The excessive value of prescribed drugs continues to be a top health care priority for the general public. Policymakers from each events on the federal and state stage have been pursuing a variety of choices to decrease drug costs for Individuals, one in every of which might enable for the protected importation of prescribed drugs from Canada. This concept is predicated on knowledge displaying that folks within the U.S. usually pay extra for drugs than individuals in different international locations.
On January 5, 2024, Florida became the first state to achieve authorization from the Meals and Drug Administration (FDA) to import sure prescribed drugs from Canada. Florida’s plan is predicated on an strategy developed below the Trump Administration and executed below the Biden Administration, following an executive order issued by President Biden in July 2021 directing the FDA to work with states to import prescribed drugs from Canada. The concept of importing prescribed drugs has bipartisan support among the general public (Determine 1), though there are long-standing concerns with this approach when it comes to guaranteeing drug security, and the thought is opposed by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Canadian authorities.
Many research have proven that folks in america usually pay extra for his or her prescribed drugs than in different developed international locations, together with Canada. One analysis of a broad vary of medication discovered that Canadian costs are 44% of these in america, and in accordance with a KFF analysis, per capita spending on prescribed medicines was 42% larger in america than Canada. Canada’s drug costs are typically decrease than these in america as a result of the Canadian authorities has various mechanisms to decrease the price of prescribed drugs.
The Inflation Reduction Act included many provisions that affected Medicare drug costs and out-of-pocket prices, however didn’t deal with drug costs for others, which has contributed to ongoing curiosity in adopting methods, equivalent to importation, to decrease drug prices for different Individuals.
These FAQs deal with questions associated to prescription drug importation, together with the present standing of importation proposals, particulars of Florida’s importation program just lately approved by the FDA, and issues and challenges with this strategy.
1. How does the U.S. presently regulate the importation of prescribed drugs from different international locations?
Presently, the one sort of legally imported FDA-approved drugs are these which can be: 1) manufactured in international FDA-inspected amenities, meant to be used by U.S. customers, and imported into the U.S. by the drug producer, and a pair of) these which can be U.S.-approved and manufactured within the U.S., despatched overseas, then imported again into the U.S. below uncommon circumstances equivalent to for emergency medical functions or within the case of product remembers.
Drug importation as a part of efforts to decrease drug costs within the U.S. takes a unique kind. In 2000, Congress enacted the Medicine Equity and Drug Safety (MEDS) Act, which added Part 804 to the FD&C Act, to permit pharmacists and wholesalers to import prescribed drugs instantly from sure industrialized international locations, together with Canada. The MEDS Act permits such importation provided that the HHS Secretary certifies that this system: “poses no further threat to the general public’s well being and security,” and “leads to a big discount in the price of lined merchandise to the American client.” The Medicare Modernization Act of 2003 (MMA) amended Part 804 by specifying that wholesalers and pharmacists can solely import prescribed drugs from Canada, not different industrialized international locations. The MMA additionally requires the HHS Secretary to problem rules that may grant waivers to people to import medicine for private use below sure circumstances.
In September 2020, the Trump Administration issued a final rule that created a brand new pathway, referred to as the Section 804 Importation Program (SIP) pathway, for states and different entities to import medicine from Canada. To adjust to the statutory necessities associated to well being and security and value financial savings, then-HHS Secretary Alex Azar certified that importation of prescribed drugs poses no threat to public well being and security and would end in important value financial savings to the American customers.
2. How did Florida achieve approval to import medicine from Canada and what necessities have to be met earlier than the plan could be applied?
In January 2024, the FDA below President Biden granted its approval to Florida’s state plan to import sure prescribed drugs from Canada for a interval of two years, stating that it met the requirements that importation would offer financial savings to customers with out sacrificing well being and security. When submitting its SIP software for approval, Florida was required to specify: the medicine it seeks to import; the international vendor in Canada that may buy the drug instantly from its producer; the importer within the U.S. that may purchase the drug instantly from the international vendor in Canada; the re-labeler or re-packager of the drug itself that may make sure the drug meets all labeling necessities within the U.S.; the qualifying lab that may conduct testing of the drug for authenticity and degradation; and steps that may be taken by the SIP to make sure the provision chain is safe.
Even with FDA approval, Florida might want to meet additional requirements earlier than the plan could be applied. For instance, earlier than Florida is permitted to import any medicine from Canada, it might want to submit a pre-import request to the FDA for every drug it seeks to import, and it might solely import that drug if the FDA approves that request. The state of Florida will even be required to conduct high quality testing of the medicine and be sure that drug labels meet FDA requirements.
3. Which medicine could be imported by Florida and different states below the SIP importation pathway?
Underneath the SIP pathway, solely medicine which can be presently marketed within the U.S. are eligible for importation. As well as, to ensure that a drug to eligible, it must also be approved by the Well being Canada’s Well being Merchandise and Meals Department (HPFB) and have applicable labeling to be marketed in Canada.
As below present legislation, sure sorts of medicine are excluded from the definition of a prescription drug eligible for importation together with: managed substances, organic merchandise (together with insulin), infused medicine, intravenously injected medicine, and inhaled medicine throughout surgical procedure. Moreover, medicine which can be topic to threat analysis and mitigation methods (REMS), that are high-risk merchandise with severe security issues, equivalent to opioids, aren’t eligible for importation.
Florida seeks to initially import 14 drugs that deal with HIV/AIDS, psychological sickness, prostate most cancers, and urea cycle dysfunction. In Florida, imported medicine will solely be out there for individuals receiving companies by way of sure state businesses and authorities packages, together with individuals lined below Medicaid, individuals served by way of county well being departments, and others residing in sure state amenities. This system doesn’t prolong to individuals with different sorts of insurance coverage, equivalent to employer insurance coverage, or the uninsured.
4. What are the estimated financial savings related to Florida’s drug importation plan?
In response to Florida’s January 5, 2024 press release, the state’s plan will save the state as much as $183 million within the first 12 months of implementation, and primarily based on Florida’s October 20, 2023 estimate of cost savings, these financial savings will accrue to the state’s Medicaid program. Whether or not any Floridians pays decrease out-of-pocket prices on imported medicine, or how a lot they’re prone to save, is unclear.
Neither the September 2020 last rule that created the SIP pathway nor the FDA’s full final regulatory impact analysis offered an estimate of the anticipated financial savings. The ultimate regulatory evaluation famous that responses by different stakeholders, equivalent to Canadian regulatory businesses and drug producers, may affect the potential advantages of this program.
5. What are different states doing to implement drug importation proposals?
Many states are considering legislation that may facilitate drug importation from Canada. A number of states, together with Colorado, Vermont, Maine, New Mexico, New Hampshire, North Dakota, and Texas have enacted legal guidelines to ascertain importation packages and are actively pursuing the importation of prescribed drugs from Canada.
- Colorado: In February 2024, Colorado submitted a revised version of its SIP to the FDA. In its proposal, Colorado notes that it has been having issue negotiating with drug producers in Canada to permit exportation of their medicine to the U.S. and has been in search of extra steering from the FDA on deal with this problem. Colorado seeks to import 24 drugs to deal with blood clots, cystic fibrosis, respiratory diseases, most cancers, sort 2 diabetes, HIV/AIDS, psoriatic and rheumatoid arthritis. Of the medicine Colorado lists in its software, 4 overlap with these which can be on Florida’s importation drug listing.Colorado estimates this system will save $50.9 million within the first 3 years of implementation if all 24 eligible medicine are imported. Not like the Florida evaluation of financial savings, Colorado’s evaluation assumes value financial savings for people with industrial insurance coverage, together with employer-sponsored and individually bought insurance coverage. In response to Colorado, Medicaid isn’t a focused inhabitants as a result of it “receives steep rebates for lined medicine, decrease than what any importation program may present,” and subsequently, its estimates of financial savings don’t embody people lined by Medicaid, nor does it embody Medicare or the uninsured. Colorado expects the almost all the financial savings (93.5%) will likely be handed onto customers within the type of decrease premiums although customers will even see some financial savings within the kind decrease out-of-pocket bills.
- New Mexico: New Mexico submitted its SIP application in December 2020 for FDA approval and remains to be awaiting a response from the FDA.
- New Hampshire: New Hampshire submitted a SIP proposal in August 2021, which was rejected by the FDA in November 2022 as a result of the state had not recognized a International Vendor nor offered different requested info. New Hampshire has not but submitted a revised software.
- Vermont: Vermont submitted a concept paper in November 2019, however it has not submitted a brand new importation proposal following the SIP pathway being finalized in September 2020.
- Maine: Maine submitted an importation proposal in Might 2020 for FDA approval, additionally previous to the SIP pathway being finalized, and has not submitted a brand new proposal.
- North Dakota: North Dakota handed a invoice in April 2021 that requires a research on the potential impacts of prescription drug importation.
- Texas: In June 2023, Texas enacted legislation to ascertain an importation program and printed a wholesale prescription drug importation report in December 2023 with analysis and suggestions to help implementation of this system.
6. How does Canada view these importation packages?
When the SIP importation pathway was first proposed, the Government of Canada acknowledged that it will be unable to satisfy the wants of the U.S. market with out impacting entry to drugs for Canadians. The Canadian authorities additionally expressed concern that this coverage would create drug shortages in Canada, and issued an order in November 2020 prohibiting the distribution of medication that might trigger or exacerbate a scarcity. Subsequently, it’s potential that the Canadian authorities might impose limitations for importation to the U.S. Canadian legislation limits the sale of medication exterior of Canada that might create or worsen provide points for Canadians. In response to the latest FDA motion, Well being Canada launched a statement saying, “the Authorities of Canada is taking all vital motion to safeguard the drug provide and guarantee Canadians have entry to the prescribed drugs they want” and added, “bulk importation won’t present an efficient answer to the issue of excessive drug costs within the U.S.”
7. Underneath what circumstances can people legally import medicine from different international locations, like Canada?
In most circumstances, it’s illegal for people to import FDA-approved medicine from different international locations for private use. Nonetheless, primarily based on modifications enacted by the MMA, private importation of prescribed drugs that haven’t been authorised by the FDA to be used within the U.S. is permitted on a case-by-case foundation. Underneath this statutory authority, FDA has put out guidance that lays out sure circumstances the place importation of non-FDA authorised medicine for private use is perhaps allowed. For instance, private importation is mostly allowed if the remedy is for a severe situation, there isn’t any efficient remedy out there within the U.S., and there’s no commercialization of the drug for U.S. residents. Sometimes, solely a three-month provide is allowed, and people should affirm in writing that the drug is for private use and supply details about the doctor chargeable for their remedy.
There appears to be little enforcement by the FDA of the ban in opposition to importing FDA-approved medicine for private use. Even when the non-public importation of a drug is technically unlawful, current law directs the FDA to train discretion in allowing private importation of medication when the product is “clearly for private use, and doesn’t seem to current an unreasonable threat to the consumer,” which is bolstered in FDA guidelines.
