by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 17, 2020 | FDA enforcement
Unbelievably, the FDA has increased seizures of international mail-order prescriptions over the past month.
Historically, far less than one percent of personal medicine imports are taken away by the FDA, despite the federal restrictions on importation. I only believe this to be the case if the exporting pharmacy requires a valid prescription. I don’t know if the FDA is more aggressive with rogue pharmacy actors than with legitimate pharmacies. I hope they are.
There are a few basic reasons why so many imports get through even when they may technically violate U.S. law:
First, enforcement discretion, through which the FDA can permit otherwise prohibited imports;
Second, political considerations, in that no administration wants to be viewed as taking away people’s medications, especially from older folks;
Third, the volume of imports being too great to handle with millions of packages coming in through international mail facilities;
and Fourth, in some instance the drug imports, as long as they are for personal use, could be deemed compliant with federal law.
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by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 8, 2020 | Drug Importation
The pharma-funded and industry opponents of drug importation from Canada just love to talk about how “even the Canadian government opposes importation.” For a quick clarification, Canada has not minded or stopped its pharmacies from safely dispensing medicines by mail to Americans. That’s personal drug importation. When I write that Canada opposes importation, I mean the wholesale drug importation currently proposed by the Trump administration.
Hey, if Canada doesn’t want this new policy, then what the hell can we do? As I see it, Pharma-funded groups, like the Partnership for Safe Medicines and Alliance for Safe Online Pharmacies, have—almost gleefully— pointed out to the U.S. FDA that Canada is opposed to the implementation of Section 804 to allow registered wholesalers in the U.S. to import drugs from Canada. This is mainly due to Canada’s fear of drug shortages. Drug manufacturers supply Canada to meet the needs of its much smaller population. If Canadian wholesale drug exports increase substantially under the new Trump administration policy then it could exacerbate supply problems in Canada.
(more…)Tagged with: Horvath Health Policy, Scott Gottlieb, Stephen Salant
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Apr 3, 2020 | Drug Safety
When I read fancy-looking international reports that address the problem of counterfeit drugs, too seldom is our work recognized in verifying international online pharmacies in a manner that saves the lives of consumers looking online for affordable medicine. To some extent, that’s because the global pharmaceutical industry is often a major data source for these reports. But a joint effort between the Organization for Economic Cooperation and Development (OECD) and the European Union Intellectual Property Office (EUIPO)” recently recognized PharmacyChecker in a report on counterfeit drugs called “Illicit Trade: Trade in Counterfeit Pharmaceutical Products.” Under the sub-section “Online Pharmacy Authentication,” PharmacyChecker is mentioned as a free resource for consumers to identify trustworthy online pharmacies:
“PharmacyChecker is a free-to-consumer online service which produces reports on the credentials, prices and customer feedback of online pharmacies, focusing mainly on the United States and Canada. It is designed to help users identify reputable and trustworthy businesses. The site publishes a list containing the web addresses and business names of what it considers to be disreputable, dishonest and/or illegal online medicine trade sites.”
It should be clarified that, although our consumer advocacy and writing are focused on Americans, PharmacyChecker online pharmacy accreditation and pricing are there for global consumption.
(more…)Tagged with: Counterfeit Drugs
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Mar 27, 2020 | Drug Safety
This week, the FDA
issued an alert that the EpiPen, a brand name epinephrine injection that should
help someone having a serious allergic reaction, might not work properly. The
problems include delayed injection, failure to inject, and difficulty removing
the product from its container to commence an injection. If this drug fails to
work on a patient who is in anaphylactic shock, the result can be death. In
fact, such product failures were
reported to have killed seven people in 2017 and led to 35
hospitalizations.
Warnings about bad drugs or medical products are often
associated with imports, such as from India or China – or buying drugs online.
But here we have a homegrown problem, which we actually export.
(more…)Tagged with: EpiPen
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Mar 20, 2020 | FDA
Americans who have been relying on trips to Canada for cheaper prescription drugs may not be able to do so for about a month, but really who knows how long. As reported in the Washington Post yesterday, to slow the spread of the Coronavirus, President Trump and Prime Minister Justin Trudeau of Canada agreed to close the border yesterday to all but “essential” travel.
SPECIAL NOTE: On this blog I’m sometimes a bit snarky in poking fun at drug companies, drug company-funded groups and the FDA when it comes to their public education information about drug importation and buying drugs online. But let’s face it: we need drug companies and the FDA more than ever right now, and I wish them Godspeed in efforts to find and approve treatments to fight COVID-19. Within that spirit of coming together, I’ll continue to raise the same issues found on this blog.
When the border re-opens, the FDA should immediately, expressly permit personal drug imports from Canada. I’m not talking about “Canadian online pharmacies” or buying on the Internet. I do believe people should be able to do that as well, but my focus for this post is on border crossing prescription drug imports by individuals from Canada.
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by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Mar 11, 2020 | Drug Importation
Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020.
Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796“
Docket No. FDA-2019-N-5711
Date: March 9,
2020
Submitter: Gabriel Levitt, Co-founder and President,
PharmacyChecker; Founder and President, Prescription Justice
I appreciate the opportunity to comment on this notice of
proposed rulemaking (NPRM). Founded in 2002, and launching its website in 2003,
PharmacyChecker provides consumers with online pharmacy verification and
comparative drug price information to help them make the best decisions for
themselves and their families on how to afford prescription drugs.
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