Scrip 100 December 2008

POLICY & REGULATION
health policy advisor told a generics industry take time and money and is unlikely to have the generics sector. Representative Henry
meeting in September. Manufacturing quality any short-term impact on drug sales or Waxman, co-author of the 1984 law and a
problems at Ranbaxy’s Indian facilities and healthcare spending, experts said. good friend to the unbranded industry, won
ongoing reports of melamine-contaminated the chairmanship by successfully challenging
food from China have added to the public’s
year of the biosimilar?
the committee’s long-time Democratic leader
worries about foreign-sourced products.
The generics industry is positioned for strong
John Dingell.
“There’s an increasing awareness that
gains under an Obama Administration. The
While Mr Dingell has moved cautiously
just opening the borders to importation
country’s economic woes “put our industry
on biosimilars, Mr Waxman was the ﬁ rst to
raises serious safety concerns,” said Michael
front and centre, and it allows us to be able
introduce legislation in the House in 2006.
Ruggiero, senior director of government
to bring a very strong message to Congress
His proposal would provide no additional
policy and external affairs for Astellas Pharma
and the new administration that generics
marketing exclusivity to innovators, and he
US. “It’s what industry has been saying for
really are the solution to decrease healthcare
has repeatedly challenged the brand industry
a long time.”
costs and to increase access”, said Kathleen
to justify its need for additional protections
What an importation measure would look
Jaeger, president and CEO of the generics
beyond currently available exclusivities and
like is an open question. Any legislation that
trade group GPhA.
patent term extensions.
depends upon HHS certiﬁ cation that drugs
2009 marks the 25th anniversary of the
The generics industry also may gain
can be safely imported from certain countries
Hatch/Waxman law creating the ANDA
some leverage in its ﬁ ght against “carve-
seems hard to reconcile with the globalised
process for small molecules, and it could
out” practices that block automatic generic
nature of the pharmaceutical supply chain, the
become the legislative birth year for a
substitution for certain epilepsy, mental health
FDA’s widely publicised struggles to inspect
biosimilars approval pathway. “I believe there
and immunosuppression drugs in some
and regulate foreign drug manufacturing
will be a major effort to get that done,” BIO
state Medicaid programmes. Mr Obama has
operations and previous HHS leaders’ refusal
president and CEO Jim Greenwood said.
pledged his support to counter this practice,
to make such a certiﬁ cation.
“We do believe it’s going to move in
and states facing severe ﬁ nancial difﬁ culties in
2009,” Ms Jaeger said. “The new Congress
no NICE
the year ahead may be less willing to pay for
and the new administration understand that
more costly brand medicines.
While innovator groups publicly support it’s imperative that they establish an approval
The new administration and Congress
comparative effectiveness research, they pathway for biogenerics.”
will mean changes for the FDA beyond
harbour deep concerns over how it will be
the inevitable replacement of the agency’s
used and fear development of a system akin
to the UK’s National Institute for health and
Pharmaceutical manufacturers’
commissioner and other political appointees.
Clinical Excellence (NICE). direct-to-consumer advertising
Congressional passage of a measure to
give the FDA new powers and resources,
“Comparative clinical effectiveness
and other promotional
including user fees, to inspect and oversee
research should be used to help inform
physicians’ and health professionals’ clinical
practices are expected to face
foreign drug manufacturers is expected in
2009.
judgements and decisions rather than be
heightened scrutiny
Avalere’s Mr Mendelson said the incoming
used to make system-wide decisions that
administration will look to repeal or revise
could limit patients’ access to beneﬁ cial care,”
some rules passed late in the Bush era. The
the trade group PhRMA said in its principles Jake Hansen, Barr Pharmaceuticals’ senior
FDA’s controversial August rule governing
for healthcare reform. The research “should vice-president of global government affairs, is
the types of labelling revisions that can be
assess all points along the continuum of care more cautious on the timing. “I would hope
made through a “changes being effected”
to better inform healthcare decisions and at a minimum that we would be able to
supplement is ripe for modiﬁ cation or
improve patient outcomes”. advance the ball signiﬁ cantly, that there would
reversal, he predicted. Pharmaceutical
Comparative effectiveness proposals be legislation that our industry can support
manufacturers’ direct-to-consumer
have been ﬂ oated over the past few years, that would be introduced and moving along
advertising and other promotional practices
including one from Senate ﬁ nance committee and at least gotten through hearings” in 2009,
are expected to face heightened scrutiny
chairman Max Baucus that would create an he said.
from the FDA and Congress as well.
institute to identify national priorities for The innovative and generics sectors
During the past few years the FDA has
comparative clinical effectiveness research, still disagree on several key provisions,
felt the full force of Democratic lawmakers’
establish a research project agenda and particularly the marketing exclusivity
attacks against Bush Administration policies,
contract out studies. The measure would period for branded products. BIO’s
and some observers hope the adversarial
bar the institute from making coverage or Mr Greenwood said 14 years’ exclusivity is
relationship will ease under the Obama
reimbursement policies. needed to provide the necessary innovation
Astellas’ Mr Ruggiero said any comparative
incentives by allowing companies to recoup
Administration. “I’m certainly hopeful that the
effectiveness entity must operate with
their R&D costs and turn a proﬁ t, which
political environment will improve,” Astellas’
transparency and a broad range of
is necessary to attract investors. GPhA
Mr Ruggiero said. “A lot of the heat the FDA
stakeholder input, and not be aimed at
suggests the exclusivity term should more
has been taking has been politically driven.”
rationing care. “I don’t think the American
closely resemble the Hatch/Waxman model
public is interested in seeing that kind of a
of three to ﬁ ve years because the average
rationing entity as part of our healthcare
development time for biologicals is not
system. It seems contrary to what people
much longer than that for small molecules.
have grown accustomed to.”
The generics sector can be expected to
Mr Mendelson was conﬁ dent the Medicare
push back hard against any proposal with a
Sue Sutter is Scrip’s
programme would not go the way of
double-digit term of protection for branded
Washington editor.
requiring a cost-effectiveness evaluation for
products, Barr’s Mr Hansen said.
reimbursement. “We’re not going to NICE
The new leadership of the House energy
this year,” he said. Setting up an institute will
and commerce committee bodes well for
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