Will FSMA Court-ordered Deadlines Set a Precedent?

The Obama Administration recently announced that it will delay the employer health insurance mandate under the Affordable Care Act (aka “Obamacare”) until 2015. When questioned about the delay, White House Press Secretary Jay Carney said “people who suggest that there’s anything unusual about the delaying of the deadline, implementation of a complex, comprehensive law, are deliberately sticking their heads in the sand, or just willfully ignorant about past precedent.” But, Mr. Carney may himself have been forgetting one very recent precedent.

On June 21st, the U.S. District Court for the Northern District of California ordered FDA to meet specified deadlines for several major regulations implementing the Food Safety Modernization Act (FSMA). Specifically, the court ordered FDA to:

  • Publish proposed rules by November 30, 2013;
  • Close comment periods for those proposed rules by March 31, 2014; and
  • Issue final rules by June 30, 2015.

The court was less clear about which rulemakings were covered by its order, but the court-ordered deadlines appear to apply to the following:

  • Foreign Supplier Verification Programs (FSMA section 301(a))
  • Accreditation of third party auditors (FSMA section 307)
  • Preventive controls for animal feed (FSMA section 103)
  • Sanitary transportation of food and feed (FSMA section 111)
  • Prevention of intentional contamination (i.e., “food defense”) (FSMA section 106(b))

The June 30, 2015, deadline for issuance of final rules apparently would also apply to the final rules on:

  • Preventive controls for human food (FSMA section 103)
  • Produce safety standards (FSMA section 105).

FDA has 60 days to decide whether to appeal the court order, and has not yet made any official announcement regarding its intentions. There has been speculation that FDA may wish to use the court order as a weapon in its intra-administration battles with OMB over the rulemakings in question.

In FDA’s world, statutory deadlines have in the past not meant very much. To give just one example, the FD&C Act requires FDA to decide whether to approve drug applications within 180 days, something which the agency rarely does, and the courts have not required FDA to comply with this statutory deadline. See, e.g., In re Barr Laboratories, Inc., 930 F.2d 72 (D.C. Cir. 1991) (refusing to grant a petition for a writ of mandamus compelling FDA to promptly approve or disapprove 23 abbreviated new drug and antibiotic applications). This is not to suggest that the agency does not do its best to meet deadlines imposed by Congress given its limited resources. However, FDA has a long history of not complying with statutory deadlines without being seriously called on the carpet…. until now.

Does this court order represent a sea change? Will statutory deadlines for other FDA actions besides rulemaking (say, drug applications) need to be taken more seriously going forward? Will this court order have broader implications for the timeliness of FDA decision making generally? Even where there is no statutory deadline, will the courts impose time limits?

There is evidence that the courts are unwilling to abandon any notion of timeliness, even in the absence of a statutory deadline. Last year, another federal court, the U.S. District Court for the Southern District of New York, ordered FDA to finalize proceedings to withdraw its approval of three animal drugs, penicillin and two tetracyclines – proceedings which the agency had initiated in 1977. Natural Resources Defense Council, Inc. v. FDA. The NRDC suit alleged that agency action had been unlawfully withheld or unreasonably delayed in violation of the Administrative Procedures Act, 5 U.S.C. § 706(1). The district court’s decision is currently on appeal to the Second Circuit.

And, returning to where we started, will the courts be willing to consider enforcing statutory deadlines for other agencies involved in implementing other massive, complex pieces of legislation, such as the Affordable Care Act and the Dodd-Frank financial reform legislation? It’s possible this court order could have far-reaching implications for the Executive Branch.

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