Michael Causey, Editor & Publisher, eDataIntegrityReport.com
The agency withered during the Bush Administration, with reduced funding, less emphasis on inspections, and a general viewpoint that government should generally get out of the way and let business and the “invisible hand” run the show. On top of that, some of the agency’s “best and brightest” became discouraged and retired or moved to private sector jobs.
But then came salmonella problems, cashew and nut health alerts, meat recalls and a financial market implosion that suddenly made the words “government regulation” less of a dirty term. Now the FDA is under big pressure from lawmakers on Capitol Hill to show it can be proactive and better protect the American public from risks associated with food, medical devices and drugs.
Add a new, more activist president named Obama to the mix, and you’ve got the makings of a revitalized, energetic FDA in 2009 and beyond.
For example, the agency is pushing electronic medical device reporting (eMDR), though the guidance has been delayed for unknown reasons that don’t appear to be related to eMDR itself (Assurx eMDR white paper is available here http://www.assurx.com/emdrebook.html), and has also recently released tighter new import controls that are putting manufacturers on notice that responsibility for quality begins at the very top (get that white paper at http://www.assurx.com/FDAImporterGuidanceWhitePaper.html).
Signs of a new more action-oriented FDA are everywhere, but let’s look at two recent ones that illustrate our point:
- The agency has recently issued high profile recalls of pistachios and announced a more aggressive regulatory regime for medical devices made before 1976. Devices found by the FDA to be of high risk to consumers will be required to undergo the agency’s most stringent pre-market review process. A transcript of the March 30 teleconference the FDA conducted can be found here http://www.fda.gov/bbs/transcripts/2009/transcript033009.pdf
- After a huge peanut recall effort last year, the FDA is now engaged in an expanding recall of pistachios. Information on that is available here: http://www.fda.gov/pistachios/
But remember, this isn’t just about old medical devices and nuts. If the FDA is devoting this much new energy to regulating pistachios and medical devices made before 1976, what kind of regulatory scrutiny should makers of important medical devices and drugs expect today from a “new” FDA?
You know the answer.
