February 27, 2012 - IMM@BUCT

GOVERNMENT & POLICY
FDA USER FEES SWELL
Agency proposes HUGE INCREASE in industrypaid
fees to ensure food, drug safety
BRITT E. ERICKSON , C&EN WASHINGTON
UNDER PRESIDENT Barack Obama’s proposed
fiscal 2013 budget , the Food & Drug
Administration would receive a total of
$4.5 billion—an increase of $654 million, or
17.1%, compared with 2012. The bulk of the
increase, $643 million, would come from
industry-paid user fees.
In 2013, FDA would receive a total of
$2.0 billion in user fees, a 48.5% increase
from 2012. The agency’s $2.5 billion in allocated
money, on the other hand, is only
0.4% higher than the 2012 level.
The projected increase in user fees for
2013 includes first-ever fees for food, food
packaging, cosmetics, generic drugs, and
biosimilars, or generic-like versions of
complex biological drugs. Congress has to
approve the proposed fees, and it also needs
to reauthorize existing user fee programs
for prescription drugs and medical devices
by Sept. 30, the end of this fiscal year.
Food safety would continue to be a priority
for FDA in 2013 under the proposed
budget. The agency is asking for $220 million
from the food industry in new registration
and inspection user fees to beef up
inspections of food facilities and the review
of imported food as required under the
Food Safety Modernization Act.
It is unclear whether Congress will go
along with the proposed food-safety user
fees. Similar fees were included in early
versions of the food-safety legislation, but
they did not make it into the final bill that
was signed into law last year.
Increased globalization of the foodpackaging
market has also prompted FDA
to propose $5 million in new user fees to
support FDA’s safety review of new foodpackaging
materials. And FDA is requesting
$19 million in new user fees for cosmetics.
The money would be used to enhance
international activities, improve outreach
and communications, and strengthen science
in FDA’s cosmetics program.
For the first time, FDA is asking for
$299 million in new user fees from manufacturers
of generic drugs. The money
would be put toward speeding up the review
of low-cost generic drugs. Under the
proposed budget, FDA would also receive
$20 million from manufacturers of biosimilars
to help cover the cost of reviewing
the safety and efficacy of those products.
In terms of existing user fee programs,
FDA would receive $713 million from prescription
drug manufacturers, an increase
of $11 million or 1.6% compared with 2012.
The budget proposal also includes $70 million
in medical device user fees, an increase
of $12 million or 20.7% compared with
2012. FDA, however, is still working out the
agreement with the medical device industry
regarding user fees for 2013. The agency
anticipates that the medical device fees will
actually be higher than what is reflected in
the proposed budget.
It is now up to Congress to reauthorize
the Prescription Drug User Fee Act and the
Medical Device User Fee & Modernization
Act, as well as consider the host of other
fees proposed by FDA for 2013. Lawmakers
in the House of Representatives are already
working on legislation to authorize such
fees. Rep. Tim Murphy (R-Pa.) introduced
the Generic Drug & Biosimilar User Fee Act
(H.R. 3988) earlier this month. Prescription
drug and medical device user fee bills are
expected to be introduced soon.
THE HOUSE Energy & Commerce Subcommittee
on Health held three hearings
earlier this month to consider FDA user
fees for prescription drugs, generic drugs
and biosimilars, and medical devices.
Members used the opportunity to address
a laundry list of concerns related to FDA’s
USER FEES
Industry-paid fees are slated to grow significantly
$ MILLIONS 2011 a 2012 b 2013 c 2012–13
CHANGE
Prescription drug $667 $702 $713 1.6%
Family Smoking Prevention & Tobacco
450 477 505 5.9
Control Act
Human generic drug d 0 0 299 nm
Food registration & inspection d 0 0 220 nm
Medical device 62 58 70 20.7
Animal drug 19 22 31 40.9
Biosimilars d 0 0 20 nm
Cosmetics d 0 0 19 nm
Mammography Quality Standards Act 19 19 19 0.0
Food reinspection 0 15 15 0.0
Medical products reinspection d 0 0 15 nm
Food recall 0 12 13 8.3
Animal generic drug 5 6 8 33.3
Color Certification Fund 8 8 8 0.0
International courier d 0 0 6 nm
Export Certification Fund 3 3 5 66.7
Food-contact notification d 0 0 5 nm
Priority review voucher 0 5 0 -100.0
TOTAL USER FEES $1,233 $1,326 $1,969 48.5%
NOTE: Totals may not sum because of rounding. a Actual. b Enacted. c Proposed. d New user fee proposed for 2013.
nm = not meaningful. SOURCE: Department of Health & Human Services
“We are concerned that if a national system doesn’t go into
place, we run the risk of having a patchwork of state laws.”
WWW.CEN-ONLINE.ORG 48 FEBRUARY 27, 2012