The FDA is having a very busy year.  Q1 saw a slew of approvals, policy changes, high-profile stories, enforcement activities, and personnel changes.  Q2 was no different.  Here are our top 30 stories on the FDA for Q2 of 2011.

The Big Stories of the Quarter

  1. The Drug Shortage:  Some people say the FDA is inadvertently at fault.  Some say the FDA prevented 38 close calls. Some say that the shortage is a niche business opportunity.  There was also some chatter that the FTC take these drug shortages into account when looking at M&A.
  2. The Avastin Battle: back and forth, back and forth, the FDA and Roche have gone. Finally last week, the FDA rejected arguments from Roche/Genentech that its approved anti-cancer drug  should continue as an approved therapy for advanced breast cancer.  Now that the science round is over, let the politics round begin.
  3. The other Triad/H&P Industries shoe drops. The big MSNBC lead story in February was just the beginning.  Here’s a good background post by PharmaLot.  And finally, in June, the FDA issued the consent decree.

Recalls & Warning Letters

  1. 160 warning letters posted (155 were posted in Q1).  Some of the big ones that caught some attention are below.
  2. Endo Pharma intiated 2 product recalls.  Labeling errors typically come in 2 varieties – wrong-label/bottle and label-content errors.  Looks like Endo got both.
  3. Dr. Reddy’s Lab got a warning letter, but honestly, that may be the least of their concerns, given the 2 contract employee deaths from the API manufacturing facility fire.
  4. Triad got its much-anticipated consent decree in June 2011 (as mentioned above)
  5. Baxter recently received a warning letter for 2 facilities in Puerto Rico related to product discoloration.
  6. Abiomed received a warning letter for marketing its heart pump for uses it was not approved for.

Drug Industry

  1. A lot is riding on FDA visit for Ranbaxy that just wrapped up end of June. Up to 30 drugs were banned from import.  The results of this inspection could potentially be the start of lifting that ban, or deeper problems.
  2. A new list of the 12 greenest pharma companies was published by Fierce Pharma Manufacturing.  Green is one of numerous “social responsibility” efforts undertaken by big pharma (as well as most Fortune 500 companies), and many of these initiatives are becoming more integral to core business strategy.
  3. Some analysts say that manufacturing-savvy generic companies are going to get a business boost.  Because of FDA enforcement on cGMP issues, there is less competition among generic manufacturers, and thus, stronger pricing tailwinds.
  4. Still no social media guidance issued by the FDA this quarter, and I honestly doubt there will be anytime soon. But the FDA did tell Cephalon “how not to build a website.” (common sense note: don’t overstate the case for your drug)
  5. FDA rejects Gardisil for most adult women.  This was a long-standing battle with billions of dollars at stake for Merck (Gardisil brought in just under $1B in 2010).
  6. One QA Exec muses on the most pressing pharma industry cGMP compliance trends.

Device Industry

  1. FDA leaves breast implants on the market despite risks. 20%+ of women end up removing the implants within 10 years.  A quick look at the FDA’s MAUDE database shows 6,000+ reports of adverse events related to breast implants.
  2. FDA has started stress-testing medical devices (and metal detectors).  Basically, how do all these electromagnetic waves coming from all of our electronic device interact with each other?
  3. Dr. Shuren of the FDA responded to 510(k) criticism. Does it take took long to get much needed approvals?  Good question, but honestly, the tension between innovation and safety will never be resolved, just managed.
  4. Slowly but surely, there’s more and more guidance coming out on medical apps.

Food, Tobacco, and Other FDA-Regulated Industries

  1. The FDA has decided to go graphic on its new cigarette labeling. New to the US, but not new around the world.
  2. FDA’s new sunscreen labeling rules are out.  Anything above SPF 50 will be labeled 50+.  Anything under SPF 15 will have more cautionary wording.


  1. CDER went through a re-organization, and FDA wades into nanotech
  2. FDA reports that FOIA requests jump
  3. FDA Chief Counsel leaving.  Not even 18 months in.
  4. FDA Press Officer leaves amid some controversial calls throughout her tenure.  And wow, those folks in Kansas are all connected.
  5. A new FDA web portal dedicated to enforcement activities was released, continuing their transparency efforts.
  6. The FDA is starting to grapple more deeply with the complicated import problem.  Hamburg launched a new initiative in June, calling for a dramatic change in strategy since the line between domestic and imported products is “obselete.”  Believe it or not, imports are growing 15%+ per yearFDA’s China outpost (13 staff over 3 sites) has been challenging, to say the least.
  7. The FDA and EMA are planning a co-review pilot for drug candidates developed using Quality by Design methods.
  8. The FDA now has 10 twitter accounts and it’s facebook page now has more than 10,000 fans.  I’ve been tracking its growth – about 1,000 new fans every month.
  9. The FDA is devising a user fee system for biosimilars.  They’re soliciting comments by Jan 2012 for their proposal.

What other stories made was at the top of your radar this past quarter?

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