We’ve blogged a lot about implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and in particular how the FDCA expressly bars private enforcement of purported violations of the Act.  That’s good – very good indeed – as far as it goes.  But what’s the point as a practical matter?

We think the point is how preemption protects Congress’ additional decision in the FDCA to grant the FDA almost unlimited discretion to prosecute, resolve, or excuse violations as the Agency sees fit.  Basically, the FDA’s exclusive enforcement authority reinforces those parts of the FDCA that confer upon the FDA the ability to select which violations of the FDCA to prosecute and which to settle administratively.  As the Court observed in Buckman, FDA has “complete discretion” in deciding “how and when [its enforcement tools] should be exercised” and must exercise that discretion “to achieve a somewhat delicate balance of statutory objectives.”  531 U.S. at 348.  Preemption and prosecutorial discretion go hand in hand.

The Supreme Court looked at this interplay some years earlier in Heckler v. Chaney, 470 U.S. 821 (1985), in which death row inmates tried to throw a monkey wrench into their sentences by seeking to force the FDA to prevent the use of certain drugs use in executions.  The FDA had exercised prosecutorial discretion to refuse to enforce the statute in this manner.  The Supreme Court affirmed the FDA’s right to determine for itself how to enforce the Act:

[A]n agency decision not to enforce often involves a complicated balancing of a number of factors which are peculiarly within its expertise.  Thus, the agency must not only assess whether a violation has occurred, but whether agency resources are best spent on this violation or another, whether the agency is likely to succeed if it acts, whether the particular enforcement action requested best fits the agency’s overall policies, and, indeed, whether the agency has enough resources to undertake the action at all.  An agency generally cannot act against each technical violation of the statute it is charged with enforcing.  The agency is far better equipped than the courts to deal with the many variables involved in the proper ordering of its priorities.

Id. at 831-32.


Continue Reading Don’t Forget FDA Prosecutorial Discretion

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