Topic
PhRMA
23 published works
Drug & Device Law
PhRMA Comment on the FDA’s Proposed Off-label Rule: The Rule of Law is the Best Medicine
The FDA cannot get out of its own way on the issue of off-label communications. Its power to punish off-label promotion comes from an odd regulatory two-step, whereby off-label promotions…
Health Law Update
As Urged by PhRMA and BIO, Supreme Court Agrees to Review Claim Construction Standard Used in Patent Office Trials
By Laura Gordon
Pharmaceutical companies have reason to be pleased with the United States Supreme Court’s recent decision to grant a petition for a writ of certiorari in Cuozzo Speed Technologies, LLC v. Michelle…
To Be or Not to 340B Blog
PhRMA 2-0 in The Orphan Drug Wars
By Alyce Katayama, Elizabeth Gebarski
U.S. Federal District Court Judge for the District of Columbia, Rudolph Contreras, ruled Wednesday, October 14, 2015 that manufacturers need not offer 340B discounts for orphan drugs sold to a specified…
Focus on Regulation
Recent First Amendment Rumblings
By Susan Lee, Meredith Manning, Heidi Gertner, Nancy Parsons
Lately, there seems to be a palpable uptick in news related to FDA’s regulation of off-label communications. Here are some of the developments we’ve been following: In April: CDER Director…
Drug & Device Law
The FDA Gets an EARful on Label Changes
By Bexis
We’ve blogged several times about the FDA’s pending proposal to gut preemption with respect to generic drugs, and that proposal’s numerous flaws. We have been remiss, however, in not mentioning the industry’s 2014 counter-proposal that’s was…
Triage Health Law
HRSA issues 340B Interpretive Rule
The Health Resources and Services Administration (HRSA) of the US Department of Health and Human Services (HHS) recently announced the availability of an interpretive rule (the “Interpretive Rule”) regarding section…
Mass Tort Defense
Industry Comments on Draft FDA Guidance
By Sean Wajert
Several leading drug manufacturers have worked to shed light on serious issues with the social media guidance issued earlier this year by the U.S. Foo
Dangerous Drugs & Medical Devices
2013 – New Bill Would Allow for Personal Importation of Drugs, Driving Down Prescription Costs
By Jared Fink
It is no secret that Americans pay some of the highest prices for pharmaceutical drugs in the world. And, while the Affordable Care Act will help maybe 50 million uninsured…
Focus on Regulation
PhRMA Files Suit Challenging 340B Orphan Drug Final Rule
By Alice Valder Curran, Emily Gebbia
On Friday, September 27th, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed suit against the Department of Health and Human Services challenging the 340B orphan drug final rule. The…
Health Law Prof Blog
Discussion on <em>Pharma Face-Off</em>
I was recently invited to debate issues in the Vermont data mining case on the program Pharma Face-Off. We've had some pro-PhRMA and anti-PhRMA perspectives at Health Reform Watch over…