Sources: FDA, HHS Leaders Clash On Off-Label Communication Next Steps

Internal disagreement within FDA, as well as between the agency and HHS, regarding what policy path to take on off-label promotion of drugs has stalled several long-promised draft guidances, as well as stifled the agency’s enforcement against violators, several sources speaking on the condition of anonymity tell Inside Health Policy . The HHS general counsel, sources say, is confident FDA can prevail in future litigation and has been reluctant to sign off on pending guidance clarifying the agency's position on...