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Dec 2010 FDA Round-up: 5 Trending Topics

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We live in a news-driven world, and sometimes it’s like drinking out of a

firehose.  So, to save time, here were some of the key developments related to

the FDA over the last month.

FDA vs. no FDA. Commissioner Hamburg wrote an elaborate piece on Innovation,

Regulation, and the FDA, essentially justifying the existence of the FDA. 

Well-written and rich in lessons from history.  For better or worse, the FDA

usually gets a big boost in funding and responsibilities every time there is a

big health outbreak or crisis.  Only then is it politically tenable.  And only

then do we not take for granted the safety of the products we put in our

bodies.  Speaking of which, the Food Safety Modernization Act was passed, or was

it?  Odds are it will be passed in the next week.

Tweeting vs. FDA. There are some rumors that the FDA might provide some initial

guidance on how pharma companies can utilize social media tools like facebook

and twitter.  Alas, nothing so far, which has led most pharma companies to stay

on a wait-and-see approach.  Here’s a good round-up on JAMA. And here’s some

good thoughts from eyeonFDA.  The folks over at Ogilvy have a good piece on what

to expect for 2011.

Tough FDA vs. Tougher FDA We did a round-up of the facts on how the FDA has only

gotten tougher this year.  And it’s only getting worse. In anticipation of that,

Fierce did a good analysis of common warning letter language to watch out for

this coming year.

Innovation vs. FDA PwC unveiled its survey on small life science companies’

relationships with the FDA.  Overall, most folks believe the FDA is unequipped

(both in terms of pace and expertise) to meet the demands of the future. 

However, most also felt that their relationship with the FDA has improved over

the last 2 years. On a similar note: very unusual, but the FDA took issue with

Stanford’s study that concluded that the FDA is stifling medical device

innovation.  Related: Minnesota lawmakers are teaming up to oppose proposed 510k

process changes.  Here’s an interesting interview with the FDA’s #2 device guy,

Dr. Maisel.

Old employees vs. young employees Okay, so this is just probably news for the

sake of news, but there were some internet rubblings of an age purge in the

FDA’s communications department.  Here’s a blog post from one of those old guys

(who happens to be an esteemed professional) who was unfortunately let go.

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