There are several prescription drug importation bills now pending in Congress that would allow foreign medicines that are not approved by the Food and Drug Administration to enter U.S. borders. These proposals could open the U.S. drug supply system to potentially dangerous and counterfeit foreign medicines that could harm American patients.

To find out how these proposals could endanger the lives of American patients and compromise the relatively safe drug supply system in the U.S., please read below.

Consequences of Importation
on Patient Health

How the System Works Under Current Law
• Under current law, pharmaceutical companies in the U.S. strictly control the manufacturing and distribution processes to ensure their products are not compromised and counterfeits do not enter the system.
• In many cases, a pharmaceutical company may import a prescription drug into the U.S. itself to help ensure control over handling, storage, shipping and transportation, or it may carefully select another party to manage imports. These controls help to ensure that the safety and efficacy of any prescription drug is not
compromised.

How it Would Work if Importation Schemes Were Passed
• Importation bills now being considered by Congress would permit U.S. wholesalers and pharmacies to purchase foreign drugs from entities that may not be regulated under either U.S. or foreign law.
• If enacted, the bills would impact the closed drug supply system by allowing the distribution of medicines that had been circulated by third parties overseas, outside the jurisdiction of the Food and Drug Administration (FDA) and beyond the control of the pharmaceutical company.

Patient Health Could be at Risk
• Imported medicines could put at risk the health of American patients who may unknowingly receive a counterfeit medicine that could contain the wrong amount of active ingredient, no active ingredient, or a toxic substitute.
• Patient harm could also occur if a foreign drug had a different potency than the FDA-approved drug or if it was shipped, stored, or handled in a way that could introduce contaminants or affect its purity or stability. Any labeling or dosing differences could also cause consumer confusion and could result in medication
errors.

Who will be Liable for Patient Harm?
• If patients are harmed or seriously injured by imported counterfeit medicines, the parties involved in the drug’s manufacture, import, distribution and delivery to the patient could be subject to lawsuits even if they were unable to prevent the injury.
• At the same time, those responsible for selling counterfeit medicine may not be held liable because they may be unknown, in a foreign country, or have sought liability waivers from U.S. consumers.
• In fact, it is common for Canadian internet sellers to force American patients to waive their right to the protection of U.S. product liability laws.

Conclusion
American patients deserve better. Members of Congress should carefully consider the dangers these bills pose to patients before they move forward with any importation scheme.