads Guilty to Misdemeanor Violations of the FDCA, and Accepts Probation, a $25,000 Fine and a Permanent Injunction
…each pled guilty to a misdemeanor criminal violation of the Federal Food, Drug, & Cosmetic Act (FDCA). Under the terms of the plea deal, David Newbaker was sentenced to 12…
First the Courts, Now Congress… House Committee Throws its Weight Behind Evolving Legal Landscape of Off-Label Promotion
…reactive, of scientific, medical, or technical information or findings, including communication of such information by personnel in scientific, medical, or clinical development departments of manufacturers; and [C]ommunication, both proactive and…
Another Brick in the Wall: A New Commitment Implementing the Mutual Recognition of Inspections
…confidentiality commitment that allows the FDA to share non-public and commercially confidential information, including trade secret information, contained in drug inspection reports with these European Agencies. As you may recall,…
PhRMA and BIO Team Up Again to Challenge a State Drug Pricing Law
…Care Component (“CPI Medical”) during the preceding calendar year or twice the CPI Medical during the preceding two years. Thus, under S.B. 539, manufacturers must choose how to forego their…
The Worm Turns: the Government Stakes Out a Standard that May Foreclose Many Federal False Claims Act Cases Based on Certain Alleged FDCA Violations
…of the FCA cases that are based on alleged FDCA violations involving adverse drug events, alleged cGMP violations and many other “routine” alleged FDCA violations. The brief may not deter…
AMS Issues Final Rule BE Labeling; Narrow Definition of BE and No Disclosure for Highly Refined Foods
On December 20, 2018, the Agricultural Marketing Service announced the availability of its long-awaited final rule implementing the national mandatory bioengineered (BE) food disclosure standard (NBFDS). The history of the…
Up in Smoke? Will the Feds Ramp Up Enforcement Action Against Budding State Marijuana Industry?
…use of low-THC (e.g. cannabidiol or “CBD”) for medicinal purposes and/or for personal, non-medical use. California started allowing sales of marijuana for recreational use on January 1st. On January 4th,…
Final Guidance Issued for Considering Benefit-Risk Factors in 510(k)s with Different Technological Characteristics
On September 25, 2018, FDA issued a final guidance document: Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics (“guidance”). A draft of…
Key Insights from FDA’s Webinar on the Breakthrough Designation Program
…draft and final versions. This portion of the presentation was relatively brief; most of the time was allocated for questions and answers. We found much of the information provided during…
This Cannot Stand, Man! The BLOCKING Act of 2019 Would Unnecessarily Reform 180-Day Generic Drug Exclusivity
…ANDA approval and commercial marketing under that application (thus triggering 180-day exclusivity) while subsequent ANDA applicants otherwise ready for approval are blocked from obtaining final approval solely because of a…
Pharmaceutical Manufacturers Must Submit 340B Ceiling Prices Starting in the First Quarter of 2019
…of covered outpatient drugs, as a condition of having its drugs be eligible for federal payment under Medicaid and Medicare Part B, to enter into a Pharmaceutical Pricing Agreement with…