Periodically, legislators and others become concerned about reports citing the high price of some orphan drugs, including drugs that achieve blockbuster status (earning more than $1 billion a year). Several proposals have been introduced in response to such concerns. In 1990, Congress passed legislation that …
We recently blogged about whether FDA’s recent amendment to the intended use regulation could be considered essentially null and void based upon a failure to comply with the Congressional Review Act. Apparently, this suggestion caused quite a stir and even excitement in some quarters, as it …
With the expanding market for plant-based foods, often developed as an alternative to the animal-based food products which consumers avoid for various reasons (allergies, health concerns, ethical concerns, environmental concerns, or taste preference), the naming of plant-based foods has become a major issue. Although the issue …
A few weeks ago, we blogged about FDA’s final rule amending the “intended use” regulation. The final rule looks very different than the proposed rule, and adopts a new “totality of the evidence” standard that does not resolve the old problems with the regulation but …
Some lawyers old enough to remember carbon paper may also remember, in their archaic law school teaching, the “eggshell plaintiff” rule, accurately described as “a maxim that a tort defendant takes his victim as he finds him.” Also referred to as the “eggshell skull rule,” …
Every year, hundreds of rare disease patients and caregivers descend on Capitol Hill to participate in Rare Disease Week to learn about federal legislative issues, meet other advocates, and share their unique stories with legislators. As part of this, on March 2, 2017, Hyman, Phelps …
Believe it or not, Hyman, Phelps & McNamara, P.C.’s FDA Law Blog turns 10 years old today (Monday, March 6, 2017). Where have all of the years gone? It seems like Tuesday, March 6, 2007 was just yesterday. That’s when we put up our initial …
Last week, the United States and the European Union agreed to recognize each other’s drug cGMP inspections. The agreement reached (see here and here) amends the Pharmaceutical Annex to the 1998 U.S. – E.U. Mutual Recognition Agreement, with a view to avoiding duplicative inspections and …
In January 2017, FDA issued two Draft Guidance documents concerning communications made by medical device manufacturers about information not expressly contained within a product’s labeling: Medical Product Communications That Are Consistent With the FDA-Required Labeling – Questions and Answers: Guidance for Industry [Draft] (January 2017), hereinafter …
Well, that was quick! Only two weeks after filing, the U.S. District Court of Delaware dismissed Genentech’s Complaint under the Biologics Price Competition and Innovation Act (“BPCIA”) against Amgen. As we explained here, Genentech sued Amgen for failure to comply with the patent dance provisions …
In the absence of blogworthy FDA regulatory pronouncements (draft regulations, draft guidances, and oxymoronically named “tentative final rules”), material for FDA Law Blog posts is harder to come by these days (meaning, since President Trump’s inauguration, not coincidentally). Now comes across our computer screen a …
