IMPORTATION OF DRUG PRODUCTS

To oppose wholesale importation of drug products as a method to lower drug costs.

Rationale

Recent efforts to rein in drug pricing have centered on proposals to allow the wholesale importation of drugs (meaning importation of drugs by healthcare providers and distributors on a larger scale, rather than by individuals on a small scale) from foreign countries (e.g., Canada) as a means to reduce patient costs. Although states (e.g., Florida and Colorado) have passed wholesale importation laws, those laws cannot take effect until the state has crafted an importation plan, the Food and Drug Administration (FDA) has signed off on it, and the Department of Health & Human Services (HHS) Secretary has made the required certification to Congress.

Current law allows wholesale importation only in very limited circumstances (i.e., shortages) and requires the HHS Secretary to certify to Congress that allowing importation of drugs will not put public health and safety at risk and that it will result in significant savings. No Secretary has ever been able to make such a certification.

ASHP believes that wholesale importation of drugs cannot be accomplished while: (1) maintaining the integrity of the pharmaceutical supply chain and avoiding the introduction of counterfeit products into the U.S.; (2) providing for continued patient access to pharmacist review of all medications and preserving the patient-pharmacist-prescriber relationship; and (3) providing adequate patient counseling and education, particularly to patients taking multiple high-risk medications. Further, wholesale importation is unlikely to result in significant cost savings and reduces focus on drug pricing solutions that can reduce prices over the long term.

Nothing in this policy should be construed to oppose personal importation of drugs, meaning when a person travels over international borders (e.g., to Canada, Mexico, etc.) to access medications. The policy also does not oppose importation of drugs and related medical devices to alleviate a drug shortage when such importation is overseen by the FDA.