Wall Street Journal Examines FDA’s Credibility after Recent Court Losses
The Wall Street Journal today 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 overturned 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.
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).