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
Articles | Manufacturers | Pharmaceutical Manufacturers | Plan Sponsor PBM Contract Services

On June 27, 2022, FDA issued a Proposed Rule which would facilitate Rx to OTC switches. While OTC products are typically for acute self-limiting conditions, OTC use of certain prescription medications for chronic diseases or conditions would be... Read More
Articles | Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA | White Collar Criminal Defense & Government Investigations

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
Articles | Life Sciences | Manufacturers | Pharmaceutical Manufacturers | Regulatory Compliance, including FDA, DEA and HIPAA

Lately, Frier Levitt has seen an increase in actions by pharmaceutical manufacturers (and their vendors) against pharmacies related to the use of certain patient-savings programs, such copay coupon programs.  The programs are designed to reduce... Read More
Articles | Community, Retail Pharmacies | Life Sciences | Manufacturers | Pharmacy Law

Under the Section 340B federal discount drug program (340B program), pharmaceutical manufacturers enter into contracts with the Health & Human Services (HHS) in exchange for having their drugs covered by Medicaid and Medicare.  Pursuant to... Read More
Articles | Life Sciences | Manufacturers | Pharmacy Law | Section 340B In-House and Contract Pharmacies

As a follow-up to our previous article on the CREATES ACT, other types of clinical trials for which we seek comparator drugs are mostly for head-to-head comparisons for new indications, or non-inferiority trials, and generally fall under 505(b)(1),... Read More
Articles | Biotech Companies | Life Sciences | Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

The refusal to provide comparator products violates federal and state antitrust laws and the CREATES Act. Although the Supreme Court has expressed caution about imposing antitrust liability based on a monopolist’s unilateral refusal to deal, the... Read More
Articles | Biotech Companies | Life Sciences | Manufacturers | Pharmaceutical Wholesalers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA

Thirty-seven years after enactment of the Hatch Waxman Act 2, it remains difficult for Congress, and the drug supply chain industry to strike the appropriate balance of legal rights between brand name and generic drug manufacturers as it relates to... Read More
Articles | Intellectual Property Services | Life Sciences | Manufacturers | Pharmacy Law | Regulatory Compliance, including FDA, DEA and HIPAA