It has been quite a year for FDA 483s and Warning Letters. Here are the top 5 stories for 2013:
- The number of Inspections and 483s came down again for the 2nd year in a row. Is this a long-term trend? Hard to say. Here’s the data.
- No 483s and inspections for about 2 weeks – during the government shutdown. We also heard through the grapevine that inspections occurring at the end of September (just before the shutdown) were “sped up,” so that the FDA could get them down before closing shop. (see comments on this post)
- Will India get its act together? 2 of India’s largest pharma manufacturers got nailed this year with import bans, costing each of them hundreds of millions of revenues – not even mentioning credibility, contracts, settlements/fines (Ranbaxy – $500MM fine)and the cost to address the problems. Even with all the drama, PwC reports $4.2B of biopharma imports coming in from India, and still growing. Whether that growth can continue falls onto India’s own regulatory systems.
- FDA 483s get front page coverage on Wall Street Journal. Yup, the investment community has always been interested in whatever information they can get for that little bit of extra intelligence. And it turns out the 483s are possibly the earliest publicly available indicator that a company could be having manufacturing problems. The WSJ article talked about increased demand from hedge funds. Hey, if you’ve got $20MM invested in a pharma company, wouldn’t you want to know how their latest inspection went?
- Product recalls are high again – both mandatory and (maybe suprisingly?) voluntary. Here’s the data from the Quarterly RECALL INDEX.
Here are a few other articles that we found to be interesting:
- Can Reddit be used as a regulatory affairs intelligence tool?
- $2.2B (yes with a B) settlement paid by J&J for off-label marketing – 3rd largest in history.
- RAPS started a daily intelligence briefing called the Regulatory Reconnaissance. Every weekday since February 11! This has been a great resource – thanks to @RAPSorg and @AlecGaffney
- 10 new FDA inspectors are now stationed in China. After a raft of import bans from India, will 2014 be the year for China to be in the spotlight?
- 13 years of inspection and 483 data – we’ve published it all here. Do a search on company name or location.
- FDA 483s store – instant, anonymous access to 483 PDFs
- Free, searchable list of 13 years of 483s
- The FDA conducted 40,000 inspections in 2012
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