June 23, 2022

Is Rubio’s Drug Law the right prescription for the problem of counterfeit pharmaceuticals? – Internal sources

The FDA and DEA sent warning letters in April to Wellerectile.com and Kubapharm.com, two websites selling what they claim are pharmaceuticals like green Xanax bars and Viagra pills, all without prescription. The sites are so sketchy, not only does the description of the drug on Kubapharm.com fail to tell consumers the dosage of the drug, but it also refers to Wikipedia when listing its precautions.

The letters gave the sites 15 days to respond to the steps they would take to remedy the violations. But according to Libby Baney, senior adviser at Alliance for Safe Online Pharmacies Global, such warning letters carry little weight. Both sites are still in operation, which is why Baney believes the DRUGS Act needs to be passed.

The problem of counterfeit pharmaceuticals often made with the deadly drug fentanyl has come to light during the COVID-19 lockdown. People who needed their prescription drugs, including older customers unfamiliar with internet commerce, went online rather than to their local pharmacy. Counterfeit versions of prescription drugs were showing up in Google searches by unsuspecting customers.

Counterfeit oxycodone tablets seized by the DEA (courtesy photo)

In an effort to curb illegal drug sales online, Sen. Marco Rubio (R-Fla.) introduced the Domain Reform Act for Illegal Drug Sellers, better known as the Drug Act. The bill would require Internet domain registrars like Verisign and GoDaddy to lock down and suspend websites selling illegal drugs.

“We must crack down on bad actors, including those in China, who target our young people and our families with the online sale of counterfeit and illicit drugs like fentanyl,” Rubio said. “Without legislative action, this highly addictive drug will continue to fuel America’s growing opioid crisis.”

The DRUGS Act was inspired by a 120-day voluntary pilot program launched by the FDA in 2020 to help curb the sale of illicit drugs. In partnership with three Internet registrars, the program shut down nearly 30 websites selling illegal opioids.

“Domain registrars are like owners of the Internet,” Baney said. “They control dot-coms and website namespaces. They have the ability to shut down bad tenants on these landing pages. Just as a landlord cannot keep a lease with a tenant using a house for drug trafficking, Internet landlords should not make money from criminals.

As the bill is drafted, a trusted notifier such as a state or federal agency or chosen nonprofit organization would send a warning letter to a site. Registrar would be notified and given seven days to suspend the site.

Opponents of the DRUGS Act, however, fear it is casting too wide a net and depriving American customers of their drugs.

Backed by the British Columbia government, Tim Smith, chief executive of the Canadian International Pharmacy Association, said his organization has 20 years of experience in providing safe prescriptions to patients and fears that new legislation only deprives an estimated 2.3 million Americans of access to affordable medicines. prescriptions.

“There’s a lot of room in the bill as it currently exists for subjectivity,” Smith said. “Let’s talk about opioids. Let’s talk about fentanyl. Let’s tackle falsified and substandard medicines. If that is what this bill intends to do, then the way it is written should change. But from my reading, the words opioid or fentanyl do not appear once.

Jay Baldwin is a thyroid cancer survivor from Detroit. For the rest of his life, every day, he must take Synthroid. Even with insurance, Baldwin’s out-of-pocket purchase of his drugs in the United States would still be more than double the full retail payment in Canada.

“I’ve saved thousands of dollars over the past 10 years filling my prescription at a reputable Canadian pharmacy. It’s money I need to live on,” Baldwin said. “I fear the legislation will be used to shut down reputable online pharmacy websites, especially given the vested interests that support these bills and their co-sponsors.”

Once a co-sponsor of the bill, Sen. Amy Klobuchar (D-Minn.) withdrew her support. Klobuchar has previously drafted legislation supporting the importation of prescription pills from Canada, and the campaign to import personal prescriptions has argued that the drug law would also target pharmacies offering legitimate prescriptions.

According to Niamh Lewis of the National Association of Board of Pharmacy, three conditions are necessary for a pharmacy to operate legally in the United States. First, the pharmacy must have a pharmacy license in the state where it operates and in the state where it dispenses. It should only sell prescription drugs that have been cleared for sale by the FDA and require a valid prescription.

Technically, no state has measures on the books that would authorize pharmacies from Canada, and the FDA has not approved drugs from Canada. However, the FDA has the discretion to allow personal importation of drugs when the product is clearly for personal use and does not appear to pose an unreasonable risk to risk.

With malicious sites selling fake drugs, Gabe Levitt founded PharmacyChecker.com with Dr. Tod Cooperman to inform consumers of sites offering safe prescriptions.

“There is common ground on this issue,” Levitt said. “It has to do with patient-focused advice on how to find the safest online pharmacies and how to avoid dangerous websites.”

But according to Lewis, without a valid pharmacy license, it’s difficult for state regulators to directly investigate claims of patient harm and for patients to know if what they’re getting is safe.

“We don’t walk out of our neighborhood pharmacies wondering if our drugs are safe and effective,” Lewis said. “We also rely on our well-regulated healthcare professionals to ensure drug therapies are appropriate for each patient.”

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