A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a ?Dear Doctor? letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.
A South Carolina court found that Ortho-McNeill-Janssen Pharmaceuticals, a subsidiary of Johnson and Johnson (J&J), violated state consumer-protection laws by using misleading marketing for its antipsychotic drug, Risperdal. Janssen Pharmaceuticals, the maker of the drug, received a Warning Letter from FDA in April 2004 over misleading product claims made in a “Dear Doctor” letter that the company sent to healthcare providers in November 2003. According to FDA, the Janssen promotional material minimized the risks of hyperglycemia-related adverse events associated with Risperdal, and misleadingly claimed that Risperdal was safer than other atypical antipsychotics.
The South Carolina court ordered J&J to pay $327 million in fines. According to an article in Bloomberg, Circuit Court Judge Roger Couch assessed a $300 penalty per sample box of the drug that was distributed and a $4000 penalty for the publication of the “Dear Doctor” letter, for a total penalty of more than $327 million. A much larger penalty could have been assessed if the fines had been levied on a per-prescription basis.
J&J plans to appeal the ruling. According to Bloomberg, the South Carolina case is one of about 10 such suits brought by states over misleading marketing of Risperdal. J&J succeeded in getting the charges dismissed in a similar suit in Pennsylvania and won an appeal after being fined in West Virginia, after which the state dropped its case.
The Future of Cleanroom Construction: How Hybrid Solutions are Changing the Game
May 14th 2025Imagine a world where cleanroom facilities—essential for pharmaceutical manufacturing, biotechnology, and high-tech industries—are built with unparalleled speed, precision, and efficiency. That world is here, thanks to the hybrid construction approach. By blending traditional stick-built methods with modular and prefabricated solutions, companies are overcoming the limitations of conventional construction while ensuring compliance with stringent industry regulations. In this interview, we explore how hybrid cleanroom construction is transforming the industry, offering faster project timelines, improved quality control, and significant cost advantages. Join us as we delve into this game-changing approach with industry experts who are leading the charge in revolutionizing cleanroom infrastructure.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
Novartis Acquisition of Regulus Therapeutics is Complete
June 25th 2025A key property included in the acquisition is farabursen, an investigational next-generation oligonucleotide targeting the microRNA miR-17 with preferential kidney exposure, intended to treat people with autosomal dominant polycystic kidney disease.