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 by 2017, FDA official Russell Wesdyk, BS, MBA, said in a presentation last month.
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 Formulary 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.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
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