{"id":701212,"date":"2026-01-17T03:00:13","date_gmt":"2026-01-17T03:00:13","guid":{"rendered":"https:\/\/www.europesays.com\/uk\/701212\/"},"modified":"2026-01-17T03:00:13","modified_gmt":"2026-01-17T03:00:13","slug":"fda-commissioners-drug-review-plan-sparks-alarm","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/uk\/701212\/","title":{"rendered":"FDA commissioner’s drug review plan sparks alarm"},"content":{"rendered":"

WASHINGTON (AP) \u2014 The Food and Drug Administration<\/a> commissioner\u2019s effort to drastically shorten<\/a> the review of drugs favored by President Donald Trump\u2019s administration<\/a> is causing alarm across the agency, stoking worries that the plan may run afoul of legal, ethical and scientific standards long used to vet the safety and effectiveness of new medicines.<\/p>\n

Marty Makary\u2019s<\/a> program is causing new anxiety and confusion among staff<\/a> already rocked by layoffs<\/a>, buyouts and leadership upheavals<\/a>, according to seven current or recently departed staffers. The people spoke to The Associated Press on the condition of anonymity because they were not authorized to discuss confidential agency matters.<\/p>\n

At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioner\u2019s National Priority Voucher program<\/a>, which promises approval in as little as one month for medicines that support \u201cU.S. national interests.\u201d<\/p>\n

Traditionally, approval decisions have nearly always been handled by FDA review scientists and their immediate supervisors, not the agency\u2019s political appointees and senior leaders.<\/p>\n

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But drug reviewers say they\u2019ve received little information about the new program\u2019s workings. And some staffers working on a highly anticipated anti-obesity pill were recently told they can skip certain regulatory steps to meet top officials\u2019 aggressive deadlines.<\/p>\n

Outside experts point out that FDA drug reviews \u2014 which range from six to 10 months \u2014 are already the fastest in the world.<\/p>\n

\u201cThe concept of doing a review in one to two months just does not have scientific precedent,\u201d said Dr. Aaron Kesselheim, a professor at Harvard Medical School. \u201cFDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesn\u2019t have the resources to do it.\u201d<\/p>\n

On Thursday Reuters reported that FDA officials have delayed the review of two drugs in the program, in part due to safety concerns, including the death of a patient taking one of the medications.<\/p>\n

Health and Human Services<\/a> spokesman Andrew Nixon said the voucher program prioritizes \u201cgold standard scientific review\u201d and aims to deliver \u201cmeaningful and effective treatments and cures.\u201d<\/p>\n

The program remains popular at the White House, where pricing concessions<\/a> announced by the Republican president have repeatedly been accompanied by FDA vouchers for drugmakers that agree to cut their prices.<\/p>\n

For instance, when the White House announced that Eli Lilly<\/a> and Novo Nordisk<\/a> would reduce prices on their popular obesity drugs<\/a>, FDA staffers had to scramble to vet new vouchers for both companies in time for Trump\u2019s news conference, according to multiple people involved in the process.<\/p>\n

That\u2019s sparked widespread concern that FDA drug reviews \u2014 long pegged to objective standards and procedures \u2014 have become open to political interference.<\/p>\n

\u201cIt\u2019s extraordinary to have such an opaque application process, one that is obviously susceptible to politicization,\u201d said Paul Kim, a former FDA attorney who now works with pharmaceutical clients.<\/p>\n

Top FDA officials declined to sign off on expedited approvals<\/p>\n

Many of the concerns around the program stem from the fact that it hasn\u2019t been laid out in federal rules and regulations.<\/p>\n

The FDA already has more than a half-dozen programs intended to speed up or streamline reviews<\/a> for promising drugs \u2014 all approved by Congress, with regulations written by agency staff.<\/p>\n

In contrast, information about the voucher program is mostly confined to an agency website. Drugmakers can apply by submitting a 350-word \u201cstatement of interest.\u201d<\/p>\n

Increasingly, agency leaders such as Dr. Vinay Prasad<\/a>, the FDA\u2019s top medical officer and vaccine center director, have been contacting drugmakers directly about awarding vouchers. That\u2019s created quandaries for FDA staffers on even basic questions, such as how to formally award a voucher to a company that didn\u2019t request one.<\/p>\n

Nixon, the HHS spokesman, said that voucher submissions are evaluated by \u201ca senior, multidisciplinary review committee,\u201d led by Prasad.<\/p>\n

Questions about the legality of the program led the FDA\u2019s then-drug director, Dr. George Tidmarsh<\/a>, to decline to sign off on approvals under the pathway, according to several people with direct knowledge of the matter. Tidmarsh resigned from the agency in November after a lawsuit challenging his conduct<\/a> on issues unrelated to the voucher program.<\/p>\n

After his departure, Dr. Sara Brenner, the FDA\u2019s principal deputy commissioner, was set to have the power to decide, but she also declined the role after looking further into the legal implications, according to the people. Currently the agency\u2019s deputy chief medical officer, Dr. Mallika Mundkur, who works under Prasad, is taking on the responsibility.<\/p>\n

Giving final approval to a drug carries significant legal risks, essentially certifying that the medicine meets FDA standards for safety and effectiveness. If unexpected safety problems later emerge, both the agency and individual staffers could be pulled into investigations<\/a> or lawsuits.<\/p>\n

Traditionally, approval comes from FDA drug office directors, made in consultation with a team of reviewers. Under the voucher program, approval comes through a committee vote by senior agency leaders led by Prasad, according to multiple people familiar with the process. Staff reviewers don\u2019t get a vote.<\/p>\n

\u201cIt is a complete reversal from the normal review process, which is traditionally led by the scientists who are the ones immersed in the data,\u201d said Kesselheim, who is a lawyer and a medical researcher.<\/p>\n

Not everyone sees problems with the program. Dan Troy, the FDA\u2019s top lawyer under President George W. Bush, a Republican, says federal law gives the commissioner broad discretion to reorganize the handling of drug reviews.<\/p>\n

Still, he says, the voucher program, like many of Makary\u2019s initiatives, may be short-lived because it isn\u2019t codified.<\/p>\n

\u201cIf you live by the press release then you die by the press release,\u201d Troy said. \u201cAnything that they\u2019re doing now could be wiped out in a moment by the next administration.\u201d<\/p>\n

The voucher program has ballooned after outreach by FDA officials<\/p>\n

Initially framed as a pilot program of no more than five drugs, it has expanded to 18 vouchers awarded, with more under consideration. That puts extra pressure on the agency\u2019s drug center, where 20% of the staff has left through retirements, buyouts or resignations over the past year.<\/p>\n

When Makary unveiled the program in October there were immediate concerns about the unprecedented power he would have in deciding which companies benefit.<\/p>\n

Makary then said that nominations for drugs would come from career staffers. Indeed, some of the early drugs were recommended by FDA reviewers, according to two people familiar with the process. They said FDA staffers deliberately selected drugs that could be vetted quickly.<\/p>\n

But, increasingly, selection decisions are led by Prasad or other senior officials, sometimes unbeknownst to FDA staff, according to three people. In one case, FDA reviewers learned from GlaxoSmithKline<\/a> representatives that Prasad had contacted the company about a voucher.<\/p>\n

Access to Makary is limited because he does not use a government email account to do business, according to people familiar with the matter, breaking with longstanding precedent.<\/p>\n

Under pressure from drugmakers, some FDA reviewers were told they can skip steps<\/p>\n

Once a voucher is awarded, some drugmakers have their own interpretation of the review timeline \u2014 creating further confusion and anxiety among staff.<\/p>\n

Two people involved in the ongoing review of Eli Lilly\u2019s anti-obesity pill<\/a> said company executives initially told the FDA they expected the drug approved within two months.<\/p>\n

The timeline alarmed FDA reviewers because it did not include the agency\u2019s standard 60-day prefiling period, when staffers check the application to ensure it isn\u2019t missing essential information. That 60-day window has been in place for more than 30 years.<\/p>\n

Lilly pushed for a quicker filing turnaround, demanding one week. Eventually the agency and the company agreed to a two-week period.<\/p>\n

Lilly\u2019s CEO, David Ricks, told attendees at a health care conference on Tuesday that the company expects FDA approval of its pill in the second quarter of the year.<\/p>\n

Nixon declined to comment on the specifics of Lilly\u2019s review but said FDA reviewers can \u201cadjust timelines as needed.\u201d <\/p>\n

Staffers were pushed to keep the application moving forward, even though key pieces of data about the drug\u2019s chemistry appeared to be missing, according to one person involved in the process. When reviewers raised concerns about gaps in the application, the person said, they were told by a senior FDA official that it was OK to overlook the regulations if the science is sound.<\/p>\n

Former reviewers and outside experts say that approach is the opposite of how FDA reviews should work: By following the regulations, staffers scientifically confirm the safety and effectiveness of drugs.<\/p>\n

Skipping review steps could also carry risks for drugmakers if future FDA leaders decide a drug wasn\u2019t properly vetted. Like other experts, Kesselheim says the program may not last beyond the current administration.<\/p>\n

\u201cThey are fundamentally changing the application of the standards, but the underlying law remains what it is,\u201d he said. \u201cThe hope is that one day we will return to these scientifically sound, legally sound principles.\u201d<\/p>\n

___<\/p>\n

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/p>\n","protected":false},"excerpt":{"rendered":"WASHINGTON (AP) \u2014 The Food and Drug Administration commissioner\u2019s effort to drastically shorten the review of drugs favored…\n","protected":false},"author":2,"featured_media":701213,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4315],"tags":[95897,112413,51,210981,210982,32,5835,4179,175432,12266,70494,31990,105,210985,98492,4326,33853,210983,285,106548,210984,6587,16,15,148676,10673],"class_list":{"0":"post-701212","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-medication","8":"tag-andrew-nixon","9":"tag-ap-investigations","10":"tag-business","11":"tag-dan-troy","12":"tag-david-ricks","13":"tag-donald-trump","14":"tag-eli-lilly","15":"tag-general-news","16":"tag-george-tidmarsh","17":"tag-george-w-bush","18":"tag-government-regulations","19":"tag-gsk-plc","20":"tag-health","21":"tag-mallika-mundkur","22":"tag-marty-makary","23":"tag-medication","24":"tag-novo-nordisk-as","25":"tag-paul-kim","26":"tag-politics","27":"tag-richard-nixon","28":"tag-sara-brenner","29":"tag-u-s-food-and-drug-administration","30":"tag-uk","31":"tag-united-kingdom","32":"tag-vinay-prasad","33":"tag-washington-news"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@uk\/115908209792202816","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/701212","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/comments?post=701212"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/posts\/701212\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media\/701213"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/media?parent=701212"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/categories?post=701212"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/uk\/wp-json\/wp\/v2\/tags?post=701212"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}