As surveyed in detail by our colleagues in an earlier blog post, FDA’s PDUFA VII goals letter, for fiscal years 2023-2027, is full of announcements and new agency initiatives. One of those announcements is a commitment to create a new process for reviewing sponsor-initiated requests …
Last week, we blogged about a growing list of drug manufacturers that have refused to follow a 2010 guidance issued by the Health Resources and Services Administration (“HRSA”), which permits 340B covered entities to contract with multiple pharmacies to dispense drugs to covered entity patients. …
In the appellate courts lately, it’s been FDA “Against the Music.” In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. …
The tale of “David versus Goliath” is never a dull skirmish. This time, “David” consists of a cast of seven compounding pharmacies and their amicus curiae supporters. And the “David” cast of characters has successfully challenged FDA’s promulgation of its final Memorandum of Understanding (“MOU”) …
On September 24, 2021, the owner of a pharmacy in Puerto Rico pleaded guilty to participating in a felony conspiracy to convert government property and to commit health care fraud in connection with the illegal vaccination of minors between the ages of 7 to 11 …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Jeffrey Shapiro and Serra Schlanger will present at this year’s Food and Drug Law Institute virtual Advertising and Promotion for Medical Products Conference on October 13–15. This conference will analyze the latest regulatory issues related …
Few FDA publications are as eagerly anticipated in the drug development world as the twice-a-decade PDUFA Reauthorization Performance Goals and Procedures (hereinafter the “goals letter”). When FDA published the fiscal years (FY) 2023-2027 goals letter at the end of August, making known their commitments and …
Drug pricing and payment reform is a three-legged stool drawing support from the Administration, the House, and the Senate. Yesterday our post focused on the Administration’s priorities and initiatives, as described in HHS’s recent Comprehensive Plan for Addressing High Drug Prices. Today we focus on …
Despite vigorous criticism of high drug prices from the public and politicians in both parties, drug companies have largely dodged bullets on drug pricing and payment reform. In 2018, Trump’s Department of Health and Human Services (HHS) released its Blueprint to Lower Drug Prices and …
Innovators rejoice while generic sponsors mourn: In the wake of the latest in GSK v. Teva decision, the skinny label may be dead. The “skinny label,” also known as a “carve-out” or a “section viii statement,” is a widely-used statutory provision adopted in the Hatch Waxman …
Companies often use rebranding to reposition and refocus their business. Sometimes they do it with great fanfare; sometimes it is done quietly and incrementally. The federal government does its own version of rebranding with each change in administration. Just before the July 4 holiday weekend, …
It is a well-accepted fact that even well run ethical and compliant organizations can have serious problems. The Sentencing Guidelines, the DOJ Manual, and the HHHS OIG–among others–all recognize that reality. In its Compliance Guidance for Pharmaceutical Manufacturers, the HHS OIG notes: The OIG recognizes that …
On August 6, 2021, the Pharmaceutical Research and Manufacturers of America (PhRMA) announced the release of a revised PhRMA Code on Interactions with Health Care Professionals, which takes effect on January 1, 2022. The PhRMA Code is a voluntary code of conduct focusing on the …
A determination of “intended use” is fundamental to FDA’s regulation of drugs and medical devices. It is a primary basis for determining if an article is regulated by FDA at all, and if so, what regulatory requirements apply. It is embodied in parallel drug and …
About two weeks ago, FDA made an exciting announcement (and it remains exciting even if we’re late posting about it): FDA approved the first interchangeable biosimilar. On July 30, 2021, FDA approved Semglee (insulin glargine-yfgn), an insulin product that relies on Lantus (insulin glargine) as …
