US generics group GPhA encouraged with initial dialogue on FDA User Fees; AstraZeneca backs increased funding for the agency

Following last Friday’s public meeting with the US Food and Drug Administration concerning the generic drug user fee program, Gordon Johnston, vice president for regulatory science at the Generic Pharmaceutical Association (GPhA), one of the presenters at the meeting, said the group was encouraged by the initial dialogue. Also last night, Anglo-Swedish drug major AstraZeneca lent its support for FDA funding.

“Generic drug manufacturers are acutely aware of the need to get much-needed additional resources to the FDA and the Office of Generic Drugs to help handle the work associated with the review and approval of generic applications. Today’s meeting between FDA leadership and industry stakeholders to discuss a new generic drug user fee program is a critical step forward in assuring that added funding becomes available,” he noted.

He continued: “GPhA is especially delighted that FDA Commissioner Margaret Hamburg opened the meeting by pointing out that ‘generic drugs have carved out a critical role in health care for the 21st century…and provide affordable access to treatment for the public.’ The Commissioner added that the Agency and industry ‘hold a joint stake in moving forward to develop a solid use fee program.’ Her remarks today affirmed her commitment made at the GPhA annual meeting earlier this year to work toward a meaningful user fee program; one that will ‘help serve the FDA's mission of protecting public health’.”