Kurt R. Karst

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 …

Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased and excited to announce that Dr. Ellis F. Unger has joined the firm as a Principal Drug Regulatory Expert.  Dr. Unger is a cardiologist and former Director of the Office of Drug Evaluation-I in FDA’s Office of …

There’s a lot of things packed (and that need to be unpacked to understand) into the latest version (as amended) of H.R. 5376, the 2100-plus page bill better known as the “Build Back Better Act.”  The bill has gone through the House Committee on Rules …

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.  …

Over the past few days there’s been an avalanche of FDA-related legislation introduced in both the U.S. House of Representatives and the U.S. Senate.  Some of the bills introduced are related to a House Judiciary Antitrust Subcommittee hearing, titled “Addressing Anticompetitive Conduct and Consolidation in …

Those of you keeping up with the Orange Book know that FDA has been considering changes to patent listing requirements, many of which industry has been requesting for decades.  Now, Congress is trying to facilitate effective administration of the Orange Book.  On January 5, 2021, …

If your 2020 FDA BINGO card included the end to FDA’s Unapproved Drugs Initiative, then, BINGO!  Late last Friday, the Department of Health and Human Services—but not FDA—announced a forthcoming Federal Register Notice withdrawing both the 2006 (Docket No. FDA-2003-D-0030) and 2011 (Docket No. FDA-2011-D-0633) …

For those of us of “a certain age,” the original “Sesame Street” recalls fond memories: Mr. Hooper, Mr. Snuffleupagus (when only Big Bird could see Snuffy), and those catchy songs like “C Is For Cookie” and, of course, “Pinball Countdown” – those animated segments with …

No, “Tick Tock, Goes The Clock” is not a reference to Doctor Who poetry, Ke$ha (TiK ToK), or to that “TikTok” destination for mobile videos that’s been in the news recently.  We’re talking about the countdown to October 1, 2020, when the Fiscal Year 2021 …

Anyone who has recently (on Tuesdays and Thursdays at least) tried – and we mean tried – to wander on to www.regulations.gov to do a little FDA docket research has likely been redirected to a new URL: https://outage.regulations.gov/beta-redirect/.  And the first thing you see on …

FDA’s recent announcement (see our previous post here) that after 40 years the Orange Book may get a bit of a facelift – as well as a comment in a new draft guidance that folks could obtain prior editions of the Orange Book through the …

Much to our delight, the Orange Book is getting quite a bit of attention from FDA in 2020.  And why not?!?  After all, the Orange Book is celebrating its 40th anniversary this year.  There was even a special “BPCIA Orange Book Transition Edition” published in …

Hyman, Phelps & McNamara, P.C. is  pleased to announce that Sara Koblitz will be speaking in an upcoming Strafford live webinar, “Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation” scheduled for Thursday, February 13, 1:00pm-2:30pm EST. The panel will provide …

Earlier this week, House Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ), Ranking Member Greg Walden (R-OR) and Senate Health Committee Chairman Lamar Alexander (R-TN) announced that they reached agreement on a bipartisan, bicameral drug pricing bill, called The Lower Health Care Costs Act …

Does the U.S. legal system steer researchers away from drugs that take a long time to develop?  That’s the question asked and answered in a new research paper authored by our friend Erika Lietzan, Associate Professor of Law at the University of Missouri School of …