FDA Policy/General
Right-wing activist and commentator Laura Loomer is now publicly criticizing FDA commissioner Marty Makary over recent comments surrounding the departure of CBER director Vinay Prasad, accusing Makary of undermining the authority of president Donald Trump and his top advisors. Her criticism of Makary in an 8/5 X post
FDA Policy/General
Former FDA chief of staff Elizabeth Jungman has joined law firm Hogan Lovells as a partner in its pharmaceuticals and biotechnology practice in the Washington, D.C. office. As chief of staff under Biden Administration commissioner Robert Califf, Jungman oversaw the day-to-day management of the agency and provided
FDA Policy/General
FDA has granted TransMedics Group conditional approval to begin its next-generation Organ Care System (OCS) ENHANCE heart trial. The trial is designed in two parts, according to the company, and will assess the capabilities of TransMedics’ proprietary heart technology. TransMedics says it's OCS platform is designed to
FDA Policy/General
HHS acting general counsel Sean Keveney has been appointed FDA’s new chief counsel. Most recently at HHS, Keveney led the Department’s work for the Trump Administration on “discrimination crackdowns” involving Harvard, Columbia, Brown and Duke and their alleged violations of Title VI of the Civil Rights Act of
Biologics
Based on conversations with four anonymous knowledgeable sources, Politico is reporting that President Donald Trump overruled FDA commissioner Martin Makary and HHS secretary Robert F. Kennedy, Jr., to insist that CBER director Vinay Prasad be removed from FDA. Prasad had come under attack from conservative presidential whisperer Laura Loomer, former
FDA Policy/General
Top House Democrats on the Energy and Commerce Committee are raising concerns over what they describe as a coordinated effort by the Trump Administration to restrict access to vaccines and undermine public trust in the nation’s immunization system. Two oversight letters sent to FDA commissioner Marty Makary and HHS
FDA Policy/General
FDA commissioner Martin Makary says that while he wants to speed patients’ access to needed drugs, he also wants to reduce the need for pharmaceuticals by addressing the root causes of diseases. In an interview with Yahoo Finance, Makary said he has been focused on ensuring quicker access to drugs,
FDA Policy/General
FDA has posted the following user fee rates for fiscal year 2026 (effective 10/1). They are: * Prescription drugs and biologics: $4.682 million for an application requiring clinical data. This is an 8.6% increase in the current fee. The annual program fee is $442,213, which is a
FDA Policy/General
U.S. Representative Richard Hudson (R-NC) is leading a group of bipartisan House lawmakers in sending a letter to FDA commissioner Marty Makary urging the agency to take immediate action against the rising threat of illegal, counterfeit anti-obesity medications entering the U.S. The counterfeit products, which include
FDA Policy/General
FDA commissioner Marty Makary has defended CBER director Vinay Prasad from an online attack by far-right influencer and Trump confidant Laura Loomer in which she called for his removal for being too left-wing. In an interview with Politico, Makary said Prasad does not have a “political bone” in
FDA Policy/General
Rep. Nikema Williams (D-GA) and three other legislators have introduced the Plain Prescription Prices Act that would require direct-to-consumer TV ads for prescription drugs to include a statement of the drug’s list price. In a statement, Williams says the legislation “will empower consumers to hold drug
FDA Policy/General
Former and current FDA employees who have used the agency’s new internal generative artificial intelligence (AI) tool Elsa report that it can’t be trusted. An online Gizmodo post says three employees told CNN that Elsa makes up nonexistent studies, something commonly referred to in AI as “hallucinating.” The
FDA Policy/General
FDA has released a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products that provides recommendations to industry on formal meetings between the agency and sponsors relating to the development and review of proposed biosimilar, including interchangeable, products. The document discusses good meeting management
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