Brook­ings is­sues rec­om­men­da­tions for gener­ic drug com­pe­ti­tion as PDU­FA VI ex­pi­ra­tion looms

While the FDA, in­dus­try in­sid­ers and politi­cians have all weighed in on what the newest it­er­a­tion of PDU­FA should look like, a new re­port from a pri­vate re­search group out­lines an op­por­tu­ni­ty to change some of the FDA’s au­thor­i­ty to pro­mote gener­ic en­try.

The Brook­ings In­sti­tu­tion’s Rachel Sachs, Mar­ta Wosińs­ka, Richard G. Frank, and Loren Adler part­nered with USC’s Leonard D. Schaf­fer Cen­ter for Health Pol­i­cy & Eco­nom­ics to au­thor a pa­per pub­lished Tues­day to ad­dress some con­cerns with­in FDA’s cur­rent reg­u­la­to­ry process­es. They specif­i­cal­ly re­fined three mea­sures to pro­mote bet­ter gener­ic drug com­pe­ti­tion: the Cit­i­zen Pe­ti­tion mech­a­nism; the ap­proval of “com­plex gener­ic drugs;” and gener­ic drug “park­ing” un­der the Hatch-Wax­man Act.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER