[Ip-health] FDA Budget includes Follow-on Biologic Pathway

[Sarah Rimmington]

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=46799

FDA $2.4B Budget Includes Follow-on Biologic Pathway


By Donna Young

Washington Editor

WASHINGTON - The Bush administration's proposed 2009 fiscal year budget
for the FDA includes not only a 5.7 percent increase but a plan to seek
authority to allow the agency to approve abbreviated applications for
certain biologic products, or follow-on biologics.

The administration is seeking $2.4 billion for the FDA for fiscal year
2009 as part of its record $3 trillion budget proposal unveiled Monday.

The FDA's budget includes $628 million in industry user fees, an
increase of $79 million over the current fiscal year. The lion's share
of that increase is for the prescription drug user fee program, Robert
Miller, deputy director of budget formulation and presentation in the
FDA's Office of Management, said Monday during a media briefing.

About $35 million of the user fees will be directed specifically to drug
safety activities, he told reporters.

Miller noted that a portion of the proposed user fee budget will go
toward reviewing certain television advertisements for prescription
drugs, a program that was created under the FDA Amendments Act of 2007,
which was enacted in September.

Because Congress failed to appropriate the initial funds necessary to
get the program off the ground under the 2008 budget, the FDA suspended
the program for the current year. (See BioWorld Today, Jan. 22, 2008.)

However, Miller said, the FDA is reproposing the funds in the 2009
budget and will work with lawmakers to ensure that the agency can
operate the commercial review program.

As part of the budget package, the administration said it is seeking
regulatory authority for the FDA to approve follow-on biologics, also
called biosimilars or biogenerics, which would be financed through user
fees.

Currently, no such approval pathway exists for follow-on biologics.

The House and the Senate both introduced follow-on biologics legislation
in 2007, with the Senate's bill moving the furthest by achieving passage
by the Health, Education, Labor and Pensions Committee. Lawmakers have
pledged to move the legislation forward in 2008.

Regulators were unable to provide details during Monday's media briefing
about the administration's plan to use user fees to support follow-on
biologic approvals.

"We don't have the specifics yet," said John Dyer, the FDA's deputy
commissioner for operations and chief operating officer.

The agency said it is drafting a legislative proposal that will include
the "necessary provisions to ensure the safety and effectiveness of
these biologic products for patients."

In a document titled "Other Legislative Items" that is part of the White
House fiscal year 2009 budget, the administration said the follow-on
biologic legislative proposal would include a "predictable and public
guidance process for licensing follow-on protein products" under the
Public Health Service Act.

"The proposal will prescribe the type of data required for FDA to review
applications for follow-on protein products and will require labeling
for the safety concerns related to the interchangeability of these
products," the Bush administration said.

The proposal also will include "adequate intellectual property
protections to preserve continued robust research into new and
innovative life-saving medications," the document stated.

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO),
said he was "pleased" that the administration included language in the
budget proposal calling for a pathway to approve follow-on biologics.

"BIO strongly believes that the FDA should have a pathway for the
approval of follow-on biologics, which protects patient safety and
promotes continued innovation," Greenwood said in a statement.

"The creation of a pathway for follow-on biologics is a top legislative
priority for BIO, and we are meeting with members of the House and
Senate to encourage them to consider and pass follow-on biologics
legislation this session," he added.

Kathleen Jaeger, CEO of the Generic Pharmaceutical Association (GPhA),
also praised the budget plan's follow-on biologics measure.

"We welcome the news that the administration has endorsed the fact that
FDA has the scientific expertise to establish a safe and workable
regulatory approval pathway for biogenerics," Jaeger said in a
statement. She called on the Bush administration to require the FDA to
"provide timely access" to follow-on biologics.

"A pathway filled with roadblocks to access, including excessive market
exclusivity provisions, is an empty promise for countless patients who
need these affordable life-saving medicines," Jaeger contended.

She noted that the FDA budget package includes a proposal to allow the
agency to collect $16.6 million in user fees from makers of generic
drugs to support the review process for those medications.

The generic drug user fee program would provide "urgent" increased
resources necessary to respond to the growing number of abbreviated new
drug applications, the FDA said.

Regulators first sought approval of the program last year under the Bush
administration's 2008 budget.

Not proceeding with the user fees for the generic drug review program
will result in "the inability to capture significant savings from
generic drug use," the FDA argued, adding that government health care
programs rely on the availability of generic drugs to hold down costs.

GPhA supports the generic drug user fee program, Jaeger said. But, she
added, "to truly benefit consumers, the program must be effective and
remove longstanding barriers to access."

Although the White House is proposing a 5.7 percent increase in the
FDA's budget, some consumer groups and lawmakers called the raise
insufficient to improve the embattled agency.

"The amount in the administration's proposed budget is not only
inadequate, it is barely half of what FDA needs just to keep pace with
inflation," said William Hubbard, a former FDA deputy commissioner and a
member of the Alliance for a Stronger FDA, a 170-member organization
that has pushed for increased funding for the agency.

"The FDA's ability to fulfill its mission could be in serious jeopardy
if additional increases aren't enacted," Hubbard said. "This proposed
budget would likely force the agency into further staff decreases, at a
time when it is urgent to increase staff."

Lawmakers Reps. Henry A. Waxman (D-Calif.), John D. Dingell (D-Mich.),
Bart Stupak (D-Mich.) and Frank Pallone Jr. (D-N.J.) argued that the
proposed FDA budget "barely covers the cost of inflation and continues
the trend of the inadequate budgets of previous years that have led to
the current crisis at the agency."

The congressmen called on the FDA's Science Board Subcommittee on
Science and Technology to assess whether the FDA budget package would
provide the resources needed to correct the serious deficiencies
revealed late last year in a report authored by the panel.

In the report, the subcommittee criticized the FDA for allowing its
scientific base to erode and called the agency's scientific
organizational structure weak.

Although the subcommittee recently disbanded and no longer exists as a
formal entity, the lawmakers urged the group to reconvene to review the
Bush administration's FDA budget proposal.

"We want to ensure that funding for FDA is sufficient to permit the
agency to fulfill its many regulatory responsibilities," the lawmakers
said in a letter to the group.

Published  February 6, 2008

--
Sarah Rimmington
Attorney
Essential Action, Access to Medicines Project
Washington, DC
Tel: (202) 387-8030
Cell: (202) 422-2687
www.essentialaction.org/access/