HHS Pushes Out Policy Changes In Last Days Of Trump Administration
Powers related to FDA scrutiny of drugs or penalties for HHS guidance violations could be impacted by the final flurry of action.
FDA Fights For Independence In Trump Administration's Final Days
The Department of Health and Human Services is rushing to enact major policy changes at the Food and Drug Administration without the agency’s input — the latest example of Trump political appointees exerting control over scientific decisions. FDA was blindsided Monday when HHS Secretary Alex Azar approved rules designed to reduce scrutiny of drugs and medical devices before they reach market, four senior FDA officials and a person familiar with discussions said. Now the agency is trying to stop HHS from jamming through an industry-backed plan to effectively strip FDA oversight of genetically modified animals. (Owermohle and Cancryn, 1/12)
New Rule Makes It Harder For HHS To Penalize Guidance Violations
HHS officials bolstered President Donald Trump's deregulation agenda on Tuesday, signing off on a rule that makes it more difficult for regulators to go after individuals and organizations for not following standards laid out in guidance documents. The rule effectively bans the department from penalizing individuals and organizations for noncompliance with a standard or practice if HHS only announced it in a guidance document. It also lays out a substantial process HHS must follow to carry out civil enforcement actions for potential violations. HHS said the rule is necessary to ensure fairness. (Brady, 1/12)
Trump Administration To Invest $8M In Broadband For Rural Telehealth Access | FierceHealthcare
The Trump administration is doling out $8 million to improve broadband access for rural telehealth services. The Health Resources and Services Administration (HRSA), part of the Department of Health and Human Services, awarded the funding to the Telehealth Broadband Pilot (TBP) program. That program will assess the broadband capacity available to rural health care providers and patient communities to improve their access to telehealth services. (Landi, 1/12)