GPHA's JAEGER PAINTS BRIGHT PICTURE FOR GENERICS' FUTURE

Noting thatmore than 56%of all prescriptionsdispensedtoday are filled with generics, GenericPharmaceutical Association (GPhA)President and Chief Executive OfficerKathleen Jaeger predicted that MedicarePart D will fuel even strongergrowth for low-cost generic drugs inthe years ahead.

In an address to GPhA's Fall TechnicalConference, Jaeger said that the billionsof dollars that Americans save each yearas a result of generic pharmaceuticals willincrease in the years ahead "as morebrand products come off patent, morestates adopt regulations to encourage theuse of affordable generics, and moreolder Americans enroll in the Medicareprescription drug benefit."

But the growing public acceptance ofgeneric medicines "will inevitably puteven greater demands on the FDA," theGPhA chief said. "And that means that theFDA—specifically, the Office of GenericDrugs (OGD)—and the industry mustwork closely together to ensure that consumershave speedy access to the safe,effective, and affordable medicines theyare looking for."

Last year alone, the OGD's workloadincreased by 36%, and it approved morethan 550 generic applications with noreal increase in staff or budget, Jaegertold the industry. "In the face of this hugeworkload and limited resources, OGD'sstaff should be commended for theirefforts in rigorously reviewing andapproving affordable medicines forAmerican consumers," she said.

Although Jaeger predicted that thenew Congress would increase the FDA'sbudget for generic drug approvals, shesaid more money alone will not beenough. "In addition to increased funding,it is imperative that OGD is able tocommunicate effectively within theagency and with the industry," Jaegersaid. "It's hard to believe that a simplequestion that could be solved by a quickphone call or brief e-mail cannot beanswered that way. But it's true. And itneeds to be fixed."