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Is The FDA Really So Weak?

By James M. Beck and Mark Herrmann

We've grown accustomed to hearing complaints that the Food and Drug Administration is powerless. "How can the Agency possibly cause companies to act responsibly?," critics (and plaintiffs' counsel) ask. Historically, the FDA lacked the power to order product recalls, and its authority is limited in other ways. Companies, we're told, run roughshod over the Agency.

We've always known (from personal experience and things we've heard in the industry) that this wasn't true, but it hasn't always been easy to find authority in the legal literature to belie these claims.

Now, there is.

If you're ever in need of helpful authority, take a look at Lars Noah, "The Little Agency That Could (Act With Indifferernce to Constitutional and Statutory Strictures)," 93 Cornell L. Rev. 901 (2008).

We offer these two tasty morsels from Professor Noah's work, just to whet your appetite:

"Congress originally granted the FDA only limited and procedurally cumbersome mechanisms for securing compliance with the statute: product seizures, injunctions, and criminal penalties. The agency has, however, deployed these tools in creative ways: for instance, the FDA may threaten to impose a sanction or withhold a benefit in the hopes of encouraging 'voluntary' compliance with a request that the agency could not impose directly on a regulated entity. . . .

"Such 'arm-twisting' succeeds, and evades judicial or other scrutiny, in part because companies in pervasively regulated industries believe that they cannot afford to resist agency demands."

Id. at 906.

Or how about this?

"The FDA generally lacks the statutory authority to order a recall of potentially dangerous products subject to its regulatory jurisdiction. . . . [T]he FDA generally has resisted proposals to provide it with explicit recall authority. Instead, the agency prefers encouraging voluntary recalls . . . .

"This strategy has succeeded because firms know that a failure to cooperate with an agency request would invite more draconian enforcement measures authorized by statute."

Id. at 908-09.

Needless to say, both of the preceding excerpts omit the usual detailed footnotes that one finds in scholarly work.

The next time your opponent is shedding crocodile tears about the FDA's lack of authority, use Noah's article to wipe away those tears. The FDA has plenty of power to cause industry to obey its "requests."

Full post as published by Drug and Device Law on September 15, 2008 (boomark / email).