Dear Mr. Solis:
On behalf of the Cystic Fibrosis Foundation, we write to express our concerns about third-party entities that contract with employer-sponsored health plans to import prescription drugs from outside the United States, also known as alternative funding programs (AFPs). We ask the U.S. Food and Drug Administration (FDA) to issue a guidance document and initiate legal action against AFPs (including, but not limited to, seizure, injunction, and/or temporary restraining order) that use international importation programs as a cost-saving measure for health plans. Such action is necessary to safeguard patients from potential hazard of receiving illegally imported prescription drugs.
Background on Cystic Fibrosis and Alternative Funding Programs
Cystic fibrosis is a rare, genetic disease that affects close to 40,000 children and adults of every racial and ethnic group in the United States. CF causes the body to produce thick, sticky mucus that clogs the lungs and digestive system, which can lead to life-threatening infections. As a complex, multi-system condition, CF requires targeted, specialized treatment and medications. If left untreated, infections and exacerbations caused by CF can result in irreversible lung damage, and the associated symptoms of CF lead to early death, usually by respiratory failure. Through careful, aggressive, and continuously improving disease management, the average life expectancy for people with cystic fibrosis has risen steadily over the last few decades. This milestone reflects over 50 years of hard work to improve CF treatments, develop evidence-based standards of care, and encourage adherence to a lifetime of chronic care. However, this system of care and the improvements in length and quality of life for those with CF can only be realized if patients have access to essential therapies.
AFPs are advertised to employer-sponsored health plans as a way to lower prescription drug spending by sourcing prescription drugs from outside the conventional health plan framework. When a health plan contracts with an AFP, the program directs the plan to exclude specific high-cost drugs from its covered drug formulary by designating the medication as non-essential health benefits (non-EHBs). Patients are informed that to access their medication they must enroll in the AFP. Given the prescription drug’s non-EHB designation, patients are told failure to enroll in the program will result in them bearing 100 percent of the drug cost unless the AFP is able to get the drug through another pathway, including international importation, manufacturer assistance programs, and charitable and patient assistance programs.
Laws, Regulations, and Agency Policy Related to Drug Importation
The federal Food, Drug, and Cosmetic Act (FDCA) limits the types of drugs that may be imported in the United States to help ensure that the domestic drug supply is safe and effective. It is illegal under the FDCA to import non-FDA approved drugs, including “foreign versions” of FDA approved drugs, with a few limited exceptions noted below. Furthermore, Congress implemented this prohibition to protect consumers from internationally developed drugs that are not vetted for safety in accordance with FDA’s standards.
Regardless of whether a new drug is manufactured in the United States or in a foreign country, the drug must comply with the FDCA prior to being marketed in the United States. For example, it must be approved by the FDA, produced in FDA-inspected plants operating in accordance with current good manufacturing practices, and labeled with all required information.
Limited exceptions exist to the general prohibition on drug importation including FDA’s personal importation policy and federal regulations permitting importation of prescription drugs from Canada under certain circumstances. As such, any entity that intends to import prescription drugs for human use into the United States must ensure that the drug satisfies these requirements.
FDA’s Personal Importation Policy
While importing unapproved prescription drugs is illegal, FDA’s policy on importing prescription drugs for personal use recognizes that there may be circumstances in which the FDA may exercise enforcement discretion with respect to illegal importation. The personal use policy provides that an individual may be permitted to import an unapproved prescription drug for personal use if:
- The product is not used to treat a serious condition, such as the use of an over-the-counter treatment (OTC); or
- The product is used to treat a serious condition; and
- The product is needed to treat the serious condition and the medication is not available in the United States;
- There is no commercialization or promotion of the drug to U.S. residents;
- The drug does not represent an unreasonable risk;
- The quantity is not more than a 3-month supply; and either:
- The consumer provides contact information for the U.S. doctor providing treatment with the drug; or
- The consumer provides evidence that the product is for continuation of treatment begun in a foreign country.
The FDA’s personal importation program is not intended as a way for patients to bring lower-priced prescription drugs into the United States; rather FDA intended this enforcement discretion to allow individuals to access treatments not otherwise available in the United States.
Section 804 Importation of Prescription Drugs from Canada
Section 804 of the FDCA permits importation of eligible prescription drugs from Canada by a state, Indian Tribe, or for certain pharmacists or wholesale distributors. FDA updated the Section 804 Importation Program (SIP) in 2020 in accordance with the Safe Importation Action Plan. All prescription drugs are eligible for this program except (1) controlled substances; (2) a biological product; (3) an infused drug; (4) an intravenously injected drug; (5) a drug inhaled during surgery; (6) an intrathecally or intraocularly injected drug; (7) a drug that is subject to REMS; and (8) a drug that is not a “product” for purposes of section 582 of the FDCA. To import prescription drugs into a state under this exception, the state’s law must allow such importation and the eligible importing entity must receive a Section 804 program approval in accordance with the procedures set forth in the final rule.
To date, seven states have passed importation legislation to establish a state drug importation program, five of which have submitted proposals to the FDA. In January of 2024, Florida’s proposal was the first to receive FDA approval. Even with FDA approval, there are a number of additional requirements the state must meet before it is permitted to import any drugs from Canada.
Alternative Funding Programs and International Importation
Drug importation through alternative funding programs is inconsistent with the FDCA, FDA’s personal importation policy, and the final rule on Section 804 Drug Importation from Canada.
We stress especially the abuse of the personal importation policy. Consumers, including people with CF, who are forced into AFPs are further coerced into drug importation. Enrolling in an AFP and then accepting drug importation are presented to them as their only means of obtaining life-changing medications. People with CF involuntarily accept an AFP even though it exposes them to the possibility of receiving misbranded, ineffective, and unsafe drugs and undermines the assurances that they otherwise can rely on FDA review to protect their access to safe and effective therapies.
As you can see in the attached documents, some AFPs are advertising to employers that importation of specialty medications is legal based on FDA regulations. The advertisement falsely conflates the Section 804 Drug Importation regulation with the personal importation policy requirements. Anecdotally, we have heard from clinicians and patients who are trying to get essential medications that they have had to send prescriptions abroad to unknown practitioners or pharmacies, are required to conduct telehealth visits with a practitioner in a foreign country, and sometimes are required to provide a passport as form of identification to access medications. This practice is unacceptable, particularly for medications that are readily available, and FDA approved here in the United States.
To the extent that such programs source drugs manufactured in non-FDA-inspected facilities, they violate important safety and effectiveness protections set forth in the FDACA. Furthermore, when a patient is enrolled in an AFP, the importation activity cannot satisfy the FDA’s personal importation policy. Individuals seeking to use the prescription drug do not personally import the drug in a manner anticipated under FDA’s policy, rather the AFP applies for importation on behalf of the patient. Even if these coercive programs were considered a form of personal importation, the type of prescription drugs they are importing fall outside the scope of FDA’s policy because they are used to treat serious chronic conditions, like cystic fibrosis, and are already available in the United States. The operation of these importation schemes is the exact situation the FDCA, FDA personal use policy, and FDA regulations aim to avoid.
We appreciate the FDA’s previous attention to these programs and awareness the risk this may pose to patients. In a letter last year warning one AFP, the FDA states, “[t]his distribution scheme is particularly concerning, as employees are likely inclined to trust that they will receive safe and effective drugs through their employer’s “insurance” plan and may not question their legitimacy.” However, this is just one program, and we are seeing increased use of AFPs and these concerning tactics among insurance plans that cover people with cystic fibrosis. In the same warning letter, the FDA states, “failure to adequately address this matter may result in legal action, including but not limited to, seizure, injunction, and/or temporary restraining order.” We ask the FDA to initiate these enforcement actions in order to stop this coercive and harmful practice.
Unregulated Importation is Dangerous for People with Cystic Fibrosis
Cost-containment strategies imposed by plans and their contracted alternative funding programs should not come at the expense of patient health and safety. The FDA has recognized that importing medications raises the risk of quality assurance deficiencies; counterfeit potential; presence of untested substances; unsupervised use; labeling and language issues; and lack of information from the importation sources. Moreover, even in case where the drug is a foreign-made version of an FDA-approved drug (i.e., the same active ingredient made by the same manufacturer), the FDA has stated that it is highly unlikely that the version of the foreign market would meet all the requirements in the FDCA for approval.
Furthermore, purchase of medications directly from foreign pharmacies side-steps the Drug Supply Chain Security Act tracking system. Patients who are required by their health plan to obtain drugs outside of this tracking system are opening the door to bad actors that may be selling false or substandard medications, the wrong amount of medication, the wrong medication, or exposure to dangerous contaminants. There are already concerns from clinicians and patients about getting medications delivered due to potential temperature changes, delivery handling, and timeliness — including potential delays. For example, many patients with CF take the medication Pulmozyme (dornase alfa) as part of their regular treatment regimen. This is a medication that must be refrigerated at temperature between 2°C to 8°C (36°F to 46°F) in their protective foil pouch to protect from light and heat until the ampules are ready to use. We know that Pulmozyme is one of the medications that is often listed by AFPs as an importable drug. It is dangerous to force patients to rely on international mail and customs clearance for essential therapies that are not subject to the same level of FDA-scrutiny.
While some individuals may elect to import their medications from Canada, this is intended to be a personal choice, not a mandate from a health plan. When a health plan partners with an AFP, the AFP contacts the enrollee and tells them they must enroll in this separate program, or they will be responsible for a 30 percent to 100 percent co-insurance that will not count towards their deductible or annual limit on cost-sharing. By structuring these programs in a highly coercive way, patients are left with no option but to enroll in these programs. Consequently, this also means they are unable to object to their medication being imported from outside the United States — this is not the personal choice the FDA was trying to protect under the personal importation policy.
Thank you for your time and consideration of how these alternative funding programs are inconsistent with federal laws, regulations, and policy. We are very concerned with the coercive nature of these programs mandating importation of essential therapies for people with cystic fibrosis.