Makary’s FDA Has Options In Industry Fight Over Weight Loss Drugs

Americans are facing exorbitant prices for prescription drugs, with the U.S. accounting for half of global pharmaceutical sales revenue but only consuming 13 percent of the total volume of prescription drugs. The U.S. Department of Health and Human Services recently highlighted this disparity, showing that the U.S. contributes 60 percent of pharmaceutical revenues but only 24 percent of volume compared to other wealthy nations in the Organization for Economic Co-operation and Development.

One area where this issue is particularly evident is in the pricing of glucagon-like peptide-1 (GLP-1) receptor agonists, a class of drugs that are effective for controlling type 2 diabetes and aiding in weight loss. Despite the research behind these drugs being funded by U.S. taxpayers, Americans are charged significantly more for them compared to other countries. For example, the list price for a month’s supply of Ozempic in the U.S. is over five times higher than in Japan and ten times higher than in Sweden, the United Kingdom, Australia, and France.

The high demand for these weight loss drugs led to compounding pharmacies producing lower-cost copies using the same active ingredients as brand-name GLP-1 drugs. Approximately two million Americans are currently using compounded GLP-1 medications, raising concerns for manufacturers like Novo Nordisk and Eli Lilly. In response, these companies ramped up production to end shortages and prevent compounding pharmacies from producing the drugs.

However, this move has sparked worries among patients who cannot afford the high prices of brand-name GLP-1 drugs, especially those without insurance coverage. Novo Nordisk and Eli Lilly have introduced discounted direct-to-consumer options, but the affordability of these prices remains questionable for many cash-paying customers.

As the newly confirmed Commissioner of the FDA, Dr. Marty Makary faces several options to address this issue. These options range from allowing FDA enforcement to proceed, pressuring manufacturers to lower prices, limiting enforcement to essential copies, pursuing licensing agreements with manufacturers, to invoking federal laws to secure access to generic versions of the drugs.

The safety and efficacy of compounded drugs are also under scrutiny, with the FDA preparing to shut down competition without clear data on patient outcomes. Dr. Makary could consider pausing enforcement to gather objective data and allow independent testing of compounded drugs to ensure quality and safety.

The resolution of this issue could impact millions of Americans and billions in healthcare costs. Dr. Makary’s decisions at the FDA could influence how brand-name drug prices are set in the U.S. for years to come. It remains to be seen how the fight over weight loss drugs will unfold and what implications it will have for the pharmaceutical industry and patients in need of affordable medications.