Communications Freeze, Canceled Meetings Worry FDA Stakeholders

Many meetings with HHS’ outside advisors have been canceled or rescheduled since the Trump administration took office, alarming stakeholders about what’s happening within an agency that is, for the most part, not communicating with the public. A pause in HHS communications was initially set to end Saturday (Feb. 1), but it’s now unclear if that’s the case, with the website Prevision Policy reporting the FDA communications freeze will last at least until Feb. 22. FDA did not respond to a...
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Policy Experts Forecast Potential Trump Admin Sympathy For Generics

AMELIA ISLAND, FL -- The next months of the new Trump administration could bring opportunities for generic drug manufacturers, pharmacy benefit manager reform, possible tweaks to Medicare drug negotiation and potentially major cuts to Medicaid, according to health policy experts who spoke at the Association for Accessible Medicines conference this week. Experts predicted the push for generics could translate to FDA regulatory reforms or potentially preferred formulary placement. One expert predicted CMS might use international benchmarking to drive down negotiated...
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Most Groups Support Proposed MA AI Equity Guardrails

Several groups representing doctors, Medicare Advantage advocates and other stakeholders are backing language proposed by the former Biden administration specifying MA plans that use artificial intelligence must ensure patients have equitable access to services, in addition to other safeguards. However, AHIP -- the main trade group for health insurers -- opposed the proposed AI language, citing the “evolving nature of AI and lack of cohesive federal policies” in a comment to CMS on its proposed MA-Part D rule. It’s unclear...
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Alliance For Connected Care Circulates Letter Asking Bondi To Scrap DEA Prescribing Rule

The Alliance for Connected Care is seeking signatures from digital health stakeholders for a letter to the newly appointed Attorney General Pam Bondi urging her to scrap the Drug Enforcement Administration’s proposed restrictive controlled substances remote prescribing rule. The stakeholder group points to Bondi’s past leadership on using telehealth access to expand access to substance use disorder treatment in the draft letter. “The Biden Administration recently proposed a telehealth regulation and finalized a substance use disorder regulation that do not...
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Experts Call RFK Jr.‘s Nomination A ‘Wake-Up Call’ As Finance Advances HHS Pick

Health experts said the Senate Finance Committee’s vote to advance Robert F. Kennedy, Jr.’s nomination for HHS secretary Tuesday (Feb. 4) is a wake-up call to combat health care misinformation, stressing a need for increased fact-checking and better communications if the long-time vaccine-skeptic takes HHS’ helm. An anti-RFK Jr. lobby organization says it’s “not giving up” on defeating Kennedy’s nomination, but Senate health committee Chair Bill Cassidy’s (R-LA) last-minute decision to support the nomination Tuesday appeared to seal RFK Jr.’s...
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FDA Week - 02/07/2025
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Doctors Group Sues HHS, FDA, CDC Over Mass Removal Of Health Webpages

After federal health agencies scrubbed thousands of webpages to comply with an order from President Donald Trump, Doctors for America filed a lawsuit Friday (Jan. 31) against HHS, FDA, Centers for Disease Control and Prevention, and Office of Personnel Management (OPM). The nonprofit, which represents physicians and medical students, alleges the agencies violated the Paperwork Reduction Act (PRA) and the Administrative Procedure Act (APA), which require federal agencies to ensure “timely and equitable access” to public information. The complaint was...
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Trump Admin To Nix 10 Rules For Each New One

The Trump administration issued a new executive order mandating elimination of 10 regulations for every new one and prohibiting agencies from releasing a rule or guidance that is not already on the Unified Regulatory Agenda. The new order goes way beyond the regulatory scrapping initiative of President Donald Trump’s first term that required two rules be scrapped for every new one issued. The new order and an accompanying fact sheet dated Jan. 31 explain that if an agency issues a...
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AdvaMed, AAM: Tariff Exemptions Needed For MedTech, Generics

The Advanced Medical Technology Association (AdvaMed) and the Association for Accessible Medicines (AAM) are seeking exemptions from tariffs the Trump administration imposed on China Tuesday but paused for 30 days for Mexico and Canada, noting medical products were carved out of tariffs during the prior Trump administration. AdvaMed said it has shared concerns with the Trump administration about the impact tariffs could have on the medical technology supply chain. “In light of that risk, an exemption was provided for most...
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RFK To Boost AI Through ‘Clear, Stable’ Regulatory Environment, Backs Telehealth

HHS secretary nominee Robert F. Kennedy Jr -- whose nomination passed out of the Senate Finance Committee Tuesday (Feb. 4) on party lines -- said in written responses to senators that he would support the development of health care artificial intelligence by offering “a clear and stable regulatory environment” and cutting regulatory barriers. Kennedy also said he would work with Congress to ensure continued access to telehealth but dodged questions on access to the abortion pill mifepristone. President Donald Trump...
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Labor Lawsuit Adds To Health Data Privacy Challenges Facing Trump’s DOGE

A coalition of labor groups representing federal workers has filed a lawsuit accusing President Trump’s Department of Government Efficiency initiative of violating personal data protections by tapping into a Treasury Department data base that pays out Medicare, Social Security and other federal benefits, adding to a growing number of legal challenges raising privacy concerns over DOGE efforts led by Elon Musk. The Feb. 3 lawsuit filed with the U.S. district court for the District of Columbia is focused on DOGE...
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