|
FDA would have to receive about 11 times more in dedicated
federal funding for biosimilar application reviews than fiscal year
2011 in order to collect user fees, if the tentative agreement
awaiting stakeholder ratification is implemented.
The agency and industry reached what was termed a "tentative
agreement, pending ratifier approval," on statutory language to
create the user fee program and proposed performance goals at an
Aug. 26 meeting, according to minutes released Sept. 21.
The agreement includes an appropriations trigger that would
require at least $20 million a year in "non-user fee funds," i.e.
federal funding, to be devoted to biosimilar product reviews. That
figure also would be adjusted for inflation, according to the
minutes. Without the federal money, FDA would not be allowed to
collect or spend biosimilar user fees.
A similar trigger is included in the Prescription Drug User Fee
Act legislation to ensure that user fees supplement, rather than
supplant, appropriations.
Assuming the agreement is ratified and the program launches in
FY 2013, Congress would be forced to devote significantly more
money to the biosimilar program. In FY 2011, only $1.8 million was
allocated. Still, FDA has stated it could accept biosimilar
applications and had been talking to several sponsors ("FDA “Busy” With Biosimilars; Sponsors Already In Pre-IND Meetings" — "The Pink Sheet," May 16, 2011).
The new user fee program also would be separate from the others,
namely PDUFA, according to the minutes.
The Generic Pharmaceutical Association and a Momenta
Pharmaceuticals representative argued at previous meetings that
Congress intended the program to remain part of PDUFA throughout
the first five-year program cycle. The Biotechnology Industry
Organization and Pharmaceutical Research and Manufacturers of
America disagreed, saying the intent was for a separate
program.
The issue lingered through a negotiating session in early
August, but appeared to be resolved by Aug. 8 ("Biosimilar Product Development Meetings With FDA To Be Flexible Under User Fee Program" — "The Pink Sheet" DAILY, Sep. 15, 2011).
Ratification Questions?
GPhA has ratified the agreement and BIO's board of directors is
considering it, according to officials at the two groups. PhRMA
refused to comment about the negotiations.
Ratification could become a thorny issue because of the nature
of the negotiations. FDA allowed any trade group or company with a
stake in the biosimilar market to sit at the negotiating table
because the sector is fragmented and still emerging in the U.S.
A relatively small group of stakeholders emerged during the
negotiations, including BIO, PhRMA and GPhA. Representatives from
10 pharmaceutical companies also attended the Aug. 17 and Aug. 26
meetings.
FDA did not respond to questions Sept. 22 about whether the
companies that participated in the negotiations will be required to
ratify the agreement. After it is ratified, the agreement will go
to the Department of Health and Human Services and White House for
clearance, then to Capitol Hill.
Ratification efforts also appear to have started about a month
later than FDA hoped. The agency had wanted to finish the talks by
the end of July ("Biosimilar User Fee Negotiations Under Way; Timetable Compressed" — "The Pink Sheet," Jul. 4, 2011).
The biosimilar user fee agreement likely will be included in an
omnibus user fee bill that also will include reauthorizations for
PDUFA and the Medical Device User Fee and Modernization Act, as
well as the new generic drug user fee program.
FDA and industry completed PDUFA negotiations in late March, but
added another provision in mid-May. Generic user fee negotiations
finished in early September ("ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five" — "The Pink Sheet," Sep. 12, 2011).
Fee Schedule Largely Resembles Original Agency
Proposal
The program would include an application fee, product fee and
establishment fee, according to minutes of an Aug. 17 negotiating
session. It also would include the new product development fee to
be collected annually as long as an application is in active
development. FDA proposed collecting the fee at that time of the
IND filing in order to support pre-marketing application scientific
activities at the agency.
FDA proposed setting the application, product and establishment
fees equal to the corresponding PDUFA amounts each fiscal year. The
product development fee would be 10% of the PDUFA application fee
in a given fiscal year, according to the Aug. 17 minutes.
FDA set the cost of an application requiring clinical data at
$1.842 million for FY 2012, an increase of 19% from the previous
year ("NDA, BLA Submissions Expected To Fall Again in FY 2011" — "The Pink Sheet" DAILY, Aug. 1, 2011).
The biosimilar user fee proposal largely fits with the agency's
original idea for the program. Biosimilar applicants were meant to
be charged the same as BLA sponsors, with some of the money
collected before the marketing application is filed ("Biosimilar User Fees Would Be Same As BLAs, Only Earlier" — "The Pink Sheet" DAILY, May 9, 2011).
GPhA had argued biosimilar fees should be 50% to 65% of the full
BLA fee, in part to reflect that biosimilar data packages are
expected to be less extensive ("Biosimilar Product Development Fee Should Be Temporary, Trade Groups Say" — "The Pink Sheet," Jun. 20, 2011).
FDA also intends to discount product development fee payments
from the marketing application charge. A reactivation fee, set at
twice the product development fee, also was included in the
proposal for applications that had fallen out of active development
after IND filing, but had been restarted, according to the Aug. 17
minutes.
Reactivation fees also would be subtracted from a marketing
application charge.
Performance goals also were set for the program, but not
specified in either set of meeting minutes. In addition to review,
major dispute resolution, clinical hold and meeting management
goals, both sides also agreed to a special protocol assessment goal
and created a new formal meeting to address stalled biosimilar
development programs.
Both sides already had decided meetings would not be required at
specific times or for specific purposes during the IND phase to
give sponsors more flexibility.
- Derrick Gingery (d.gingery@elsevier.com)
|