We were promised “radical transparency” by the incoming Secretary of HHS. We recently received something that, while meeting the description of “radical,” doesn’t exactly fit the definition of “transparent.” Since 1971, that is for over 50 years, HHS has had a policy called the “Richardson waiver” (after Elliot Richardson), whereby it expanded the “notice and comment” concept created by the Administrative Procedure Act, beyond the bare minimum required by the APA itself. For one thing, as we mentioned most recently here, the FDA takes notice and comment on guidance documents, such as those it issues that concern off-label speech. As we’ve pointed out many times, guidance documents are not regulations with force of law.
