Manager’s Amendment in FDA Safety and Landmark Advancements (FDASLA) Act Would Include and Allow Drug Importation
By: Colorado BioScience Association Date: 06/24/2022
Earlier this month, Colorado BioScience Association (CBSA) engaged on the U.S. Food and Drug Administration’s (FDA) Safety and Landmark Advancements (FDASLA) Act. CBSA and our national partners support the critically important reauthorization of the FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements. In a 13-9 vote, the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee approved the FDASLA Act, which reauthorizes most of the FDA’s user fee programs and other major provisions. It is important that this legislation ultimately passes for user fees reauthorization. The passed Senate HELP committee legislation included is a manager’s amendment that has a provision requiring the FDA to develop rules for importing drugs from Canada. The plan would allow states to build their own programs then apply for federal approval. It would also require the FDA to legalize personal importation.
According to a recent article in The Colorado Sun, “In the days leading up to the hearing, the pharmaceutical lobby raised concerns about the safety of drug importation, questioning how well programs would be able to track exactly where the drugs they bring in are coming from.” CBSA’s partner PhRMA Priscilla VanderVeer, vice president of public policy, said in a statement after the bill passed committee. “‘[A]s a result, counterfeit, substandard or diverted, repackaged and adulterated drugs would be more likely to enter the United States with life-threatening consequences.'”
Like our national partners, CBSA supports FDASLA to oppose prescription drug importation. *Note that this provision is different than the failed amendment that Senator Bernie Sanders offered, which would have required the FDA to allow importation from Canada and other countries.
Further details from the Senate HELP Committee on the importation amendment:
According to the Senate HELP Committee, “The importation provision negotiated in FDASLA would establish drug importation from Canada by:
- Removing barriers that have prevented personal importation in the past and paving the way for FDA to establish a program for importation of prescription drugs for personal use—while ensuring the drugs are the same safe and effective drugs available domestically.
- Building on work the FDA has begun to expand commercial importation of less costly prescription drugs from Canada by states, Indian Tribes, and other groups.
- Giving the FDA the tools it needs to quickly address any importation program that poses a risk to public health and safety.”
Colorado Importation Program
As a reminder, Colorado is building an importation program after legislation passed by the Colorado General Assembly in 2019, SB19-005, authorized the Department of Health Care Policy & Financing (HCPF) to seek approval from the federal government to create a Canadian drug importation program in the state. Currently, there are existing 2020 FDA rules on this and if the amendment eventually passes, it will write those rules into national law.
CBSA’s Position on Drug Importation
This legislation will jeopardize patient safety and do little to lower out-of-pocket costs for Coloradoans. The resources required to ensure the safety and efficacy of imported drugs will far outweigh any potential savings for Colorado consumers.
FDA is the gold standard of treatment and device review in our industry. Opening the U.S. drug supply chain would compromise safety and expose patients to counterfeit, adulterated or unapproved drugs that will lack oversight by any health authority. The resources required to ensure the safety and efficacy of imported medicines would far outweigh any potential savings.
CBSA will continue to monitor, engage, and advocate on behalf of our industry on importation both at the locally and nationally.