Senators Max Baucus (D-Mont.) and Chuck Grassley (R-Iowa) send letters to opoid manufacturers and pain groups asking them to disclose financial ties.
Senators Max Baucus (D-MT) and Chuck Grassley (R-IA) are probing ties between manufacturers of opiod painkillers and medical groups that have advocated for increased use of such drugs for pain management. The intent of the probe is to establish the extent of financial ties between the two to determine whether there has been undue influence of industry on prescribing practices. The impetus for the probe is the high rate of abuse of prescription opoids, and the dangers such drugs pose. According to a press release from the two senators, deaths from painkiller overdoses have tripled over the last decade and led to the deaths of 14,800 Americans in 2008, exceeding those caused by heroin and cocaine combined.
Letters were sent to Perdue Pharma, Endo Pharmaceuticals, and Johnson & Johnson, asking them to disclose financial ties to 10 medical groups and eight individuals who played a prominent role in setting pain management guidelines. The companies were also asked to provide all communications in regard to the book Responsible Opioid Prescribing: A Physician's Guide, distributed by the Federation of State Medical Boards, and communications in regard to the pain management guidelines published by several medical groups.
The Senators also sent letters to the American Pain Foundation, the American Academy of Pain Medicine, the American Pain Society, the Center for Practical Bioethics, the Wisconsin Pain and Policy Study Group, the Joint Commission on Accreditation of Healthcare Organizations, and the Federation of State Medical Boards asking them to disclose financial support from any company that develops, manufactures, or distributes opiod pain medications.
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
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.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.