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behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”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

The FDA has done something that prescription drug importation advocates had possibly given up on.  Not me. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices. The proposed rule provides specifics so that states contemplating or already formulating wholesale drug importation programs have a shot at gaining approval for those programs, per Section 804 of the Food, Drug and Cosmetic Act.

Year after year after year, the media has reported Pharma’s talking point: No Secretary of Health and Human Services, Republican or Democrat, has been able to certify the safety of importation from Canada. That’s never been true, at least not exactly. It’s not that they haven’t been able. It’s that they haven’t been willing. Also, it’s not just certifying the safety, it’s certifying that there will be “no additional” safety risk – a high standard. Well, apparently it can be done. The FDA stated:

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China Opens the Door to Personal Medicine Imports and Third-Party Online Platform Sales

A new Chinese law (in effect as of December 1, 2019) makes third-party online platform medicine sales legal, appropriately ends a draconian definition of counterfeit drugs, and effectively decriminalizes personal drug importation, but with a lot of gray! The changes were part of a major overhaul of the Drug Administrative Law of the People’s Republic of China (DAL). The previous linked to page is in Chinese but you can use Google translate to read it in English or another language. A summary in English can be found here:

Summary of Revised Chinese Drug Administration Law

For supporters of online access to safe and affordable imported medicines, this is kind of cool.

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