FDA’s Credibility Waning in Light of Recent Court Rulings, Wall Street Journal Reports
The Wall Street Journal on Nov. 19 examines the FDA's "eroding" credibility amid recent losses in federal court cases, which are "tempering" the agency's "aggressiveness" and "emboldening its industry adversaries." The Journal reports that the string of losses for the FDA includes the following:
- A ruling last month in which a federal judge overthrew a requirement that drug companies perform pediatric drug trials for some medicines;
- Two Supreme Court decisions rejecting the agency's attempt to regulate tobacco and striking down its restrictions barring pharmacies from advertising drug compounds;
- An appeals court decision finding that the agency inappropriately rejected health findings from dietary-supplement manufacturers; and
- A successful challenge to its oversight of the marketing of "off-label" drugs.
These and other "less-visible" setbacks are contributing to the perception that the FDA is "legally vulnerable," and, according to the Journal, "it is more likely that future challenges will get a sympathetic ear from an increasingly conservative and skeptical judiciary." The Journal reports that judges are "giving greater weight" to a strict interpretation of statutes that govern the FDA's actions rather than relying on the agency's judgment about which rules are necessary to its mission, as the courts have done in the past. Future "potential regulatory casualties" could include FDA restrictions on the marketing of drugs, medical devices and food products. In response to its recent losses, the agency has begun a review of past litigation and regulations to determine whether any of the court cases "cast doubt" on other FDA rules, and it recently invited public comment on its advertising rules. While the agency has won 94 federal court cases and only lost 23 since 1990, the recent losses have "taken a bite out of its credibility," the Journal reports, although some officials say that their impact has been "overblown." According to a top agency official, "It doesn't help our public health mission to lose cases in court. We don't want to get a reputation for being arbitrary and capricious" (Adams, Wall Street Journal, 11/19).
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