United States President Donald Trump told Fox News on Tuesday that he cannot comment on Pakistan's proposal for a two-week extension of his deadline to Iran, adding that the US is currently engaged in "heated negotiations" with Tehran.
The US leader added he would soon receive a full briefing on the proposal.
https://breakingthenews.net/Article/Trump-says-US-in-'heated-negotiations'-with-Iran/66024399
Saudi Aramco's oil facilities could become Iran's next target, should the United States start striking the country's power plants, Tasnim News reported on Tuesday, citing a military source.
"We have prepared some nice surprises for [US President Donald] Trump’s possible madness," the official was quoted as saying, adding that Yanbu and Fujairah oil facilities are also possible targets. "In the event of Trump’s crime, Iran will not hesitate to impose heavy costs on the United States and its partners," he noted.
The source added that Trump can expect oil prices to reach $200 per barrel in the coming days if he delivers on his earlier threats.
https://breakingthenews.net/Article/Aramco-eyed-as-target-if-US-hits-Iran-power-plants/66024138
The FDA is seeking new powers to enforce requirements related to postapproval manufacturing changes as part of the Trump administration’s fiscal year 2027 budget proposal.
Through the funding request, released April 3, the agency proposed legislative changes intended to help it meet its goals for 2027. One proposal covers the validation and authorization of postapproval manufacturing updates. These include major changes such as the use of a different facility or active pharmaceutical ingredient (API) supplier. Such changes can adversely affect the safety or effectiveness of the finished product.
To mitigate that risk, the FDA has proposed revising drug and biologics laws to clarify the agency’s ability to enforce manufacturing change requirements. The legislative changes are intended to ensure that people are not exposed to medicines until postapproval changes have been appropriately validated.
Legislation published in 1997 requires manufacturers to receive approval for major changes, which the FDA will review before they apply to products delivered to patients. However, the agency has identified a need to revise various sections of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act to clarify its powers.
The FDA has also requested “express authority to require actions to address residual quality risks in the postapproval period.” Using its authority, the agency could make companies provide information on ongoing quality via postapproval updates.
The FDA said the powers would support its ability to identify and act against adulterated products.
The agency also wants lawmakers to confirm and expand its ability to disclose and use certain information related to drug impurities when it deems these actions to be in the interest of public health. The FDA said early identification of impurities and disclosure of acceptable intake limits would support timely corrective actions, such as changes to manufacturing processes and product reformulations.
Other proposals include a request for powers to withdraw products from the market if companies fail to report how much API they source from each supplier listed in their approval submissions. The FDA said the current situation hinders its visibility into the supply chain.
The proposals will facilitate the FDA’s transition “from a reactionary system to a proactive system,” Commissioner Marty Makary wrote in his opening letter for the 2027 budget document.
Finally, the budget proposal includes a request for $9 million and 19 full-time employees to accelerate advanced manufacturing. The money will fund initiatives including PreCheck, a new FDA program intended to help companies build manufacturing facilities in the U.S.
If President Donald Trump has his way, the FDA will have more money to work with next year, and the agency plans to use the funds for a series of regulatory reforms, including making a priority voucher program permanent and easing the burden of launching Phase 1 trials in the U.S.
The president has allotted $7.23 billion for the FDA in 2027, an increase of approximately $232 million (3.2%) from 2026, according to the agency’s proposal document published April 3. This budgetary bump is a distinct departure from the Department of Health and Human Services, which overall will see its funds slashed by 12% to $111.1 billion for fiscal year 2027. The HHS’ budget for 2026 totaled $126.9 billion.
The 2027 budget will facilitate the FDA’s transition “from a reactionary system to a proactive system,” Commissioner Marty Makary wrote in his opening letter for the proposal document. Part of this change, he noted, is creating new pathways to expedite the development of drugs, boost national security and promote “radical transparency.”
To meet these goals, the agency has proposed a slew of reforms that will be implemented with the help of the 2027 war chest. One such initiative is the permanent authorization of the rare pediatric disease priority review voucher program—a move that the agency says will not only create “more predictability for sponsors” but also ensure that patients will continue to “have access to safe and effective therapies.”
The FDA’s rare pediatric priority review voucher program was first enacted in 2012 and is meant to incentivize companies to develop therapies for rare diseases in children by offering a reward: a ticket that, when used, could expedite the review of their products. But the program has to be renewed by Congress every few years, and failure to do so can cause gaps in its implementation.
That’s what happened in September 2024, forcing the FDA to “sunset” the program at the end of that year. Lawmakers restarted the scheme in September 2025.
The FDA in its budget document last week also proposed a new “clinical trial notification pathway” to offer an alternative to the current Investigational New Drug application system—a “burdensome” process, the agency noted.
Details for how this new pathway would work remain sparse, but the FDA “aims to reduce duplicative and time-consuming requirements while maintaining safety and ethical standards.” This new framework will be particularly beneficial to smaller companies, which the regulator said “face greater barriers to entry under the current paradigm.”
Makary has previously raised concerns that the regulatory burden in the U.S. has been chasing companies away, which in turn have increasingly been conducting their early-stage studies abroad. Makary has been weighing ways to encourage these companies to come back, but mostly through adjustments in the user fee structure: lower fees for firms who conduct their Phase 1 studies in the U.S., and higher duties for those who hold them overseas.
The new pathway, the FDA said in its budget proposal, “would create an accelerated path to initiate U.S.-based Phase 1 clinical programs, drive market competition by reducing the regulatory burden for drugs with adequate preclinical data to support first-in-human studies, and lower drug development costs.”
Also on the FDA’s roadmap is to expand the scope of its rejection disclosures. The regulator plans to amend existing regulations to allow it to disclose “information on deficiencies in safety and efficacy data” for drugs or biologics that are rejected. It remains unclear what specific information the agency wants to make public, but the move “could help others prevent similar deficiencies in their own development programs and marketing applications.”
The FDA last year dumped a trove of more than 200 complete response letters (CRLs). These rejections remain publicly available and cover a wide variety of applications, including those that had been filed by some of the biggest players, including Eli Lilly and Gilead. Then in September, the FDA released another batch of CRLs and pledged to make the rejection letters available in real-time going forward.
AbbVie’s mega-blockbuster Humira will be sold through the government’s direct-to-consumer (DTC) platform TrumpRx for around $950, roughly an 86% discount to its usual price, which can reach over $6,900 for uninsured patients, CBS News reported on Tuesday.
AbbVie announced its participation in TrumpRx in January but did not say at the time how much these products would go for on the government platform. In exchange for its TrumpRx commitment as well as a $100 billion R&D manufacturing pledge, AbbVie secured an exemption from tariffs—which were announced on Friday— and other future “price mandates” that the government might impose.
In addition to Humira, AbbVie will also sell its hypothyroidism drug Synthroid and its eye drops Combigan and Alphagan for discount on the site. Prices on TrumpRx will apply only for patients who aren’t on any insurance plan or those whose plans don’t cover the specific medicines, CBS reported, citing anonymous government sources familiar with the matter. These patients would otherwise pay the drugs’ full list price out-of-pocket. People who are insured usually already pay lower prices for treatments.
TrumpRx went live in February after a brief delay. Many other industry giants have offered discounted products on the site, including Pfizer and AstraZeneca. The DTC platform is part of the Trump administration’s push to lower prescription drug prices in the U.S., in accordance with Trump’s Most Favored Nation mandate, which seeks to bring costs down to the same level as those in similarly developed countries.
Several companies have struck deals with the government for exemptions to these price controls—as in the case of AbbVie, drugmakers promise to participate in TrumpRx in exchange for immunity to these policies—but those agreements haven’t panned out. Indeed, when President Donald Trump announced 100% tariffs on pharma imports last week, many of the companies with existing exemption arrangements found that they would still be subject to these levies.
