U.S. House and Senate Democrats Pen Letter to FDA Expressing “Profound Regret” Over FDA’s Proposed Labeling Rule

January 28, 2008

Last week, we reported on a January 16, 2008 proposed rule issued by FDA that would “reaffirm [the Agency’s] longstanding position that” labeling changes for approved drugs, biologics, and medical devices made by Changes Being Effected Supplements (“CBE Supplements”) may only be made to show newly acquired information or to “add or strengthen a contraindication, warning, precaution, or adverse reaction” when there is sufficient evidence to support the change.  We also commented that the proposed rule, if finalized, could give significant support to firms that invoke an FDA preemption defense in product liability cases where plaintiffs argue that firms should revise their own labeling in accordance with state law. 

On January 23, 2008, several influential U.S. House and Senate Democrats sent a 5-page letter to FDA Commissioner Andrew von Eschenbach expressing their “profound regret” about FDA’s proposed rule and, not surprisingly, blasting the Bush Administration.  The letter states: 

FDA has failed to provide any justification for expending its very limited resources on issuing this 26 page proposal that will serve only to deprive American consumers of critically important and timely information about the safety of their drugs and medical devices. We are concerned that the intent of this proposal is to protect companies in the pharmaceutical and device industry from being held liable for marketing products they know are unsafe. Such a policy change comes at the expense of consumers and violates the mission of the FDA. The issuance of the proposed CBE rule is not an isolated case, but part of a pattern of actions in the Bush Administration’s final months to permanently insulate the drug and device industry from liability.

The letter also cites the “rule of construction” added to FDC Act § 505(o)(4)(I) by Title IX (Enhanced Authorities Regarding Postmarket Safety of Drugs) of the FDA Amendments Act (“FDAAA”).  The rule of construction states:

This paragraph shall not be constructed to affect the responsibility of the responsible person or the holder of the approved application under section 505(j) to maintain its label in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 601.12 of title 21, Code of Federal Regulations (or any successor regulations).

In noting the rule of construction, the Congressional Letter criticizes FDA’s “glaring omission” in describing Congress’ intent with respect to FDA’s labeling change authority under FDAAA:

It is indeed true that, in FDAAA, Congress intended to give FDA, for the first time, the clear authority to require certain changes in drug labeling. Vioxx is a painful illustration of what had previously been a serious gap in FDA’s authority. In that instance, FDA haggled with the company about the content of the labeling change for over 14 months while consumers continued to take the drug, completely unaware of the serious health risks associated with it. Thus, FDAAA provides FDA with the ability to avoid this kind of protracted negotiation so that the agency can ensure that the important safety information it believes should be on the label is promptly added.

The preamble, however, makes a glaring omission in its description of congressional intent with respect to FDAAA’s labeling change authority. FDA failed to cite the “Rule of Construction” which clearly demonstrates Congress’ equally important goal: to preserve the responsibility of drug companies to promptly update their own product labels to reflect the most current safety information available.

The Congressional Letter goes on to note that “the proposed rule fails to identify a single problem associated with [FDA’s CBE Supplement regulations] that would warrant modification, much less a public health threat of such magnitude as to put issuing the proposal at the top of FDA’s priority list,” and that “the proposal was immediately cited by the Solicitor General in a letter to the United States Supreme Court in support of the industry’s argument that FDA approval preempts individual product liability cases.”  The case referred to is Wyeth v. Levine, which concerns whether prescription drug labeling preempts state law product liability claims.  A copy of the Solicitor General’s brief in that case is available here.  Other documents in the case are available at SCOTUSBlog.

Finally, the Congressional Letter requests that FDA provide certain information by February 13, 2008, including: (1) the number of CBE Supplements FDA received each year since 1982; (2) any cases in which “a manufacturer used the CBE procedure to add or strengthen a contraindication, warning, precaution, or adverse reactions in a manner that harmed the public health, including the dates of such cases;” and (3) documents from FDA officials expressing concern about misuse of CBE Supplements.

By Kurt R. Karst