WARNING LETTER
ElectRx and Health Solutions, LLC
MARCS-CMS 614251 —
March 02, 2023
Product:
Drugs
Recipient:
ElectRx and Health Solutions, LLC
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
FROM: The United States Food and Drug Administration
RE: Causing the Introduction of Unapproved and Misbranded Drugs into Interstate Commerce
DATE: March 2, 2023
WARNING LETTER
The United States (U.S.) Food and Drug Administration (FDA) has observed that ElectRx and Health Solutions, LLC (“ElectRx”) causes the introduction of unapproved new drugs and misbranded drugs into interstate commerce in violation of sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), and 355(a)].
There are inherent risks to consumers who purchase unapproved new drugs and misbranded drugs. Unapproved new drugs do not carry the same assurances of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether. Accordingly, FDA requests that ElectRx cease causing the introduction of unapproved and misbranded drugs for sale to U.S. consumers. This is critical to shielding the American public from potential harm.
ElectRx contracts with public and private sector employers throughout the U.S. to provide select prescription drugs to employees. ElectRx acts as a broker between foreign pharmacies and the employee-sponsored health insurance plans to provide enrolled employees with prescription drugs. ElectRx accepts the employee’s U.S. prescription and facilitates the dispensing of the prescription drug by a foreign pharmacy. The foreign pharmacy then ships the drug directly to the employee in the U.S. Invoices for prescription drugs purchased through ElectRx state, “You may have noticed that the medication which has been shipped to you is different in name or presentation to that which you may have received in the past. IF YOU HAVE ORDERED A BRANDED DRUG the name may appear different to the one you are used to. The reason for this is that you have been supplied internationally branded product and for various reasons drug companies market their products under different names and packaging in different countries.” Additionally, several of ElectRx’s formularies include the statement, “Please note that the medications ordered from the ElectRx formulary are sourced internationally, and may be marketed with a different name or a different strength to medications in the USA.” These statements demonstrate that ElectRx has designed its business to operate in a manner that substitutes the FDA-approved drugs prescribed by the U.S. healthcare provider with unapproved drugs. This 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.
The substitution of FDA-approved prescription drugs with unapproved drugs poses significant health risks to U.S. consumers. For example, ElectRx offers certain drugs on its formularies for which the FDA-approved version is subject to a Risk Evaluation and Mitigation Strategy (REMS)
1
program, has a narrow therapeutic index (NTI)
2
, is a controlled substance, and/or is indicated to treat serious conditions such as HIV, cancer, or hepatitis. ElectRx also offers maintenance medications that are indicated for conditions such as high blood pressure, high cholesterol, and acid reflux. Substituting an unapproved drug for the FDA-approved drug prescribed by a patient’s healthcare practitioner can negatively affect patient outcomes because the healthcare practitioner may unknowingly make subsequent treatment decisions based on the patient's response to the unapproved drug. This can also cause potentially dangerous drug interactions with the patient’s other medications. This is of particular concern for drugs subject to REMS programs and NTI drugs. Moreover, the substitution of FDA-approved prescription drugs with unapproved versions that may have substantially different risk profiles can pose serious health risks to consumers, especially in vulnerable patient populations that suffer from serious conditions.
Prescription medicines that are approved for use in the United States have been reviewed by FDA for safety, effectiveness, and quality and are subject to FDA-regulated manufacturing controls and FDA inspections of manufacturing facilities. Unapproved foreign drugs circumvent these safeguards, which are designed to protect patients. Unapproved drugs do not have the same assurance of safety and efficacy as drugs subject to FDA oversight and may be subpotent, superpotent, or adulterated with unknown active ingredients. Treatment with drugs that may be subpotent, superpotent, or adulterated can lead to drug resistance and/or therapeutic failures, and jeopardize the effectiveness of alternative drug therapies on patient outcomes.
FDA has also established processes to recall unsafe, substandard, and poor-quality drugs within the legitimate U.S. drug supply chain. No such safeguards exist for unapproved drugs illegally distributed in the U.S. from foreign sources such as those provided through ElectRx. In addition, the unapproved versions of FDA-approved drugs offered by ElectRx may have different trade names and/or strengths in their labeling than their FDA-approved counterparts. Such differences can cause patient confusion and lead to medication errors.
Examples of drugs offered on ElectRx’s formularies and a general description of their respective indications are depicted in the table below. These include drugs that are for vulnerable patient populations with serious medical conditions. This is not an exhaustive list of the drugs offered on ElectRx formularies.
Advair Diskus (asthma, COPD)
Invirase (HIV)
Afinitor (cancer)
Opsumit (pulmonary arterial hypertension)
Astagraf XL (organ rejection)
Tasigna (cancer)
Descovy (HIV)
Truvada (HIV)
Epivir‐HBV (hepatitis)
Vemlidy (hepatitis)
Gilotrif (cancer)
Vimpat (epilepsy)
Inlyta (cancer)
Zortress (organ rejection)
Unapproved New Drugs:
As described above, ElectRx causes the introduction of unapproved new drugs from foreign sources into interstate commerce in the United States in violation of the FD&C Act by substituting the FDA-approved drugs prescribed by a patient’s physician with unapproved drugs sourced from foreign pharmacies. Because these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or affect the structure or function of the body, these products are drugs within the meaning of section 201(g)(1) of the FD&C Act [21 U.S.C. § 321(g)(1)]. These products are also new drugs as defined by section 201(p) of the FD&C Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. With certain exceptions that do not apply here, new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No FDA-approved applications pursuant to section 505 of the FD&C Act [21 U.S.C. § 355] are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act [21 U.S.C. §§ 331(d) and 355(a)].
For example, one of the drugs provided via ElectRx is tacrolimus extended-release capsules, manufactured by Astellas and marketed as “Advagraf.” While there are FDA-approved versions of tacrolimus extended-release capsules on the market in the U.S., including “Astagraf XL” manufactured by Astellas, there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Advagraf” provided by ElectRx. Extended-release capsules of tacrolimus administered orally are NTI drugs. FDA-approved tacrolimus extended-release capsules are indicated for the prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants in adult and pediatric patients who can swallow capsules intact. FDA-approved tacrolimus extended-release capsules bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning addresses an increased risk for developing serious infections and malignancies with tacrolimus or other immunosuppressants that may lead to hospitalization or death, and increased mortality in female liver transplant patients.
Misbranded Drugs:
Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can be used safely only at the direction, and under the supervision, of a licensed practitioner. Because ElectRx advises consumers that their U.S. prescriptions are being filled with less expensive, foreign drugs, ElectRx concedes that these drugs are prescription drugs.
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). The drugs offered by ElectRx are prescription drugs intended to treat conditions that are not amenable to self-diagnosis and treatment by persons who are not medical practitioners. Therefore, adequate directions for use cannot be written for these drugs, and they must qualify for one of the exemptions to section 502(f)(1) to avoid being misbranded. The exemption to section 502(f)(1) found at 21 CFR § 201.100 does not apply to unapproved new drugs because that exemption requires that such drugs bear “the labeling authorized by the approved new drug application.” In addition, because these drugs are not approved in the U.S., they are also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. Because none of the exemptions to section 502(f)(1) apply, these drugs are misbranded under section 502(f)(1).
By causing these products to be shipped to U.S. consumers, ElectRx is causing the introduction of misbranded drugs into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
FDA is sending this Warning Letter to ElectRx because of the risks posed by its conduct in causing the importation of unapproved new drugs and misbranded drugs to U.S. consumers. FDA’s regulation and oversight of the drug approval process protects consumers by requiring rigorous scientific standards for new drug approval, labeling review for accuracy and completeness, and manufacturing procedures and testing performed under closely controlled conditions at FDA-registered and inspected facilities.
This letter is not intended to identify all the ways in which your activities might be in violation of U.S. law. You should promptly cease causing the distribution of unapproved new drugs and misbranded drugs to U.S. consumers and correct any other violations of the FD&C Act.
Please notify this office in writing within 15 working days of receipt of this letter describing the specific steps you have taken or will take to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately address this matter may result in legal action, including but not limited to, seizure, injunction, and/or temporary restraining order without further notice. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days. Please direct your response, and any inquiries concerning this letter, to FDA at CDERDrugSupplyChainIntegrity@fda.hhs.gov.
Sincerely,
/S/
S. Leigh Verbois, Ph.D.
Director, Office of Drug Security, Integrity, and Response
Office of Compliance
Center for Drug Evaluation and Research
_____________________
1
A REMS is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.
2
Narrow therapeutic index (NTI) drugs are drugs where small differences in dose or blood concentration may lead to serious therapeutic failures and/or adverse drug reactions that are life-threatening or result in persistent or significant disability or incapacity.
Content current as of:
03/14/2023
Regulated Product(s)
Drugs