In the past month, amidst the COVID-19 pandemic, the FDA has spent government money and resources to seize prescription drugs being sent to American customers from pharmacies in Canada and other countries, according to operators of stores in Florida that facilitate the transactions.
While seizures at the nation’s international mail facilities have been gaining government priority during the past two decades, the latest crackdown is distressing many older customers whose goal is to stay home during the coronavirus pandemic.
“How can the FDA justify spending resources on this during a worldwide pandemic?” Bill Hepscher, co-owner of Canadian MedStore, asked. Many drugs sold in the United States are made in other countries, and avoiding international shopping is impossible.
Reason for compounding
The FDA defines compounding as “a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.”
Although compounded drugs can serve an important medical need for certain patients, they also present a risk to patients.
The FDA’s compounding program is clear on their intentions. They aim to protect Americans from unsafe, ineffective, and poor quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for Americans who have a medical need for them.
“We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy. We’ve seen firsthand the harm they can cause patients when they’re not appropriately compounded.
Over the past year, we’ve taken significant new steps to modernize and clarify our policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of contaminated or otherwise harmful products,” stated the U.S. Federal Food and Drug Administration.
Who is being affected?
Two percent of Americans, which is about 6.5 million Americans, say they buy drugs from outside the United States, either over the internet or during travels to Canada or overseas.
Hepscher said more than 200 of his customers have had prescription drugs seized since early March. They have to reorder the medication or pay much higher prices at their local pharmacy.
Linda Gebhards, age 69, said she has been buying the hormone drug Premarin for more than two years from Canadian MedStore, which reaches her from pharmacies in New Zealand or England. Canadian MedStore allows her to pay only $97 for a three-month supply, compared with more than $500 at a pharmacy in her home town of Gulfport, Florida.
“It was really a shock when I got a seizure letter,” Gebhards said. “I only had three pills left.
Unfortunately, this is the scary new reality for elders who cannot leave their homes due to COVID-19: running out of medication due to the inability to pay domestic prices and not being told of the unavailability of their prescriptions until they have a little medicine left, or none at all.
Judy Vobroucek, owner of Discount Med Direct, which has storefronts in Florida and Illinois that aid consumers with prescriptions, orders drugs from Canada and other countries. Ms. Vobroucek states that about 40 of her customers have had their medications seized during the pandemic.
“It’s odd that during a pandemic the FDA is spending resources seizing packages,” she said.
After having his asthma drug seized by the FDA in March, Cabot Jaffe Sr., age 83, of Maitland, Florida said, “It’s very aggravating.” He gets his inhaler through Canadian MedStore. They allow Jaffe to purchase his medication 35 percent cheaper than the cost from his local pharmacy, saving him hundreds of dollars a year.
More results of seizing
As a result of the pandemic, Canada, New Zealand and other countries that sell to Americans will provide only a 30-day supply instead of the typical three months’ worth of a drug, Vobroucek said.
The FDA has said that in most cases importing drugs for personal use is illegal, although the organization very rarely tries to stop Americans from bringing drugs across the Canadian border. They attest to having only been able to intercept a fraction of those sent by mail from foreign pharmacies.
In 2019, the FDA said it planned to screen 45,000 packages after recently increasing staffing at the mail facilities. Previously, the FDA was inspecting 10,000 to 20,000 packages annually, which amounts to less than 20 percent of the packages assumed to actually contain drug products.
With additional resources, the agency has said it plans to increase that number to 100,000 packages per year.
Have questions? Email the FDA’s compounding team at [email protected].