To all of our readers – Have 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, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as we follow the ever-changing landscape of FDA regulatory science, enforcement, and policy.

This past year has had many twists and turns (some of which we are still trying to figure out), layered on top of plenty of political controversy.  There have been almost as many cabinet changes as there have been new FDA guidance documents issued.  Communications from and to the FDA have taken a peculiar turn, and the Controlled Correspondence situation has left many of us in the industry scratching our heads.  Let us hope that 2019 provides further resolution of some of the confusion and clarifies some of the uncertainty so that we can work together with our colleagues at the FDA in a more effective and efficient manner.

Just take a minute for a little holiday walk down memory lane to round out 2018:

  • We used to dash through the snow to FedEx to get our applications to the Agency, now we hope and pray the gateway to FDA heaven does not crash!
  • Suitability petitions used to be acted on in ninety days, now some are entering old-age homes.
  • You used to be able to call the FDA to get your questions answered, now you need to phone a friend.
  • First-to-file applications used to camp out at Metro Park North with their guardians, now we have a new definition of what first-to-file day is! Imagine that camping led to a new definition of a day!
  • Before I worked at FDA, I thought “evergreening” was taking a walk in the forest.
  • Who would have ever thought that the document room at Metro Park North would have gotten full?
  • Who even remembers Metro Park North?
  • Roaming the halls at the Parklawn Building used to be an industry given, now you can’t walk into a federal building unless you go through a metal scanner and your possession are x-rayed. Leave those bottles of liquid containing three ounces or more in your car.
  • You used to go to work for a single company and stay there for your entire career, now you need a score card to see who the new players are and where everyone has gone.

The world is different, the FDA is different, the industry is different, but we are all members of the same race, not the rat race, but the human race.  Let’s remember that this holiday season.  Reach out and touch 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 2019!