Is the Obama Administration Poised to Undo FDA’s Preemption Stance?

January 26, 2009

By Kurt R. Karst –      

Those following the subject of preemption of conflicting state laws have speculated for months whether the Obama Administration might undo the position FDA has advanced in Federal Register announcements and in court filings in which the Agency has generally staked out a pro-preemption position.  Earlier today, Inside Health Policy published a report that might offer some clue as to the Obama Administration’s plans. 

On January, 23, 2009, just three days after the White House issued a memorandum ordering that “no proposed or final regulation should be sent to the Office of the Federal Register . . . for publication unless and until it has been reviewed and approved by a department or agency head appointed or designated by the President after noon on January 20, 2009,” and just two days after the Office of Management and Budget issued a memorandum providing guidance on the White House memorandum, FDA’s advance display Federal Register feature of its website included a 96-page final rule – signed off on by FDA’s Associate Commissioner for Policy and Planning on January 15, 2009 – that would have required new organ-specific warnings and related labeling for Over-The-Counter (“OTC”) Internal Analgesic, Antipyretic, and Antirheumatic (“IAAA”) drug products.  The final rule included the following statements concerning preemption:

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.

This final rule will require important new organ-specific warnings and related labeling requirements for OTC IAAA drug products. The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using [non-steroidal anti-inflammatory drugs].  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)).

We believe that the preemptive effect of the final rule would be consistent with Executive Order 13132.  Section 4(e) of the Executive Order provides that “when an agency proposed to act through adjudication or rulemaking to preempt state law, the agency shall provide all affected State and local officials notice and an opportunity for appropriate participation in the proceedings.”

Curiously, the version of the final rule, which was approved prior to Inauguration Day, was reportedly taken down from the advance display Federal Register feature of FDA’s website late on January 23rd.  While the posting of the final rule on FDA’s Federal Register website might have been an error and its removal from the website might have been done by FDA simply in an effort to comply with the Obama Administration’s directive, it might also signal the new Administration’s intent to take a much closer look at the issue of preemption, and perhaps take an FDA position that is different from that supported by the Bush Administration.