Last January, in the process of explaining how some major federal agency actions, like the Food and Drug Administration’s pending guidelines on FDA-regulated entities’ use of social media, would evade President Obama’s executive order on regulation, we parroted FDA’s claim that the guidelines would be out in the first quarter of 2011.
Well, here it is the first day of the second quarter of 2011, and news is circulating that FDA is delaying the guidelines’ release with no end in sight. A statement attributed to FDA is a model of opacity from an agency whose decision-making process is famously non-transparent:
It is difficult to provide a timeframe for the issuance of our guidances due to the extensive work and review process, or “Good Guidance Practices” (GGPs), which ensures that FDA’s stakeholders are provided well vetted guidances articulating FDA’s current thinking on a topic.
The repeated delays and the timing of FDA’s most recent non-release announcement inspired a lampooning April Fool’s statement from Medical Media and Marketing. For those health product companies wishing to disemminate information in a 21st Century manner, and for the patients who would benefit from such efforts, however, the FDA’s pedantic pace is no joke. Formal rulemaking with due process protections here would be preferred. But agency guidelines are far preferrable to the current situation, which leaves drug, device, and biotech businesses at the whim of FDA bureaucrats wielding warning letters.