STAT+: Pharmalittle: We’re reading about FDA eyeing PDUFA changes, compounded weight loss drugs, and more
Online weight loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk's Wegovy
Top of the morning to you, and a fine one it is. Clear, blue skies and comfortable breezes are enveloping the Pharmalot campus, where the short person is sleeping in and the official mascots are threatening local cats to keep their distance. As for us, we are engaged in the usual rituals — firing up the coffee kettle in order to brew a cup of stimulation (the choice today is pecan bourbon) and foraging for items of interest. On that note, here are a few tidbits to help you get started on your journey today, which we hope will be meaningful and productive. Meanwhile, do keep in touch — we enjoy secret dossiers and saucy tips. …
Online weight loss company Noom has begun offering smaller doses of compounded versions of Novo Nordisk’s Wegovy as the U.S. Food and Drug Administration clamps down on mass production of copies of the in-demand medicine, Reuters informs us. Noom will offer its version of compounded semaglutide — the active ingredient in Wegovy and diabetes drug Ozempic — as part of a program personalized for patients, which it says will comply with changing FDA regulations. Taking small doses of the weight loss drugs, sometimes referred to as micro-dosing, has become popular due to the high cost and side effects. For hundreds of dollars less than the name-brand drugs, patients could access doctors and pharmacy-made versions based on semaglutide or tirzepatide, the main ingredient in Eli Lilly’s rival Zepbound and Mounjaro, due to a regulatory exception allowing them during drug shortages. Noom offers its compounded semaglutide at a starting price of $149 for the first month. A 2.5-milligram vial of Wegovy or Zepbound costs $349, according to the Novo and Lilly websites.
The FDA is exploring the possibility of changing the fee structure of the Prescription Drug User Fee Act, according to Regulatory Focus. “As we look towards the next reauthorization, it is time to take a step back and think about if the fee structure and amounts have any unintended consequences. The perception of a company handing over a multi-million-dollar application fee when they are submitting their application may cause some American people to question the outcome of those reviews. It is worth exploring whether and how restructuring and simplifying the user fee program may help rebuild trust in the FDA in its decisions and to take advantage of the upcoming reauthorization to do so,” said Grace Graham, the newly named deputy commissioner for policy, legislation, and international affairs at a meeting last week of the Food and Drug Law Institute. The FDA will hold two public meetings in July to discuss reauthorization of its use fee act programs for the fiscal year 2028-2032 period. The current legislative authority for the programs expires at the end of September 2027.
