House panel blasts FDA labeling rules
Career agency officials objected to the new regulations, warning that they could harm patients.
Food and Drug Administration political appointees made recent changes in labeling rules that protect drugmakers from costly lawsuits over the objections of career agency officials who warned the new rules harm patients and were based on false justifications, according to a Democratic report released Wednesday.
The report, issued by the House Oversight and Government Reform Committee, comes on the heels of a hearing set before the U.S. Supreme Court next week on the issue.
"These internal document[s] 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 report states.
The internal documents also revealed the White House played a significant role in drafting the industry-friendly rules. The high court is scheduled to hear Monday from drug giant Wyeth and a Vermont woman who lost an arm after receiving an injection of an anti-nausea drug. At issue is whether FDA-approved labeling pre-empts state tort claims and protects drug companies from being sued over pharmaceutical safety.