Importation of Prescription Medicines

HDMA’s Position:
HDMA is opposed to permitting the commercial importation of pharmaceuticals into the United States. Importation, whether restricted to Canada or a select list of other countries, significantly increases the likelihood of counterfeit or adulterated prescription medicines entering the U.S. marketplace and puts patients at risk.  HDMA believes that instead of exposing U.S. patients to such risks, Congress should act to further enhance the safety and security of the domestic supply chain through enactment of uniform federal prescription drug pedigree requirements.

Issue:
The presence of counterfeit medicines in other, less regulated countries puts U.S. patients at risk. For example, according to the World Health Organization (WHO), in many Latin American, African and Asian countries, more than 30 percent of prescription medicines can be counterfeit. The WHO also found that purchases from illegal Internet sites are counterfeit more than half the time.

HDMA distributor members serve as a vital link in the healthcare supply chain by ensuring product integrity and providing the highest-quality medicines and services, ensuring that costs are as low as possible and enabling providers to deliver care more effectively to patients. Patient safety and product integrity will suffer as a result of prescription medicine importation.

HDMA supports enacting a uniform federal pedigree requirement as a necessary step to further enhance the security of the nation’s prescription medicine supply chain. A practical and comprehensive federal approach will increase safety, facilitate efficient interstate commerce and minimize the inconsistencies among competing state requirements. Before considering importation of potentially dangerous products from under-regulated countries, Congress should first focus on achieving national uniformity that will help combat threats to the safety of the supply chain; utilize the most effective technologies to help stop counterfeiting and diversion of prescription medicines; and facilitate efficient interstate commerce.

While some Congressional importation proposals include attempts to include additional safety measures, they do not provide for practical, achievable solutions such as those envisioned by the industry and states such as Maryland and California. 

Additional Background:

• HDMA does not support commercial importation of medicines whether by wholesale distribution companies, pharmacists or individuals.
• Limiting personal or commercial importation from a specific country or countries does not diminish the likelihood of counterfeit or adulterated drugs entering the U.S., nor will it assure significant reductions in the costs of prescription drugs.
• HDMA members have serious concerns that imported prescription medicines may not have been properly stored and handled, and that they may have been tampered with or mislabeled.
• For more information on risks associated with counterfeits, please also see FDA’s Web site by clicking here

About HDMA
HDMA is the national association representing primary healthcare distributors, the vital link in the healthcare system. Each business day, HDMA member companies ensure that more than nine million prescription medicines and healthcare products are delivered safely and efficiently to more than 164,000 pharmacies, hospitals, nursing homes, clinics and others nationwide. HDMA and its members work daily to provide value and contain costs, saving the nation's healthcare system an estimated $32 billion per year.