Are US pre-filing user fees in pharma's future?
This article was originally published in SRA
When the US Food and Drug Administration negotiates with brand-name manufacturers on the next round of the Prescription Drug User Fee Act - PDUFA VI - the agency may try to find a way of receiving some payments earlier on in the drug development process, said Dr Gillian Woollett, senior vice president at Washington-based analysis and consultancy firm Avalere Health.
Under PDUFA, companies don't pay until they submit their marketing applications to the FDA. Under the PDUFA VI negotiations, the agency likely would try to move PDUFA more to the Biosimilar User Fee Act (BsUFA), model, where manufacturers must pay 10% of the application fee up front on an annual basis, Woollett said. The FDA officially launched the process for reauthorizing PDUFA VI with a public meeting on July 151.
The upside for the FDA in BsUFA is that it gets funds right away from biosimilar makers – allowing the agency to expand its resources and staffing, Woollett told Scrip Regulatory Affairs sister publication Scrip Intelligence in an interview.
The Europe Union already uses a process in which drug makers pay fees up front for meetings when they want to seek scientific advice from the European Medicine Agency, and companies can schedule as many as of those sessions as they like, although the regulators must still agree to hold them, she said. Woollett noted that when the FDA and biosimilar makers were negotiating the fee structure of BsUFA, the initial discussions revolved around the agency charging "meeting fees," similar to what's done in Europe. But ultimately, the idea for the annual fees won out.
Moving some of the user fee payment upfront in the drug development process is "one of the things I anticipate to be under consideration" in the PDUFA VI negotiations, Woollett said. While she acknowledged that this was "purely conjecture" on her part, she said it was nonetheless a "logical conclusion."
While the European scientific advice payment process may be "easier" for the FDA to adopt, Woollett said it was more likely that the agency would try to move PDUFA more to the BsUFA model.
In fact, she added, "the logic is even more compelling under PDUFA for originator products than it is under BsUFA" for such an up-front payment structure – and possibly even something that could be adopted for all of the "UFAs," including fees for generics and medical devices.
"I think the FDA is going to be very strategic, very adept" in the PDUFA VI negotiation process, Woollett declared. "Everything is on the table," she said.
The BsUFA model
Under BsUFA, biosimilar manufacturers pay 10% of the application fee up front on an annual basis, with that amount subtracted from the overall user fee total when companies file their applications, known as a 351(k)s, Woollett explained.
Like PDUFA, the BsUFA fees are intended to expedite the application review process.
For fiscal year 2015, fees for biosimilar applications requiring clinical data are $2,335,200, so the current annual up-front fee is $233,520.
Biosimilar product firms must pay a development fee, or BPD, to participate in the FDA's program to receive a Type 1, 2, 3 or 4 meeting with the agency. The FDA's guidance notes there is no fee for a "biosimilar initial advisory meeting" with US regulators.
Regulators emphasized the BPD fee is an annual per-product fee, "not a per-meeting or per-review" activity fee.
Under BsUFA, there are three types of BPD fees: initial BPD fee ($233,520), annual BPD fee ($233,502) and the reactivation fee ($467,040). Woollett noted that companies pay the annual BPD fee until they submit an application or discontinue participation.
But if biosimilar maker wants to re-engage with the FDA after the firm has discontinued, the company must pay the reactivation fee.
According to the FDA, if a company submits a 351(k) to the agency, the fee for the application is reduced by the cumulative amount of the previously paid BPD fees.
The initial BPD fee is due on the date a company submits an investigational new drug application for an investigation the FDA determines is intended to support a 351(k) or within five calendar days after the agency grants a request for a firm's BPD Types 1-4 meeting, whichever occurs first.
If a firm fails to pay the BPD fees on time, the FDA may cancel or deny requests for the meetings.
References
- PDUFA VI: US FDA ponders trimming its responsibilities, Scrip Regulatory Affairs, 16 July 2015
This story has also been published inScrip Intelligence. Scrip Regulatory Affairs brings selected complementary coverage from our sister publications to our subscribers.