CSHP & Counterparts Oppose Executive Order Signed by Trump Administration Focused on Bulk Importation of Prescription Medications
On July 24th, the Trump Administration signed an Executive Order (EO) focused on the bulk importation of prescription medications from Canada and other countries. CSHP strongly opposes these measures, as do our counterparts at ASHP. We continue to monitor this situation and will update members as information becomes available.
Letter from the Alliance for Safe Online Pharmacies (ASOP) Canada of which CSHP is a member.
As many of you will have likely seen, the Trump Administration announced this afternoon [July 24, 2020] the signing of four Executive Orders aimed at addressing high prescription drug prices. One of the four was focused on the importation of prescription drugs from Canada and other countries. The Executive Order outlines three specific importation pathways, including:
- Individual waivers for personal importation of prescription drugs under Section 804(j)2 of the FDCA;
- The reimportation of insulin products for the purposes of emergency medical care under Section 801(d) of the FDCA; and
- Encouraging completion of the FDA’s rulemaking process around the wholesale importation of prescription drugs from Canada under Section 804(b-h) of the FDCA (Pathway 1 of the FDA’s Safe Importation Action Plan).
View the full EO here.
As you may recall, the FDA draft rule allowing for the importation of medicines from Canada has not been finalized. Currently, the final rule is scheduled to be issued in December. We are concerned the EO means the final rule will come out sooner.
There have been additional developments on the importation file at the state level. Those updates are included below.
Florida: Seeking a Vendor to Support Drug Importation Program
- In late June, the state of Florida allocated $10 million in the annual budget to establish its importation program and hire a vendor. They have now issued a vendor solicitation notice.
- The solicitation outlines what Florida is looking for in a Canadian importation vendor and asks prospective vendors to apply. The state will evaluate each proposal based on a points system and then negotiate with vendors who score the top three point amounts to select a winner.
- Our concern: does this document say that Florida will only import from Canadian wholesalers and not pharmacies? NO, it does not say that. It says that your bid will get 10 extra points out of a total of 1,077 points if you are a Canadian wholesaler with a Drug Establishment license and have an active registration with the U.S. FDA as a Canadian supplier. You could still win the contract and become the vendor without being or partnering with a licensed Canadian wholesaler.
- Draft federal regulations to implement the federal law suggest that it should be a Canadian licensed wholesaler, but several states have said this definition is a non starter and have urged the White House to expand it. We will see what happens with the final FDA rule, and if greater flexibility is provided around the definition of a wholesaler.
- What happens next? Responses are due to the state and then they will open them to the public around September 29th. Given the timing of the solicitation deadline, we could expect an award to be made prior to early November.
- New Hampshire: Last week, Governor Chris Sununu signed a bill to import prescription drugs. The bill, which passed the Senate March 12 and the House June 30, directs the state Department of Health and Human Services to create a program to import wholesale prescription drugs from Canada. By February 2021, the department must submit its plan to the federal Centers for Medicare & Medicaid Services for approval.
- Maine: Has submitted their proposal to HHS to import medicine from Canada.
- New Mexico: Is developing a plan and will submit it to HHS for approval by December 15, 2020.