The FDA and the National Institute of Standards and Technology are collaborating on a project to develop and harmonize methods to standardize the description of the temperature sensitivity and stability of monoclonal antibodies (mAbs) and other large molecules used for vaccines and therapeutics. When new mAbs and other large biomolecules for drugs and vaccines are developed, they often must be stored in very cold temperatures to ensure their quality and efficacy. This puts a large burden on the supply chain to maintain these freezing temperatures. Testing to reduce cold storage requirements takes time, and there is often not enough information about these biomolecules to predict their temperature sensitivity. This effort aims to help product developers and the FDA understand molecule stability at different temperatures. This could help simplify test design and reduce testing to more quickly reduce the burden on cold storage supply chains, and help facilitate the distribution of mAbs and other biomolecules during public health emergencies.
Federal plans to distribute prepaid envelopes for patients to return unused analgesic medications have run into opposition from the Community Anti-Drug Coalitions of America, according to an article in Stat. CADCA says that mailing the drugs creates opportunities for theft, but some believe the group’s opposition comes from a “cozy relationship with Deterra, a private company that manufactures and markets drug deactivation devices,” the article explains. “The two organizations are also intertwined on a far deeper level. CADCA’s president and CEO, the former U.S. Army Gen. Barrye Price, sits on Deterra’s board. Mary Bono, the former Republican congresswoman who chairs CADCA’s board of directors, also sits on Deterra’s board of directors.”