Innovation in medicine offers great hope for improving lives, and pharmaceutical research companies are making every possible
effort to fight life-threatening diseases to ensure people's health. Unfortunately, consumers do not always have affordable
access to prescription drugs that can help treat their medical conditions.
In the United States, 15 to 25% of the population has reported not filling a prescription on time and/or reducing a prescribed
dosage due to cost (1, 2). Although the US Medicare Prescription Drug, Improvement, and Modernization Act (MMA), enacted in
2003, provided the largest overhaul to date of America's public health program, many beneficiaries still face challenges in
getting healthcare and medication benefits (3, 4). And while the Affordable Care Act of 2010 increased benefits and access
for Medicare beneficiaries, many of the legislation's overhauls have yet to be implemented.
As a result, many Americans continue to purchase drugs outside US borders at a lesser cost. Many of the drugs bought abroad
were actually approved by FDA, manufactured in the US, and sold to other countries. Canada, in particular, is a prime recipient
of such products. When these drugs are sold to Americans who bring them back into the US, they become illegally imported and
hence are referred to as "reimported drugs."
Brand-name drugs that are manufactured in foreign countries, on the other hand, can be legally imported into the US if
they comply with the Food, Drug, and Cosmetic Act (FD&C Act). This process is often referred to as "drug importation." Under
the FD&C Act, any entity that intends to import prescription drugs into the US must ensure that the drug products are FDA-approved,
meet all US manufacturing and labeling requirements, and do not violate the FD&C Act's import and and export section (5).
Although there is always some concern about the safety and quality of imported drugs, reimported drugs, in particular, carry
more potential for being illegitimate and unsafe. Specifically, they may lack proper authentication, originate from unreliable
outlets, be expired or contaminated, and lack correct dose information or directions for use. FDA has traced multiple violations
of drug reimportation laws and found that most reimported drugs do not include the required label information.
Nevertheless, for many US residents, financial concerns outweigh the risks of prescription drug reimportation. There is a
need, therefore, to prevent consumers from falling prey to online marketing of unsafe drugs.
In 2000, the US Congress passed the Medicine Equity and Drug Safety (MEDS) Act to provide Americans with a legal means to
obtain low-cost prescription drugs from industrialized countries. Later, MMA sought to prevent Americans from seeking less
expensive drugs from Canada by authorizing drug reimportation, but providing veto authority to the US Secretary of Health
and Human Services over its implementation, and to date, the secretary has used this veto power (6). Thus, MMA has not enabled
safe drug reimportation.
In 2009, US Senator Byron Dorgan (D-ND) pushed to include drug importation in President Obama's healthcare reform bill. Dorgan's
legislation, called the Pharmaceutical Market Access and Drug Safety Act of 2009 (PMADS), was designed to establish a system
for American consumers to import low-cost prescription drugs safely (7). The PMADS Act was designed to legalize reimportation
as well. The amendment is still in legislative process.
The President's Fiscal Year 2010 budget request included $5 million to allow FDA to begin working with various stakeholders
to develop policy options related to drug importation (8).
FY2011 budget provides $2.5 billion in budget authority and $4 billion in total program resources for FDA in this regard.
The funds include efforts to bring more safe, effective, and low-cost generic drugs (including follow-on biologics) to the
US market (9). These activities will ultimately help to make safe drugs more affordable and readily available to American