Expecting something from the FDA is a risky endeavor, and that makes it all the more worthwhile to read the tea leaves every once in a while.
*Note: This blog post is excerpted and adapted from Cerulean's special FDA in the New Year issue of our SmarterCompliance regulator intelligence newsletter, a yearly forecast of FDA activities and challenges in the new year along with specific recommendations and suggested activities for quality, regulatory affairs, records management, IT and other compliance executives.
General Outlook for FDA in 2012
The agency will struggle to maintain traction in 2012. Congress began second guessing a number of the agency’s actions in 2011. With tight budgets, no real money to spend and heavy lobbying pressure, Congress will continue to pull the FDA’s leaders into hearings and push FDA for new reports on its activities. This will divert agency energy away from making meaningful progress on the broad array of challenges faced by a government agency that oversees at least 27% of the US economy.
Meanwhile, FDA executives will have to ride through congressional hearings and inquiries with calm as President Obama cannot afford embarrassments or distractions in an election year. Expect Republicans in Congress to try to make the most of any FDA missteps. This will act as a drag on agency momentum and further drive downward agency morale. Congressional negativity had a poor effect on the agency in 2011, and we expect more of the same in 2012. Sadly, this will result in more retirements from the agency, continuing the loss of institutional knowledge.
- FDA’s continuing knowledge loss, its growing reliance on external regulatory science partnerships, and congressional pressure to "encourage innovation" (i.e., foster jobs in an election year) will leave the agency vulnerable. If you have borderline technologies or medicines that will be made in the US, bring validated, independent science - with data that has integrity - to back up your claims (or counterclaims), the agency may be forced into a stalemate you can favorably resolve with post-market surveillance promises. Even if you are in a device firm, look to recent REMS guidance and examples to pro-actively propose a series of post-market surveillance activities and patient safety control measures.
- Emphasis on corporate responsibility at the executive level will continue as a subtext of inspections. As we predicted in 2010, this became evident in 2011 with the increased emphasis on the Park Doctrine. Expect more of the same in 2012; the more FDA can showcase industry executives who ignored patient safety regulations, the greater leeway the agency will gain in congressional hearings and in budgetary battles. Thus, if you've been putting it off or haven't done it regularly enough, this is the year to review with senior management their role and seven key responsibilities in ensuring an effective quality system (see a related webinar on January 31 on FDA expectations for senior management).
December's issue of SmarterCompliance included 32 outlooks for FDA in 2012 like the ones above, along with 24 specific recommendations for subscribers to consider adopting in their organizations. Get your copy of the issue by subscribing today.
And on another note - FDA has again redesigned its website. For those of you who remember the 2010 redesign, don't start redoing the bookmarking immediately, wait 6-8 months for the agency to get all the kinks worked out. Currently, a number of the links on the new fda.gov landing page don't work or send you off in the wrong direction. Nonetheless, the redesign will be helpful when its complete (Yes, properly functioning links are part of a completed redesign - you can't give a house an exterior paint job and call it "newly renovated").
Here's to a positive 2012 full of easy surprises.