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Regulatory News | 01 August 2016 | By Michael Mezher
In the late 1980s, the US lagged behind Europe in drug approvals, and individual drug reviews often took years to complete. These lengthy approval times were a significant source of frustration not only for patients and drug companies, but for the US Food and Drug Administration (FDA) itself.
The problem, FDA argued, was that the agency lacked adequate funding to hire the staff it needed to review drugs in a timely manner. The solution FDA proposed was to collect fees from the companies it regulates for each new product, which would provide the agency with a substantial source of funding to boost its staff and reduce review times.
Eventually, this led to the passage of the Prescription Drug User Fee Act (PDUFA) in 1992, which authorized FDA to collect such fees for its review activities in return for a speedier, more predictable review process.
Since then, Congress has reauthorized the user fee acts to enable FDA to collect fees for other regulated products, including medical devices, biosimilars, and generic and animal drugs.
FY 2017 Fees
For FY 2017, FDA has lowered most of its application fees, while increasing some of its other fees, such as facility fees for certain products.
For new drugs and biosimilars, fees are down across the board from 2016, and are at their lowest point since FY2013. For new drug applications requiring clinical data, FDA has lowered the fee by more than $300,000, from $2,374,200 in FY2016 to $2,038,100 in FY2017.
Medical device makers will also get a significant break on fees in FY2017, with nearly all fees down to their lowest point under the 2012 Medical Device User Fee Amendments (MDUFA II). FDA on Monday also released new guidance on small business qualification and certification.
For generic drugmakers, FY 2017 fees will be slightly lower than in FY 2016, though fees for drug master files, finished dosage forms and active pharmaceutical ingredients have all increased.
Tags: User Fees, PDUFA, BsUFA, MDUFA, GDUFA, FY2017