GPhA Seeks Additional ODG Funding, Not User Fees

The Generic Pharmaceutical Association (GPhA, Washington DC, www.gphaonline.org) says that more funding for FDA's Office of Generic Drugs (OGD) would produce more benefits than the agency's proposal for generic-maker user fees.

Last Friday, FDA Deputy Commissioner Scott Gottlieb told GPhA's annual meeting that FDA is interested in establishing user fees to help speed new generic drugs to market by increasing staff and review capabilities. “From our perspective at FDA, we have seen user-fee programs applied to our medical device and new drug programs with great success,” Gottlieb said.

The GPhA expressed concern that since user fees, developed to help brand-name manufacturers to boost approval time for new drug applications, would not speed up delivery of generics to the consumer. “Unlike applications from brand or medical device companies, generic applications are subject to an intellectual property-based approval system,” said GPhA President and CEO Kathleen Jaeger. “This system is fraught with unintended legal and regulatory loopholes.

“Congress needs to take steps now to provide additional funding for OGD. While FDA and others continue to debate user fees, the backlog at OGD continues to grow, denying consumers access to affordable medicines,” said Jaeger.

According to The Washington Post, the OGD receives approximately $28 million a year, compared to the more than $400 million (half of which comes from new drug application user fees) allocated to the Office of New Drugs.

Gottlieb said that, since 2001, OGD's budget has doubled and its staffing rolls have increased from 143 to 201.

“As generic drugs continue to play an increasingly prominent role in the health of Americans, we need to also continue to make sure that the generic drug program remains on stable financial footing,” Gottlieb said.

At this time, the user fees are still in the discussion stage. The proposal would need to be approved by Congress to be put in effect.

In related news, the OGD announced that they would start calling generic drug applicants by telephone when possible, rather than relying on letters. This is being done to help speed up the application review process and cut down on application backlog, according to OGD Director Gary Buehler. E-mail is also being taken into consideration to inform applicants of deficiencies in their applications.