A little-noticed “Miscellaneous Provision” of the “Food and Drug Administration
Safety and Innovation Act” (aka PDUFA, pdf), which was signed into law by president Obama on July 10, 2012, simply states:
SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION
USING THE INTERNET.
Not later than 2 years after the date of enactment of this
Act, the Secretary of Health and Human Services shall issue guidance
that describes Food and Drug Administration policy regarding
the promotion, using the Internet (including social media), of medical
products that are regulated by such Administration.
Does that mean the FDA will deliver? If not, it wouldn’t be the first time that a government agency missed deadlines imposed by Congress.
Usually, Congress specifies that regulatory agencies must issue regulations that spell out how to comply with the laws it passes. Regulations, therefore carry the weight of law. FDA Guidance (guidelines), however, is just FDA’s current thinking on a topic. “It does not create or confer any rights for or on any person and does not operate to bind FDA or the public.”
So, if FDA misses the deadline set by PDUFA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I’m sure FDA is shaking in its boots.
The only thing interesting about this provision of the PDUFA act is why it was included and who lobbied to have it included? It couldn’t have been Pfizer (see “Pfizer Asks for New FDA Regulations, Not Guidance, for Social Media“), but it could have been PhRMA (see “PhRMA Statement on FDA Social Media Guidance Delay“).
