FDA telehealth crackdown highlights role of national doctor networks

The FDA is expanding its crackdown on telehealth companies marketing compounded weight loss drugs, warning them not to imply their products are FDA-approved or that they manufacture the medications. But a STAT analysis shows the ecosystem behind those brands is far more concentrated than it appears.

Roughly 30% of the more than 70 telehealth companies warned in the past six months rely on just four nationwide "white-label" medical groups — Beluga Health, OpenLoop, MD Integrations, and Telegra — that provide the clinicians who actually prescribe the drugs.

That structure has helped telehealth brands scale quickly, but it also creates a supply chain that may draw regulatory scrutiny as misleading marketing proliferates and lawsuits mount.

"The whole reason these companies are able to get away with these personalized compounded drugs is because some provider believes that that personalized drug can be helpful for someone, and so we're putting a lot of trust into these provider firms in making that decision," said Ashwin Chetty, a medical student at the Yale School of Medicine who co-authored a study of 79 telehealth companies marketing GLP-1s. "Should we be questioning that trust?"

competition

BIO's Crowley warns U.S. risks losing lead

The U.S. must overhaul policies to preserve its global leadership in biotech as competitors like China race to catch up, BIO chief John Crowley opines for STAT. He frames the industry's rise — from Genentech's founding 50 years ago to today's ecosystem responsible for most new FDA-approved drugs — as both a scientific and economic success story that delivers medicines, jobs, and trillions in economic activity.

"But to ensure America remains the most-favored nation when it comes to biotech, Washington officials need to create a world-class policy environment for a world-leading industry," he writes.

Crowley warns that policies like international reference pricing or other forms of price controls could undermine the venture-backed innovation model that fuels drug development. Instead, he calls for modernizing the FDA, pressuring other countries to pay more for medicines rather than "free riding" on U.S. spending, and cracking down on pharmacy benefit managers that influence drug access and pricing.

fda

FDA launches unified system for adverse event reports

The FDA yesterday launched a new platform meant to replace the patchwork of databases the agency has long used to track safety problems after products reach the market.

The system, called the FDA Adverse Event Monitoring System, or AEMS, consolidates reports for drugs, vaccines, biologics, cosmetics, and other regulated products into a single searchable dashboard.

In a statement, the agency said that it will continue to build on the system and that by the end of May it will contain "real-time adverse event reports for all FDA-regulated products, consistent with meeting agency obligations not to release individually identifiable patient or consumer information."

biotech scorecard

Aldeyra's short seller complaints raise familiar red flag

Aldeyra Therapeutics is awaiting the FDA's decision on its dry eye drug reproxalap after years of regulatory back-and-forth. But some of the company's recent corporate messaging sends a cautionary signal, STAT's Adam Feuerstein writes in his weekly Biotech Scorecard newsletter.

In late 2025, Aldeyra added unusual language to its SEC filings warning investors that "short sellers may be manipulative and may drive down the price of our common shares." It repeated the claim again in its annual report. Complaints about short sellers tend to be a tell, Adam says: Management teams often invoke them when scrutiny is rising.

The timing is notable. Shortly after raising those concerns — and just days before an expected FDA decision — the company disclosed a three-month review delay, but characterized it as procedural.

"Another red flag with consequences?" Adam writes. "We'll know soon."