Policy & Compliance

  • January 02, 2025

    1st Private Co. Joins Insulin Price-Fixing MDL

    A Florida-based car dealer is the first private company to join a multidistrict litigation accusing Novo Nordisk, Eli Lilly and Sanofi-Aventis of fixing the prices of insulin and other drugs to treat diabetes.

  • January 02, 2025

    Eli Lilly Slams Suit Alleging Shortage Of Weight-Loss Drug

    Eli Lilly is seeking permission to join a legal fight over whether compounding pharmacies can keep making copycat versions of the company's lucrative weight-loss and diabetes drug, telling a federal court Wednesday that its interests aren't adequately represented by federal regulators.

  • January 01, 2025

    Healthcare and Life Science Deals Attys Expect In 2025

    As the healthcare industry heads into 2025, deals attorneys are optimistic as they look to falling interest rates and a potentially more business-friendly administration set to enter the White House.

  • January 01, 2025

    High-Stakes Healthcare Court Battles To Watch In 2025

    With pivotal health law cases on the docket in 2025, attorneys will be watching how the incoming Trump administration proceeds in ongoing litigation over abortion care, the Affordable Care Act and the Medicare drug price negotiation program.

  • January 01, 2025

    Healthcare And Life Science Policies To Watch In 2025

    Healthcare and life sciences attorneys will have their eyes on Washington, D.C., in the next few months. They will be keen to understand how a new presidential administration and a new Congress with razor-thin GOP control will approach a bevy of fraught issues.

  • January 01, 2025

    Pa. Cases To Watch In 2025: Climate Change And Skill Games

    President-elect Donald Trump's impending return to the White House casts a new light on certain pending cases in Pennsylvania courts with federal implications, such as a suburban Philadelphia county's climate change claims against oil companies that contend the suits are preempted and the U.S. Department of Justice's entrance into monopoly allegations against University of Pittsburgh Medical Center.

  • January 01, 2025

    NC Cases To Watch In 2025: NASCAR Fight, Healthcare Rows

    NASCAR is fighting antitrust claims in North Carolina even after removing a controversial exclusivity clause from its race team contracts, and the Tar Heel State's medical industry could see massive shake-ups from a challenge to a healthcare competition law and alleged impropriety in a major hospital system acquisition.

  • December 23, 2024

    HHS Can't Enforce Abortion Privacy Rule Against Texas Doctor

    A Texas federal judge has granted a Lone Star State doctor a reprieve from a new U.S. Department of Health and Human Services rule that aims to protect the privacy of abortion providers and patients, saying that the rule likely exceeds the Health Insurance Portability and Accountability Act's statutory authority.

  • December 20, 2024

    Sens. Aim To Protect Generics With Skinny Labels In New Bill

    A bipartisan group of senators from Colorado, Arkansas, Vermont and Maine have introduced a bill that would shield generic-drug and biosimilar manufacturers from infringement liability when using approved "skinny labels."

  • December 20, 2024

    3rd Circ. Denies Challenge To Pa. Autism Settlement

    A Third Circuit panel on Friday rejected claims a settlement requiring around-the-clock care for a woman with autism is too impractical to be enforced, reversing a lower-court decision and handing a victory to the Pennsylvania woman's family.

  • December 20, 2024

    Psychedelics Law Reformers Hit Multiple Setbacks In 2024

    In 2024, advocates, physicians and researchers attempted to broaden lawful access to federally illegal psychedelic drugs through a variety of avenues — the new drug approval process, litigation and a ballot initiative — with the upshot that the law remains largely unchanged and, for the most part, still restricts legal use and possession of these substances.

  • December 20, 2024

    Lambda Legal Adds Attorney In NY Focused On Trans Rights

    LGBTQ+ advocacy group Lambda Legal has hired a new senior attorney focused on the organization's work defending the transgender community.

  • December 20, 2024

    Top NJ Cases Of 2024: COVID Test Kits And Political Favors

    After failed attempts in previous years, 2024 was the year prosecutors secured convictions in separate cases against a longtime New Jersey senator and a healthcare software executive. In another closely watched white collar matter, a Garden State law firm executive met his fate for stealing from his employer. 

  • December 19, 2024

    PhRMA Wins Bid To Halt W.Va. Drug Discount Expansion Law

    The country's biggest pharmaceutical lobbying group has won preliminary injunctions against a West Virginia law that the Pharmaceutical Research and Manufacturers of America claims unconstitutionally expands a federal drug discount program, with a federal judge finding that the law threatens to create a situation where "the fox guards the henhouse."

  • December 19, 2024

    FTC Says PBMs Can't Get Preliminary Block In Insulin Case

    The Federal Trade Commission urged a Missouri federal judge Thursday not to temporarily block its in-house case accusing pharmacy benefits managers of artificially inflating insulin prices through unfair rebate schemes, arguing Congress clearly empowered such in-house adjudications and the officials who handle them.

  • December 19, 2024

    9 Charged In $20M Medicaid Fraud Linked To Philly Pharmacy

    Nine people associated with a South Philadelphia pharmacy have been charged with an alleged five-year scheme to defraud Medicare and Medicaid out of $20 million by submitting false claims for prescription reimbursement of expensive medications like HIV drugs, the Pennsylvania Attorney General's Office said Thursday.

  • December 19, 2024

    Generic-Drug Cos. Get State AGs' Trial Order Flipped

    A Connecticut federal court has sided with the generic-drug makers accused of price-fixing by state-level enforcers and will allow a narrower case involving 15 drugs to move ahead prior to a much broader case involving more than 100 medications.

  • December 19, 2024

    FDA Declaration May Restart Compounders' Shortage Suit

    Federal regulators pulled Eli Lilly's lucrative weight-loss and diabetes drug off the national shortage list Thursday and gave compounding pharmacists two months to stop making copycat versions of the injectable medication, a move with the potential to reignite a Texas legal clash.

  • December 19, 2024

    Addiction Group Pays $2M In Mass. AG False Billing Probe

    An addiction treatment physician group with offices across western Massachusetts will pay $2 million to settle allegations that it overcharged for visits and billed for tests that were not medically necessary, the state's attorney general said Thursday.

  • December 19, 2024

    NYU Langone Wrongly Exempts IT Workers From OT, Suit Says

    New York University's academic medical center improperly classifies information technology workers as overtime-exempt despite their duties not falling under an exemption, causing them to lose out on extra wages, a proposed class and collective action filed in New York federal court said.

  • December 18, 2024

    Patent Limits For Biosimilar Litigation Lands In Spending Bill

    Congress' spending package to keep the government open through March would also limit how many patents a biologics maker can assert when trying to prevent a competitor from getting on the market.

  • December 18, 2024

    FDA's Gastro Drug Fast-Track Denial Survives DC Circ.

    A D.C. Circuit panel upheld federal regulators' refusal to streamline approval of a drug to treat nausea in patients with a chronic gastric condition, ruling that the U.S. Food and Drug Administration was right to consider the drug's development plan when deciding whether it qualified for fast tracking.

  • December 18, 2024

    Destroyed Docs Merit Harsher Sanctions, Mich. Panel Says

    A Michigan appellate panel on Tuesday said fees awarded to the estate of a man who died after choking in an adult foster care facility were likely too low, finding a lower court erred by limiting the scope of available sanctions over the destruction of "copious amounts" of digital evidence.

  • December 18, 2024

    Philip Morris Sues FDA Over New Cigarette Warning Labels

    Tobacco giant Philip Morris and a group of Georgia convenience store interests have sued the U.S. Food and Drug Administration over a rule that would add graphic warnings to cigarette labels, alleging the agency is exceeding its statutory authority in a move that would mark a "sea change" for the industry.

  • December 18, 2024

    CVS Fueled Opioid Epidemic In Rush For Profits, Feds Say

    The U.S. Department of Justice unveiled a suit Wednesday accusing CVS, the nation's largest pharmacy chain, of knowingly filling invalid prescriptions for powerful opioids and ignoring internal pleas from its pharmacists as it allegedly put profits over safety. 

Expert Analysis

  • A Primer On EU's Updated Human Substance Regulations

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    The European Union's updated standards regarding quality and safety of substances of human origin meant for human application carry significant implications for companies that work with cells and tissues, and U.S. companies active in the EU market should pay particular attention to the import and export rules, say Geneviève Michaux and Georgios Symeonidis at King & Spalding.

  • CFPB's Medical Debt Proposal May Have Side Effects

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    The Consumer Financial Protection Bureau’s recent proposal to prevent medical debt information from appearing on consumer reports and creditors from basing lending decisions on such information may have initial benefits for some consumers, but there are potential negative consequences that should also be considered, say attorneys at Cooley.

  • 15 Areas That Would Change Under Health Data Rule Proposal

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    If finalized, the Office of the National Coordinator for Health Information Technology's proposed rule will significantly progress its efforts to advance interoperability, respond to stakeholder concerns and clarify compliance with the health IT certification program, say attorneys at Ropes & Gray.

  • 3 Healthcare FCA Deals Provide Self-Disclosure Takeaways

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    Several civil False Claims Act settlements of alleged healthcare fraud violations over the past year demonstrate that healthcare providers may benefit substantially from voluntarily disclosing potential misconduct to both the U.S. Department of Justice and the U.S. Department of Health and Human Services, say Brian Albritton and Raquel Ramirez Jefferson at Phelps Dunbar.

  • Takeaways From High Court's Tribal Health Admin Cost Ruling

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    The U.S. Supreme Court's recent determination that the government must reimburse two Native American tribes for administrative healthcare costs will help tribes maintain equal footing with the Indian Health Service when administering programs, and continues a pattern of how the current court aligns on tribal concerns, say attorneys at Lewis Roca.

  • FTC Focus: Private Equity Investments In Healthcare

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    As the Federal Trade Commission is tightening its scrutiny of private equity investment in healthcare, the agency is finding novel grounds to challenge key focus areas, including rollup acquisitions, the flip-and-strip approach and minority investments in rival providers, say attorneys at Proskauer.

  • High Court's Expert Ruling May Help Health Fraud Defendants

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    The U.S. Supreme Court's decision in Diaz v. U.S. appears to give the government a powerful new tool in calling its own agents as expert witnesses, but it could also benefit defense counsel in criminal healthcare fraud and other white collar criminal cases that arise in complex legal or regulatory environments, say attorneys at Holland & Knight.

  • Unpacking HHS' Opinion On Cell Therapy Refund Programs

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    A recent advisory opinion from the U.S. Department of Health and Human Services, determining that a biopharma company's refund program for its cell therapy will not be penalized, indicates an encouraging willingness to engage, but the regulator's assumptions about the program's limited term warrant a closer look, says Mary Kohler at Kohler Health.

  • DOJ Innovasis Settlement Offers Lessons On Self-Disclosure

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    The recent $12 million settlement with Innovasis and two of its executives demonstrates the U.S. Department of Justice's continued prioritization of Anti-Kickback Statute enforcement amid the growing circuit split over causation, and illustrates important nuances surrounding self-disclosure, say Denise Barnes and Scott Gallisdorfer at Bass Berry.

  • How Orange Book Antitrust Scrutiny Is Intensifying

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    Pharmaceutical patent holders should be reviewing Orange Book listing practices, as the Federal Trade Commission takes a more aggressive antitrust approach with actions such as the Teva listing probe, and the U.S. Food and Drug Administration calls attention to potentially improper listings, say attorneys at McDermott.

  • After Chevron: Slowing Down AI In Medical Research

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    The U.S. Supreme Court's recent decision overturning the Chevron doctrine may inhibit agencies' regulatory efforts, potentially slowing down the approval and implementation of artificial intelligence-driven methodologies in medical research, as well as regulators' responses to public health emergencies, say Ragini Acharya and Matthew Deutsch at Husch Blackwell.

  • FDA's Multifaceted Role On Display In MDMA Therapy Scrutiny

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    Ongoing deliberations at the U.S. Food and Drug Administration regarding MDMA-assisted therapy for post-traumatic stress disorder serves as a window into the intricate balance of scientific innovation and patient safety oversight, and offers crucial insights into regulatory nuances, say Kimberly Chew at Husch Blackwell and Kevin Lanzo at Pharmaka Clinical Consulting.

  • Analyzing FDA Draft Guidance On Clinical Trial Diversity

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    In light of the U.S. Food and Drug Administration's draft guidance on clinical trial diversity action plans, there are several important considerations for sponsors and clinical researchers to keep in mind to prevent delay in a drug or device application, say attorneys at Crowell & Moring.