Carrying out his campaign promises to reform government, President Donald Trump signed 46 executive orders (EOs) between Jan. 20-31 that have been published in the Federal Register. Of those, 26 were signed after noon and between all the inaugural events on Trump’s first day in office. Since then, he’s signed at least eight more orders, and the administration has issued numerous memos, several of which are intended to implement the EOs. Given the quantity, scope and content of the EOs Trump has issued over the past few weeks, it’s no surprise that they’ve generated controversy, a lot of uncertainty and at least a few court challenges.
When the U.S. CDC and FDA recently removed several webpages and datasets from their websites in compliance with a directive from the Office of Personnel Management, they broke the law and harmed public health and research, according to a lawsuit filed Feb. 4 by Doctors for America.
Robert F. Kennedy Jr. moved a step closer Feb. 4 to becoming the next secretary of the U.S. Department of Health and Human Services (HHS). The Senate Finance Committee voted 14-13 along party lines to send Kennedy’s nomination to the Senate floor for confirmation. While “no” votes were expected from the 13 Democrats serving on the committee, a big question mark had hung over which way Sen. Bill Cassidy, R-La., would vote, given the comments he made at two committee hearings on the nomination. In the end, Cassidy voted along with his 13 Republican colleagues, offering no comment on his vote at the meeting.
Whether Robert F. Kennedy Jr. (RFK) advances in his quest to become the top health care voice in the Trump administration could come down to one vote – that of Sen. Bill Cassidy. The Louisiana doctor is one of 14 Republican members of the Senate Finance Committee, which is scheduled to vote Feb. 4 on whether to send Kennedy’s nomination as Health and Human Services secretary to the full Senate for confirmation. If all 13 Democrats on the committee vote against it, one no vote from a Republican could stop the process.
Now that Novo Nordisk A/S’ blockbuster semaglutide franchise has been selected as one drug for the next round of the CMS price negotiation, the Bagsværd, Denmark-based company is asking a U.S. appellate court to expedite its consideration of Novo’s challenge to the negotiations and the way CMS is implementing the program.
One of the uncertainties in the changing of the guard in both the U.S. administration and Congress is the future of 340B reforms. Now the Inflation Reduction Act makes reforms more critical than ever, as it requires manufacturers of drugs selected for price negotiations to certify that they’re giving 340B entities the lowest price, be it the 340B discount or the maximum fair price set by the CMS as part of the negotiation process.
In a U.S. Senate Finance Committee confirmation hearing marked by shouted protests, outbursts of applause and tense exchanges on several issues, including ones beyond the reach of the Department of Health and Human Services (HHS), Robert F. Kennedy Jr. (RFK) tried to present himself as someone who follows the science, not a conspiracy theorist or anti-vaxxer.
In another cautionary tale of kicking all the tires before an acquisition, Pfizer Inc. agreed to a nearly $60 million settlement to resolve a whistleblower’s claims that Biohaven Pharmaceutical Holding Co. Ltd. was paying kickbacks to induce prescriptions of its migraine drug ahead of Pfizer’s $11.6 billion acquisition of the company in October 2022.
A U.S. Federal Claims Court judge shot down Vanda Pharmaceuticals Inc.’s accusations that the FDA disclosed the company’s trade secrets to generic competitors, finding that the trade secrets weren’t really secret or necessarily proprietary to Vanda.
With key officials yet to be confirmed at the U.S. Department of Health and Human Services, the acting secretary imposed an immediate pause throughout the department on publicly issuing any document or communication without first getting it approved by a presidential appointee.
