The past two weeks have seen two noteworthy developments relating to CMS’s Medicaid Drug Rebate Program (MDRP) regulations. 1. PhRMA Sues CMS Challenging MDRP Rule Curbing Patient Assistance In December 2020, CMS published a final rule making several changes to the MDRP regulations. See our post …
NDA approval – that pinnacle of drug development – marks a moment of success for both FDA and the drug applicant. The regulated and the regulator, having worked together for years, place a novel or improved therapy, with adequate directions for its use, in the …
Hyman, Phelps & McNamara, P.C., is proud to announce that Frank J. Sasinowski, a Director at the firm, this past Saturday was awarded by Pope Francis the “2021 Pontifical Hero Award for Inspiration” for his “unwavering advocacy for those who live with rare diseases.” The award …
On April 28, FDA issued its first Notice of Noncompliance for failure to submit required clinical trial results information to ClinicalTrials.gov. The notice was given to Acceleron Pharma, Inc., for failure to submit the required information following completion of a clinical trial evaluating the safety …
Over the past few days there’s been an avalanche of FDA-related legislation introduced in both the U.S. House of Representatives and the U.S. Senate. Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “Addressing Anticompetitive Conduct and Consolidation in …
So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013). …
We have blogged recently about several FDA setbacks in court (here, for example). Add one more to that tally. Genus Medical Technologies secured an important victory in the D.C. Circuit Court of Appeals on Friday. In Genus Medical Technologies v. FDA, the Court of Appeals ruled …
There’s no question that drug pricing is one of the most important issues in health care right now, and while such pricing considerations are outside FDA’s statutory mandate, it has not stopped FDA from trying to address pricing issues through enhancing drug competition (see, for …
On March 24, 2021, Virginia became the latest state to enact a prescription drug price transparency law. Similar to other state drug price transparency laws (see, for example, our coverage here and here), HB 2007 sets forth reporting requirements applicable to health carriers, pharmacy benefit …
On March 24, 2021, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its first advisory opinion of the year. Advisory Opinion 21-01 addresses whether the provision of a specific drug at no cost by a pharmaceutical manufacturer to a …
Perhaps when you’re carving out a patented method of use? Well, at least that’s what GSK is arguing. As the now-infamous GSK v. Teva case makes its way through the Federal Circuit once again to address what many have called the death-knell to skinny-labeling (also …
Well, it’s been busy for OPDP (and the Rx Ad/Promo bloggers over at the FDA Law Blog). After getting off to a slow start in 2021, OPDP issued yet another Warning Letter, apparently the day after its first. Unlike the first letter, this OPDP Warning …
Yesterday’s FDA Warning Letter, Press Release, and accompanying public relations campaign related to AcelRx’s promotional material for Dsuvia (sufentanil) are remarkable for exactly the reasons FDA intended them to be remarkable: these actions all signal to industry that despite anemic levels of FDA enforcement related …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 36th iteration – is scheduled to take place from March 24-25, 2021 (Eastern Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult …
In late November, the OIG published a final rule that excludes from the Federal healthcare program safe harbor for discounts rebates paid to Medicare Part D plans, or their PBMs (see our post here). The rule also establishes two new safe harbors: one for rebates …
