Policy

HHS budget hearing not so much about budget

Thu, 16 Apr 2026 12:00:00 -0400

U.S. Health and Human Services (HHS) Secretary Robert Kennedy made his first stop April 16 on a congressional tour in support of President Donald Trump’s proposed fiscal 2027 budget, which would reduce discretional spending for HHS and its agencies by about 12%.

Flow of Trump EOs slowing way down

Wed, 15 Apr 2026 12:00:00 -0400

Despite key vacancies, ongoing staffing challenges and policy issues at the U.S. CDC, FDA and NIH, some of the regulatory churn that roiled those agencies in the first year of the second Trump administration is settling a bit, at least in terms of the number of executive orders (EOs) coming out of the Oval Office.

Kennedy expands ACIP function, membership criteria

Fri, 10 Apr 2026 12:00:00 -0400

Amending his previous two-year-renewal of the standard charter for the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP), Health and Human Services Secretary Robert Kennedy made monitoring adverse vaccine events a primary function of the committee and expanded its liaison membership to include organizations that have challenged vaccine safety.>

UK formalizes zero tariffs deal with US, will pay more for drugs

Wed, 08 Apr 2026 12:00:00 -0400

The U.S. confirmed the agreement in principle made last December to exempt U.K. pharmaceuticals from import tariffs, as the U.K government put its commitment to spend more on patented drugs into effect.

Kennedy sidestepping court order sidelining ACIP?

Tue, 07 Apr 2026 12:00:00 -0400

Don’t like a court order? Sidestep it. That seems to be the idea behind U.S. Health and Human Services Secretary Robert Kennedy’s latest changes to his renewal of the charter for the CDC’s Advisory Committee on Immunization Practices (ACIP).

Sector tariff now more than a threat – for some Rx companies

Tue, 07 Apr 2026 11:00:00 -0400

Sector tariff now more than a threat – for some Rx companies

Mon, 06 Apr 2026 12:00:00 -0400

After nearly a year of threats and promises of a global biopharma tariff of 25% to 500%, U.S. President Donald Trump finally delivered it. In the name of national security, he imposed a 100% sector tariff on prescription drugs and their associated ingredients beginning in about four months for large manufacturers and six months for smaller companies. However, depending on the drug, where it’s made and whether a manufacturer has reached onshoring and pricing agreements with the Department of Health and Human Services, the actual tariff could be as low as 0%.

Drama encases ACIP, CDC amid lawsuit, deadline

Wed, 25 Mar 2026 12:00:00 -0400

Chaos continues at the U.S. CDC and its Advisory Committee on Immunization Practices (ACIP) with the resignation of ACIP member Robert Malone and the impending deadline for the president to nominate a new CDC director following the dramatic exit last year of Susan Monarez and months of acting directors.

Australia’s R&D reset puts biotech translation in focus

Tue, 24 Mar 2026 12:00:00 -0400

Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.

China’s pharma rise rattles US policymakers

Tue, 24 Mar 2026 12:00:00 -0400

U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.

Australia’s R&D reset puts biotech translation in focus

Fri, 20 Mar 2026 12:00:00 -0400

Judge’s order shuts down new vaccine schedule, ACIP itself

Tue, 17 Mar 2026 12:00:00 -0400

In one fell swoop March 16, a U.S. federal judge stayed the CDC’s January memo revising the childhood vaccine schedule and the Advisory Committee on Immunization Practices (ACIP) as reconstituted by Health and Human Services Secretary Robert Kennedy, along with everything that committee has done since early June.

ACIP grows by two ahead of next meeting

Mon, 02 Mar 2026 12:00:00 -0500

The U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) has two new members, bringing its total membership to 15. As he has done since dismissing the entire ACIP panel last June, Health and Human Services Secretary Robert Kennedy named the new members, Angelina Farella and Sean Downing, barely two weeks before the next ACIP meeting, March 18-19.

Changing US FDA trial default a global matter

Fri, 27 Feb 2026 12:00:00 -0500

The U.S. FDA’s expectations that its new default position of basing marketing authorization of novel drugs on one adequate, well-controlled trial may be overstated. In explaining the policy in a recent article in The New England Journal of Medicine, FDA Commissioner Marty Makary and CBER Director Vinay Prasad said they expect the initiative will create a “surge in drug development,” substantially reduce development costs and will speed drugs to market. While the initiative could reduce the time to the U.S. market, those expectations don’t take into consideration global norms and payer expectations.

Another lawsuit challenges changes to ACIP, US vaccine schedule

Wed, 25 Feb 2026 12:00:00 -0500

U.S. Health and Human Services Secretary Robert Kennedy is facing a second lawsuit challenging his replacement of all the members of the Advisory Committee on Immunization Practices (ACIP) and seeking to undo the CDC’s Jan. 5 revision of its childhood immunization schedule.

State of the biopharma industry filled with uncertainty

Wed, 25 Feb 2026 12:00:00 -0500

While the annual State of the Union address has morphed over the years from a summation of the state of the U.S. government and the president’s legislative agenda into political theater on both sides of the aisle, President Donald Trump did include some recommendations to Congress in his Feb. 24 speech. Among those recommendations was a request for Congress to codify his most-favored-nation pricing policy for prescription drugs.

Supreme Court ruling not a death knell for US tariffs

Mon, 23 Feb 2026 12:00:00 -0500

The ramifications of the U.S. Supreme Court’s decision Feb. 20 that shot down President Donald Trump’s reciprocal tariffs issued under the International Emergency Economic Powers Act are rippling across the world. And Trump’s immediate response to that ruling – a proclamation imposing a temporary 10% import duty on most goods brought into the country beginning Feb. 24 – isn’t helping.

February ACIP meeting not happening

Mon, 23 Feb 2026 12:00:00 -0500

Amid an ongoing court challenge to the current composition of the CDC’s Advisory Committee on Immunization Practices (ACIP), the committee’s Feb. 25-27 meeting has been removed from its calendar.

Tariffs nixed by Supreme Court, Trump still has options

Fri, 20 Feb 2026 12:00:00 -0500

U.S. President Donald Trump’s foreign-imports tariff policies did not hold up well at the Supreme Court, which ruled unconstitutional his edicts under the International Emergency Economic Powers Act. The sharply worded 6-3 opinion was authored by Chief Justice John Roberts.

US GAO: March-ins not much of a solution for Rx prices

Thu, 19 Feb 2026 12:00:00 -0500

Driven by prescription drug prices and oft-repeated claims that nearly every drug developed in the U.S. owes its origins to taxpayer-funded research, watchdog groups and some lawmakers have led demands over the years for price to be considered a “reasonableness” factor in determining whether the government can march in on patents under the Bayh-Dole Act.

VCs launch coalition to strengthen Europe life sciences investment

Fri, 13 Feb 2026 12:00:00 -0500

Venture capital firms and research institutions have launched the European Life Science Coalition in a bid to strengthen Europe’s VC ecosystem by mobilizing more private and public investment.

VCs launch coalition to strengthen Europe life sciences investment

Fri, 13 Feb 2026 12:00:00 -0500

Venture capital firms and research institutions have launched the European Life Science Coalition in a bid to strengthen Europe’s VC ecosystem by mobilizing more private and public investment.

China amends drug rules to enforce lifecycle accountability

Tue, 10 Feb 2026 11:00:00 -0500

China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.

Unburdening the past, HELPing NIH advance the future

Thu, 05 Feb 2026 12:00:00 -0500

In keeping with the congressional practice of passing major NIH reform legislation every 10 years, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee took the first step in looking at what can be for the NIH while unburdening it from what has been over the past few years.

China amends drug rules to enforce lifecycle accountability

Wed, 04 Feb 2026 12:00:00 -0500

China’s State Council updated its Drug Administration Law, and the changes mark a substantive evolution in the country’s drug regulatory framework.

Trumprx launch threatened by shutdown, kickback concerns

Tue, 03 Feb 2026 12:00:00 -0500

At a recent Cabinet meeting, U.S. Health and Human Services (HHS) Secretary Robert Kennedy reportedly said he expected Trumprx to probably go live within 10 days. That was Jan. 29, two days before HHS was once again forced to shut down many of its activities due to a congressional gridlock over a fiscal 2026 appropriations package to keep the department and several others open beyond Jan. 30.

Rx manufacturing pilot program launches in US

Mon, 02 Feb 2026 12:00:00 -0500

The U.S. FDA is now accepting requests from biopharma companies to participate in its new Precheck pilot program, which is intended to make it faster and easier for companies to relocate their prescription drug manufacturing to the U.S.

US childhood vaccines trapped in the crosshairs of trust

Tue, 27 Jan 2026 12:00:00 -0500

Although the American Academy of Pediatrics has been releasing guidances on vaccines for decades, the 2026 immunization schedule it issued Jan. 26 is creating some buzz given the U.S. CDC’s newly abbreviated childhood schedule that removed several routine recommendations.

Fiscal 2026 HHS spending bill in jeopardy?

Mon, 26 Jan 2026 12:00:00 -0500

After the U.S. House passed a package of spending bills Jan. 22 to fund several agencies and departments, including Health and Human Services, through fiscal 2026, the Senate was expected to quickly follow suit to ensure that no part of the federal government would shut down when the current continuing resolution expires Jan. 30. That was before a confrontation with Immigration and Customs Enforcement in Minnesota turned deadly over the weekend.

Legislation seeks to guard NIH from politicization

Fri, 23 Jan 2026 11:00:00 -0500

The U.S. NIH may be weathering the budget storm thanks to bipartisan congressional support, but another squall line is forming on the horizon over politicization of the research agency.