Earlier this week, the Trump Administration issued a 172-page Notice of Proposed Rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs and biologic products from Canada. The Administration also announced the availability of draft guidance on how manufacturers can import certain FDA-approved products that were originally intended for sale in a foreign country.
The NPRM would allow states and certain other non-federal government entities to submit importation program proposals to the FDA for review and authorization. The program could be co-sponsored by a pharmacist, a wholesaler, or another state or non-federal governmental entity. Eligible drugs would have to be relabeled with the required U.S. labeling prior to importation and undergo testing for authenticity, degradation, and to ensure that the drugs meet established specifications and standards. Programs would also have to demonstrate significant cost reductions to the American consumer.
“Today’s announcement outlines two pathways for the safe importation of certain prescription drugs to help provide safe, effective, more affordable drugs to American patients,” said Health and Human Services Secretary Alex Azar in a press release jointly issued by HHS and the FDA.
Comments on the NPRM will be accepted for 75 days after publication in the Federal Register, and comments on the draft guidance will be accepted for 60 days after publication in the Federal Register. Publication will most likely happen on December 23, 2019, but industry groups are not waiting to make their opinions known.
“[T]oday’s announcement is the latest empty gesture from our elected lawmakers who want us to believe they’re serious about lowering patients’ prescription drug costs,” said Jim Greenwood, president and CEO of the Biotechnology Innovation Organization (BIO) in a statement posted on the group’s website. “The idea that this plan will result in savings for patients at the pharmacy counter is a talking point that’s been debunked by nonpartisan budget experts and past FDA commissioners who served under both Republican and Democratic administrations.”
The Healthcare Distribution Alliance (HDA) asserted, “Such policies will … ultimately threaten patient safety without any meaningful cost reductions. … Further, as an HDA Research Foundation study indicates, federal importation policies would lead to at least $1.1 billion in unforeseen costs for the healthcare system, regulators and patients alike.”
Finally, there was this observation from Pharmaceutical Commerce magazine: “The NPRM also specifies that … sponsors are obligated to collect data on cost savings to consumers, and report that data to HHS. Given the convoluted state of drug pricing and reimbursement today, that will be a significant undertaking all by itself.”
“Our ultimate goal is to provide a robust program that clearly lays out procedures to import drugs that could provide lower prices while also maintaining the high-quality Americans expect,” said Assistant Secretary for Health Brett Giroir.
It’s safe to say that the promise of high-quality drugs at lower prices is one that all Americans would welcome. The question remains, however, whether these proposed rules can be finalized in the face of pharmaceutical industry opposition and, if finalized, they can actually deliver on the promise they make.