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Forbes
27-03-2025
- Health
- Forbes
Makary's FDA Has Options In Industry Fight Over Weight Loss Drugs
Interior view of Novo Nordisk's headquarters in Denmark. It is a leading global pharmaceutical ... More company. (Photo by SERGEI GAPON/AFP via Getty Images) Americans pay more for prescription drugs than citizens in any other country—so much more that the U.S. accounts for half of world sales revenue from pharmaceuticals, but only consumes 13 percent of the total volume of prescription drugs. Compared to other wealthy nations in the Organization for Economic Co-operation and Development, the U.S. accounts for 60 percent of pharmaceutical revenues but only 24 percent of volume, according to a recent issue brief from the U.S. Department of Health and Human Services. If the newly confirmed Commissioner of the U.S. Food and Drug Administration (FDA), Dr. Marty Makary, wants to change this lopsided deal, the fight over weight loss drugs is a good place to start. The high prices Americans pay are due to several reasons, including a lack of reasonable price controls, 'patent gaming' to restrict competition as long as possible, the tendency of drug companies to set prices as high as the market will bear and no central negotiator with the power to walk away. Case in point: glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that are effective at controlling type 2 diabetes, helping people lose weight loss and may prevent a wide range of chronic conditions from heart disease to dementia. Although the scientific research that led to the development of GLP-1 drugs was funded by U.S. taxpayers, Americans are charged far more for them than citizens in other wealthy countries. For example, in 2023 the list price for a month's supply of Ozempic (semaglutide) in the U.S. ($936) was more than five times higher than the list price in Japan ($169), and about ten times the list price in Sweden, the United Kingdom, Australia and France, according to the Peterson-KFF Health System Tracker. List Prices for Drugs Used For Weight Loss in the U.S. Versus Other High-Income Nations When the public learned that these drugs help people lose weight, demand quickly exceeded supply. This opened the door for FDA-licensed and state-licensed compounding pharmacies to produce lower-cost copies using the same active pharmaceutical ingredients (semaglutide or tirzepatide) as brand-name GLP-1 drugs at far lower cost. About two million Americans are currently using compounded GLP-1 medications, according to Kaiser Health News. This did not sit well with Novo Nordisk and Eli Lilly, the two multinational manufacturers of FDA-approved brand-name GLP-1 drugs. To reclaim market exclusivity as quickly as possible, they raced to boost production. Last month, the FDA announced that their brand-name GLP-1 drugs are no longer in shortage. On Mar. 10, the Agency notified compounding pharmacies that they should wind down production of medications containing semaglutide or tirzepatide, or risk enforcement action. While the FDA focus is on availability, Americans are far more worried about the cost of brand-name GLP-1 drugs. This is particularly true for patients with health insurance that don't cover them. Anticipating pushback, Novo announced earlier this week that it will directly sell Wegovy to cash-paying patients at a discounted price of $499 per month. In a dig aimed at compounders, Novo said it is launching the program to give patients access to a drug that is 'authentic' and 'FDA-approved' so they can 'avoid the significant risks that can be posed by the compounding marketplace.' Lilly already sells direct-to-consumer versions of its weight loss products at prices ranging from $349 to $699 monthly, depending on the dose. In contrast to Novo, it offers its discounted versions in vials, rather than pricy autoinjectors. Since these 'discounted' monthly prices are significantly more expensive than those charged by compounders, its unclear how many cash-paying customers will be able to afford them. Losing Access to Compunded GLP-1 Drugs Worries Many Americans Who Cannot Afford the Brand-Name ... More Products The most industry-friendly option is to allow FDA enforcement to proceed. If, however, compounding pharmacies are forced to stop production, many Americans currently using GLP-1 products will be unable to afford the brand-name drugs. That number could quickly grow. GoodRx recently reported that 4.9 million people whose health insurance covered Zepbound last year lost coverage of the drug in 2025. About 1.1 million lost coverage of Wegovy. If Congress cuts Medicaid, states that currently cover GLP-1 drugs will probably stop. None of this will sit well with low and middle-income voters. Novo and Lilly profit from GLP-1 sales in Europe, Japan and elsewhere, but they make much bigger profits selling the same products in the United States. That's because longstanding U.S. policies and practices allow them to charge American patients higher prices. The gap is so large, its unlikely that either company will voluntarily relent. Enabling lower-cost competition may be a better option. Under this scenario, compounding pharmacies will not be allowed to sell weight loss products using the same doses and dose-escalation schedules as Novo and Lilly. They could, however, keep making personalized doses of semaglutide or tirzepatide as long as a reasonable medical necessity (such as avoidance of intolerable adverse effects) is stated in the prescriber's order. This scenario would allow FDA 503B and state-licensed 503A compounders to keep producing affordable doses of semaglutide and tirzepatide in exchange for reasonable royalty payments. The catch is reaching agreement on a price that's 'reasonable.' If Lilly and Novo seek to replace their huge profit margins with equally large royalty payments, this idea won't work. If a fair deal cannot be reached, the Trump administration could invoke a seldom-used federal law (28 U.S. Code § 1498) that gives the U.S. government the power to produce or use a patented product without the permission of the patent holder in exchange for reasonable compensation. In past cases, this was typically about 10% of the manufacturer's annual sales. In the case of brand-name GLP-1 drugs, that's a consequential sum, but it would be substantially less than the amount Medicare, the Veterans Health Administration and other public and private payers shell out today. Once the rights are secured, the FDA could authorize FDA-licensed 503B and state-licensed 503A compounding pharmacies to produce personalized doses of semaglutide and tirzepatide at prices patients can afford. Alternatively, the FDA could seek to roll back the secondary patents on semaglutide Novo Nordisk secured to extend its control of U.S. sales well beyond the date its core patent expires. Currently, semagultide will go generic in most countries in 2026, but not in the U.S. until 2033. Brazilian drugmaker Hypera has already announced plans to launch a generic version when the drug's patent protection expires in Brazil in Mar. 2026. Eli Lilly's core patent on tirzepatide does not expire until 2036. Remarkably, the FDA is preparing to shut down competition from compounders without knowing whether the outcomes of patients taking their GLP-1 drugs are worse, the same or better than those taking a brand-name weight-loss drug. If compounded GLP-1 drugs are as 'risky' as Novo and Lilly want us to believe, a well-designed study should prove it. But if they work as well as the brand name drugs, and the flexible dosing they allow results in fewer side effects and higher sustainment, they may be an excellent alternative for many patients. In addition to pausing enforcement to collect objective data, Dr. Makary could direct the FDA to allow, if not encourage, independent testing of compounded drugs to assure their quality. Since reputable compounders already test their products before sale, they should welcome this policy. Independent testing would allow purchasers of GLP-1 drugs to choose their supplier based on quality as well as price. How Makary's FDA resolves the fight over weight loss drugs could affect the health and well-being of millions of Americans and tens of billions in annual health care costs. It could also influence how brand-name drug prices are set in the U.S. for years to come. If President Trump and RFK Jr. give their new FDA Commissioner the latitude he deserves, it will be Dr. Makary's call.
Gulf Insider
26-03-2025
- Health
- Gulf Insider
A New Study Says Baldness May Be Reversible
Researchers believe that sugar naturally occurring in the human body can help stimulate hair growth. Hair regrowth came after the formation of new blood vessels, thanks to a boost in the blood supply to hair follicles. Male pattern baldness impacts up to 50 percent of men worldwide with few FDA-licensed treatments. We've all been told that a spoonful of sugar helps the medicine go down, but research shows that a it may also help regrow hair. It gets a bit more scientific than that, but a recent study showed there's some promise in using a naturally occurring sugar found in the human body to stimulate blood flow to form new blood vessels and encourage hair regrowth. Testing the method worked in mice, and we all know the best laid schemes of mice and men may coexist, especially in a world where up to 50 percent of all men encounter male pattern baldness. In a 2024 study published in the journal Frontiers in Pharmacology , researchers at the University of Sheffield and COMSATS University Pakistan found that the natural sugar 2-deoxy-D-ribose (2dDR) can stimulate hair regrowth. 'Our research suggests that the answer to treating hair loss might be as simple as using a naturally occurring deoxy ribose sugar to boost the blood supply to the hair follicles to encourage hair growth,' Sheila MacNeil, emeritus professor of tissue engineering at the University of Sheffield, said in a statement. 'The research we have done is very much early stage, but the results are promising and warrant further investigation.' With only two drugs licensed by the FDA to treat male pattern baldness, a naturally occurring condition brought on by genetics, aging, stress, and hormones, MacNeil believes that the researchers are on track for something altogether new. As researchers spent eight years studying how the sugar can help to heal wounds on mice by promoting the formation of new blood vessels, they saw that the hair around those healing wounds appeared to grow more quickly compared to those that hadn't been treated. In came more mice. To study the hair regrowth side of the blood vessel research, the scientists created a model of testosterone-driven hair loss in mice to mimic human-style male pattern baldness and found that applying a small dose of the naturally occurring sugar helped to form new blood vessels. New blood vessels directly led to hair regrowth within weeks. The mice 'demonstrated an increase in length, diameter, hair follicle density, anagen/telogen ratio, diameter of hair follicles, area of the hair bulb covered in melanin, and an increase in the number of blood vessels,' the authors wrote. 'This pro-angiogenic deoxy ribose sugar is naturally occurring, inexpensive, and stable, and we have shown it can be delivered from a variety of carrier gels or dressings,' Muhammed Yar, associate professor at COMSATS University Pakistan, said in a statement. 'This makes it an attractive candidate to explore further for treatment of hair loss in men.' Of the two drugs licensed to treat hair loss, minoxidil (brand name Rogaine) is topical and approved for men and women, and finasteride (brand name Propecia) is taken orally, has been linked to side effects, and is not considered suitable for women. The study claims the deoxy ribose sugar proved as successful as minoxidil at regrowing hair, with both between 80 and 90 percent effective. That's a lot of new blood vessels, and a fair bit of new hair. 'This could offer another approach,' MacNeil said, 'to treating this condition.' Also read: Court Orders Father To Pay Legal Fees For Refusing To Apply For Child's Passport
