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FDA Proposed Pregnancy/Lactation Rule Discusses Preemption

By James M. Beck and Mark Herrmann

The other day the FDA proposed a rule to revise those aspects of drug labeling dealing with pregnancy and childbirth. The FDA Law Blog has a good description of the proposed changes. The FDA proposal itself is at 73 Fed. Reg. 30831 (FDA May 29, 2008). We were, however, most interested in whether the proposed rule contained anything about preemption, since it amends the Physician Labeling Rule that produced the 2006 Preemption Preamble.

As it turns out, this latest proposal does have something - not a great deal - to say on the subject of preemption, and it's supportive of the defense position:

In this proposed rule, FDA is proposing to revise its existing requirements concerning the format and content of the ??Pregnancy,?? ??Labor and delivery,?? and ??Nursing mothers?? subsections of labeling for human prescription drug and biological products. To the extent that a State requires labeling that conflicts with these requirements, the State required labeling would be subject to implied conflict preemption. ... [T]his proposed rule would amend portions of FDA?s regulations that were recently revised by the PLR [Physician Labeling Rule]. When FDA finalized the PLR, the agency responded to ... [s]everal comments on the proposed PLR had raised concerns about State requirements on drug labeling, often as a result of product liability lawsuits, that conflict with federal requirements. As a result of those comments, and in discussing federalism issues, FDA restated its longstanding views on preemption. For further discussion of this issue, see 71 FR 3922 at 3933 through 3936 and 3967 through 3969. FDA?s statements in this regard are applicable to this proposed rule as well, and reflect the agency?s current position on this issue.

73 Fed. Reg. at 30861-62 (emphasis added).

The FDA thus states: (1) the pregnancy changes are intended to preempt any conflicting state law tort claims; (2) the Preemption Preamble "restates" a "longstanding" FDA position on preemption; and (3) the Preamble, continues to "reflect" FDA's "current position" on preemption.

Full post as published by Drug and Device Law on May 30, 2008 (boomark / email).