Top FDA Officials: Agency Actively Cracking Down On Medical Products With Sham COVID-19 Claims
US FDA commissioner Stephen Hahn and ORA associate commissioner for regulatory affairs Judith McMeekin said in a joint 24 February statement that the agency continues to aggressively monitor the market for firms selling products with fraudulent COVID-19 prevention and treatment claims. The officials also explained that the FDA has the authority under FDASIA to ask for records from drug manufacturers in lieu of conducting facility inspections. It can't do the same for device companies, however, because no similar provision exists. The FDA had announced on 14 February that it paused all inspections of Chinese manufacturing facilities in the near-term.
You may also be interested in...
The US agency has suspended all routine surveillance inspections in China through the end of March because of coronavirus fears, commissioner Stephen Hahn announced late on 14 February. Despite expecting medical product shortages, Hahn said the agency is being proactive: “We are not waiting for drug and device manufacturers to report shortages to us” before acting. The timing of Hahn’s statement – at 6 p.m. EST on a Friday, at the beginning of a three-day US holiday weekend – suggests he isn’t particularly excited to share the information.
Trump Uses Defense Production Act To Push Ventilator Materials To GE, Medtronic, ResMed, Hill-Rom, Royal Philips And Vyaire
The US president used his DPA powers on 2 April to make sure the six manufacturers of medical ventilators get the materials and components they need to make the much-needed devices as the COVID-19 pandemic scythes through the US.
The US agency has pushed to next month a public meeting on the latest incarnation of the Medical Device User Fee Amendments. The meeting will be held remotely.