Critical health care issues were front
and center in Congress during 2007 and
will likely drive the domestic debate in
the 2008 election year. Many of these
issues affect the generic pharmaceutical
industry, pharmacists, and patients
across the country.
Looking back at 2007, the generic
industry had a very productive year, from
the introduction of groundbreaking biogenerics
legislation to efforts to stop proposals
that would have harmed patient
access to safe and affordable generic
The progress made on legislation to
create an FDA approval pathway for biogenerics
was extraordinary. More than
70 diverse organizations representing
consumers, older Americans, businesses,
and patients joined us in the fight to bring
lifesaving biogenerics to those in need.
And, in spite of intense pressure from
our opponents, legislation was approved
by a Senate committee within 5 months,
which is remarkable progress for new
Although much work still needs to be
done?particularly in ensuring that market
exclusivity provisions do not needlessly
keep biogenerics from patients?
we were pleased by the commitment
from lawmakers to move biogenerics
legislation forward in 2008. With momentum
growing and patients needing
access, real potential exists to pass legislation
that will give patients timely
access to biogeneric medicines.
2007 also saw the enactment of legislation
to stop the long-standing practice
of brand companies using citizen petitions
to keep generics out of the hands of
patients. As part of an FDA reform bill
signed into law, brand companies will
find it more difficult to use citizen petitions
to block generic competition. The
FDA is now required to review petitions
within a 6-month time period and consider
generic applications and petitions
simultaneously. This important new law
took 1 tool out of the brand company
arsenal in delaying access to generics.
In addition, great progress was
achieved on the trade agreement front.
Last spring, Congress and the Bush
administration unveiled the bipartisan
New Trade Policy for America which took
a major step forward in ensuring that our
trade agreements recognize the critical
balance between ensuring access to
safe and affordable medicines and fostering
pharmaceutical innovation. This
past fall, Congress approved the U.S.-Peru Free Trade Agreement. This new
agreement demonstrates that bringing
competition into the pharmaceutical
marketplace results in lower patient
costs without stifling innovation.
In fact, as generic competition has
grown in the United States, so has investment
by brand companies in new drug
development, with new blockbuster
drugs regularly coming to market.We are
now hearing the federal government saying
that the free trade agreements
should reflect the balance between
access and innovation that the domestic
market has achieved.
Additionally, as the backlog of generic
drug applications continues to grow, we
successfully worked to increase funding
for the FDA?s Office of Generic Drugs. We
also thwarted an attempt to increase
the Medicaid rebate for generic drugs,
and convinced lawmakers not to include
major windfalls for brand pharmaceutical
companies as part of an amendment
concerning antibiotics and enantiomers.
Finally, we are spending considerable
time on the issue of pharmacy reimbursement
and the calculation of the Average
Manufacturer Price. While we submitted
extensive comments to the Centers for
Medicare & Medicaid Services, the final
rule published in July 2007 did not
address many of our stated concerns. We
are working with a coalition that includes
the National Association of Chain Drug
Stores, the National Community Pharmacists
Association, and many others to
promote legislation that would revise the
rule so that it will not adversely affect
patients? access to generic medicines.
We have also been active in state legislatures
across the country beating back
attempts to pass carve-out legislation.
Brand companies are trying to take steps
to block generic substitution on various
mental health and HIV/AIDS drugs, at
substantial cost to states and patients.
We were successful in 2007, but we are
already seeing signs that brand companies
will continue to promote carve-outs
in 2008. We will be back to ensure that
access is not jeopardized.
It is clear that 2008 will be another
busy year for the generic pharmaceutical
industry, and we will be delivering the
message loud and clear that generics are
the right choice for better health.