Former HHS General Counsel and Deputy FDA Commissioner Bill Schultz recently expressed his belief that FDA policies developed 50 years ago remain sufficient to govern life in the 21st century. He's wrong. Time marches on and regulatory practices must evolve to better serve the public health. Nowhere is this more urgent than in making sure physicians and patients have unencumbered access to accurate information about FDA-approved medicines.
Almost no one is against sharing valuable information about FDA-approved medicines. The discussion—often heated —is over how (or if) that conversation should be regulated by the FDA.