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 …
The Department of Health and Human Services (HHS) is proposing to rescind a Trump era rule that would have established a “most favored nation” (MFN) model to base Medicare Part B drug payment on international prices. The Trump Administration rule had a troubled history. The …
On the heels of Genus Medical Technologies’ successful lawsuit against FDA—Genus was represented by Hyman, Phelps & McNamara PC—in both the District Court of D.C. and the Court of Appeals for the D.C. Circuit, FDA published a Federal Register Notice today (August 9) soliciting comments …
We are old enough to remember the “poke” function on Facebook, and too old to remember what purpose it served. We are similarly at a loss to understand the purpose of Facebook’s new policy requiring that pharmaceutical manufacturers, telehealth companies, and online pharmacies apply for …
On Monday August 2, 2021, the Senate took up for review H.R. 3684, the Infrastructure Investment and Jobs Act, following House passage of its version last month. Although the bipartisan bill largely deals with the nation’s transportation infrastructure, Section 90006 delays the so-called “rebate rule,” …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 37th iteration – is scheduled to take place from September 29-30, 2021 (Eastern Standard Time). The conference is billed as the premier event to provide folks with a roadmap to navigate the …
Maine and Nevada previously enacted laws requiring drug manufacturers to report information about the pricing of their products. (See our coverage here and here). As summarized below, each state has recently updated their reporting requirements. Both states’ new requirements will become effective in October 2021 …
In case you missed it, FDA took to email and social media earlier this week (the equivalent of shouting it from the rooftops) to announce that it has notified Amgen Inc. of Neulasta (pegfilgrastim) misbranding due to false or misleading promotion. This is OPDP’s second …
On Friday, President Biden issued a wide ranging Executive Order seeking to address overconcentration, monopolization, and unfair competition in the U.S. economy. Using an aptly named “whole-of-government” approach, the Order calls on the Department of Justice, the Federal Trade Commission, the Agriculture Department, the Treasury …
FDA has long taken the position that a Complete Response Letter (“CRL”)—a letter sent when FDA has determined that it “cannot approve” a New Drug Application (“NDA”) or an Abbreviated New Drug Application (“ANDA”) “in its present form”—is not a final agency action and thereby …
For the last 13 years, this blogger has been at the center of what has now been dubbed “patient-focused drug development.” For 6 years, I served as a patient liaison within FDA in what was then called the Office of Special Health Issues. This was …
End-of-Phase 2 (EOP2) is, in our view, one of the most critical moments in drug development. It’s the moment at which a drug sponsor selects, and seeks FDA agreement on, its critical Phase 3 study parameters: dose, eligibility criteria and endpoints, to name a few. …
