As regular readers of Focus
know, the US Food and Drug Administration (FDA) releases draft and final guidance documents each year to help the biopharma industry understand the agency’s thinking on particular topics.
The guidance (almost 100 new draft guidance documents are slated for release
this year by FDA’s Center for Drug Evaluation and Research) can be a helpful way to keep industry informed of the agency’s expectations. But the guidance can also raise significant questions and concerns from industry and other stakeholders. And although the agency maintains that it does not regulate based on any of the non-binding guidance documents, in some cases, the biopharma industry has called on FDA to dispense with certain guidance in favor of binding notice-and-comment rulemakings.
For instance, in December 2015, FDA released quality metrics draft guidance, spelling out new manufacturing data to be submitted to the agency. But that guidance was later revised and then pulled altogether after industry pushback, including suggestions from several industry groups
that FDA should instead go through notice-and-comment rulemaking procedures to allow industry more "meaningful input on the definitions and format to be used by FDA."
Back in 2016, several GOP senators also raised concerns
with FDA’s overuse of draft guidance in carrying out its regulatory responsibilities, complaining that draft guidance can often linger without finalization for years.
Similarly, the FDA Law Blog
pointed out how guidance from last December on data integrity imposes significant burdens on industry. The lawyers wrote
: “Suffice it to say that the guidance on data integrity is replete with instances of regulation by guidance.”
Now, the White House’s Office of Management and Budget (OMB) will make it more difficult for FDA and other federal agencies to draft and finalize guidance that could be “major,” meaning likely to result in being economically significant (i.e. An annual effect of $100 million or more on the economy), likely to increase costs or prices for consumers or industries, or bring about “significant adverse effects on competition, employment, investment, productivity, innovation” or hamper a US company’s ability to compete globally.
The Congressional Review Act
(CRA), enacted in 1996, establishes a mechanism by which Congress can exercise direct oversight of federal agency action in real time.
And OMB said in a memo released last week
that the CRA applies to not just notice-and-comment rulemakings, but also “encompasses a wide range of other regulatory actions, including, inter alia, guidance documents, general statements of policy, and interpretive rules.” So, any guidance document deemed major by the Office of Information and Regulatory Affairs would then have to be reviewed by Congress and could be dispensed with.
For guidance documents that impose new, perhaps unintended, regulations, the new congressional reviews could add an extra layer of protection for the biopharma industry.