FDA to offer faster drug reviews to companies promoting 'national priorities'
U.S. regulators will begin offering faster reviews to new medicines that administration officials deem as promoting 'the health interests of Americans,' under a new initiative announced Tuesday.
Food and Drug Administration Commissioner Marty Makary said the agency will aim to review select drugs in one to two months. FDA 's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.
Since arriving at the FDA in April, Makary has repeatedly told FDA staff they need to 'challenge assumptions' and rethink procedures. In a medical journal commentary published last week, Makary suggested the agency could conduct 'rapid or instant reviews," pointing to the truncated process used to authorize the first COVID-19 vaccines under Operation Warp Speed.
For the new program, the FDA will issue a limited number of 'national priority vouchers' to companies 'aligned with U.S. national priorities,' the agency said in a statement. The special designation will give the selected companies access to extra FDA communications, streamlined staff reviews and the ability to submit much of their product information in advance.
Speeding up drug approvals has long been a priority of the pharmaceutical industry, which has successfully lobbied Congress to create a variety of special programs and pathways for faster reviews.
Many aspects of the plan announced Tuesday overlap with older programs. But the broad criteria for receiving a voucher will give FDA officials unprecedented discretion in deciding which companies can benefit from the fastest reviews.
"The ultimate goal is to bring more cures and meaningful treatments to the American public,' Makary said in a statement.
Makary previously said the FDA should be willing to ease its scientific requirements for certain drugs, for instance, by not always requiring randomized studies in which patients are tracked over time to track safety and effectiveness. Such trials are generally considered the gold standard of medical research, though the FDA has increasingly been willing to accept smaller, less-definitive studies for rare or life-threatening diseases.
In several recent cases, the FDA has faced criticism for approving drugs based on preliminary data that didn't ultimately show benefits for patients.
The push to rapidly accelerated drug approvals is the opposite approach that Makary and his boss, Health Secretary Robert F. Kennedy Jr., have taken on vaccines.
Promising a 'return to gold-standard science,' Kennedy previously announced that all new vaccines would have to be compared to placebo, or a dummy shot, to win approval. Kennedy and Makary also have announced a stricter policy on seasonal updates to COVID-19 shots, saying they will have to undergo new testing before they can be approved for use in healthy children and most adults.
___
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Sky News
12 minutes ago
- Sky News
Plans unveiled for NHS funding to be linked to patient feedback
NHS funding could be linked to patient feedback under new plans, with poorly performing services that "don't listen" penalised with less money. As part of the "10 Year Health Plan" to be unveiled next week, a new scheme will be trialled that will see patients asked to rate the service they received - and if they feel it should get a funding boost or not. It will be introduced first for services that have a track record of very poor performance and where there is evidence of patients "not being listened to", the government said. This will create a "powerful incentive for services to listen to feedback and improve patients' experience", it added. Sky News understands that it will not mean bonuses or pay increases for the best performing staff. NHS payment mechanisms will also be reformed to reward services that keep patients out of hospital as part of a new 'Year of Care Payments' initiative and the government's wider plan for change. 2:04 Speaking to The Times, chief executive of the NHS Confederation Matthew Taylor expressed concerns about the trial. He told the newspaper: "Patient experience is determined by far more than their individual interaction with the clinician and so, unless this is very carefully designed and evaluated, there is a risk that providers could be penalised for more systemic issues, such as constraints around staffing or estates, that are beyond their immediate control to fix." He said that NHS leaders would be keen to "understand more about the proposal", because elements were "concerning". Health Secretary Wes Streeting said: "We will reward great patient care, so patient experience and clinical excellence are met with extra cash. These reforms are key to keeping people healthy and out of hospital, and to making the NHS sustainable for the long-term as part of the Plan for Change." In the raft of announcements in the 10 Year Health Plan, the government has said 201 bodies responsible for overseeing and running parts of the NHS in England will be scrapped. These include Healthwatch England, set up in 2012 to speak out on behalf of NHS and social care patients, the National Guardian's Office, created in 2015 to support NHS whistleblowers, and the Health Services Safety Investigations Body (HSSIB). Elsewhere, the new head of NHS England Sir Jim Mackey said key parts of the NHS appear "built to keep the public away because it's an inconvenience". "We've made it really hard, and we've probably all been on the end of it," he told the Daily Telegraph.
The Independent
15 minutes ago
- The Independent
What next for Gaza as Israel's shaky truce with Iran holds?
In the wake of Donald Trump 's extraordinary outburst of profanity outside the White House, a fragile US-brokered truce between Israel and Iran appears to be tentatively holding. In recent days, this has been accompanied by a flurry of messaging from Israel that this cessation of hostilities is just the start. Benjamin Netanyahu, in a brief but emphatic video on Thursday, insisted that after Israel achieved 'a great victory' over its staunchest foe, a new opportunity had opened up for a 'dramatic expansion of peace agreements'. 'There is a window of opportunity here that must not be wasted. We must not waste even a single day,' he said with emphasis. For the two million Palestinians in Gaza facing starvation and slaughter, the hope is that this new climate of negotiations might herald the end of 20 months of Israel's unprecedented bombardment, which has reduced the 25-mile-long strip to ashen rubble and claimed over 56,000 lives, according to local officials. Senior Palestinian health workers told The Independent that without a ceasefire and the immediate delivery of desperately needed aid, they were 'scared we are teetering on the very edge'. 'We are so tired—we can't keep going,' said Yosef Abureesh, Gaza's deputy health minister, outlining how half of the essential drugs list is missing and that none of the 38 hospitals in Gaza are fully functioning. 'Don't rely on our resilience. We are no longer able to continue as health staff,' he added. But what would this peace actually look like - and at what cost? Over the weekend, Netanyahu proclaimed a 'tectonic shift' in the Middle East with Iran weakened, claiming it could herald many more regional states signing the Abraham Accords and thereby recognising and normalising relations with Israel. 'We have broken the axis,' he told reporters triumphantly. 'This is a huge change, and Israel's status is rising—not just in the Middle East but across the world.' Netanyahu's comments on Thursday, though still animated, were more vague. The entire statement lasted just 28 seconds, during which he referred to a 'window of opportunity' alongside 'the defeat of Hamas' and 'the release of the hostages'. There are thought to be around 50 Israelis seized by Hamas during its bloody 7 October 2023 assault in southern Israel who remain in Gaza. Of those, only 20 are believed to still be alive. Netanyahu has faced mounting pressure from the families of the captives and the deceased to sign any truce that could bring the hostages home. According to leaks in Israeli media, the US is also piling on pressure for a rapid peace deal in Gaza that could include broader regional implications . The left-leaning Israeli daily Haaretz reported on Friday that senior Trump administration officials have urged Israel to send its negotiating team to Cairo next week to advance talks with Hamas. Israel Hayom reported a four-way call involving Trump, secretary of state Marco Rubio, Netanyahu, and Israel's minister of strategic affairs, in which they discussed the possibility of a rapid end to the war in Gaza—possibly within just two weeks. The newspaper said the deal discussed could lead to an expansion of the Abraham Accords to include Saudi Arabia and a post-Assad Syria. The Accords, announced in 2020, saw diplomatic normalisation and trade deals signed between Israel and Arab states including the United Arab Emirates and Bahrain. The deal would allegedly be conditional on Hamas being replaced by an 'Arab coalition' to administer Gaza, with multiple nations accepting large numbers of Gaza residents 'seeking emigration'—a potentially alarming indication of transfer of the population. In exchange, the leaks said, the US would recognise 'limited Israeli sovereignty' in the occupied West Bank —likely meaning Trump is preparing to acknowledge Israel's de facto annexation of parts of territory that Palestinians hope to include in a future state. This includes settlements considered illegal under international law and a major obstacle to peace. In return, Israel would have to declare a willingness for a future resolution to conflict based on a 'two-state concept'—a notable watering down of the long-held and widely accepted belief that the creation of two sovereign states - Israel and Palestine - is the best solution to the conflict. But even these conditions will likely face push back from Netanyahu's extreme-right cabinet. Extreme-right ministers Itamar Ben-Gvir and Bezalel Smotrich have repeatedly called for the permanent conquest of Gaza and the re-establishment of Jewish settlements in Gaza that were dismantled in 2005. Without their support, Netanyahu risks the collapse of his razor-thin governing coalition. In a statement on Thursday, Smotrich declared: 'Mr prime minister, let it be clear: you do not have a mandate - not even a hint of one, or a lip-service one. If there are countries that want peace in exchange for peace - welcome. If they want a Palestinian state - they can forget it. It won't happen.' Secondly, these are conditions that the Palestinian leadership is unlikely to accept - especially if the proposal excludes the full withdrawal of Israeli forces from Gaza and involves annexation of parts of the occupied West Bank. The Independent reached out to Hamas for comment on the reported leaks but has yet to receive a reply. Hamas badly needs a ceasefire. It is struggling to survive in Gaza, short of commanders - many of whom have been eliminated by Israel - deprived of much of its tunnel network , and now unsure of continued support from Iran (whose own military leadership has been battered). Yet, according to Gershon Baskin - a veteran Israeli hostage negotiator and peace activist - even under extreme conditions Hamas is still unlikely to accept the proposed terms. 'Hamas is ready to release all of the hostages and give up control over Gaza, but not as a surrender to Israel or to Trump - it must be part of a wider plan, which includes the reconstruction of Gaza,' he told The Independent. 'The idea of expanding the pie and adding extra components is good, but it must include ending the war and Israel withdrawing from Gaza. 'If it includes annexation of parts of the West Bank, Hamas - and all Palestinians - will never agree.' In the interim, time is running out for civilians in Gaza. On Friday, the World Health Organization warned that their first delivery of medical supplies to Gaza since March - when Israel imposed a full blockade on the strip - was merely a 'drop in the ocean' compared to what is needed. 'Open the routes and make sure that we can get our supplies in,' said WHO's Dr Rik Peeperkorn from Jerusalem, adding that Israel had denied entry to nearly 45 percent of the organisation's aid teams. From inside Gaza, Dr Abureesh warned that the population simply cannot continue in these conditions. 'Even someone working in Hollywood preparing a horror movie would not be able to invent the scenario that people in Gaza are living through right now,' he told The Independent. 'All the ways to kill people are being used together.'
The Independent
20 minutes ago
- The Independent
‘Cervical cancer has affected generations of my family - NHS changes mean women like me could be missed out'
A woman whose grandmother and mother both had cervical cancer has called for the reversal of recent changes lengthening the intervals between life-saving screenings. Gemma Barley, 34, had to undergo a biopsy in January 2022 after her regular three-year check-up found abnormal cells in her cervix - despite her previous screening being completely clear. She fears that if she had been subject to new NHS England rules - which have lengthened the time between check-ups to five years - the outcome could have been worse. 'After a regular smear check-up in 2022 I got a letter to say we've found something abnormal in your smear and told I needed a biopsy,' the mother-of-one said. 'It was like my full life had flashed before my eyes. I thought my son was going to be left without a mum. It was horrifying.' Cervical cancer has affected Ms Barley's family for generations. She lost her grandmother to the disease aged 54, just three months after being diagnosed in 2004. Her mother was also diagnosed with cervical cancer in 2018 and had to undergo a hysterectomy to mitigate the risks of the disease. Ms Barley waited four weeks for her results - which said the cells were not cancerous. But the psychology graduate said the experience proves how quickly things can change, and fears recent changes to screenings for cervical cancer could 'put women's lives at risk'. Women aged 25 to 49 who test negative for human papillomavirus (HPV) will now be invited to cervical screening every five years instead of every three, under new NHS guidelines. According to Cancer UK, nearly all cases of cervical cancer are caused by HPV. Most of the time HPV is cleared from the body by itself, but some types can cause cancer if they stay in the body for a long time so require extra monitoring. After seeing the planned changes, Ms Barley started a petition to have them reversed and said: 'I was really angry when I saw the changes. Because of my first-hand experience, it petrified me. 'My first smear was fine, and I'd seen no significant changes in my life since then. But then my second smear found abnormalities. That's how quickly that could change - and yet they're happy to extend it by a further two years.' The change, set to take effect next month in England, follows recommendations from the UK National Screening Committee. According to analysis from King's College London, extending the screening interval to five years for HPV-negative women is just as safe as the current three-year interval, with a similar rate of cancer detection. An NHS England spokesperson said: 'We recognise that changes to cervical screening can seem worrying but want to reassure everyone that this new approach is based on robust scientific evidence and an expert recommendation from the UK National Screening Committee. 'The NHS cervical screening programme tests for HPV and uses a better and more accurate test than before. This means if you test negative for HPV, you don't need to be screened as often as your risk of developing cervical cancer is very low. If you test positive for HPV, we'll monitor you more closely with additional tests and follow-up appointments. 'This personalised approach ensures everyone receives the right level of screening based on their individual risk factors, providing better protection while reducing unnecessary procedures.' A Department of Health and Social Care spokesperson said: 'These changes are based on robust scientific evidence and an expert recommendation from the UK National Screening Committee. 'The NHS cervical screening programme tests for HPV which is a more accurate test than the old cytology (smear) test, therefore intervals for those not at high risk can be safely extended from three to five years. 'If you test positive for HPV, you can be assured you will be monitored closely with additional tests and follow-up appointments.'
