Healthy Skepticism Library item: 14524

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Publication type: report

United States House of Representatives Committee on Oversight and Government Reform
FDA Career Staff Objected To Agency Preemption Policies
Washington, DC: United States House of Representatives Committee on Oversight and Government Reform 2008 Oct 29
http://web.archive.org/web/20081118233857/http://oversight.house.gov/documents/20081029102934.pdf

Abstract:

TABLE OF CONTENTS
EXECUTIVE SUMMARY
I. INTRODUCTION
A. The 2006 Physician Labeling Rule
B. The 2008 “Changes being Effected” Regulation
II. THE FDA INTERNAL DOCUMENTS
A. Objections to the Discussion of Preemption in the 2006 Preamble
B. Objections to the 2006 Drug Labeling Changes
C. Resistance to a Proposal to Allow Waivers from Prior Approval Requirements
D. Objections to the 2008 Drug Labeling Changes
E. Evidence of White House and Department Interference
F. Public Health Implications of the Changes
1. Delay in Tykerb Label Changes
2. Delay in Levaquin Label Changes
III. CONCLUSION

EXECUTIVE SUMMARY

Historically, the Food and Drug Administration (FDA) has viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency’s regulatory efforts. The longstanding view of the agency has been that private litigation can provide an additional layer of protection against unsafe drugs.

Under the Bush Administration, however, FDA has reversed this position and advocated in favor of preemption of individual state tort liability cases. FDA rewrote drug labeling regulations in 2006 and 2008 to restrict the ability of manufacturers to disclose new safety risks without prior FDA approval. The agency also added a lengthy preamble to the 2006 rule in favor of preemption of state lawsuits. The changes to the labeling rules (known as the “changes being effected” or CBE rules) and FDA’s preamble have become a cornerstone of drug industry preemption arguments.

Internal agency documents obtained by the Committee show that these regulatory changes were made by FDA over the objections of key career officials. According to internal agency documents, high-ranking career officials repeatedly warned that the central factual justifications for the agency’s new positions were false. They also expressed concern that the changes in the labeling rules would harm patients by significantly delaying the addition of important safety information to drug labels. These internal document show that FDA career officials asserted that the regulations were based on a “false assumption,” “naïve to what actually occurs in practice,” relied on “gross overstatement,” and made “false and misleading” assertions.

The preamble to the 2006 labeling rule asserted that FDA has the ability to “carefully control” drug labeling and to continuously monitor the safety of pharmaceutical products, incorporating information into the labeling when appropriate. Dr. John Jenkins, the highest official in FDA’s new drug review process, strongly disagreed with these assertions, writing:

“[M]uch of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”

He later amplified his objection, explaining: “we know that many current approved drug labels are out of date and in many cases contain incorrect information (e.g., the overdose section) … [I]t is unwise to suggest that FDA approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information.”

The preambles to both the 2006 and 2008 rules repeatedly state that without preemption and the new labeling restrictions, manufacturers will add unnecessary warnings. For example, the 2006 preamble asserts that state lawsuits “could encourage manufacturers to propose ‘defensive labeling’ to avoid State liability, which, if implemented, could result in scientifically unsubstantiated warnings and underutilization of beneficial treatments.” This position was rejected by Jane Axelrad, Associate Director for Policy in the Center for Drug Evaluation and Research. She wrote to agency political appointees:

“[T]here are continued references to sponsors “disclosing too much” risk information and its adverse impact. … We rarely find ourselves in situations where sponsors want to disclose more risk information than we think is necessary. To the contrary, we usually find ourselves dealing with situations where sponsors want to minimize the risk information.”

She also asserted: “the statement that ‘FDA believes manufacturers should add risk information to labeling only after consulting with the agency … is not true and is not consistent with our CBE regulations. … [W]e do not discourage sponsors from adding new information. … In fact, the regs encourage use of this route as it allows the label to be updated in the most timely manner.”

The preamble to the 2008 labeling rule claims that the revision merely conforms the language of the rule to the agency’s settled interpretation. Yet before the rule was issued, Ms. Axelrad advised that “[t]he rule is not, as it purports to be, consistent with the agency’s role in protecting the public health.” Ms. Axelrad also warned that, instead of reaffirming FDA’s long-standing interpretation, the 2008 rule created new standards that would create confusion:

“We have not experienced problems with sponsors’ use of CBE supplements to over warn, and this rule tips the balance against early warnings by using vague and confusing terms such as “causal association” and “reasonable time” that will be difficult for staff and sponsors to apply.”

At least one document suggests that the White House played a significant role in the preemption provisions and pressured the agency to reject the concerns of career experts. A senior career official wrote in 2006 that the FDA Chief Counsel “stated unequivocally that without the cbe language the rule will not go forward (this is per the White House).” Other documents reveal that after the changes went into effect, they delayed by months the addition of important safety information on drug labels.

FDA is charged with protecting public health by ensuring the safety and effectiveness of drugs and medical devices. But the documents received by the Committee call into question whether FDA has acted in the best interests of public health. The agency’s actions have undoubtedly helped shield drug manufacturers from liability. According to the agency’s own experts, however, they have done so at the cost of delaying the dissemination of important safety information to the public.

Notes:

Original documents also available at Committee’s site