GPhA outlines key GDUFA II goals at public meeting

WASHINGTON — On Oct. 21, the Food and Drug Administration held a public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) II. At the meeting were various stakeholders, including the Generic Pharmaceutical Association’s SVP sciences and regulatory affairs, David Gaugh, who outlined the goals of GPhA and the FDA in negotiations over the second iteration of GDUFA. 

 

In terms of generics access, Gaugh said the FDA will expedite the availability of generics by bringing more predictability to the process by offering eight-month priority review of critical products and 10-month review for standard products., with complex products supplying early data to be eligible for enhanced communications opportunities. 

 

When it comes to transparency, Gaugh said that GDUFA II would enhance the FDA’s ability to protect American patients in a complex global supply environment by requiring identification of manufacturing facilities and by improving industry communication and feedback. Additionally, there will be increased transparency between companies seeking approval and the FDA through the use of information requests and discipline review letters. He also mentioned increased reporting and accountability, with such efforts as reporting requirements to enhance transparency and efficiency. 

 

Additionally, under the five-year GDUFA II program, Gaugh said the industry would be providing the FDA with $2.6 billion in addition to the federal government’s budget authority funding to help ensure timely access to generics. 

 

“To function most effectively, and to promote the goal of achieving first cycle approvals and approvals on the earliest legally eligible date, [the] industry focused during the negotiations on increasing transparency and communication during the review process,” Gaugh said. “Maximizing the effectiveness of the review process requires the cooperation of FDA and the generic drug industry, both of which will benefit from sharing their knowledge and concerns throughout the review. The fewer review cycles to approval, the sooner patients and payers can experience the benefits of generic competition.”