PharmacyChecker Blog

Helping Americans Get The Truth About Prescription Drug Savings
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Even Drugs Manufactured in America are not “Made in the USA”

PharmacyChecker pays close attention and has performed considerable research related to where drugs are made. Most notably, by researching drug labels and contacting drug companies, we found that 71% of brand name drugs sold in the U.S. are foreign made, a number far higher than the 40% figure regurgitated by the FDA year after year. Americans care a lot about this issue. One of our more popular Ask PharmacyChecker posts is called “How can I determine where a drug is manufactured?” But here’s something different to chew on: Even drugs that our research categorized as manufactured in the U.S.  are often not really very “American.” In fact, many are categorized as imported and considered to be foreign-made pharmaceuticals by U.S. Customs and Border Protection (CBP).

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Canada’s Message to the U.S. on Drug Importation: We care more about our citizens than you.

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.

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Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. Reg. 70796”

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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The Drug Reimportation Law Curtails Wholesale Not Personal Importation: Who Knew?

On behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”

I published the comments in their entirety on Prescription Justice here: https://prescriptionjustice.org/resources/blog/opportunities-safe-personal-drug-importation-under-section-801-public-comments-prescription-justice.

I have a different story to tell here about the new, or newish reimportation law.

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Section 804’s Conflicting Standards for Personal vs. Wholesale Drug Importation and Why it Matters

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. Importation from Canada is legal under this section of U.S. law, but only if the Secretary of Health and Human Services (HHS) certifies, as stated in Part L, that such importation would pose “no additional risk” to the public and would help save the American consumer money. It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation. What about personal drug importation? Wholesale drug importation is when people or companies import drugs for re-sale, usually described as commercial quantities. Personal drug importation is when a consumer fills a prescription in Canada or another country and imports it either carrying it across the border or through the mail.

Section 804, as clearly stated in Part J (1), treats personal drug importation differently, and this is of paramount importance for policymakers and the general public to understand. Section 804 doesn’t legalize it across the board but affirms that Americans should be permitted to import prescription drugs for personal use, as long as it doesn’t represent an “unreasonable risk” to the patient. This more liberal standard is fundamentally different from Part L of Section 804, which mandates “no additional risk” to the public health, the standard necessary for the overall section to become effective. Where does that leave us in terms of law and policy?

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Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit

The following statement, recently published in the Congressional Record, was submitted by Gabriel Levitt on October 30, 2019, on behalf of PharmacyChecker and Prescription Justice, to the Committee on Ways and Means of the U.S. House of Representatives 116th Congress pertaining to a hearing entitled: “Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”.

“Investing In The U.S. Health System By Lowering Drug Prices, Reducing, Out-of-Pocket Costs and Improving the Medicare Benefit”

October 29, 2019

Gabriel Levitt

Co-founder and President, PharmacyChecker.com, 333 Mamaroneck Avenue, White Plains, NY 10605, 718-554-3067, gabriel.levitt@pharmacychecker.com

Founder and President, Prescription Justice, 3309 Robbins Road, #412, Springfield, Illinois 62704, gabriel@prescriptionjustice.org

Our company, PharmacyChecker.com verifies online pharmacies, and compares drug prices among those accredited in our online pharmacy Verification Program. Consumers, Americans and worldwide, access our website for free. Our website has received about 30 million visitors since we launched our virtual doors in 2003. Our niche is comparative pricing and the proper credentialing of international online pharmacies, which process prescription drug orders filled by licensed pharmacies in several countries, require valid prescriptions, and do not ship controlled drugs into the U.S. We also provide information about discounted U.S. pharmacy prices and patient assistance programs.  The information we provide helps people make the best decisions for themselves and their families when struggling with the cost of prescription drugs.[i]

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