FDA commissioner praises generic industry's efforts on quality, shortages, follow-on biologics in GPhA speech

NEW YORK — One of the Food and Drug Administration's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered Friday morning by FDA commissioner Margaret Hamburg at the Generic Pharmaceutical Association's annual meeting.

In the address, viewed via webcast, Hamburg addressed issues ranging from quality to drug shortages to follow-on biologics, praising the generics industry's role in contributing more than $1 trillion in savings to the healthcare system over the past decade.

"There are few American households that have not benefited from the success of the generic drug industry," Hamburg said.

One thing that may help that along is the Generic Drug User Fee Amendments to the Prescription Drug User Fee Act, passed last year, which created a system of user fees to address the FDA's backlog of generic drug approval applications.

"You all really stepped up to the plate to make sure that it got done," Hamburg said. "And even though it came at a cost literally and figuratively, it was the right thing to do."

Noting that quality had made the U.S. drug industry the "gold standard for the world," Hamburg nevertheless cited a study from the Harvard Medical School showing that of 506 physicians surveyed, half reported negative perceptions about the quality of generics, though the FDA requires generics to be therapeutically equivalent to their branded counterparts. Physicians aged 55 years and older were three to four times more likely to report negative perceptions, Hamburg said.

"We've chosen to make quality one of our highest priorities this year," she said. "You want providers and the public alike to never have to question their confidence in the high quality of generic products."

Quality also was an important factor when Congress enacted an abbreviated pathway for the approval of follow-on biologics as part of the Patient Protection and Affordable Care Act, Hamburg said. The pathway divides follow-on biologics into two categories: biosimilars, which are highly similar to the reference products, and those that are interchangeable. The FDA has yet to receive an approval application for a biosimilar, she said, but the industry had expressed significant interest. The agency expects to see formal applications arrive in the near future, and FDA scientists had been meeting with manufacturers.

Hamburg also praised the industry's role in addressing the problem of drug shortages, which have risen dramatically since 2006 due to a number of factors ranging from problems securing raw materials and manufacturing issues. Most of the shortages involve generic injectables, particularly used in hospitals, and Hamburg cited a survey showing that 82% of hospitals had to delay patient treatments due to shortages, along with reports of deaths among patients who couldn't get needed drugs in time. The agency responded by working with industry to find alternative sources of drugs, allowing temporary importation of foreign supplies and using alternative manufacturing processes, and last year, the industry and the FDA prevented 282 shortages, 87 more than in 2011.

"As a result of these combined efforts, patients' needs are now being met," she said.

Overall, Hamburg complimented the industry on its investments in keeping generic drugs available, safe and effective. "It's evident that several generic manufacturers have already begun to make very substantial investments to this end," she said. "This will be money well spent, both for patients and the bottom line."