These are turbulent times for the Food and Drug Administration. The almost daily barrage of headlines questioning the safety of marketed drugs is probably depleting regulators’ personal stocks of aspirin and antacids. But as they try to soothe their own pain, regulators must not forget their mission: to ease the plight of patients who need new medicines.
We need to insulate policy-making and decisions on individual products from politics to the extent possible, require regulators to make decisions based on the facts and improve pharmacovigilance — the safety monitoring of drugs already on the market. Finally, and most important, we need to reform the culture of excessive risk-aversion and defensive decision-making that pervades the FDA.