The next major shock wave to hit the U.S. biopharma and med-tech industries could be the fiscal 2026 federal budget. Nearly one-third of the discretionary budget for the Department of Health and Human Services (HHS) could be wiped out, according to the White House Office of Management and Budget’s “pre-decisional” budget proposal, or passback, for HHS.

In a blast from the past, U.S. President Donald Trump signed an executive order April 15 to deliver on his 2016 campaign promises and strengthen or reinstate efforts of his first administration to drive down prescription drug prices. “My first term included numerous significant actions, including some of the most aggressive in recent history, to deliver lower prescription drug prices to American patients,” Trump noted in the order, which builds on many of those actions, including increased competition, re-importation, price transparency and a mandate to pass discounts through to patients.

U.S. tariffs on biopharmaceuticals have advanced beyond administration talking points.As a precursor to tariffs, Commerce Secretary Howard Lutnick initiated an investigation under section 232 of the Trade Expansion Act to determine the effects on national security of importing prescription drugs, according to a request for public comments scheduled to be published in the April 16 Federal Register. Publication of the notice will kick off a 21-day comment period.

“We’ve lost 1,000 person-years of expertise in a few weeks,” former U.S. FDA Commissioner David Kessler said in an April 9 House Oversight and Government Reform hearing as he discussed the impact of the termination of 3,500 FDA employees the previous week, on top of the 1,000 who were let go or offered retirement in February.

The on-again, off-again U.S. tariffs are off again, at least for now, for more than 75 countries that have reached out to the Trump administration to negotiate instead of retaliating. The 90-day pause will provide some breathing room for the med-tech industry. Pharmaceuticals and active pharmaceutical ingredients were among the few products exempted from the reciprocal tariffs, but that exemption for pharmaceuticals was expected to be short-lived. Meanwhile, pharma CEOs warned European Commission President Ursula von der Leyen April 8 that, unless the EU quickly changes its policy, pharmaceutical research, development and manufacturing is increasingly likely to be directed to the U.S.

Ill-considered government policies, pharmacy benefit manager market abuses and an unpredictable future are casting doubt on the long-term sustainability of the U.S. biosimilar market, Craig Burton, the executive director of the Biosimilars Council, told a House Ways & Means subcommittee April 8.

The nationwide preliminary injunction keeping the U.S. NIH from slashing its indirect cost rate to a flat 15% has become permanent. In issuing the permanent injunction and final judgment April 4 in three challenges to the rate change, Judge Angel Kelley, of the U.S. District Court for the District of Massachusetts, said the NIH’s Feb. 7 notice that it would begin imposing the 15% rate Feb. 10 to all existing and future grants violated the Administrative Procedure Act, as the action was arbitrary and capricious, was impermissibly retroactive and failed to follow notice-and-comment procedures.

At first glance, it appears that biopharmaceuticals dodged the latest U.S. tariff bullet; med-tech, not so much. According to the executive order President Donald Trump signed in the Rose Garden late yesterday, pharmaceuticals are one of the few things exempt from the new country-by-country reciprocal tariffs that will be going into effect over the next week. However, U.S.-based manufacturers of both drugs and devices could face supply chain disruptions, further market restrictions and increased operating costs as the new tariffs take effect and other countries retaliate.

After several on-again, off-again tariff threats, U.S. President Donald Trump made it official April 2: Beginning immediately, the U.S. will levy “kind reciprocal” tariffs on countries across the world. Focusing on the numbers, Trump didn’t mention whether any goods would be exempt from the new tariffs, and the executive order he signed at the Rose Garden ceremony wasn’t available as of press time. However, in concluding his remarks, Trump said the pharmaceutical industry would “come roaring back” in the U.S., because if biopharma companies don’t, they will be facing big taxes.