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DEA Extends Temporary Placement of Synthetic Cannabinoids; Proposes Permanent Placement in Schedule I
…the chemicals. 77 Fed. Reg. 12,510. DEA also noted that “these products are manufactured by spiking plant material with the synthetic cannabinoids and then distributed in a way that poses…
KV Says “Heckler/Chaney Defense” is Inapplicable in Appeal Concerning Compounded 17P and Orphan Drug MAKENA
…unapproved sodium thiopental for use by state Departments of Corrections to carry out death sentences by lethal injection. (See our previous post here.) KV argues in its Opening Brief that…
California Court Decides that the Organic Food Production Act Does Not Apply to Personal Care Products
…alternative, Defendant moved to dismiss the case under the primary jurisdiction doctrine and because of the Plaintiff’s failure to satisfy Federal Rule of Civil Procedure 9(b). Judge Houston denied the…
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…
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…
HPM’s Larry Houck Speaking at Opioid and Fentanyl Abuse Management Summit
…hospitals has also resulted in large civil monetary settlements, some in the millions of dollars, costly compliance remediation programs, and in unwanted local and national publicity. HPM Director Larry Houck…
Senators Kohl and Grassley Introduce Bill Targeting Industry Gifts to Physicians
Many pharmaceutical manufacturers are already struggling under the regulatory burden associated with the various requirements of state gift reporting statutes. That burden may soon be made heavier. Earlier this month,…
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…
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…
Prescribing Red Flags: Pharmacists Be Wary of What the Doctor Orders
…be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of their professional practice. 21 C.F.R. § 1306.04(a). Prescribers are responsible for the proper…
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…