FDA Layoffs Will Likely Force Cutbacks In Food And Drug Inspections
CBS reports that roughly 170 workers were laid off from the FDA's Office of Inspections and Investigations. In related FDA news, the pharmaceutical industry is worried about the cuts; layoffs include senior veterinarians working on bird flu; and more. Also, President Donald Trump's tariff exemptions for pharma.
CBS News:
FDA Planning For Fewer Food And Drug Inspections Due To Layoffs, Officials Say
Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week in support staff. Around 170 workers were cut from the FDA's Office of Inspections and Investigations, according to two federal health officials who were not authorized to speak publicly. (Tin, 4/2)
The Washington Post:
FDA Cuts Senior Veterinarians Working On Bird Flu
Nearly half a dozen senior veterinarians at the Food and Drug Administration were laid off in a sweeping purge, including employees in a center that has played a key role in the recent bird flu outbreak that began rampaging through dairy herds for the first time last spring, according to three FDA staffers. Some of the veterinarians laid off this week had helped design studies last year showing pasteurization kills the virus in milk found on store shelves, according to the three staffers who spoke on the condition of anonymity because they were not authorized to speak publicly. (Roubein and Sun, 4/2)
Axios:
Drug Industry Worries About FDA Delays
Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the agency back as crucial review deadlines loom. Health industries pay billions developing and shepherding drugs through the regulatory process, including user fees that help ensure there are enough staff to evaluate products on a predictable timeline. (Reed, 4/3)
Stat:
FDA's Marty Makary Focuses On MAHA, Not Agency Plans In Speech
Marty Makary’s first address to staff as FDA commissioner on Wednesday afternoon sounded a bit like an introduction to one of his books. It included sweeping declarations about the need to challenge scientific norms, and to identify the root causes of chronic disease. Makary sprinkled in anecdotes intended to stir emotion, recounting the time when his father gave a cancer patient a hug at the grocery store. (Lawrence, 4/2)
On President Trump's tariffs —
Fierce Healthcare:
Trump's New Tariffs Include Pharma Exemption
President Donald Trump made good on his threat of announcing new and steeper tariffs during a Wednesday afternoon White House event, setting the stage for higher prices and supply chain uncertainty for numerous industries including healthcare. The tariffs, set to go into effect at midnight, are the largest trade policy shift for the U.S. in decades and an end to the so-called free-trade era. They include a minimum 10% tariff that affects "all countries," according to the White House. (Muoio, 4/2)
The Wall Street Journal:
Trump’s Tariffs Could Blow Up Big Pharma’s Tax Shelter
Pfizer in 2019 sold $20 billion of drugs in the U.S. Its federal tax bill? Zero. That revelation was part of a Senate Finance Committee investigation done by Democratic staff, released in March, that examined how U.S. pharmaceutical giants exploit a loophole created by the 2017 Trump tax overhaul to shift profits offshore. (Wainer, 4/2)
Axios:
Drug And Device Makers Confront Trump Tariffs
A day after deep Food and Drug Administration cuts rocked their world, drug and med tech companies faced another potentially big hit when President Trump announced a baseline 10% tariff on U.S. imports. (Bettelheim, 4/3)
Also —
The Wall Street Journal:
FTC’s Case Against Drug Managers On Hold After Commissioners Fired
The Federal Trade Commission’s lawsuit against three large pharmacy-benefit managers over insulin prices is on hold after President Trump fired two of the agency’s commissioners. The FTC this week halted a lawsuit against the country’s largest drug middlemen, which negotiate drug prices for employers and insurers. The FTC said it needs to pause the litigation because its two remaining commissioners, both Republicans, are recused from the case, leaving none to oversee it. (Michaels and Walker, 4/2)