Year: 2023

As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court.  Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in …

The Inflation Reduction Act’s price negotiation program for drugs covered under Medicare Parts B and D (“Negotiation Program”) has been challenged in federal court.  Yesterday, Merck filed a complaint in the D.C. District Court challenging the Negotiation Program as a “sham,” an “extortion,” and a violation …

The Academy of Managed Care Pharmacy (AMCP)’s Format Executive Committee is excited to let you know that after two years of work, version 5.0 of the Format for Formulary Submissions (also known as dossiers) is on the horizon.  And we need your feedback!  We’ve included …

FDA recently released further updates to the Customer Collaboration Portal (“CCP”).  Readers of the blog will know that I am a HUGE fan of the CCP (see our earlier posts here and here).  It has made filing of all premarket submissions much easier by facilitating …

Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulations governing the Medicaid Drug Rebate Program.  Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to …

CBS News caused a bit of commotion last week in reporting that after a four-year delay, DEA issued a final order revoking Morris & Dickson’s DEA registration.  However, until today there had been no public information about this decision. This morning, the Federal Register published two …

ONE WEEK AWAY! Join attendees from around the globe at the IBA’s World Life Sciences Conference in Washington, DC.  We are honored to have keynote addresses from DOJ and FDA officials.  The conference will highlight hot topics affecting the healthcare and life sciences industries. Hyman Phelps …

On May 16, the U.S. Food and Drug Administration (FDA) released a draft update to its Compliance Policy Guide (CPG) for FDA staff on the Agency’s enforcement of major food allergen labeling and cross-contact.  The draft CPG reflects the three major laws and regulations that …

Well, it’s official: The Federal Circuit decision in GSK v. Teva stands, as the Supreme Court has decided not to hear the case on appeal.  While the statistics were against the Supreme Court taking up the case given the limited number of cases heard per …

Accounting for controlled substances, maintaining complete and accurate records/reports and employing effective, compliant security do not alone guarantee a successful Drug Enforcement Administration (“DEA”) inspection.  A negative DEA inspection can plague registrants for years. Hyman, Phelps & McNamara, P.C. (“HP&M”) invites you to join Director Larry Houck …

In a dense, multi-part opinion, the Supreme Court affirmed 5-4 the lower courts’ dismissal of a challenge to California’s Proposition 12. That law bans the knowing sale of eggs, uncooked pork, or veal derived from farm animals that are housed under conditions that do not …

As we noted in our previous blog post available here, Quidel’s Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set’s De Novo, now opens the door for follow-on 510(k) submissions that declare this product as their predicate, if the product meets …

For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials.  At the federal level, the Center of Veterinary Medicine (CVM) …

Well, we’re a little late to blogging about this, but the significance of the ongoing Teva v. GSK litigation to Hatch-Waxman aficionados makes this case still ripe for blogging. Six months after the Supreme Court asked the Solicitor General to submit a brief on behalf of …

We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. Today is indeed the official “end” of the COVID-19 pandemic Public Health Emergency (PHE) Declaration, and DEA, jointly with the Substance Abuse Mental Health …