Kennedy says he will finalize rules that increase diversity in clinical trials
CHICAGO, Jan 29 (Reuters) - Robert F. Kennedy Jr., President Donald Trump's pick to lead the top U.S. health agency, told U.S. senators during his confirmation hearing on Wednesday that he would finalize regulations aimed at increasing the participation of diverse patient populations in clinical trials.
The comment followed a purge last Friday of draft guidance and other diversity-related information from the U.S. Food and Drug Administration's website. Kennedy is nominated to run the U.S. Department of Health and Human Services, which oversees FDA.
Asked by Democratic Senator Ben Ray Lujan whether he would commit to finalizing the guidance on clinical trial diversity mandated by Congress, Kennedy replied, "Yes."
The FDA's Diversity Action Plan draft guidance to drugmakers and medical device companies fulfills a requirement laid out in the 2022 Food and Drug Omnibus Reform Act.
Historically, most available evidence from clinical trials is based largely on white patients and may not account for differences in how drugs and devices work, or what side effects they may cause, in various patient populations. The law aims to increase participation of underrepresented groups, including Black and Hispanic Americans.
The guidance would require drug and device makers to set goals and detail their strategies for enrolling people from diverse populations for every late-stage clinical trial of medicines and medical devices slated for U.S. regulatory review.
The guidance was due to be finalized by June 2025, and it is not clear why it was removed from the FDA website.
HHS and FDA spokespeople declined to comment, citing a communications moratorium imposed by the Trump administration until Feb. 1.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Independent
an hour ago
- The Independent
Egg recall over salmonella warning spans across nine states
Almost two million eggs have been recalled in the United States over concerns of salmonella contamination. The recall, announced on Friday by the U.S. Food and Drug Administration, affects products distributed in nine states and is associated with various grocery store chains. According to the FDA, California -based August Egg Company of Hilmar is recalling 1,700,000 dozen brown cage-free and brown certified organic eggs due to potential contamination. The eggs were distributed from February 3 through May 15, with sell-by dates from March 4 to June 4, within California and Nevada. Products were distributed at locations including Save Mart, FoodMaxx, Lucky, Smart & Final, Safeway, Raleys, Food 4 Less, and Ralphs. Eggs were also distributed from February 3 through May 6 with sell-by dates from March 4 to June 19 to Walmart locations in California, Washington, Nevada, Arizona, Wyoming, New Mexico, Nebraska, Indiana, and Illinois. The recalled eggs will have the plant code number P-6562 or CA5330 printed on the carton or package, with Julian Dates between 32 and 126. The recalled retail eggs will be in fiber or plastic cartons, with the above codes printed on one side of the carton. Salmonella can cause serious and sometimes fatal infections in young children, the frail or elderly, and others with weakened immune systems, according to the FDA. Healthy persons infected with Salmonella often experience fever, nausea, vomiting, abdominal pain, and even bloody diarrhea. In rare circumstances, infection with Salmonella can result in more severe illnesses. A statement from August Egg Company read: 'It is important to know that when our processing plant identified this concern, we immediately began diverting all eggs from the plant to an egg-breaking facility, which pasteurizes the eggs and kills any pathogens. 'August Egg Company's internal food safety team is also conducting its own stringent review to identify what measures can be established to prevent this situation from recurring. 'We are committed to addressing this matter fully and to implementing all necessary corrective actions to ensure this does not happen again.'
The Herald Scotland
8 hours ago
- The Herald Scotland
Trump asks Supreme Court to let him gut Education Department
In an emergency appeal, the administration said the court should lift a judge's order blocking Trump from carrying out those moves while they're being challenged by Democratic-led states, school districts and teachers' unions. "The Constitution vests the Executive Branch, not district courts, with the authority to make judgments about how many employees are needed to carry out an agency's statutory functions, and whom they should be," Solicitor General John Sauer told the Supreme Court. U.S. District Judge Myong Joun said the White House's decision to fire more than 1,300 workers in March has prevented the federal government from effectively implementing legally required programs and services. Such changes can't be made without the approval of Congress, which created the department in 1979, Joun ruled. The Boston-based 1st U.S. Circuit Court of Appeals backed that decision. The court said the administration provided no evidence to counter Joun's "record-based findings about the disabling impact" of the mass firings and the transfer of some functions to other agencies. "What is at stake in this case, the District Court found, was whether a nearly half-century-old cabinet department would be permitted to carry out its statutorily assigned functions or prevented from doing so by a mass termination of employees aimed at implementing the effective closure of that department," Judge David Barron wrote for the panel of three circuit judges. More: Trump can't erase the Education Department with an executive order. Here's why. An executive order Trump signed in March directed Education Secretary Linda McMahon to "facilitate the closure of the Department of Education." McMahon announced roughly half the agency's workforce would be eliminated through a combination of mass layoffs and voluntary buyouts. That would have reduced the staff from 4,133 workers when Trump began his second term in January to 2,183 workers. The administration also wants the Small Business Administration to take over student loans and move special education services to the U.S. Department of Health and Human Services. Joun's order blocked the administration from transferring those functions and required the department to reinstate fired workers. The appeals court said Trump doesn't have to have as many Education Department employees as the previous administration but can't cut so many that the agency can't function as Congress intended.
Scotsman
10 hours ago
- Scotsman
Why Reform UK were the biggest winners despite coming third in Hamilton by-election
Sign up to our daily newsletter – Regular news stories and round-ups from around Scotland direct to your inbox Sign up Thank you for signing up! Did you know with a Digital Subscription to The Scotsman, you can get unlimited access to the website including our premium content, as well as benefiting from fewer ads, loyalty rewards and much more. Learn More Sorry, there seem to be some issues. Please try again later. Submitting... All parties celebrate a victory, but Labour's joy at their Hamilton by-election win had an extra edge that perhaps suggested they had privately feared John Swinney's claim that the seat was a contest between the SNP and Reform would turn out to be true. However, for all their delight at proving him decisively wrong, a more sober assessment of this unexpected win paints a far less rosy picture for Labour than it might at first suggest. Labour's Davy Russell may have beaten SNP candidate Katy Loudon – although only by some 600 votes – but the story of this by-election was the 7,088 people who backed Reform UK's Ross Lambie. Advertisement Hide Ad Advertisement Hide Ad The highly respected pollster, Professor John Curtice, told The Scotsman that the result was "way below" what Labour needs if it is to win next year's Holyrood election. "I think the honest truth is that neither Labour nor the SNP can be really particularly happy with this result,' he said. He has also argued the idea that Nigel Farage's party could never 'make the political weather' in Scotland is no longer credible following the Hamilton result. Nigel Farage's Reform UK party is the coming force in Scottish politics (Picture: Lia Toby) | Getty Images Public discontent The parties that have traditionally dominated Scottish politics have been presented with a wake-up call about the challenge presented by Reform. They now need to do some serious thinking about why Farage and co have become quite so popular, so quickly. Advertisement Hide Ad Advertisement Hide Ad The most obvious answer is widespread discontent about the economy and public services, particularly the NHS's long waiting lists, and the impression given by the Conservatives and SNP in government that little can be done. Labour's first year in government at Westminster has not done much to suggest that they have found an answer. Given the extent of the problems, some voters may be still giving them the benefit of the doubt, although that will not last much longer. In such a situation, a protest or 'plague on all your houses' vote is understandable. Democratic governments must deliver for their people or they will eventually find themselves out of power.
