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The Food and Drug Administration commissioner’s effort to drastically shorten the review of drugs favored by President Donald Trump’s administration 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. Marty Makary’s program is causing new anxiety and confusion among staff already rocked by layoffs, buyouts, and leadership upheavals, 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. At the highest levels of the FDA, questions remain about which officials have the legal authority to sign off on drugs cleared under the Commissioners National Priority Voucher program, which promises approval in as little as one month for medicines that support U.S. national interests. Traditionally, approval decisions have nearly always been handled by FDA review scientists and their immediate supervisors, not the agencys political appointees and senior leaders. But drug reviewers say they’ve received little information about the new program’s 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’ aggressive deadlines. Outside experts point out that FDA drug reviewswhich range from six to 10 monthsare already the fastest in the world. The concept of doing a review in one to two months just does not have scientific precedent, said Dr. Aaron Kesselheim, a professor at Harvard Medical School. FDA cannot do the same detailed review that it does of a regular application in one to two months, and it doesnt have the resources to do it. 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. Health and Human Services spokesman Andrew Nixon said the voucher program prioritizes gold standard scientific review and aims to deliver meaningful and effective treatments and cures.” The program remains popular at the White House, where pricing concessions announced by the Republican president have repeatedly been accompanied by FDA vouchers for drugmakers that agree to cut their prices. For instance, when the White House announced that Eli Lilly and Novo Nordisk would reduce prices on their popular obesity drugs, FDA staffers had to scramble to vet new vouchers for both companies in time for Trump’s news conference, according to multiple people involved in the process. Thats sparked widespread concern that FDA drug reviewslong pegged to objective standards and procedureshave become open to political interference. Its extraordinary to have such an opaque application process, one that is obviously susceptible to politicization, said Paul Kim, a former FDA attorney who now works with pharmaceutical clients. Top FDA officials declined to sign off on expedited approvals Many of the concerns around the program stem from the fact that it hasn’t been laid out in federal rules and regulations. The FDA already has more than a half-dozen programs intended to speed up or streamline reviews for promising drugsall approved by Congress, with regulations written by agency staff. In contrast, information about the voucher program is mostly confined to an agency website. Drugmakers can apply by submitting a 350-word statement of interest. Increasingly, agency leaders such as Dr. Vinay Prasad, the FDAs top medical officer and vaccine center director, have been contacting drugmakers directly about awarding vouchers. Thats created quandaries for FDA staffers on even basic questions, such as how to formally award a voucher to a company that didnt request one. Nixon, the HHS spokesman, said that voucher submissions are evaluated by a senior, multidisciplinary review committee, led by Prasad. Questions about the legality of the program led the FDAs then-drug director, Dr. George Tidmarsh, 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 on issues unrelated to the voucher program. After his departure, Dr. Sara Brenner, the FDAs 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 agencys deputy chief medical officer, Dr. Mallika Mundkur, who works under Prasad, is taking on the responsibility. 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 or lawsuits. 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’t get a vote. It is a complete reversal from the normal review process, which is traditionally led by the scientists who are th ones immersed in the data, said Kesselheim, who is a lawyer and a medical researcher. Not everyone sees problems with the program. Dan Troy, the FDAs top lawyer under President George W. Bush, a Republican, says federal law gives the commissioner broad discretion to reorganize the handling of drug reviews. Still, he says, the voucher program, like many of Makarys initiatives, may be short-lived because it isn’t codified. If you live by the press release then you die by the press release, Troy said. Anything that theyre doing now could be wiped out in a moment by the next administration. The voucher program has ballooned after outreach by FDA officials 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 agencys drug center, where 20% of the staff has left through retirements, buyouts or resignations over the past year. When Makary unveiled the program in October, there were immediate concerns about the unprecedented power he would have in deciding which companies benefit. 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. 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 representatives that Prasad had contacted the company about a voucher. 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. Under pressure from drugmakers, some FDA reviewers were told they can skip steps Once a voucher is awarded, some drugmakers have their own interpretation of the review timeline creating further confusion and anxiety among staff. Two people involved in the ongoing review of Eli Lilly’s anti-obesity pill said company executives initially told the FDA they expected the drug approved within two months. The timeline alarmed FDA reviewers because it did not include the agency’s standard 60-day prefiling period, when staffers check the application to ensure it isnt missing essential information. That 60-day window has been in place for more than 30 years. Lilly pushed for a quicker filing turnaround, demanding one week. Eventually the agency and the company agreed to a two-week period. Lilly’s 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. Nixon declined to comment on the specifics of Lilly’s review but said FDA reviewers can adjust timelines as needed. Staffers were pushed to keep the application moving forward, even though key pieces of data about the drug’s 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. 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. Skipping review steps could also carry risks for drugmakers if future FDA leaders decide a drug wasnt properly vetted. Like other experts, Kesselheim says the program may not last beyond the current administration. They are fundamentally changing the application of the standards, but the underlying law remains what it is, he said. The hope is that one day we will return to these scientifically sound, legally sound principles. ___ The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institutes Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content. Matthew Perrone, AP health writer
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U.S. President Donald Trump suggested Friday that he may punish countries with tariffs if they dont back the U.S. controlling Greenland, a message that came as a bipartisan Congressional delegation sought to lower tensions in the Danish capital. Trump for months has insisted that the U.S. should control Greenland, a semiautonomous territory of NATO ally Denmark, and said earlier this week that anything less than the Arctic island being in U.S. hands would be unacceptable. During an unrelated event at the White House about rural health care, he recounted Friday how he had threatened European allies with tariffs on pharmaceuticals. I may do that for Greenland too, Trump said. I may put a tariff on countries if they dont go along with Greenland, because we need Greenland for national security. So I may do that, he said. He had not previously mentioned using tariffs to try to force the issue. Earlier this week, the foreign ministers of Denmark and Greenland met in Washington this week with U.S. Vice President JD Vance and Secretary of State Marco Rubio. That encounter didnt resolve the deep differences, but did produce an agreement to set up a working group on whose purpose Denmark and the White House then offered sharply diverging public views. European leaders have insisted that it is only for Denmark and Greenland to decide on matters concerning the territory, and Denmark said this week that it was increasing its military presence in Greenland in cooperation with allies. A relationship that we need to nurture In Copenhagen, a group of senators and members of the House of Representatives met Friday with Danish and Greenlandic lawmakers, and with leaders including Danish Prime Minister Mette Frederiksen. Delegation leader Sen. Chris Coons, a Delaware Democrat, thanked the groups hosts for 225 years of being a good and trusted ally and partner and said that we had a strong and robust dialogue about how we extend that into the future. Sen. Lisa Murkowski, an Alaska Republican, said after meeting lawmakers that the visit reflected a strong relationship over decades and it is one that we need to nurture. She told reporters that Greenland needs to be viewed as our ally, not as an asset, and I think thats what youre hearing with this delegation. The tone contrasted with that emanating from the White House. Trump has sought to justify his calls for a U.S. takeover by repeatedly claiming that China and Russia have their own designs on Greenland, which holds vast untapped reserves of critical minerals. The White House hasnt ruled out taking the territory by force. We have heard so many lies, to be honest and so much exaggeration on the threats towards Greenland, said Aaja Chemnitz, a Greenlandic politician and member of the Danish parliament who took part in Fridays meetings. And mostly, I would say the threats that were seeing right now is from the U.S. side. Murkowski emphasized the role of Congress in spending and in conveying messages from constituents. I think it is important to underscore that when you ask the American people whether or not they think it is a good idea for the United States to acquire Greenland, the vast majority, some 75%, will say, we do not think that that is a good idea, she said. Along with Sen. Jeanne Shaheen, a New Hampshire Democrat, Murkowski has introduced bipartisan legislation that would prohibit the use of U.S. Defense or State department funds to annex or take control of Greenland or the sovereign territory of any NATO member state without that allys consent or authorization from the North Atlantic Council. Inuit council criticizes White House statements The dispute is looming large in the lives of Greenlanders. Greenlands prime minister, Jens-Frederik Nielsen, said on Tuesday that if we have to choose between the United States and Denmark here and now, we choose Denmark. We choose NATO. We choose the Kingdom of Denmark. We choose the EU. The chair of the Nuuk, Greenland-based Inuit Circumpolar Council, which represents around 180,000 Inuit from Alaska, Canada, Greenland, and Russias Chukotka region on international issues, said persistent statements from the White House that the U.S. must own Greenland offer a clear picture of how the US administration views the people of Greenland, how the U.S. administration views Indigenous peoples, and peoples that are few in numbers. Sara Olsvig told The Associated Press in Nuuk that the issue is how one of the biggest powers in the world views other peoples that are less powerful than them. And that really is concerning. Indigenous Inuit in Greenland do not want to be colonized again, she said. Daniel Niemann and Darlene Superville, Associated Press
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OpenAI, the maker of ChatGPT, said on Friday it will start including ads for those who use the app for free, or have the cheapest subscription, ChatGPT Go. In the coming weeks, the company plans to start testing those ads in the U.S., which will directly relate to user prompts and conversations, “so more people can benefit from our tools with fewer usage limits or without having to pay,” the company said. According to OpenAI, the ads will be “clearly labeled” at the bottom of the chat and users can turn off personalization if they want. As for whether the ads will influence the answers ChatGPT provides, OpenAI said the “responses are driven by whats objectively useful, never by advertising,” and user data and conversations “are protected and never sold to advertisers.” ChatGPT Go, which launched in India last August and has since rolled out in 170 countries, is now coming to the U.S. and everywhere the AI chatbot is available. It’s ChatGPT’s fastest-growing plan, and OpenAI claims it is “among the most affordable AI subscriptions globally.” (Of course, many AI chatbots are free.) ChatGPT Go costs $8 a month, and offers access to its latest model, GPT5.2 Instant, giving users expanded access to messaging, image creation, file uploads, and memory, the company said in a statement. For those who want to avoid ads, more premium subscriptions such as ChatGPT Plus and ChatGPT Pro come ad-free. With this launch, ChatGPT now offers three subscription tiers globally: ChatGPT Go at $8 per month; ChatGPT Plus at $20 per month; and ChatGPT Pro at $200 per month.
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Stocks wavered in afternoon trading on Wall Street Friday as the first week of corporate earnings season closes out with markets trading near record levels. The S&P 500 rose 0.1% after shifting between small gains and losses. The Dow Jones Industrial Average fell 52 points, or 0.1%, as of 3:17 p.m. ET. The Nasdaq composite rose 0.1%. Technology stocks were the strongest forces behind the market’s moves. The S&P 500 has slightly more losers than gainers, but several big technology stocks made strong gains and countered losses elsewhere. Nvidia rose 0.4%, Broadcom rose 2.8%, and Micron Technology rose 6.8%. All three are semiconductor companies that are among several Big Tech companies with outsized valuations that often push the market higher or lower. A handful of regional U.S. banks reported their earnings following mixed reports from their larger peers. Pittsburghs PNC jumped 3.9% after it beat Wall Streets fourth-quarter targets, but Regions Financial fell 3% after reporting results that missed forecasts. Outside of the banking sector, transport company J.B. Hunt Transport Services fell 1% after reporting mixed quarterly financial results. The latest round of earnings updates from companies could help give Wall Street a better sense of how consumers are spending their money and how businesses are operating amid economic concerns brought on by inflation and tariffs. Results from the technology sector are being scrutinized by investors trying to figure out whether the high stock prices fueled by the craze around artificial intelligence are justified. Despite the strong start to 2026, we would not be surprised if markets experience volatility in the coming weeks as fourth-quarter earnings progress and the threat of escalating geopolitical tensions remains, wrote Doug Beath, global equity strategist at Wells Fargo Investment Institute, in a note to investors. Wall Street will have a broader mix of earnings to review next week, coming from airlines, industrial companies, and technology companies. United Airlines, 3M, and Intel are all scheduled to release their quarterly earnings results next week. Crude oil prices rose after dropping sharply on Thursday. The price of U.S. crude oil rose 0.4% to $59.44 and the price of Brent crude, the international standard, rose 0.6% to $64.13. Oil prices have been volatile amid widespread protests in Iran against that countrys leadership and President Donald Trump’s warnings that the U.S. will come to their rescue. Gold prices, which have also been volatile this week, fell. Prices for the precious metal, often viewed as a safe haven amid economic and geopolitical uncertainty, fell 0.6%, but are still up more than 5% so far in January. Treasury yields moved higher in the bond market. The yield on the 10-year Treasury rose to 4.23%, from 4.17% late Thursday. The two-year Treasury yield, which more closely tracks expectations for what the Federal Reserve will do, rose to 3.60%, from 3.57% late Thursday. The Fed’s next policy meeting on interest rates is in two weeks, and Wall Street is betting that it will maintain its current benchmark interest rate. The central bank is trying to balance a slowing jobs market with stubbornly high inflation. Updates on inflation this week showed that prices remain above the Fed’s 2% goal. The U.S. central bank will get one more update on inflation next week when the government releases the personal consumption expenditures price index, or PCE. It is Fed’s preferred measure for inflation. European markets fell, and markets in Asia were mixed. Taiwan’s benchmark index rose 1.9% after its government signed a trade deal with the U.S. China, which claims the self-governed island as its own territory, protested the agreement. The deal with Taiwan comes amid an ongoing trade war between the U.S. and much of the world. Uncertainty over tariffs have raised concerns about inflation and economic damage because of higher costs for businesses and consumers. Canada is the latest to shift its partnerships because of the uncertainty. It has agreed to cut its 100% tariff on Chinese electric cars in return for lower tariffs on Canadian farm products as part of the break with the U.S. Tesla rose 0.4%, and Rivian fell 2.6%. By Damian J. Troise, AP business writer
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The northern lights could light up the skies above several northern states this weekend. The aurora borealis will be visible Friday and Saturday nights over North America, and most prevalent for those states on the northern border of the mainland, according to a forecast from the National Oceanic and Atmospheric Administration (NOAA) Space Weather Prediction Center. Friday offers the highest odds of visibility for most Americans, with the northern lights potentially visible in those states stretching from Washington to Maine, and as far south as Iowa. And Fridays aurora could be brighter, with a score of 5 out of 9 on an index measuring the three-day geomagnetic forecast. For the aurora borealis fanatics, NOAA even offers a more detailed 30-to-90 minute forecast of the location and intensity of the lights. This weekend will mark the first in 2026 when the northern lights are predicted to be visible in the U.S. WHEN AND WHERE TO SEE THE NORTHERN LIGHTS Northern lights can bring vibrant greens and purples to the night sky, and the best aurora is typically in the 10 p.m. to 2 a.m. period. NOAA recommends facing north, in a spot away from light pollution for the best viewing. According to NOAA, the aurora borealis could be visible in up to 15 states on Friday: Alaska, Washington, Idaho, Montana, Wyoming, North Dakota, South Dakota, Minnesota, Iowa, Wisconsin, Michigan, New York, Vermont, New Hampshire, and Maine. If you seem to be seeing the northern lights more frequently than you recall in the pastor, at the very least, hearing about themits true: Theyve become a more common sighting in recent years. Thats because the sun is at the maximum of its 11-year solar cycle, according to astronomers. During solar maximum, the sun blazes with bright flares and solar eruptions, according to information from NASA about the current solar cycle that began in 2019. LOOK TO THE SKY The northern lights wont be the only highlight of the night sky this weekend: If you missed the optimal naked-eye viewing of Jupiter last weekend, when it was its biggest and brightest for the year, the largest planet in our solar system will also light up this sky this weekend with a bright orange color. With small binoculars, you may even be able to view Jupiters four moons. Saturn, Uranus, and Neptune will also be visible this weekend, according to The Sky Live. And while far fewer people will get to see this, SpaceX has a rocket launch planned for Friday evening from the Vandenberg Space Force Base, a military base near Santa Barbara, California. The launch will send the twelfth batch of satellites into orbit as part of a reconnaissance satellite constellation built by SpaceX and Northrop Grumman.
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