21st Century Cures Act Tracker

I found this handy legislative tracker, so I'm adding it to the blog, so you can bookmark this post to stay updated on this legislation. Currently, it's in the Senate and has been assigned to a committee.

Why professional associations matter

The following remarks were delivered to the Temple University QA/RA program during their 2015 career night. I'm providing here the prepared remarks, which differ slightly from what was actually presented.

I’m Dale Cooke, the president of PhillyCooke Consulting, which is an FDA regulatory consulting firm that helps pharmaceutical companies and technology platforms make information about FDA-regulated products available via new and emerging technologies.

I also serve as the co-chair of the local Regulatory Affairs Professionals Society (RAPS) chapter, and it’s in that capacity that I’ve been asked to speak to you.

Specifically, I’ve been asked to speak about the importance of professional society involvement in your ongoing career development.

So, here it is: It’s really important to be involved in professional societies.

Seriously.

What’s in it for you?

Well, first, you get to meet other people outside of your specific company. The value of having those contacts is very high. I like to say that when you hire someone you’re also hiring their Rolodex.

For those of you who have never heard of a Rolodex, it’s a mid-20th century technology, kind of like an offline LinkedIn.

And the reason you want to hire someone’s Rolodex is that no matter how talented you are, there’s always something you don’t know. There’s nothing wrong with that. It’s just a fact of life, and when you’re facing that area where your own knowledge is lacking, it’s important to be able to reach out to other people who can help. Not to mention that at some point, you hope your company will be expanding, and when you do so, the first place you turn is your (and your team’s) Rolodex to look for more talent.

So, professional societies are an important means of extending your brain to tap into the larger community of professionals who also work in your field.

Second, professional societies keep their membership up to date on the latest developments. If you’ve been paying attention to the news, you’re certainly aware that Congress has been completely gridlocked and absolutely nothing is going on in Washington…except for FDA.

In the past few years, there have been several landmark pieces of legislation passed to address issues such as the supply chain, compounding pharmacies, and generic drug development, just to point out a few items that are near and dear to my heart.

Two days ago, new draft legislation that would drastically overhaul the FDA was released. I don’t know whether it’s going to pass, but if it does, I’ll be turning to RAPS, the Drug Information Association, and Food & Drug Law Institute (I’m an active member of all three) to find out how it affects me, my job, and my clients.

For example, next week, the local RAPS chapter is hosting an event with Jay Crowley, the godfather of UDI, about how the Unique Device Identification system is being implemented. This is a massive challenge for medical device manufacturers (i.e., some of the people you might be working for).

So, perhaps there’s some value for you in learning about it. Maybe?

By the way, if you want more information about the event, stop by our table to pick up a flier.

Finally, actively participating in professional societies enables you to demonstrate to your current and future employers your commitment to your career. It looks good on your resume.

If on a Thursday night, you choose to go the Maggiano’s in King of Prussia to hear Jay Crowley speak about UDI, instead of playing Quizzo at a local watering hole, then you’re showing how highly you value staying at the top of your game in your chosen career.

And serving actively in your local chapters is a further demonstration of that commitment. I always say that if you have two hours a month to volunteer with RAPS, then I’ll find a way to have you help the chapter in those two hours. If you have 10 hours, we’ll give you an award.

In addition, actively participating is fun. If I weren’t involved with RAPS, I’d never have met Linda Bowen [Editor's Note: Linda was in the audience], and Linda’s a hoot.

So, my advice to you is to get involved with at least one (and preferably several) professional societies. They’ll help you expand your network, stay on top of the latest developments, and demonstrate your commitment to current and potential employers, all while having some fun.

New 21st Century Cures Act Removes Social Media Provision

The House Energy and Commerce Committee have released a new draft version of the 21st Century Cures Act, which would significantly change how the FDA operates.

An earlier version of this bill included a provision that would basically have written a version of the one-click rule into law and required FDA to

"review each regulation and guidance that applies to the dissemination by means of the Internet (including social media platforms and character-limited applications) of information about medical products" and "treat hyperlinked information ... as if the information" were part of the initial communication.

In essence, Congress was mandating that FDA permit some version of the one-click rule, and revise or withdraw all guidances and regulations that prevented them from doing so.

This language has been completely removed from the latest draft legislation. I haven't seen any coverage of why this provision was dropped, and I was never able to determine where the initial language came from.

So, for now, the idea that legislation will drastically alter the landscape for using social media has taken a set back. But once draft legislative language is out there, it tends to crop up again and again.