US FDA to fast-track drug reviews for firms backing national priorities

US 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.
(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

Try Our AI Features

Explore what Daily8 AI can do for you:

Learn with AIFact CheckingText to SpeechAI Summary

Related Articles

Time of India

2 hours ago

• Time of India

Deadline diet India's young workforce faces cardiac scare

Young Indians are increasingly facing heart issues. Doctors report a rise in cardiac cases among those in their 20s and 30s. Stress, lack of sleep, and unhealthy lifestyles are major factors. Sedentary jobs and poor diets contribute to the problem. Even post-Covid inflammation increases the risk. Sales of heart-related drugs have significantly increased. Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads Tired of too many ads? Remove Ads For 31-year-old techie Kumar, long hours at work carrying well into the night often led to stress eating, coupled with an occasional drink (or two) to "take off the edge".The excesses magnified over the weekend, till one day when what he suspected was an episode of indigestion turned out to be a heart attack. Kumar, who doesn't want to reveal his full name, has now been put on a strict diet by his doctor. He has been asked to cut out all unhealthy food, stop eating out and is not an isolated case. Leading cardiologists are sounding the alarm bells as they see an increase in people in their 20s and 30s being hospitalised for cardiac issues. Stress, lack of sleep, pollution and working at odd hours have all contributed to the increase in heart disease among young people, said noted cardiologist Naresh Trehan."The numbers are worrisome; out of 34 beds in my ICU, nine are occupied by patients under 40," said Naveen Bhamri, vice-chairman of cardiology at Max Super Speciality Hospital in New Delhi's Shalimar Bagh, who performed an angioplasty on a 39-year-old this week. "A majority of my patients are in their 20s and 30s, who see long periods of inactivity due to being stuck at their desks, stressed out by the constant urban hustle and pressure to hit corporate targets."Nishith Chandra, director, interventional cardiology at Fortis Escorts Heart Institute in the national capital, said he is seeing 10-20 patients in the age group of 20-30 years every month with heart-related key drivers behind this trend are sedentary lifestyle, lack of exercise, high stress, poor sleep and mental health issues, Chandra said. "Undiagnosed hypertension, post-Covid heart inflammation, use of steroids and unsafe gym supplements, smoking, alcohol and recreational drug use are some other factors," he across the country are reporting increased cases of young professionals having cardiovascular diseases, sudden cardiac arrests and heart attacks."Not all of them have the typical triggers like diabetes, hypertension, obesity and family history. Recent data shows that one in four individuals having heart attacks are aged 40 and under," said M Sudhakar Rao, consultant - cardiology at Manipal Hospital, Sarjapur, Bengaluru Tight deadlines and work pressure, constant hustle culture and impending burnout are causing Indian professionals to remain in sedentary positions for most of the day, get less sleep, and turn to unhealthy, processed foods - all of which can contribute significantly to the risk of heart attacks, say medical is the diabetes and hypertension capital of the world, and people are genetically more predisposed to getting heart diseases, often earlier than their counterparts in the West, said Mukesh Goel, senior consultant - cardiothoracic and heart and lung transplant surgery at Delhi's Indraprastha Apollo Hospitals. "There's a difference of 10-15 years with the West."Telehealth consultation data from Plum shows two-thirds of cardiac consultations come from the 25-40 age group, showing a premature cardiovascular ageing in India's prime working demographic."We've observed that 71% of Indian working professionals are at moderate risk of chronic disease, showing warning signs across blood pressure, diabetes, cholesterol and obesity," Saurabh Arora, cofounder of the insurtech startup, told has increased the risk further, said Trehan. "People who got serious Covid actually have much higher chance of developing heart disease because there is inflammation of the arteries, and the heart muscle became weak. So, if those who got serious Covid were not checked out then they should get it now".Sales of drugs in the cardiac category have risen almost 50% in five years to ₹30,723 crore in the 12 months through May 2025, according to data from market research firm PharmaTrac."Consumption of lipid-lowering agents, antianginal therapies and heart failure therapies have almost doubled in the last five years with Indians experiencing heart disease 5-10 years earlier than the global average. The age group has now come down to 30-40 years from earlier 50-60 years, said Sheetal Sapale, vice-president, commercial at of cardiac products increased 11.7% in 2024 compared with the year before.

News18

3 hours ago

• News18

Daily Olive Oil Intake May Cut Dementia Death Risk By 28 Per Cent: Study

Last Updated: A new research has found that consuming olive oil reduces the risk of dementia and it also reduces the chance of dementia-related deaths. Age-standardised dementia mortality rates have been rising over the past 20 years, despite declines in deaths from heart disease and stroke. Alzheimer's disease and other dementias claim the lives of one-third of senior citizens. Regular use of olive oil has been shown to dramatically reduce the chance of dementia-related death. According to a study published in JAMA Network Open, consuming at least seven grams of olive oil per day was linked to this lower risk, regardless of other dietary factors or genetics. This benefit appears to be unaffected by the quality of the diet as a whole, indicating that olive oil has special qualities that promote brain function. A prospective cohort research of 92,383 individuals followed for 28 years found that, regardless of their diet, consuming more than 7 g/d of olive oil was linked to a 28 per cent lower risk of dementia-related death than never or rarely consuming olive oil. These findings show that consuming more olive oil may be a way to lower the risk of dementia death. Olive Oil And Brain Function Any loss of cognitive skills that is severe enough to affect daily functioning, including memory, language, and problem-solving, is referred to as dementia. Over 55 million individuals worldwide suffer from dementia, and an estimated 10 million new cases are diagnosed each year. The study suggests that consuming more olive oil may reduce the chance of dementia-related death. A balanced diet and lifestyle can help prevent or slow the progression of Alzheimer's disease, according to the study. The researchers examined dietary questionnaires and death data gathered from over 90,000 Americans over a three-decade period to learn more about the benefits of olive oil on brain function. During this time, 4,749 study participants died from dementia, per the Times of India. According to research, people who ate more than half a tablespoon of olive oil every day were 28 per cent less likely to die from dementia than people who seldom or never had it. They also discovered that substituting just one teaspoon of margarine and mayonnaise with the same quantity of olive oil each day was linked to an 8–14 per cent reduced risk of dementia-related death. Researcher Anne-Julie Tessier warned that the study is observational and does not establish a link between olive oil and a lower risk of dementia death. Its effects need to be confirmed by more research. Moreover, one should use olives and olive oil in moderation because they are high in calories. First Published:

Time of India

3 hours ago

• Time of India

Major chocolate recall sweeps U.S stores — here's why your favorite sweet treat might be unsafe

Weaver Nut Company is recalling certain semi-sweet chocolate nonpareils distributed throughout the United States. If you recently purchased semi-sweet chocolate nonpareils from a grocery or retail store, you should double-check the lot number. Major chocolate recall sweeps U.S. stores: The U.S. Food and Drug Administration (FDA) announced in a news release on Wednesday that Weaver Nut Company was recalling its semi-sweet chocolate nonpareils with white or Christmas-colored seeds, with particular lot codes, due to possible unreported milk allergies, as per a report by Newsweek. Although no illnesses have been reported, people who are allergic to milk face a serious risk. The chocolates were sold through supermarkets and retail stores throughout the United States. ALSO READ: McDonald's boycott June 24: Who's behind it, why it's happening, and how long it will last Why is your favourite sweet treat unsafe? According to the FDA's release, the problem was discovered after a wholesale customer complained about differences in product specifications. Live Events The chocolates were labelled as being free of milk, but later laboratory testing revealed that they did contain milk proteins, it added. It further stated that consuming the affected items could result in severe or fatal allergic reactions for people with a milk allergy or severe sensitivity. One of the top nine allergens that the FDA requires to be declared is milk, and improper labelling can be very risky. Why is this recall important? According to the Pennsylvania-based Weaver Nut Company, the recall is a preventative step to protect the public's health. The business is taking all necessary steps to ensure the safety of its products. Which chocolates are affected? Customers are advised to verify product lot codes and return or dispose of any impacted items. Throw away the items or return them to the store for a complete refund. Lot numbers 204206, 204207, 204208, 204209, 204212, 224225 are for Item 47518-Nonpareil, Semi-Sweet Chocolate (Christmas Seeds). Lot numbers 204214-RL, 204214, 204215, 224221, 224222, 224223, 135215, 135216, 135217, 135220, 135221, 145204, 145205-1, 145207-1, and 145210-1 are for Item D2645, Nonpareils, Semi-Sweet Chocolate (White Seeds), as per a report by Newsweek. FAQs What do I do if I have these chocolates? Check the lot number, and if it is recalled, do not eat it. Return it for a refund or dispose of it. Why is the recall so serious? Milk is a major allergen, and consuming it when allergic can result in serious or life-threatening reactions. Economic Times WhatsApp channel )