Over the past few years, this blogger – in prior blog posts (here, here, here, and here) and in Congressional testimony – has been pretty critical of efforts to significantly revise and weaken the 180-day generic drug exclusivity incentive and framework first established with the passage of the 1984 …
Hyman, Phelps, and McNamara’s Sara Koblitz will be presenting at the DC Bar’s annual webinar, “FDA for IP Lawyers” on May 25, 2022 with Brian Malkin of McDermott, Will, and Emery. The webinar will provide practical tips for integrating FDA regulatory law into IP law practices …
Last June, we blogged about a lawsuit brought by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CMS’s ill-conceived Accumulator Adjustment Rule (“final rule”), which amended the Medicaid Rebate best price regulation. The final rule, which was set to go into effect on January …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be speaking on an expert panel at the 20th Advanced Summit on Life Sciences Patents, which is being held virtually and in-person in New York City on June 2-3, 2022. Ms. Gaulkin will join speakers …
A few weeks back, OPDP issued its second Untitled Letter of 2022 (third letter in 2022 overall) to Bausch Healthcare alleging violative DTC and HCP promotional communications for Duobrii (halobetasol priopionate and tazarotene) lotion. Of interest (to me) is the DTC communication cited where OPDP, …
Our last post on the Eleventh Circuit’s September 2021 decision in Catalyst v. Becerra got a lot of attention. We’d like to think that this is because the scope of orphan drug exclusivity is as fascinating to everyone as it is to us, but if …
The American Conference Institute (“ACI”) is hosting its 17th Annual Paragraph IV Disputes Conference in New York (and livestream) from April 26-27, 2022 (Eastern Daylight Time). Over the course of two days, this event will provide impactful and practical programming all geared towards assessing the implications and …
On March 28, 2022, FDA transmitted its justification to Congress for its Fiscal Year 2023 budget. This document contains a number of legislative proposals, including three proposed amendments to the accelerated approval statutory provisions in section 506(c) of the Federal Food, Drug, and Cosmetic Act. …
It was some time ago that we posted on what we though was “the Good” in an avalanche of FDA-related legislation that we sorted into three categories: the Good, the Bad, and the Ugly. Our prior post took a look at a couple of bills …
Legislation has been proposed in Congress that would require FDA to regulate all contrast agents as drugs even though two courts determined that doing so clearly contradicts the plain language of the Federal Food Drug and Cosmetic Act (“FDC Act”). Unless amended, the proposed legislation …
It’s not often that FDA issues an “Immediately in Effect Guidance,” but it’s not often that a case like Genus v. FDA comes along and upends twenty years of FDA practice. Almost a year after the D.C. Circuit held that products that simultaneously meet both …
All companies dread the logistics, cost, and reputational harm associated with conducting a recall when necessary to remove or correct products in the field. But the more prepared a company is for a potential recall, the less pressure it will feel when a situation necessitates …
The Centers for Disease Control and Prevention (“CDC”) issued a voluntary practice guideline on opioid prescribing for clinicians treating chronic pain five years ago. (We blogged on the final 2016 guideline here on March 17, 2016). On February 10th, the agency published a comprehensive proposal …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sophia Gaulkin will be presenting and speaking on an expert panel at Informa Connect’s Drug Pricing Transparency Congress, which is being held virtually and in-person in Philadelphia on March 28-29, 2022. Ms. Gaulkin’s presentation on Changes …
With our second OPDP enforcement letter of 2022, FDA is making one thing clear: OPDP will find your promotional content—even when it may not look like promotional content. While it’s not mind-blowing that OPDP would find a series of videos while scrolling Instagram (particularly when …
