In a significant development that could impact the future of prescription drug costs, the U.S. Federal Trade Commission (“FTC”) announced an expansion of its investigation into the country’s leading Pharmacy Benefit Managers (“PBMs”). ... Read More
Articles | Life Sciences | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Plan Sponsor PBM Contract Services

In an alarming trend, a manufacturer of diabetic test strip has taken actions against pharmacies alleging that they purchased the manufacturer’s test strips (the “Test Strips”) from unauthorized distributors or wholesalers.  The manufacturer... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Specialty Pharmacies | Supermarket Pharmacies

Congress has recently increased its scrutiny of Pharmacy Benefit Managers (“PBMs”), coinciding with a crucial policy shift by the Federal Trade Commission (“FTC”) that appears promising for independent pharmacies and other providers seeking... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Chain Pharmacies | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | DIR Fees | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | MAC Pricing & Appeals | Manufacturers | Maximum Allowable Cost Pricing & Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Plan Sponsor PBM Contract Services | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A)

The Food and Drug Administration (“FDA”) regulates and categorizes human cell and tissue products (“HCT/Ps”) based on the public health risks they pose. HCT/Ps are biological products that are used to repair, replace or regenerate human... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Federal and State Fraud and Abuse Counseling | Fertility Pharmacies | Long-Term Care Pharmacies | National Board of Pharmacy Matters | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA | Specialty Pharmacies | State Board of Pharmacy Hearings and Professional Discipline | Supermarket Pharmacies | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

In February, the Office of Inspector General (“OIG”) issued an advisory opinion regarding a pharmaceutical manufacturer’s proposal to provide a free 14-day supply of its drug to patients experiencing delays in the insurance approval process.... Read More
Articles | Chain Pharmacies | Community, Retail Pharmacies | Digital Pharmacies | Federal and State Fraud and Abuse Counseling | Federal and State Fraud and Abuse Counseling | Fertility Pharmacies | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Manufacturers | Pharmaceutical Manufacturers | Specialty Pharmacies | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | White Collar Criminal Defense & Government Investigations | White Collar Defense and Government Investigation

Enacted on December 29, 2022, the  Modernization of Cosmetics Regulation Act ("MoCRA") applies more of a drug-like regulatory framework to cosmetics. The landmark legislation significantly overhauls the Food and Drug Administration’s (“FDA”)... Read More
Articles | Drug and Device Advertising, Marketing & Promotion Legal Review | Intellectual Property Services | Manufacturers | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA

PRESS RELEASE – New Jersey/New York, March 28, 2023 – Jonathan Levitt, a renowned trial attorney in the healthcare and life sciences industries and the co-founding partner of Frier Levitt, has been invited to testify before the U.S. Senate... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Biotech Companies | Chain Pharmacies | Community Oncology Practices & Other Dispensing Physician Practices | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | Digital Pharmacies | DIR Fees | Dispensing Physician Practices and Dispensing Physicians | Fertility Pharmacies | Home Infusion Providers | Integrated Delivery Network | Integrated Delivery Network and Hospital System Pharmacy | Long-Term Care Pharmacies | Manufacturers | National Board of Pharmacy Matters | News | Outsourcing Facilities (503B) | PBM Qui Tam Lawsuits | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Transactions | Physician Dispensing | Plan Sponsor PBM Contract Services | Section 340B In-House and Contract Pharmacies | Specialty Pharmacies | State and National Pharmacy Associations | State Board of Pharmacy Hearings and Professional Discipline | Supermarket Pharmacies | Traditional Compounding Pharmacies (503A) | Urologist | Veterinary Compounders

Frier Levitt attorneys speak with prosecutors, Boards of Pharmacies, PBM auditors, wholesalers, and the like on a daily basis on behalf of pharmacies nationally. We regularly spot trends and report back to the industry. We are closely monitoring... Read More
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On Friday, March 3, 2023, the Florida Senate introduced Senate Bill 1550 (“SB 1550”) which would regulate Pharmacy Benefit Managers (“PBMs”) operating in Florida. In January 2023 Governor DeSantis announced proposed legislation designed to... Read More
Antitrust Tools Available to Combat PBM Abuse of Pharmacies | Articles | Chain Pharmacies | Community, Retail Pharmacies | Defending Pharmacies in PBM Audits | DIR Fees | PBM Qui Tam Lawsuits | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Plan Sponsor PBM Contract Services | Specialty Pharmacies

On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released a memorandum (the “Memorandum”) setting forth CMS’s proposed methods for calculating so-called “Inflation Rebates” as mandated by the recent Inflation... Read More
Articles | Manufacturers | Medicare and Insurance Audits | Medicare Audit Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Professional Practice Representation