FDA, Merck criticized for missing ‘red flags’
Harsh criticism abounded last week in the Senate Finance Committee about the U.S. Food and Drug Administration’s role regarding Merck’s painkiller Vioxx, adding Congressional pressure for a drug safety division with independent authority to act on safety concerns about FDA-approved drugs.
Witnesses and committee members charged that the FDA’s Office of New Drugs:
(1) rushed Vioxx through the new drug approval process despite concerns about cardiovascular risk raised by
the agency’s own reviewers;
(2) missed or ignored “red-flag” safety warnings once Vioxx was on the
market and sought to silence researchers whose analysis raised
additional concerns about it;
(3) delayed in adding a cardiovascular warning to the
label and gave Merck too much control over what the label would say.
(4) is too often reluctant to address safety problems that might cast doubt on previous regulatory decisions.
The prime witness and a major source for committee investigators was Dr. David Graham of the FDA’s Office of Drug
Safety. Graham described the FDA as “broken” and called Vioxx “a terrible tragedy and a profound regulatory failure. I would
argue that the FDA, as currently configured, is incapable of protecting
America against another Vioxx. We are virtually defenseless.”