Noting that more than 56% of all prescriptions dispensed today are filled with generics, Generic Pharmaceutical Association (GPhA) President and Chief Executive Officer Kathleen Jaeger predicted that Medicare Part D will fuel even stronger growth for low-cost generic drugs in the years ahead.

In an address to GPhA's Fall Technical Conference, Jaeger said that the billions of dollars that Americans save each year as a result of generic pharmaceuticals will increase in the years ahead "as more brand products come off patent, more states adopt regulations to encourage the use of affordable generics, and more older Americans enroll in the Medicare prescription drug benefit."

But the growing public acceptance of generic medicines "will inevitably put even greater demands on the FDA," the GPhA chief said. "And that means that the FDA—specifically, the Office of Generic Drugs (OGD)—and the industry must work closely together to ensure that consumers have speedy access to the safe, effective, and affordable medicines they are looking for."

Last year alone, the OGD's workload increased by 36%, and it approved more than 550 generic applications with no real increase in staff or budget, Jaeger told the industry. "In the face of this huge workload and limited resources, OGD's staff should be commended for their efforts in rigorously reviewing and approving affordable medicines for American consumers," she said.

Although Jaeger predicted that the new Congress would increase the FDA's budget for generic drug approvals, she said more money alone will not be enough. "In addition to increased funding, it is imperative that OGD is able to communicate effectively within the agency and with the industry," Jaeger said. "It's hard to believe that a simple question that could be solved by a quick phone call or brief e-mail cannot be answered that way. But it's true. And it needs to be fixed."