The issue of high priced prescription drugs is a difficult
reality that many American consumers face on a regular basis.
The high costs of prescription drugs are
prohibitive to some Americans and have forced consumers to look for alternative
methods to obtain the medications they require.
One alternative method is to import
prescription drugs for personal use from Canada, Mexico, and overseas.
This
method has seen increasing popularity, despite the fact that the importing
of prescription drugs for personal use is illegal.
The Food and Drug Administration (“FDA”) has made the
importation of prescription drugs for personal use illegal for good reason:
because most of the drugs being imported from other countries have not been
subjected to FDA approval. In order to
obtain FDA approval, a drug must be
demonstrated as both safe and effective for its intended use through
clinical testing. By ensuring that drugs
are safe and effective, the FDA is protecting the public. The FDA loses its ability to protect the
public when the public gains access to drugs that have not undergone the FDA
approval process. When drugs come from
outside of the United States, and therefore outside of the FDA approval
process, the FDA cannot guarantee the safety, efficacy, and legitimacy of the
drugs, the FDA cannot detect the origin of the drugs and the FDA cannot assure
that the drugs were manufactured under proper conditions.
As a general rule, the FDA works to protect the public from
the unknown aspects of drugs coming from outside of the United States. Yet as expressed through FDA Guidance, the
general rule against importation of prescription drugs for personal use is not
an inflexible one. If certain
circumstances are met, the FDA may choose to allow individuals to import drugs
the FDA has not approved for personal use. Those circumstances include: (1) the drug is
for use for a serious condition for which effective treatment is not available
in the United States; (2) there is no commercialization or promotion of the
drug to U.S. residents; (3) the drug is considered not to represent an
unreasonable risk; (4) the individual importing the drug verifies in writing
that it is for his or her own use, and provides contact information for the
doctor providing treatment or shows the product is for the continuation of
treatment begun in a foreign country; and (5) generally, not more than a three month supply of the drug is imported. The Guidance explicitly states that whether to
allow an importation for personal use to occur is in the discretion of FDA
personnel and should be decided on a case-by-case basis. The
Guidance is not meant to be interpreted as a license to individuals to
import drugs that have not been approved by the FDA, but simply to give
individuals a chance to import such drugs when specific criteria are met and
the FDA approves the specific importation.
Many consumers and legislators have been calling for legal
reform in this area because the high price of prescription drugs has placed a
huge strain on American consumers, with some consumers unable to purchase their
prescribed medications at all. Other
countries, such as Canada, impose price restrictions which limit what
pharmacies can charge for prescription drugs, which can lead to the drugs being
much cheaper compared to their prices in the United States, as
much as 55% cheaper. Because of the
large price differences, consumers have become willing to risk the legality of
their actions and legislators have been pushing for reform. Several
bills have been introduced in both the U.S. House of Representatives and
the U.S. Senate involving the importation of prescription drugs for personal
use in the past, but none have become law to date. Currently, the 114th
Congress is considering some bills which may help to legalize personal
prescription drug importation.
But the current legal landscape remains: importing
prescription drugs for personal use is illegal. FDA approval, although a rigorous process,
which arguably raises drug prices, is a necessary process if American consumers
want the prescription medications they are ingesting to be proven both safe and
effective for their intended uses. The
reality of soaring prescription drug prices is a tough pill to swallow, but as
of now, personal prescription drug importation remains illegal, and if
Americans wish to consume only safe and efficacious medications, they should
stick to obtaining their prescription drugs in the United States.
Lacey Rogers is a third year student at DePaul University
College of Law in Chicago, Illinois. Ms. Rogers expects to receive her J.D. and
a certificate in health law in May of 2017.