12 Dec 2018
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“Pursuant to the evidence and reasons given above, I believe my testimony overcomes the FDA’s public health justifications for refusing my medication order and ask that you release it to me. If you don’t then my health may be jeopardized because I can’t afford it locally.” Letter from a patient to the U.S. Food and Drug Administration (FDA) whose arthritis medicine was detained, and subject to refusal by the FDA.

Each year, a few million Americans import lower cost medicines because the prices are lower, despite the federal restrictions. Most such orders are received, at least when patients have valid prescriptions, but the FDA has the authority to refuse and destroy them. Originally, Prescription Justice was founded to help Americans produce letters of testimony to the FDA if their personal use medication imports were refused. While our scope has increased to include advocacy on drug prices more generally, we remain concerned about unnecessary refusal and destruction of prescription imports by the FDA. Reporting by non-profit media outlet, Tarbell, shows that the FDA may be using the crackdown against opioid drug imports to also seize prescription orders from Canada, the UK and other countries. With millions of Americans unable to afford prescription drugs, it’s important that the agency use maximum enforcement discretion to allow more affordable personal medicine imports from licensed pharmacies that require valid prescriptions.

Section 801 of the Food, Drug and Cosmetic Act requires “appropriate due process is available to the owner or consignee seeking to challenge the decision to destroy the drug.” [21 U.S. Code 381]. Recently, a woman in Florida, whose prescription order was detained by the FDA, exercised her right to due process by submitting a letter of testimony to the FDA agent on record. The patient used arguments provided in the guidance found on the Prescription Justice website and the FDA released her medications.

The medication order that was detained by the FDA is called Arthrotec 75mg diclofenac sodium / 0.2mg misoprostol. It’s prescribed to treat patients with arthritis at risk for getting stomach ulcers. It is not a prescription opioid or a controlled substance. The FDA’s letter identified that the order is “DETAINED – Subject to Refusal.” The reasons given were Misbranding and Unapproved New Drug. The patient was notified of their right to provide oral and written testimony “regarding the admissibility of these articles or, the manner in which these articles can be brought into compliance.”

The drug was deemed misbranded because, according to the FDA, it did not have the words, “Rx Only” on the label. The designation of “unapproved new drug” was not explained. As you’ll see by the letter below, the patient was required to have a prescription from the pharmacy exporting the medication. Also, the drug is approved for sale in the U.S. Since the imported drug may be a foreign-version – in this case from the UK – FDA considers it an “unapproved new drug.”

Generally, the letter provides testimony and evidence that the imported drug came from a licensed pharmacy in the UK that required a valid prescription. The evidence that a drug was dispensed from a licensed pharmacy in the UK may be enough to prove that it is a safe and effective drug. Of course, the patient made the argument that the drug sold here is too expensive.

The draft letter below was used by the patient to successfully have the order released and mailed to the patient. There is no assurance that this letter can work every time in like-circumstances.

TO: [COMPLIANCE OFFICER’S NAME], U.S. Food and Drug Administration, [FDA ADDRESS]

EMAIL: XXXXXXX@fda.gov.

FROM: [PATIENT]

SUBJECT: Release personal drug order testimony, Entry # [REDACTED], Arthrotec 75mg diclofenac sodium / 0.2 misoprostol (“Arthrotec”)

You have detained or refused medication that I ordered, 180 tablets of Arthrotec, and I’m exercising my right to appropriate due process to challenge your decision.  My health is at risk because of your action. I’m providing the testimony herein to challenge your decision so that you release my medication to me immediately. A few pertinent facts:

1.       My imported medication is for personal use only, not for re-sale.

2.       I have a valid prescription from my doctor.

3.       The attached prescription is evidence that I’m under the care of licensed provider and that the medicine is clearly for personal use only.

You assert that the Arthrotec I ordered appears to be a misbranded drug as the reason to postpone or deny its importation. Please consider why that is not a legitimate or fair reason. The absence of “Rx Only” attached to a label has no bearing on whether or not this medicine is safe and effective, or used properly, and, clearly, I do have a prescription because one was required of me to purchase this medicine.

Since this drug was dispensed to me pursuant to a valid prescription by a licensed practitioner in the U.S., the drug is exempted by FDA regulation from the “adequate directions for use” requirement. [21 CFR 201.100].

Furthermore, I have the benefit of the FDA’s guidelines for adequate directions for use and the drug warnings pertaining to this medication. As evidence, please see the attached first page of the label, which is the official FDA-approved U.S. label. You have sufficient evidence to know that I have the requisite information I need to safely use this medication.

You assert that the medication I ordered appears to be an unapproved drug as the reason to postpone or deny its importation. Please consider why that is not a legitimate or fair reason. It’s my understanding that by identifying the Arthrotec as unapproved, you are implying that it was not made under the authority of the FDA and you cannot guarantee the safety of effectiveness of the subject drug. I believe this drug was made in an establishment registered with the FDA’s counterpart in the United Kingdom, the Medical and Healthcare Products Regulatory Agency and that it was manufactured under Good Manufacturing Practices such as those that the FDA requires. For that reason, I believe the subject drug, the one I purchased using a valid prescription, is equally as safe and effective as its U.S. counterpart.

This medication was dispensed by a pharmacy in the UK called [REDACTED]. That pharmacy is licensed by the UK Pharmaceutical Council, which from a clinical standpoint is sufficient evidence of its safety and effectiveness.

Pursuant to the evidence and reasons given above, I believe my testimony overcomes the FDA’s public health justifications for refusing my medication order and ask that you release it to me. If you don’t then my health may be jeopardized because I can’t afford it locally.

Please be compassionate. Imagine if I was a member of your family and could not afford my medication. Depriving me of this medication would go against your stated mission to protect public health.

You can contact me at [REDACTED] or reply by email.

Sincerely,

[NAME REDACTED]

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