The US Department of Health and Human Services (HHS) has issued a request for proposals for the reimportation of insulin produced in the United States and exported for sale abroad.
The measure, said HHS, is meant to address the fact that “The rising price of insulin, and corresponding rationing of insulin, constitutes an emergency” within the US. The agency noted that insulin prices rose nearly six-fold between 2002 and 2016. One commonly prescribed insulin, said HHS, has gone from $20 to $250 per vial.
The request for proposals (RFP), dated 24 September 2020, also notes that “Americans pay significantly more for insulin than patients in other countries do,” citing its own September 2020 study that found that in 2018, the average gross manufacturer price for one standard unit of insulin in the US was over 10 times that price in a sample of 32 other countries. In the RFP, HHS proposes that, though reimportation, “This cost differential presents an opportunity to pass savings onto Americans who are struggling to afford this life-saving medication.”
The declaration that insulin’s unaffordability constitutes an emergency allows HHS Secretary Alex Azar to invoke section 801(d)(2) of the Food, Drug & Cosmetic Act (FD&C). This provision allows reimportation of certain drugs if required for emergency use. A separate final order issued by HHS clears a potential path for drug importation from Canada to address affordability issues; however, biologics such as insulin are specifically excluded from that order. (RELATED: HHS opens pathway to importing Canadian drugs, Regulatory Focus 25 September 2020)
This RFP was issued along with another inviting application for waivers to enable the importing of prescription drugs from acceptable foreign sources following the Trump administration’s July 2020 executive order regarding lowering prescription drug costs.
Reimportation applications responding to the RFP should address issues of registration and listing, including the plan to procure new National Drug Code (NDC) numbers for reimported drugs; similarly, the labeling must be FDA-approved and specify that the product was reimported.
Applicants should address in detail supply chain security and integrity, to include a description of how they will trace prior distribution, detect and dispose of counterfeits, and ensure that reimported insulin is not commingled with US insulin by being introduced into standard distribution channels. “[P]atients should be aware that the insulin products they receive through the program are reimported from abroad,” noted the RFP.
Standard supply chain procedures that ensure that insulin products will be maintained safely and be effective and potent should also be detailed in the RFP.
Applications for insulin reimportation under this program should be signed by all parties and submitted to import@hhs.gov as well as the appropriate director of the FDA import program for the intended port of entry. The proposals will be accepted and reviewed jointly by HHS and FDA; the agencies “will retain broad discretion to revoke authorization” to reimport under this program, while also taking into consideration the reliance interests of patients and health care providers.
HHS RFP
Source: https://www.raps.org/news-and-articles/news-articles/2020/9/hhs-to-address-insulin-price-crisis-issues-rfp-for