US Pharm.
2008;33(6)(Generic Drug Review suppl):3.
Q: While their approaches
differ, both Democratic hopefuls Senators Barack Obama and Hillary Clinton are
calling for reformation of the United States health care system by instituting
a "universal health care" model. What role do you see the generic industry
playing in this kind of health care model if a Democrat wins the presidential
election in November?
A: Health care is a key
domestic issue in the presidential elections, and both parties are clearly
looking for solutions to reducing health care costs while increasing access to
quality care. We're particularly pleased to hear our presidential candidates
express support for access to generic medicines as a means to obtain the same
medicine with the same results as the brand, but at a significantly lower
cost.
And, given that Senators
Clinton, McCain, and Obama recognize that generic medicines help make health
care more affordable and improve patient health, the generic industry looks
forward to working with the next president on increasing access to generics.
Q: The Drug Price
Competition and Patent Term Restoration Act, better known as the Hatch-Waxman
Act, will be celebrating 25 years since its introduction in 1984. While the
Act revolutionized the generic pharmaceutical industry, some critics say that
there are too many loopholes in it to compete in today's business and economic
climate and that the Act could really use an overhaul. Do you agree with this
statement? What do you think should be changed in the Act that would benefit
consumers' access to generic drugs?
A: One of GPhA's priorities is
to establish a workable FDA approval pathway that provides timely access to
safe and affordable biogenerics to Americans in need of these life-saving
medicines. A workable approval pathway is one without barriers that can
significantly delay an affordable biogeneric from reaching patients in need.
This means that patent disputes must be resolved in a timely manner; that the
filing of frivolous citizen petitions should not delay a biogeneric's
approval; and that market-exclusivity periods should not be used to stretch
patents into indefinite product monopolies, among other concerns.
It is also important to remove
the long-standing barriers to consumer access to generics. To do so, we should
ensure that citizen petitions do not delay consumer access to generics;
improve scientific consults to facilitate timely review of generic
applications; enhance communications through additional meetings; increase
inspection resources; and require more accountability from the Office of
Generic Drugs.
Q: Despite the fact that
many legislators are taking a positive position on the approval of
"biogenerics," the FDA and other regulating bodies have their doubts that
biogenerics can be 100% substitutable for their branded counterparts. Do you
believe that this statement is true? What do you see for the future of
biogenerics?
A: As FDA itself has stated,
the science has reached a point where the agency has the ability to determine
whether biopharmaceuticals, brand or generic, are the same or slightly
different. Today, FDA has the scientific expertise to determine on a
case-by-case basis whether a brand or generic biopharmaceutical is safe and
effective. In fact, the FDA establishes interchangeability each time an
innovator company makes postapproval changes, such as changing a manufacturing
process or cell line. The FDA uses sound science to determine if the level of
"sameness" is acceptable or not. The same science that FDA applies to brands
applies equally to biogenerics.
Further, FDA has established
interchangeability for some simple proteins regulated under the Federal Food,
Drug, and Cosmetic Act.
Q: Now that Medicare Part D
is firmly entrenched in the U.S. health care system's landscape, do you think
that the legislation has had an overall positive effect on the health care
system as it pertains to the generic drug industry?
A: The important question is
whether Medicare Part D is helping to provide older Americans with access to
affordable medicinesñand that answer is yes. Generics have played a key role
in providing this critical access while also reducing the overall costs of
medicines under the Medicare Part D program. This is particularly true among
seniors who fall into the so-called "doughnut hole"ñthe period when many
Medicare beneficiaries switch from making copayments to having Medicare pay
all of their costs for medicines.
Acceptance of generic drugs
has grown during the last few years, too. Today the industry provides 65% of
all prescriptions dispensed, yet they account for only 20% of the costs.
