FDA Faces Mounting Pressure on Shortcut Approval Pathway

The FDA has recently come under fire by big pharma and big biotech. The issue: FDA's interpretation of a section of the Federal Food, Drug, and Cosmetic Act—505(b)(2)—which allows companies to rely on data other than their own to attain drug approval. Exactly what data FDA can use in its determination of safety and effectiveness for section 505(b)(2) applications is becoming the subject of an intense counter-battle drug manufacturers are waging to ensure that their proprietary NDA data stays off-limits. Who ultimately prevails—industry or the FDA—will either inspire or deter the work of branded generic and biogeneric developers.

Since 1984, when the Hatch-Waxman amendments created the 505(b)(2) provision, FDA has used this abbreviated approval pathway for more than 80 drug products. Congress created this regulatory path for drugs...