User fee legislation to reach president’s desk without drug importation amendment

U.S. Senate declines to take up amendment APhA opposes

An amendment to significantly expand drug importation, introduced by U.S. Sen. Bernie Sanders (I-VT), was ultimately left out of the FDA Reauthorization Act (FDARA) passed by the U.S. Senate last week, allowing the House of Representatives’ version to proceed relatively unchanged. Sanders has touted his amendment as a solution to the high cost of drugs in the United States. APhA and other pharmacy groups had spoken out against Sanders’s amendment on the basis that it could threaten the health and safety of patients and the health care system.

FDARA reauthorizes four agreements—more commonly known as the user fee acts, or UFAs—that give FDA authority to collect fees from prescription drug and device manufacturers to fund the agency’s review process during fiscal years 2018–2022. While UFAs are a result of industry and FDA negotiations, they have served as a vehicle for other legislative issues.

In an early-August letter cosigned by the National Association of Chain Drug Stores (NACDS), APhA urged senators to reject the amendment because, among other concerns, it would have risked patient safety by allowing pharmacies, wholesalers, and patients to import non-FDA approved drugs into the U.S. from Canada and other selected countries. APhA and NACDS sent a similar letter to President Donald Trump in June. APhA had also encouraged its members to contact their senators to inform them of the impact the amendment could have on patient safety.

APhA expressed concern that the expanded importation proposal disrupts implementation of the Drug Supply Chain and Security Act of 2013, a 10-year industry-wide effort passed by Congress to protect U.S. consumers from exposure to counterfeit, stolen, contaminated, and otherwise harmful drugs.

In addition, APhA believes the amendment undermines the pharmacist–patient relationship and would further fragment care. Sanders’s importation measure would encourage patients to seek care from foreign prescribers, in addition to foreign pharmacists, because Canadian pharmacists can only dispense prescriptions from a Canadian prescriber. Foreign health care infrastructure and systems are not integrated into those used in the U.S., adding to the difficulty of trying to track, monitor, and coordinate the care and drugs received outside the U.S.

Despite the amendment’s exclusion from FDARA, the drug importation issue is likely to arise again. “APhA and our members are committed to helping find solutions to address the high cost of prescription drugs. However, importation is not a comprehensive and safe solution to the drug pricing issues that many Americans face,” said Alicia Kerry Mica, APhA senior lobbyist. “APhA will continue to monitor drug importation and engage with Capitol Hill to ensure that any actions on importation fully consider patient safety.”

FDARA, which includes provisions requiring regulations to facilitate the OTC sale of hearing aids and best practices for sharing information regarding a patient’s history of opioid use disorder which will consider the importance of pharmacists’ access to such information, will head to the President’s desk. President Trump is expected to sign the bill.