Drug and Pharmaceutical Law

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On June 24, HRSA announced that it had issued new grant award terms to its HRSA-funded health centers to provide insulin and injectable epinephrine at or below the 340B price paid by the health center for the drugs. HRSA encouraged health centers to “begin implementing these updated award terms immediately to ensure full compliance and maximize patient benefit.” The announcement comes in response to the Trump Administration’s April 14, 2025 Executive Order on “Lowering Drug Prices by Once Again Putting Americans First” (the “Executive Order”).[1] The Executive Order had instructed the Secretary of the Department of Health and Human Services to, within 90 days, ensure grants available under section 330(e) of the Public Health Services Act are conditioned upon health centers establishing practices to make insulin and injectable epinephrine available to low-income patients at or below the 340B price paid by the health center.Continue Reading HRSA Announces New Requirements for FQHCs to Provide Insulin and Epinephrine at or below 340B Price

A federal judge in D.C. recently ruled in favor of the U.S. Health Resources and Services Administration (“HRSA”), an administrative agency under the U.S. Department of Health and Human Services (“HHS”), by finding that drug manufacturers must obtain pre-approval from HRSA before implementing rebate models under the 340B Program. Specifically, U.S. District Judge Friedrich (“Friedrich”) found that HHS and HRSA did not exceed their authority when they required Eli Lilly & Co., Bristol Myers Squibb Co., Sanofi-Aventis U.S. LLC, Novartis Pharmaceuticals Corp. (“Novartis”) and Kalderos Inc., a health care tech company (together, the “Companies”) to seek pre-approval of the rebate plans they offered.[i]Continue Reading Federal District Court Upholds Authority of HHS to Pre-Approve 340B Rebate Programs; HRSA Submits Proposed 340B Rebate Guidance

As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is being transformed before our eyes. The journey ahead is anything but straightforward, with solutions ranging from bold, large-scale changes to more nuanced, focused innovations. Let’s delve into the high-level, dynamic trends shaping the pharmacy world today.Continue Reading Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March 10th, the FDA issued guidance clarifying that 503A and 503B drug compounders must soon cease compounding semaglutide injection products[i] or risk enforcement action.[ii] This has a significant impact on compounding pharmacies as, under the Federal Food, Drug, and Cosmetic Act (the “FD&C”), drug compounders are permitted to compound their own copies of a patented drug if the FDA determines it is in shortage. Due to high demand for the drugs, Wegovy was added to the FDA’s drug shortage list in March 2022, and Ozempic in August 2022.[iii] Wegovy and Ozempic are the only FDA-approved semaglutide injection products.[iv]Continue Reading FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug and biosimilar competition. In the case, Teva asserts that Amneal’s Abbreviated New Drug Application (“ANDA”) for an asthma inhaler infringes upon five patents it has listed in the FDA’s Orange Book–a challenge that under FDA regulations triggers a 30-month stay of FDA’s approval of the generic inhaler. Amneal’s counterclaims assert that the Teva patents, which relate to the inhaler device and dose counter, rather than the drug itself, were improperly listed and has asked the court for judgment on the pleadings and an order to delist the patents at issue.Continue Reading FTC’s Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may exercise “march-in” rights and take a pharmaceutical company’s drug patents developed with federal funds and share them with other companies. See Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights, available here (“Draft Guidance”).Continue Reading The March on Pharmaceutical Patents?

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting continued enforcement and recovery actions under the Health Care Fraud and Abuse Control Program (HCFAC). During fiscal year 2022 (FY 2022), over $1.7 billion was returned through HCFAC’s enforcement actions.Continue Reading HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment Centers, Among Other Initiatives

Connecticut is the latest state to join the efforts of jurisdictions such as Oregon, Nevada, Washington D.C., and the City of Chicago, Illinois, in further regulating the activities of pharmaceutical representatives. In June, Governor Ned Lamont signed into law “An Act Protecting Patients and Prohibiting Unnecessary Health Care Costs” (the “Act”), which imposes new registration, reporting, and disclosure requirements on pharmaceutical representatives in the State of Connecticut. The Act builds on Governor Lamont’s policy initiatives, which aim to improve the delivery of care and reduce healthcare costs for Connecticut residents and includes the initiative to regulate pharmaceutical marketing practices. The Act sets forth certain requirements for pharmaceutical manufacturers and “pharmaceutical representative(s)” which remain subject to further clarification based on any forthcoming guidance and regulations from the Connecticut Department of Consumer Protection (“CT DCP”).Continue Reading Connecticut Follows in the Footsteps of Other Jurisdictions Requiring Registration of Pharmaceutical Representatives

This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced by the Inflation Reduction Act of 2022 stands in violation of multiple constitutional provisions.Continue Reading The Drug Price Negotiation Program Faces Pushback from Private and Public Industry Participants

For a brief moment in time last April, the U.S. Food and Drug Administration’s (“FDA”) approval of the commonly-used abortion medication, Mifepristone, was curtailed. Just days after a Texas federal judge’s ruling suspended the FDA’s approval of the drug, the U.S. Department of Justice (the “DOJ”) asked the Fifth Circuit to grant an emergency or administrative stay of that decision. On review, the Fifth Circuit held that Mifepristone could only be prescribed in the first seven weeks of pregnancy, under a physician’s supervision, and the drug cannot be sent by mail, temporarily suspending more recent modifications to the FDA’s approval. Continue Reading Access to Abortion Pill on the Precipice: A Deep Dive into the Federal Court Rulings that will Decide the Fate of Mifepristone 

This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan Haight Act (“RHA”) promulgated during the COVID-19 Public Health Emergency (“PHE”). This is notable as access to care, including mental health and substance abuse treatment, remains a crucial industry focus, especially as the transition to the post-PHE has begun.Continue Reading DEA and SAMHSA Extend Tele-Prescribing Flexibilities