WARNING LETTER
Dream Pharmacy 24/7 Enterprises Limited 2018
MARCS-CMS 614898 —
July 01, 2021
Product:
Drugs
Recipient:
Dream Pharmacy 24/7 Enterprises Limited 2018
United States
Issuing Office:
Center for Drug Evaluation and Research
United States
DATE: July 1, 2021
WARNING LETTER
This is to advise you that the United States (U.S.) Food and Drug Administration (FDA) recently reviewed Dream Pharmacy 24/7 Enterprises Ltd. 2018’s (“Dream Pharmacy 24/7”) websites at the Internet addresses www.premier-dream.com and www.eirmed360.com, and has observed that Dream Pharmacy 24/7 introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), 331(k), 353(b), and 355(a)].
As discussed below, FDA has observed that Dream Pharmacy 24/7 introduces into interstate commerce unapproved and misbranded opioid drug products. Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.
FDA has also observed that Dream Pharmacy 24/7 introduces into interstate commerce unapproved and misbranded benzodiazepine drug products. Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use. Benzodiazepine nonmedical use is widespread, and individuals frequently co-use benzodiazepines with alcohol, prescription opioids, and illicit drugs. Associated harms of benzodiazepine nonmedical use are substantial, but occur primarily when people use benzodiazepines in combination with other drugs. Further, in cases where benzodiazepines were co-used with other substances, medical outcomes are typically more severe than in cases involving benzodiazepines alone. Polysubstance overdose deaths account for the vast majority of overdose deaths documenting involvement of benzodiazepines. The easy availability of benzodiazepines via the Internet poses additional significant risks to U.S. consumers.
Additionally, FDA has observed that Dream Pharmacy 24/7 introduces into interstate commerce drug products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 and a variety of other diseases such as lupus, rheumatoid arthritis, and malaria. There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS.
1
In addition, on March 13, 2020, the President declared a national emergency in response to COVID-19.
2
Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
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 Dream Pharmacy 24/7 cease offering any violative drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
Unapproved New Drugs:
As labeled, certain products offered for sale by Dream Pharmacy 24/7 are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body. These drugs 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 not applicable here, new drugs may not be legally 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 approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
For example, Dream Pharmacy 24/7 offers tramadol marketed as “Tramadol 50 Mg, 100 Mg” manufactured by sicomed or Sandoz. On your website www.premier-dream.com, you state that the product is “used to help relieve moderate to moderately severe pain” and that it is “similar to opioid (narcotic) analgesics.” On your website www.eirmed360.com you state that the product “[h]as a strong analgesic…activity, gives quick and lasting relief. Inferior, however, to the activity of morphine…”. While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Tramadol 50 Mg, 100 Mg” manufactured by sicomed or Sandoz, offered by Dream Pharmacy 24/7. FDA-approved tramadol is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. FDA-approved tramadol 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 risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when taken in conjunction with other central nervous system depressants, including alcohol and benzodiazepines, use may result in coma or death.
Dream Pharmacy 24/7 also offers oxymorphone marketed as “Opana (Oxymorphone) 20 Mg, 30 Mg, 40 Mg” manufactured by Endo Pharmaceuticals. On your websites, Dream Pharmacy 24/7 states the product is “a pain killer which is becoming very popular...” and states it is used “...to treat the person who has severe pain. It is an opioid pain medication and sometimes also called narcotic. It can be used for any sort of severe pain like neck pain or muscles [sic] pain as well.” This labeling accompanies pictures of bottles of Opana ER in 5, 10, 20, and 40mg strengths. There are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Opana (Oxymorphone) 20 Mg, 30 Mg, 40 Mg” manufactured by Endo Pharmaceuticals and offered by Dream Pharmacy 24/7.
3
In addition, Dream Pharmacy 24/7 offers clonazepam marketed as “Rivotril 2MG (Clonazepam)” manufactured by Roche. Your websites state that the product “is a benzodiazepine. It affects chemicals in the brain that may be unbalanced” and it “is also a seizure medicine, also called an anti-epileptic drug.” While there are FDA-approved versions of clonazepam on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Rivotril 2MG (Clonazepam)” manufactured by Roche and offered by Dream Pharmacy 24/7. FDA-approved clonazepam is indicated for the treatment of certain seizure disorders and panic disorder characterized by recurrent unexpected panic attacks. FDA-approved clonazepam bears a boxed warning that includes risks associated with the concomitant use of benzodiazepines and opioids, which may result in profound sedation, respiratory depression, coma, and death. In addition, the boxed warning addresses risks including abuse, misuse, addiction, and physical dependence.
In the “COVID-19 Meds” categories on its websites, Dream Pharmacy 24/7 offers hydroxychloroquine marketed as “Hydroxychloroquine Sulfate (Plaquenil) 200 mg” manufactured by Sanofi. Your websites tag the product as “COVID-19 Meds”[sic] and state it is“[u]sed to treat Malaria, Rheumatoid Arthritis, and Lupus.” While there are FDA-approved versions of hydroxychloroquine, including “Plaquenil,” on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Hydroxychloroquine Sulfate (Plaquenil) 200 mg” manufactured by Sanofi and offered by Dream Pharmacy 24/7. FDA-approved hydroxychloroquine is labeled for the treatment of uncomplicated malaria, discoid and systemic lupus erythematosus, and acute and chronic rheumatoid arthritis and is only available by prescription. In addition, hydroxychloroquine has not been approved by FDA for use in the prevention, diagnosis, treatment, mitigation, or cure of COVID-19.
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Misbranded Drugs:
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if it 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 (see 21 CFR 201.5). 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 only be used safely at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the products safely for their intended uses. Consequently, the labeling for these drugs fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the FD&C Act. 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. By offering these drugs for sale to U.S. consumers, Dream Pharmacy 24/7 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)].
Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. By offering the aforementioned drugs without requiring a prescription, Dream Pharmacy 24/7 jeopardizes patient safety and misbrands the drugs under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act [21 U.S.C. § 331(k)].
FDA is taking this action against Dream Pharmacy 24/7 because of the inherent risk to consumers who purchase misbranded and unapproved new drugs. This letter is not intended to identify all the ways in which your products or operations might be in violation of the law. It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.
Please notify this office in writing within 15 working days describing the specific steps you have taken 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, without limitation, seizure and injunction, without further notice. If you cannot complete corrective action within 15 working days, state the reason for the delay and the time within which you will complete the corrections. 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.
If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission. We may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be unapproved and misbranded products that cannot be legally sold to consumers in the U.S.
Please direct your response and any inquiries to FDA at
FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov
and
COVID-19-Task-Force-CDER@fda.hhs.gov
.
Sincerely,
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
_____________________________________
1
Secretary of Health and Human Services, Determination that a Public Health Emergency Exists (originally issued Jan. 31, 2020, and subsequently renewed), available at
https://www.phe.gov/emergency/news/healthactions/phe/Pages/default.aspx
.
2
Proclamation on Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19) Outbreak. Mar. 13, 2020, 85 FR 15337. (Accessible at
https://www.federalregister.gov/documents/2020/03/18/2020-05794/declaring-a-national-emergency-concerning-the-novel-coronavirus-disease-covid-19-outbreak
).
3
In December 2020, at the request of Endo Pharmaceuticals, Inc., FDA announced that it was withdrawing approval of the new drug application (NDA) for OPANA (oxymorphone hydrochloride) extended-release (ER) tablets, 5 milligrams (mg), 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg, held by Endo Pharmaceuticals, Inc. (Accessible at
https://www.federalregister.gov/documents/2020/12/23/2020-28283/endo-pharmaceuticals-inc-withdrawal-of-approval-of-a-new-drug-application-for-opana-oxymorphone
).
4
On March 28, 2020, FDA issued an Emergency Use Authorization (EUA), pursuant to section 564 of the FD&C Act [21 U.S.C. § 360bbb-3], to permit the emergency use of hydroxychloroquine sulfate and chloroquine phosphate supplied from the Strategic National Stockpile to treat adults and adolescents who weigh 50 kg or more and are hospitalized with COVID-19 for whom aclinical trial is not available, or participation is not feasible. On April 24, 2020, FDA issued a
Drug Safety Communication
cautioning against the use of hydroxychloroquine or chloroquine for COVID-19 outside of either: (1) use in a hospital setting pursuant to FDA’s EUA; or (2) participation in a clinical trial investigating use of chloroquine or hydroxychloroquine for treatment of COVID-19. FDA issued that Drug Safety Communication to remind patients and health care professionals of the known risk of serious heart rhythm problems associated with chloroquine and hydroxychloroquine. FDA revoked this EUA on June 15, 2020, based on FDA’s continuing review of available scientific evidence, including clinical trial results, that led FDA to determine that the statutory criteria for EUA as outlined in Section 564(c)(2) of the FD&C Act were no longer met. Specifically, FDA has determined that chloroquine and hydroxychloroquine are unlikely to be effective in treating COVID-19 for the authorized uses under the EUA and that the known and potential benefits of chloroquine and hydroxychloroquine no longer outweigh the known and potential risks for the formerly authorized uses.
Content current as of:
07/13/2021
Regulated Product(s)
Drugs