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.
As new clinical trials regulations were signed into law in the U.K., an analysis of 4,616 submissions to conduct studies has highlighted what is required for the updated law to translate into a more efficient, streamlined and adaptable regulatory framework.
Two days after pharma companies sounded an alarm that their investments were headed out of Europe, Novartis AG has announced plans to increase investment in the U.S. by $23 billion, bringing the total it invests over the next five years to nearly $50 billion.
The Trump administration applied a 90-day hold on nation-specific tariffs, but a group of 26 House Democrats urged the administration to think carefully before acting on a threat to impose tariffs on pharmaceuticals.
“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.
The April 8 Senate hearing on the Trump administration’s tariffs generated some heated debate, although U.S. Trade Representative Jamieson Greer parried some of the criticism by pointing to the yawing trade deficit.
The extent of the damage that will be caused if the U.S. overseas aid program, the President’s Emergency Plan for AIDS Relief (PEPFAR), is axed or has its funding cut, is laid out in an expert analysis published in The Lancet April 8, which estimates nearly 500,000 children could die from AIDS-related causes by 2030, while 1 million children will be infected with the virus.
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.
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