FDA Policy/General
Senator Dick Durbin (D-IL) is calling for a crackdown on pharmaceutical companies’ growing use of direct-to-consumer telehealth platforms, following the release of a Senate investigation that raises concerns about inappropriate prescribing, conflicts of interest, and compromised patient care. Durbin, joined by Senators Bernie Sanders (I-VT), Elizabeth
FDA Policy/General
While FDA updates and improves its Elsa internal generative artificial intelligence (AI) tool, questions and concerns persist in the industry that FDA is potentially using a tool that might not have passed the agency’s own expectations for the validation, governance and transparency of such tools when used for FDA-
Drugs
Sen. Marsha Blackburn (R-TN) and Tennessee attorney general Jonathan Skrmetti are calling on the Federal Trade Commission to investigate what they say are “shady online marketing practices of GLP-1 receptor agonists.” In a 7/17 letter, Blackburn and Skrmetti say the drugs, which are promoted as alternatives to
FDA Policy/General
In the first six months of this year, CDER lost 385 employees and only added 18, according to an online BioSpace post. That contrasts with the situation in 2024, when CDER had lost just under 130 employees and had hired nearly 250 new staff. The post says staff statistics for
FDA Policy/General
HHS has notified over 3,000 FDA employees who were told that they were placed on administrative leave 4/1 under government-wide reduction-in-force (RIF) efforts that their employment has been officially terminated effective 7/14. The notification follows the Supreme Court’s decision authorizing the Trump-ordered
FDA Policy/General
FDA is facing new uncertainty over its staffing and regulatory capacity following sweeping federal hiring restrictions and a pivotal Supreme Court decision, both issued last week. Under a new executive order (Ensuring Accountability and Prioritizing Public Safety in Federal Hiring) signed by president Trump, a government-wide civilian hiring freeze
FDA Policy/General
FDA commissioner Martin Makary marked his 100th day on the job with a statement celebrating “the agency’s accomplishments in the bipartisan effort to Make America Healthy Again.” The statement says that in the past 100 days, FDA has launched dozens of key initiatives across the full range of the
FDA Policy/General
The Senate Committee on Appropriations 7/10 voted (27 to 0) to approve and advance to a floor vote the Fiscal Year 2026 Agriculture, Rural Development, FDA and Related Agencies Appropriations Act. The bill would provide $3.6 billion in discretionary budget authority and $3.4 billion in user fees,
FDA Policy/General
FDA needs to expand its reliance on real-world clinical data to monitor the safety and effectiveness of approved medical products, a move that would augment data from initial clinical trials according to Ethics and Public Policy Center physician and bioethicist Aaron Kheriaty. Writing in an opinion piece in The
FDA Policy/General
Ten current and former FDA staff members and leaders who spoke anonymously with the investigative journalism newsroom ProPublica say agency inspectors continue to suffer from the impact of significant staff cuts and reorganizations, even as the Trump administration officially denies that the cuts had an impact on inspections. In its
FDA Policy/General
The FDA rollout of its generative artificial intelligence (AI) staff tool Elsa is in many ways a “nuanced dance between innovation and responsibility.” That’s the view of ERB Lab Services principal consultant and owner Erika Roberts, based on her more than 15 years of experience working in various areas
FDA Policy/General
Former Rep. John Doolittle (R-CA) says the restructuring underway at FDA, while well-intentioned, risks “undermining the very innovation and domestic capacity the president seeks to promote.” Writing for The Hill, Doolittle, who served on committees with FDA oversight, says the elimination of 3,500 full-time FDA employees,
FDA Policy/General
FDA has published a report, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing, describing the agency’s efforts to address cybersecurity issues affecting medical product manufacturers through the development of a demonstration manufacturing line. “If the cybersecurity of manufacturers or other supply chain participants is compromised, it
FDA Policy/General
FDA Webview is closed and will not be publishing on 6/19 in recognition of the U.S. federal holiday, Juneteenth. We will resume our newsroom activities on 6/20, and our next evening email distribution will go out that evening.
FDA Policy/General
President Donald J. Trump and his HHS secretary, Robert F. Kennedy, Jr., reportedly are considering ways to make it more expensive for drug companies to use direct-to-consumer (DTC) advertising. Bloomberg News reports they are considering not allowing companies to deduct their DTC ads as a business expense. They
Biologics
Rep. Frank Pallone (D-NJ), the top Democrat on the House Energy and Commerce Committee, is calling on the committee to open a bipartisan investigation into HHS secretary Robert F. Kennedy, Jr.’s “recent efforts to disrupt and restrict people’s access to vaccines.” In a letter to committee chairman
FDA Policy/General
FDA has granted Sumitomo Pharma a fast-track designation for nuvisertib (TP-3654) for treating patients with intermediate or high-risk myelofibrosis (MF). Nuvisertib is described as an oral, investigational, highly selective inhibitor of PIM1 kinase. Sumitomo says it has demonstrated clinical activity including symptom and spleen responses correlating with
FDA Policy/General
Senators Bernie Sanders (I-VT) and Angus King (I-ME) have introduced legislation that would ban direct-to-consumer drug advertising across television, radio, print, digital platforms, and social media. Their End Prescription Drug Ads Now Act aligns with HHS secretary Robert F. Kennedy Jr., who advocated for such a
FDA Policy/General
Rutgers Health researchers say they have determined that GlaxoSmithKline’s antiseizure drug Lamictal (lamotrigine) is safe in older adults with epilepsy, contrary to an FDA safety warning. An online university post says that in 2020 FDA put a safety warning on the lamotrigine label based on reports the drug could
FDA Policy/General
In a 6/11 email to FDA staff, commissioner Martin Makary said he wants to consolidate many agency operations to streamline its work. The Regulatory Affairs Professionals Society (RAPS) said it obtained a copy of the email for its report. The email indicated Makary wants to consolidate operations such as
FDA Policy/General
Dozens of current and former CDC employees rallied outside the agency’s Atlanta headquarters yesterday over Trump Administration-inspired chaos affecting the health agency. The protest came one day after 342 current and recently fired NIH employees posted a letter criticizing the administration’s politicization of research and the elimination
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says the Sprout Pharmaceuticals CEO made a false or misleading post about the company’s Addyi (fibanserin) tablets, for oral use, on her Instagram account. A 5/29 Warning Letter says the post made representations about Addyi’s benefits, failed to include