Opinion | Vioxx Case Indicates Need for 'Slowed' FDA Approvals of New Medications, Op-Ed Says

The COX-2 inhibitor Vioxx, which Merck withdrew from the market in 2004 over safety concerns, "might be doing some good in limited use today, if only the FDA had slowed the approval process enough for the data about danger to catch up with the marketing hype," a Boston Globe editorial states. According to the editorial, "the industry and Congress want these drugs made available quickly, and the drug manufacturers pay the cost of the FDA approval process to hurry them along. This represents a change in attitude from a generation ago, when the FDA was proud of its deliberate pace." The editorial adds that a "quicker policy is justified in treatments for such life-threatening diseases as AIDS" but not for pain medications, which "do not present the same case for urgency." The editorial concludes, "No one wants to return to the days when FDA sluggishness delayed the approval of life-sustaining medicine, but there has to be a middle way between long delays and an approval process that makes millions of pain sufferers into unknowing guinea pigs. Tighter regulations may lessen company profits, but they will ensure that the medicines Americans take are once again considered the safest on Earth" (Boston Globe, 12/19).