On September 23, 2022, the Fourth Circuit issued a per curiam opinion upholding the dismissal of a 2014 qui tam suit against Forest Laboratories, LLC while vacating both the district court and subsequent Fourth Circuit panel opinions. Although the... Read More
Articles | Federal and State Fraud and Abuse Counseling | Manufacturers | Maximum Allowable Cost Pricing & Appeals | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | White Collar Criminal Defense & Government Investigations

In May 2022, Johnson & Johnson (“JNJ”) filed a lawsuit against Save On SP, LLC (“SaveOnSP”), essentially alleging that SaveOnSP illegally pilfered co-payment coupon and manufacturer assistance programs offered by JNJ to help patients... Read More
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On May 17, 2022, the United States District Court for the District of Columbia issued an opinion granting Summary Judgment to Pharmaceutical Research and Manufacturers of America (“PhRMA”), and setting aside the December 2020 Medicaid Best Price... Read More
Articles | Life Sciences | Manufacturers | Pharmaceutical Manufacturers

In an effort to curb prescription drug prices and reimbursement, some legislators are taking a more targeted strategy by looking to lower the cost of clinical research and drug development.  To address the complaints that biopharmaceutical... Read More
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In the patent infringement case Amarin v Hikma, the plaintiffs, a biopharmaceutical company, alleged induced patent infringement against both the generic manufacturer for its skinny label not carving out the patented indications sufficiently and the... Read More
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The Section 340B federal discount drug program (340B program) is a federal program under which pharmaceutical manufacturers enter into contracts with the U.S. Department of Health & Human Services (HHS) in exchange for obtaining Medicaid and... Read More
340B Covered Entity and Contract Pharmacy Regulatory and Contract Support | Articles | Life Sciences | Pharmaceutical Manufacturers | Pharmacy Law | Pharmacy Transactions | Section 340B In-House and Contract Pharmacies

A recent lawsuit and appellate division decision provide guidance to industry stakeholders on copayment assistance programs.  Pfizer filed a lawsuit against the U.S. Department of Health and Human Services (“HHS”) Office of Inspector... Read More
Articles | Life Sciences | Pharmaceutical Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | White Collar Criminal Defense & Government Investigations

Frier Levitt Pharmacist-Attorney, Martha M. Rumore, PharmD, JD, MS, LLM, FAPhA has authored an article for Pharmaceutical Commerce published on October 14th, 2021 titled "2023 challenges of the Drug Supply Chain Security Act implementation on... Read More
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In yet another high-profile legal action, health insurance giant, Humana, has demonstrated its appetite to go after pharmaceutical manufacturers, supporting hubs and specialty pharmacies involved in patient assistance programs.  This past week,... Read More
Articles | Life Sciences | Medicare, Medicaid, and Other Commercial Payor Audits & Appeals | Pharmaceutical Manufacturers | Pharmacy Law | Specialty Pharmacies

Regeneron Pharmaceuticals, Inc., executives face a shareholder derivative suit (“Complaint”) alleging that executive officers and directors engaged in an unlawful copay reimbursement scheme for the purpose of subverting Medicare co-pay... Read More
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