Leading the Way in Life Science Technologies

GEN Exclusives

More »

GEN News Highlights

More »
Jan 3, 2012

Readers Show Confidence in FDA’s Biosimilar User Fee Framework

  • When asked whether "Do you agree with FDA's new framework covering user fees and performance goals for biosimilar developers?" 40% agreed completely and another 20% somewhat. Another 20% of respondents disagreed with FDA, while 20% were undecided. The proposed user fee structure covers federal fiscal years 2013 through 2017 and is expected to aid FDA in fulfilling its goal of creating a biosimilars pathway that balances innovation and consumer interests.

    FDA envisions creating four categories of user fees. Biosimilar product development (BPD) fees of 10% of the fee established for a drug under the Prescription Drug User Fee Act (PDUFA) will be collected, starting when sponsors submit an IND or meet with FDA and for every year after until the sponsor submits a marketing application or ends participation in BPD. Second, at marketing application submission, sponsors would pay fees equal to those established under PDUFA minus the BPD fees paid. The final two fee categories are establishment fees and product fees, both of which would be equal to those paid by drug developers under PDUFA.

Related content

Be sure to take the GEN Poll

Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

More »