FDA Destroys Elizabeth’s Personal Drug Import
Elizabeth, who is from California, periodically gets migraine headaches. To treat them, she is prescribed brand name Relpax (elitriptan), but finds that the drug is too expensive in the U.S., so she chooses to import the same drug at a much lower price. Despite federal restrictions, most medicines that are imported for personal use reach the patient. But not always. In Elizabeth’s case, instead of receiving her medication, the Food and Drug Administration (FDA) destroyed the medication after it was detained at an international mail facility (IMF). She gave Prescription Justice the green light to tell her story.
Elizabeth’s story is being told for the following reasons:
simply to bring to greater awareness that the FDA is destroying prescription drug orders coming from licensed pharmacies, depriving patients of medical treatments;
alerting the public that the FDA may have violated federal law by not providing Elizabeth due process to defend her import after it was detained;
to clarify that the destroyed prescription drug was clearly not a risk to Elizabeth, but the exact same drug she would have obtained here; and
show that congressional appropriations to combat the opioid crisis and illegal fentanyl imports are potentially being used to destroy people’s prescription orders of non-addictive medical treatments.
First, let’s look at the drug prices to firmly establish why Elizabeth purchased her medication from another country. With a discount card at GoodRx, Relpax is $698.23 for 12 tablets in the U.S. The online pharmacy used by Elizabeth had the order filled with a licensed pharmacy in the UK, and charges her $188.46. A savings of 72% or about $500.
When the medication arrived at an international mail facility (IMF) in Los Angeles, it was detained by the FDA. On June 27, Elizabeth received a notice from the FDA: “DETAINED – Subject to Refusal and Administrative Destruction.” The reason given for refusal was FD&CA Section 503 (b)(4), 801 (a)(3): MISBRANDING. The letter stated: “This article was determined to be a prescription drug but does not include the symbol ‘rx-only’ on the label.”
The law provides that such imports valued at $2500 or less can be destroyed if they are misbranded, unapproved, adulterated or counterfeit, but not until the importer, in this case a patient, is given “due process” to defend the prescription order. [21 USC 381(a)]. The dangers of adulterated or counterfeit drugs are self-evident. A “misbranded” drug, in stark contrast, including in this case of the Relpax, is often the same drug sold here with different packaging and labeling. An “unapproved” drug import is often simply a foreign version of the FDA-approved drug, and just as safe and effective. For example, Daraprim, licensed to GlaxoSmithKline and sold in the UK, is considered an “unapproved” drug if imported into the U.S.
On June 28, to defend her import, Elizabeth used the template language available for download on our website to reclaim a drug import detained by FDA. Her letter, with redactions to protect sensitive information, can be read here.
Below are the evidence and arguments that Elizabeth included in her letter to the FDA agent to get the medication released:
Elizabeth showed a valid prescription from her provider in the U.S.
Elizabeth showed that she possessed a copy of the U.S. label, downloaded from dailymed (an NIH website): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=RELPAX.
She asserted that the drug is the exact same drug sold here, one made in an FDA-registered establishment. Additional evidence we uncovered added weight to this point.
As to the labeling, she wrote:
“You assert that the medication 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. 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].”
The gist of her argument is that the drug is an FDA-approved drug, except for the label, which was the label required per UK law. CFR 201.000 allows for exemptions to the labeling for individual imports.
Upon further research by Prescription Justice, we identified more important arguments and evidence Elizabeth might have included in her letter to strengthen her case.
Relpax is made in Ireland, so it’s not banned under the reimportation clause, 21 U.S.C. 381(d).
We also verified with the UK General Pharmaceutical Council that the dispensing pharmacy is licensed.
More information came to light about the FDA’s pointing out that the label did not say “Rx-only.” We subsequently learned that the misbranding exemptions found in 502(f) (adequate directions for use) does not overcome 503(b), meaning that the exemption does not exempt the labeling from the Rx-only requirement. The drug packing did not say “Rx only” as required in the U.S., but it did say “POM” (prescription only medicine), as required in the UK. Perhaps including that in the testimony, with a note attached to the U.S. label stating “Rx only” may have helped.
For several weeks, the FDA didn’t respond to her letter of testimony. Finally, Elizabeth emailed the FDA agent on July 19 inquiring about her prescription drug order, reminding that she had provided a letter of testimony on June 28.
Thirteen days after her inquiry, she received a letter from the FDA, which was dated August 1, informing Elizabeth that her prescription drug order was destroyed. The justification was the same one given in the FDA’s first letter. There was no acknowledgement of receiving Elizabeth’s letter of testimony sent over a month ago, nor of her subsequent inquiry into the matter. The absence of “Rx only” from the imported Relpax remained the reason for its refusal and now destruction, even though Elizabeth’s letter showed that she had a prescription.
Two additional points are worth noting. In her letter of testimony to the FDA, Elizabeth referenced an online pharmacy website based in Canada as the dispensing pharmacy. She also noted that the online pharmacy was verified as licensed by a Canadian association known for its international pharmacy membership. This made sense to Elizabeth. She ordered from an online pharmacy in Canada, that fills orders with a pharmacy in Canada and pharmacies elsewhere. The online pharmacy is listed by the aforementioned Canadian association as legitimate. It’s possible that the FDA agent was not satisfied with those points of evidence. Afterall, it was discovered by Prescription Justice that the dispensing pharmacy was in the UK and was licensed by the UK General Pharmaceutical Council. Unfortunately, instead of responding to Elizabeth’s letter of testimony to inquire further, the FDA destroyed what was most likely an FDA-approved drug.
The potential for increasing numbers of personal drug imports destructions may be greater than ever, due to additional funding provided to the FDA to stop illegal fentanyl imports, which have wreaked havoc in the form of opioid overdoses. It’s incredible that a crisis caused by pharmaceutical companies is now potentially being used to exacerbate another crisis it caused – high drug prices.
Pursuant to the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the SUPPORT Act), the FDA was provided additional authorities to prevent illegal imports coming through IMFs of controlled drugs, with fentanyl and fentanyl ingredients being the main target. In testimony before Congress on July 16, the FDA explained its efforts on this front.
“Of the 4,017 drug products on which we have used our 801(u) authority, 2,639 have been refused admission into the U.S. and will be destroyed; another 1,176 have been detained and identified for destruction, if refused. As of the end of June, an additional 185 drug products are still going through our admissibility process.”
Apparently, 2,639 packages containing fentanyl or other addictive drugs will be destroyed. The use of the word “another” to describe 1,176 detentions identified for destruction probably refers to personal prescription drug imports, such as the Relpax imported by Elizabeth. The SUPPORT Act was dedicated to curbing our nation’s opioid crisis, not seizing and destroying more affordable prescription drug imports in route to people like Elizabeth.
Finally, it’s impossible to overemphasize how unfair Elizabeth was treated by the FDA. The agency not only didn’t refute her letter, it didn’t acknowledge it at all.
We will continue to investigate this case and advocate for people who choose to import medication for their own use from licensed pharmacies because the prices are too high here.