Dec 2010 FDA Round-up: 5 Trending Topics

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.

  1. 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.
  2. 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 some good thoughts from eyeonFDA.  The folks over at Ogilvy have a good piece on what to expect for 2011.
  3. 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.
  4. 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.
  5. 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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