Backlog of ANDAs could be alleviated with passage of generic drug user fee act

Congressional approval of the bipartisan Generic Drug and Biosimilars User Fee Act could eliminate 90% of the backlog of Abbreviated New Drug Applications (ANDAs) by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.

Currently, more than 2,000 ANDAs are awaiting approval, according to FDA data.

The legislation also will guarantee consumers “timely access to safe, affordable, and high-quality generic drugs,” Wesdyk, scientific coordinator in FDA’s Office of Pharmaceutical Science, told Drug Topics in a follow-up interview.

The bill was introduced in the House in February by 2 Republicans and 2 Democrats after months of negotiations between industry and FDA representatives. It appears to have little opposition.

The bill would require generic drugmakers to pay $1.5 billion in user fees over the next 5 years. The money would allow FDA to hire and train additional staff for inspections and reviews. Industry leaders feel they would make up the money by getting the new generic drugs and biosimilars to market more quickly.

“The application process would be more efficient and eliminate the backlog that we have now,” Wesdyk said.

He emphasized, however, that a more efficient process didn’t mean that it would be rushed. The 10-month review cycle would remain in place.

“A generic review can be just as complex as the review of a new drug,” Wesdyk said.