190409 s 61 senate
April 09, 2019
TO THE MEMBERS OF THE UNITED STATES SENATE:
The U.S. Chamber of Commerce believes it is important to maintain the safety and integrity of America’s drug supply and, therefore, strongly opposes S. 61, the “Safe and Affordable Drugs from Canada Act of 2019.” This legislation would allow the importation of foreign pharmaceuticals into the United States and undermine the preemptive authority of federal food and drug regulations. Members that do not cosponsor this legislation will receive credit as part of the leadership component of their rating in the Chamber’s “How They Voted” Congressional scorecard.
Changes in law to allow individual importation and distribution of drugs not approved by the Food and Drug Administration (FDA) would put Americans at risk by creating an opening in the domestic drug supply to unsafe, counterfeit, or sub-standard medicines. The results could range from an increased flow of foreign drugs of unknown origin that differ from U.S. versions, to weakened intellectual property protections that circumvent existing international standards.
According to a statement from the National Association of Boards of Pharmacy1, Canada “prohibits the filling of prescriptions issued by U.S. practitioners.” Medicines shipped to the United States by online Canadian-based pharmacies, even when operating with a legitimate Health Canada-issued license,2 fall outside the FDA’s regulatory jurisdiction. Attempts to legalize importation in this manner would prevent the FDA from ensuring the safety and effectiveness of America’s medications.
Furthermore, as reported by the Alliance for Safe Online Pharmacies (ASOP Global), there are approximately 35,000 online pharmacies in existence today. ASOP Global found that more than 96% fail to comply with applicable laws and approximately 10% sell controlled substances.3 Despite common stipulations that controlled substances would be ineligible for importation, loopholes exist in the foreign drug supply chain.4 The changes proposed by S. 61 could undermine national efforts to curb the opioid crisis by placing an increased burden on U.S. law enforcement to prevent further opioid abuse.
The Chamber strongly opposes S. 61, the “Safe and Affordable Drugs from Canada Act of 2019.” We urge senators to refrain from cosponsoring this legislation.
Neil L. Bradley
1National Association of Boards of Pharmacy, Statement on Prescription Drug Importation Proposals, February 2019.
2 The Department of Health Canada (Health Canada) is recognized by the U.S. Food and Drug Administration as a foreign food safety system comparable to the standards set forth by the FDA in the United States. See U.S. Food and Drug Administration, Consultant Update, “FDA Recognizes Canada as Having a Comparable Food Safety System to the U.S.,” May 2016.
3Alliance for Safe Online Pharmacies, “Facts About Online Canadian Pharmacies”, December 2018.
4 Alliance for Safe Online Pharmacies, “FAQs on Canadian Internet Pharmacies Selling to U.S. Residents,” March 2017. See https://buysaferx.pharmacy//wp-content/uploads/2017/03/canada_faq-1.pdf