College of Law > Academics > Centers, Institutes & Initiatives > Mary and Michael Jaharis Health Law Institute > e-Pulse Blog > Legalization of Personal Prescription Drug Importation: As Prescription Drug Prices Soar, Americans Look Outside the U.S. for Savings

Legalization of Personal Prescription Drug Importation: As Prescription Drug Prices Soar, Americans Look Outside the U.S. for Savings

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.