Change in FDA Preemption Position? New Rule Largely Eliminates Preemption Discussion

April 29, 2009

By Kurt R. Karst –      

“Is the Obama Administration Poised to Undo FDA’s Preemption Stance?” We posed this question in a post earlier this year after a pre-publication version of a 96-page final rule concerning new organ-specific warnings and related labeling for Over-The-Counter (“OTC”) Internal Analgesic, Antipyretic, and Antirheumatic (“IAAA”) drug products was posted and then quickly removed from the advance display Federal Register feature of FDA’s website late on January 23, 2009.  The pre-publication version of the final rule included a section titled “Federalism” stating, in relevant part, that:

We have determined that the rule will have a preemptive effect on State law.  Section 4(a) of [Executive Order 13132] requires agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.”  Section 751 of the Federal Food, Drug and Cosmetic Act (the act) (21 U.S.C. 379r(a)) is an express preemption provision.  Section 751r(a)) provides that “no State or political subdivision of a State may establish or continue in effect any requirement– . . . (1) that relates to the regulation of a drug that is not subject to the requirements of section 503(b)(1) or 503(f)(1)(A); and (2) that is different from or in addition to, or that is otherwise not identical with, a requirement under this Act, the Poison Prevention Packaging Act of 1970 (15 U.S.C. 1471 et seq.), or the Fair Packaging and Labeling Act (15 U.S.C. 1451 et seq.).”  Currently, this provision operates to preempt States from imposing requirement related to the regulation of nonprescription drug products.  Section 751(b) through (e) of the act outlines the scope of the express preemption provision, the exemption procedures, and the exceptions to the provision. . . .

Although this final rule would have a preemptive effect, in that it would preclude States from promulgating requirements related to these drug products that are different from or in addition to, or not otherwise identical with a requirement in the final rule, this preemptive effect is consistent with what Congress set forth in section 751 of the act.  Section 751(a) of the act displaces both state legislative requirements and state common law duties. We also note that even where the express preemption provision is not applicable, implied preemption may arise (see Geier v. American Honda Co., 529 US 861 (2000)).

Although we do not yet have a definitive answer to our question, it appears as though the Obama Administration is backing off from the Bush Administration’s preemption position. 

In an interesting turn of events this 100th day of the Obama Administration, FDA has officially published the OTC IAAA final rule.  The “Federalism” section of the rule has been significantly revised to remove much of the pro-preemption language included in the earlier version.  Now that section states: 

FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132.  We provided the States with an opportunity for appropriate participation in this rulemaking when we sought input from all stakeholders through publication of the proposed rule in the Federal Register of December 26, 2006 (71 FR 77314).

On December 27, 2006, FDA’s Division of Federal and State Relations provided notice via email transmission of a letter to elected officials of State governments and their representatives.  The letter advised the States of the publication of the proposed rule and stated that when published as a final rule, this regulation would preempt State law in accordance with section 751 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379r(a)). The letter encouraged State and local governments to review the proposed rule and to provide any comments to the docket (Docket No. 1977N–0094L) by May 25, 2007, or to contact certain named individuals.  FDA did not receive any comments in response to this notice, or any comments from the States in response to the publication of the proposed rule. 

In conclusion, we believe that we have complied with all of the applicable requirements under the Executive order and have determined that the preemptive effects of this rule are consistent with Executive Order 13132.

In another turn of events reported by Drug and Device Law Blog yesterday, the Solicitor General submitted a letter to the U.S. Court of Appeals for the Third Circuit in Colacicco v. Apotex.  That case concerns whether actions taken by FDA pursuant to the FDC Act and the Agency’s implementing regulations preempt plaintiffs’ state law failure-to-warn claims against certain drug manufacturers with respect to certain  selective serotonin reuptake inhibitors.  Several parties, including FDA, entered and argued the case as amici for the appellee.  According to the Solicitor General’s April 28, 2009 letter:

[T]he United States does not take a position on whether plaintiffs-appellants’ claims in this case are preempted.  The Food and Drug Administration has not yet conducted the sort of reexamination of various preemption issues following the Supreme Court’s decision in Wyeth that would be necessary to inform a position of the United States in this case.  Accordingly, the United States hereby withdraws the amicus brief previously filed in this Court. 

Stay tuned, as other incremental changes in the government’s preemption position seem likely to occur.

Categories: Drug Development