Short Takes and Updates February 6, 2026

by Steven Grossman | Feb 6, 2026 | Short Takes and Updates | 0 comments

Permission is granted to reprint or recirculate this column, as long as attribution is made to FDA Matters and the author.

FDA Matters doesn’t cover the news….we provide analysis of what’s behind the news.

This week, we cover:

drug ads at the Super Bowl and whether FDA will intervene against mass compounding of FDA-approved medicines;
how prediction markets may affect FDA; and
how AI can be used to cut months off the validation of new biopharma manufacturing facilities.

Super Bowl: Who Will Win the Pharma Ad Wars? Will Hims & Hers Be Flagged by FDA for Unsportsmanlike Conduct? On Sunday, February 8, at 6:30 ET more than one hundred million Americans will be watching the Seattle Seahawks and the New England Patriots. With so many eyeballs, commercials can cost $10 million each. Companies compete to be recognized for airing the best ads. In addition to the millions watching on Sunday, millions of replays will increase the reach of each investment.

This year, there will be a fierce competition between pharmaceutical company Novo Nordisk, which makes Ozempic™ and other drugs for obesity and diabetes, and Hims & Hers, a large telehealth and drug compounding company. The latter has asserted the right to make and sell its own version of Novo’s drugs without FDA review and approval. Hims & Hers has also advertised their products while ignoring FDA’s requirements for disclosure of risks and a fair balance presentation.

Starting last May with A Dangerous Idea: Two Drug Manufacturing Pathways One Regulated One Not, (This link didn’t work.) I have expressed my concern about mass compounding as a threat to FDA authority and to consumer safety. I expanded upon those thoughts here, here, here, here, and here.

Late Thursday evening (February 5), there was some indication that FDA is prepared to act against Hims & Hers. Commissioner Makary has posted on X that:

“FDA will take swift action against companies mass-marketing illegal copycat drugs, claiming they are similar to FDA-approved products.

The FDA cannot verify the quality, safety, or effectiveness of non-approved drugs.”

While sources said the tweet was directed at Hims & Hers, it is unclear what actions FDA will take either before or after the Super Bowl.

FDA and the Prediction Markets: An Invitation to Insider Trading and Other Untoward Effects? Non-monetary prediction markets have been used for forecasting for many years, including to estimate the probability and size of measles outbreaks. This old method of predicting future events has now been expanded and popularized as a new form of gambling. (For Wikipedia’s long explanation and history of prediction markets: here).

If you go to the Polymarket site (www.polymarket.com)–one of the largest prediction markets–there is a small assortment of prediction contracts about CDC pandemic issues (here).

A word search produced only one prediction tied to FDA action. Specifically, there is (currently) a 23% chance that FDA will approve Lilly’s Retatrutide this year (here). The page includes a specific discussion of what constitutes an FDA approval for purposes of settling the prediction contract.

A recent NY Times article reviewed the current status of prediction markets and the potential for insider trading and other untoward effects (here). I am not concerned about insiders profiting on foreknowledge of Taylor Swift’s wedding day; I am concerned about the potential for problems with prediction contracts based on FDA regulatory and approval decisions.

At any given moment, FDA has hundreds, if not thousands, of pieces of information that could move markets. The agency has a solid reputation for keeping that information secret.

Relative to buying or shorting stocks, however, prediction markets create a lot more temptation for a lot more individuals based on a binary event unaffected by the larger fates of a company.

Opportunity to Accelerate On-Shoring of Biopharma Manufacturing. I have written several times about AI and FDA. The title of my most comprehensive article, The Skeptical Enthusiast’s Guide to “AI at FDA” (here), tells you where I stand.

So, I am pleased, as well as challenged, by the opportunity to use AI to transform one important area (facilities validation) that is a priority of the agency (domestic manufacturing). I am working on behalf of a new client who offers a much quicker way to achieve facility validation (www.whatifs.io). It is a key to PreCheck and other programs that incentivize new biopharma construction in the US.

The target audience is drug manufacturers, CDMO’s, and later-stage clinical sponsors concerned about manufacturing readiness. If you are not involved in these areas, please send this column to your colleagues who are.

Here is the value proposition:

“The FDA PreCheck Pilot has effectively made the 18-month facility validation gap optional. By combining What Ifs Tech’s Industrial Cortex (JAX-based Physics) with the Type V Drug Master File (DMF) pathway, we allow manufacturers to demonstrate facility readiness before a product application is even filed.

This creates a pre-verified ‘Plug-and-Play’ facility, eliminating production lag at approval. More details here: https://bit.ly/3Zi0mGj

We have a confidential briefing on this methodology available for qualified manufacturers. DM me for access to ‘Scenario A: The 2026 Facility Readiness Playbook’ or write me at sgrossman@hpsgroup.com.

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My January 2026 columns:

I also participated in a Kinexum webinar with eight other FDA experts (video)

FDA Matters provides short-form analysis of FDA policy and regulatory issues. We know you are busy, so we publish 1 to 2 columns per week, each a 3-5 minute read.

FDA Matters does not report the news….we provide analysis of what’s behind the news.

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Steven A. Grossman, JD, is the founder and author of FDA Matters. Read more about Steven here.