By John A. Gilbert — 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 DEA notices on the Morris & Dickson matter (here and here). The first notice is a Final Decision and Order revoking the Morris & Dickson registration, but not effective until 90 days after publication. Usually, a Final Decision and Order is effective 30 days from publi ..read more

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 & McNamara, P.C. Director, Anne Walsh, will moderate a panel that addresses what companies should consider when in the crosshairs of a government investigation.  She will bring together speakers to discuss the wide variability in the penalties that can be brought against a company and ..read more

By Sophia R. Gaulkin & Riëtte van Laack — 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 form the foundation of FDA’s regulatory framework for major food allergens and which became effective since the issuance of the current CPG, CPG Sec 555.250 Statement of Policy for Labeling and Preventing Cross-contact of Common Food Allergens, which was first issued in 200 ..read more

By Sara W. Koblitz — 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 year, it’s definitely disappointing for those of us who have been watching the case for the last 7 years.  And, for generics, the Federal Circuit decision will be looming large behind any carve-out proposals, keeping open the possibility of liability for induced infringement even if compliant with the statutory sc ..read more

By Sara W. Koblitz — 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 year, it’s definitely disappointing for those of us who have been watching the case for the last 7 years.  And, for generics, the Federal Circuit decision will be looming large behind any carve-out proposals, eroding any certainty of liability for induced infringement even if compliant with the statutory scheme pe ..read more

By Ricardo Carvajal — 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 meet certain minimum requirements – regardless of whether the animals are raised in California or out-of-state. Our colleagues at SCOTUSblog have penned a helpful analysis that examines the basis for the Court’s opinion, as well as its multiple parts and concurring opinions. Our focus is on the decision’s ..read more

By Lisa M. Baumhardt, Senior Medical Device Regulation Expert & Richard A. Lewis, Senior Regulatory Device & Biologics Expert — 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 the established Special Controls as noted in the reclassification order.  In this blog we examine the Special Controls put in place to mitigate false results, incorrect interpretation of results ..read more

By Riëtte van Laack — 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) of FDA regulates food for animals, including livestock and pets.  As part of its regulatory responsibilities, CVM reviews the safety of new or modified animal food ingredients.  Such reviews may be in response to food additive or color additive petitions, or notif ..read more

By Sara W. Koblitz — 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 the U.S. government in the now-infamous (at least in FDA circles) Teva v. GSK skinny label case, the U.S. Government submitted an Amicus Brief—not only signed by the Solicitor General, but also the lead attorneys representing the USPTO, HHS, and FDA—encouraging the Supreme Court to grant Teva’s Petition fo ..read more

By Karla L. Palmer — 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 Services Administration (SAMHSA), have announced the issuance of a temporary rule extending the PHE telemedicine exemptions, as described below.  DEA states the temporary rule will take effect today, and “extends the full set of telemedicine flexibilities adopted ..read more