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.

An American nicotine drink being marketed as a cigarette substitute
would only be sold with a prescription if it hit the shelves in
Canada, according to Health Canada.

Health Canada spokeswoman Nathalie Lalonde said it had previously
stated that Nic Lite would fall under the definition of a natural
health product because nicotine is a natural chemical substance
derived from tobacco plants. Products containing nicotine with a dose
equal or lower than four milligrams per serving - equivalent to the
amount found in Nic Lite - are regulated as over the counter natural
health products.

"However, this only applies to certain dosage forms, such as gums and
lozenges, and not products in liquid form (such as Nic Lite)," Lalonde
wrote in an e-mail to The Canadian Press.

Lalonde said all health products must also undergo a thorough
pre-market review by Health Canada before they're approved for sale.

"Only where there is sufficient evidence supporting the safe and
effective use of a product will the product be authorized for sale in
Canada," Lalonde wrote.

Nic Lite is a lemon-flavoured drink that contains organic nicotine
equivalent to the amount found in two cigarettes.

Joseph Knight, CEO of California-based Nico Worldwide Inc., the makers
of Nic Lite, said that his company has filed an application to Health
Canada to bring the product to Canada.

"We're hoping that in the next two to three months we would have our
clearances in place," Knight told The Canadian Press in a phone
interview last week from Oxnard, Calif.

Knight said Nic Lite was designed to be used by smokers to help them
when they can't smoke.

The product is also being touted as a way to cope with smoking bans.

In a statement released in June, the makers of Nic Lite said they plan
to roll out the product in more than 50 U.S. airports, targeting
nicotine-addicted airline passengers facing smoke-free flights and
long periods where they may be unable to light up.

But Nico Worldwide Inc. may have been dealt a blow in distributing the
product in the United States. The U.S. Food and Drug Administration
told the company in June that Nic Lite doesn't meet the definition of
a dietary supplement.

"The product is considered an unapproved new drug," FDA spokeswoman
Laura Alvey wrote in an e-mail to The Canadian Press. "The company is
in violation of the (Food Drug and Cosmetic) Act in continuing to
market the product as a dietary supplement."

Nico Worldwide had cited a 1993 New England Journal of Medicine
article which stated that nicotine is a naturally occurring compound
in many vegetables including cauliflower, eggplant and tomatoes, to
support its dietary supplement claim.

Knight has said the FDA originally approved Nic Lite in 2004 and that
his company's lawyers plan to meet with the government agency in
Washington.