Baltimore Mayor Martin O'Malley announced recently in his
gubernatorial campaign that he will consider buying prescription drugs
from Canada and abroad as a way to reduce health care costs for
Marylanders. But that policy can potentially harm both consumers and
the economics of drug creation and sale in the United States.

Those unsolicited and poorly worded offers for Cialis and Viagra in
our e-mail inboxes say it all.

Drug re-importation is one situation where the invisible hand will not
solve the problem. The key prefix is the "re-" in reimportation. The
United States develops, creates and produces the bulk of the world's
drugs. Foreign governments legally purchase drugs from American
companies at discount prices and then set their own prices at home
(translation: price controls). Were Maryland to allow drug
re-importation, American firms would continue to assume the worldwide
burden of drug research and development but at a profit margin that
did not take those efforts into account.

And how does Mayor O'Malley plan to ensure that drugs coming in are
safe? This policy move cannot just be made in isolation. Federal
approval is required. Further, when American-produced prescription
drugs make their way back into this country, they will have passed
through multiple hands, increasing the risk of tampering and
counterfeiting.

To guarantee drug safety, the Food and Drug Administration would have
to investigate (and test) drugs for tampering and counterfeiting,
which would create a heavier government and taxpayer burden and
ultimately a less favorable environment for the creation of effective
medicines. The FDA does not regulate drugs obtained in foreign
markets, and describes the medical and economic drawbacks of using
these drugs on its Web site.

Randall W. Lutter, Ph.D., FDA's associate commissioner for policy and
planning told this to would-be re-importer Steven M. Saxe, director of
the Washington State Board of Pharmacy: "FDA is very concerned about
the safety risks associated with the importation of prescription drugs
from foreign countries. In our experience, many drugs obtained from
foreign sources that are represented as U.S.-approved prescription
drugs are of unknown origin and quality."

By law, if a prescription drug is originally manufactured in this
country and exported, only the United States manufacturer may import
the drug back into the United States.

In order for O'Malley to push through what he proposes, he would need
to obtain a waiver from the FDA, which is unlikely due to the agency's
consistent refusal to approve such applications elsewhere in the
United States.

The FDA is aware of patients' concerns about access to effective,
low-cost medication. Lutter said the FDA is working to change "our
regulations to reduce litigation that unnecessarily delays access to
more affordable generic drugs, and doubling the annual number of
generic drug approvals over the last five years." As an alternative,
in the meantime, numerous direct patient assistance programs exist to
help mitigate costs for consumers, such as those administered by
Lilly, Pfizer and the Partnership for Prescription Assistance in
Maryland.

Living in America is a trade-off where the prescription drug market is
concerned and not necessarily a good one. We have a broad range of
effective, cutting-edge choices, but many essential medications are
pricey because we shoulder the majority of research and development
worldwide. As a result, right or wrong, we aren't just paying for the
pill itself; we also pay for its years of testing and research and for
pills that never reach the market.

But buying medicine from abroad is not the answer. The regulatory
machinery that would be required to ensure the safety of imported
medicine would be expensive, lengthy to create and erase any potential
price benefits. The problem of high drug prices can only begin to be
solved when other countries start to devote more funds to research and
development and pharmaceutical companies here price brand-name
prescriptions more consistently.

Labels: No Prescription, Online Pharmacy, Prescription Drugs

# posted by Network @ 9:23 AM