Trump’s FDA To Require Only One Study For Drug Approvals, Not Two
In changing the longtime standard, administration officials aim to speed up the approval process. Also in the news: domestic production of glyphosate, fluoride in drinking water, and more.
AP:
FDA Drug Approvals: Makary And Prasad Say One Study Will Be Enough
The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products. Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Makary and a top deputy, Dr. Vinay Prasad, wrote in a New England Journal of Medicine piece published Wednesday. (Perrone, 2/18)
More pharma news from the Trump administration —
The New York Times:
Trump’s Order Aims To Boost Ingredient Used In Roundup
President Trump issued an executive order late Wednesday aimed at spurring the domestic production of glyphosate, a widely used weedkiller that has figured in health lawsuits. The move immediately set off alarms among supporters of Health Secretary Robert F. Kennedy Jr.’s “Make America Healthy Again” movement, and appeared to put Mr. Kennedy in an awkward position. (Tabuchi and Stolberg, 2/18)
Stat:
New FDA Guidance On Antibiotic Use In Food-Producing Animals Stirs Criticism
In a bid to mitigate antibiotic resistance, the Food and Drug Administration has released guidance for drugmakers to define how long medically important antibiotics should be used in food-producing animals. But critics argue the effort fails to consider the impact on human health. (Silverman, 2/18)
North Carolina Health News:
Dentists, Oral Health Advocates Urge EPA To Use ‘Gold Standard Science’ In Its Fluoride Review
When Lee Zeldin, head of the U.S. Environmental Protection Agency, announced almost 10 months ago that the federal regulator would reevaluate research on potential health risks of fluoride in drinking water, he said “sound science” would be used to “advance our mission of protecting human and health and the environment.” (Blythe, 2/19)
On climate, immigration, race, and RFK Jr. —
The Hill:
Groups Sue Trump Over Repeal Of Climate Regulations
A coalition of health and environmental organizations sued the Trump administration on Wednesday over its decision to repeal a landmark legal finding that climate change poses a threat to the public. The groups also challenged the administration’s move to eliminate all climate rules for motor vehicles, which were repealed along with the endangerment finding. The filing did not lay out their reasons for the challenge, but in public statements, the groups argued that the move threatens public health and the environment. (Frazin, 2/18)
AP:
US Rep. Joaquin Castro Says The US Deported A Baby With Bronchitis
U.S. immigration authorities deported a 2-month-old baby with bronchitis to Mexico along with his family, a U.S. representative from Texas said. The child was so sick he had been unresponsive “in the last several hours” but was discharged from the hospital anyway, U.S. Rep. Joaquin Castro said Tuesday in an X post. Immigration and Customs Enforcement deported the baby along with his 16-month-old sister, his mother and his father, Castro said. The Democratic lawmaker said he confirmed this with the family’s attorney. (McAvoy, 2/19)
The Washington Post:
Colleges Quietly Cut Ties With Organizations That Help People Of Color
The Trump administration’s objection to a program that helps people of color pursue doctorate degrees has prompted colleges to cut ties with a range of organizations associated with racial minority groups, a Post investigation has found. (Wallack, 2/19)
The Baltimore Sun:
Robert F. Kennedy Jr. On Faith, Recovery And President Trump
In a wide-ranging interview with The Baltimore Sun, U.S. Secretary of Health and Human Services Robert F. Kennedy Jr. reflected on his Catholic upbringing, his decades in recovery, enduring public criticism — including from his own family — and his working relationship with President Donald Trump. (Williams, 2/18)
