The National Association of Boards of Pharmacy® (NABP®) has signed the Partnership for Safe Medicines’ (PSM) letter to United States senators to show its support of PSM’s stance that the Prescription Drug User Fee Act should not be amended to allow drug importation by individual consumers. By allowing importation, the secure US drug supply chain is undermined, putting Americans at great risk.
While importation advocates believe that drugs purchased from Canada and the United Kingdom are safe because of those countries’ strict regulations, PSM and NABP point out that there are no regulations in place for products trans-shipped through these countries. Importation of Food and Drug Administration (FDA)-approved drugs from countries like Canada could endanger the US medicine supply because of the lack of FDA jurisdiction over foreign supply chains. In fact, FDA and the European Commission have both reported that consumers who purchase drugs from overseas put themselves at great risk. PSM’s letter cites a 2009 letter issued by FDA Commissioner Margaret Hamburg, MD, who stated, “In establishing an infrastructure for the importation of prescription drugs, there are two critical challenges in addressing these risks. First, FDA does not have clear authority over foreign supply chains. . . Second, FDA review of both the drugs and the facilities would be very costly.” A 2006 study from the European Commission also cited several issues that create risks for consumers including problems with packaging and labeling, communicating product recalls, the complexity of distribution channels, and the difficulty in effectively enforcing the law.
NABP has long argued the importance of maintaining a closed drug distribution system in order to maintain access to safe medicines. In 2003, the Association released a position paper on the importation of foreign prescription drugs expressing deep concern for the allowance of importation. At that time, too, NABP urged Congress to keep the system closed to protect patients.
Even at home, keeping the prescription drug distribution system safe requires constant vigilance from regulators. In fact, at the urging of FDA, in 2005 NABP launched the Verified-Accredited Wholesale Distributors® (VAWD®) accreditation program, which helps ensure that the wholesale distribution facility operates legitimately, is licensed in good standing, and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions. With over 500 accredited facilities, the accreditation program helps protect the public from drugs that have been contaminated, diverted, or counterfeited.
With NABP’s findings that 97% of Web sites selling prescription drugs to consumers online are not legitimate, buying online requires savvy shoppers, a situation that will be further exacerbated if importation is allowed. NABP’s research shows that many Web sites purporting to be “safe” Canadian online pharmacies are in fact rogue drug sellers. To assist consumers in identifying online pharmacies from which they can safely buy prescription drugs, NABP operates the Verified Internet Pharmacy Practice SitesCM (VIPPS®) accreditation program and posts accredited sites on www.nabp.net as well as on www.AWARErx.org, the Web site for the Association’s consumer protection program, AWARXE®. NABP also posts its list of Not Recommended sites where consumers can check to see if the site from which they plan to purchase does not meet NABP practice standards or does not comply with state and federal law.
NABP is the independent, international, and impartial Association that assists its member state boards and jurisdictions in developing, implementing, and enforcing uniform standards for the purpose of protecting the public health.