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Is FDA Hiding Behind Guidance Docs To Circumvent Formal Rulemaking?

The process applicable to formal rulemaking engaged in by federal agencies is lengthy and laborious. A recent Bloomberg article discussing how ideas turn into final administrative rules describes it as “cumbersome.”

No one likely knows that better than principal employees of the U.S. Food and Drug Administration. The FDA is an agency that is routinely involved with reams of rule-linked documentation that, in instances of final rule implementation, intimately affects scores of thousands of actors within the health care realm.

The gist of the above-cited Bloomberg piece is that FDA officials are themselves so overwhelmed by formal notice-and-comment rulemaking requirements that they have been purposefully circumventing the process over many years.

Their preferred method of doing so, say multiple commentators in the Bloomberg piece, is through the issuance of less formal guidance documents. One free-market advocacy organization states that the agency has collectively churned out more than 2,000 such documents, which is “far too many for industry to keep track of.”

The benefits of doing so for the FDA are both many and clear. For starters, changing an agency position on a matter is far more easily and quickly done through a document revision than via another round of formal notice and public comment preceding a formal rule change. And importantly, as noted by Bloomberg, guidance differs starkly from rulemaking because it “cannot be reviewed by the courts.”

In essence, say some commentators, the FDA hides behind guidance to effect wanted outcomes without having to do the work that has historically been mandated.

And that, states one critic, makes guidance issuance an agency tool “that can be subject to abuse.”


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