To all our readers – We wish you a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday, starting Friday (unless something extremely urgent occurs), and I hope that all of you will join me back in the New Year as we follow the ever-changing landscape of FDA regulatory science, enforcement, and policy.

This past year has seen many twists and turns (some of which we’re still trying to figure out), layered on top of plenty of political controversy and worldwide turmoil. There have been almost as many changes in Congressional members as there have been new FDA guidance documents issued. Let us hope that 2024 provides further resolution of some of the confusion in the world and clarifies some of the uncertainty at the FDA so that we can work together with our colleagues at the FDA in an even more effective and efficient manner.

Just take a minute for a little forty-year holiday walk down memory lane to round out 2023:

  • We used to dash through the snow to FedEx offices to get our applications to the Agency; now we hope and pray the gateway to FDA heaven does not crash!
  • Remember when the Drug Price Competition and Patent Term Restoration Act was called Waxman-Hatch?
  • Suitability petitions used to be acted on within ninety days (which morphed into years), and now there is hope that 180 days will be the norm, but only for fifty petitions a year thanks to GDUFA goals! Time will tell!
  • You used to be able to call the FDA to get your questions answered; now you need to phone a friend or submit a controlled correspondence and wait sixty days to get a response that (many times) is not responsive to the question you asked.
  • Before I worked at the FDA, I thought “evergreening” was taking a walk in the forest.
  • Who would have ever thought that entering a federal building would be like dealing with the TSA on steroids?
  • Now many face-to-face meetings with the Agency are called “hybrid”! Sounds like some kind of gene therapy gone awry.
  • You used to go to work for a single company and stay there your entire career; now you need a scorecard to see who the new players are and find where everyone has gone.
  • Institutional memory will take a big hit with the retirement of Janet Woodcock, but at least Bob Temple is still around.
  • This is the year of further reorganization of the FDA – time to play musical chairs again. Last one standing without a desk or chair must remain standing or work remotely.
  • I guess I didn’t pay my User Fee because when I tried to get into the FDA Daily Approval page or the “All Approvals” page on the FDA’s CDER website, it took me to the wrong URL! Better get that check in the mail!
  • Is a skinny label akin to a pre-holiday diet? Just saying!
  • As far as comparative similarity, in the FDA’s mind, biosimilars are now becoming a real look in the mirror, and the evidence seems to suggest that the Agency is correct.

The world is a different place today; the FDA continues to evolve, and industry is becoming a different place with all the new technology, but we are all members of the same race, and I’m not talking about the rat race, but the human race. Let’s remember that this holiday season. Reach out and touch or help someone. Make someone’s day brighter. Make someone feel like you really care even if you don’t know them. Pay forward what we are all so blessed to have. Remember, there are plenty of us humans that are not so lucky!

Enjoy your families over the next couple of weeks and take a well-deserved break. See you in 2024!