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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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Lower-Cost Imported Drugs Can Save Lives

Millions of people are dying because they are not getting the healthcare they need and that includes prescription drugs. New research has made a slam dunk case for why international online pharmacy options are needed urgently. We can’t allow drug companies to continue fooling the public about drug importation. 

A Gallup Poll survey announced yesterday found that 34 million Americans know someone who died because they could not afford medical treatments. That doesn’t mean prescription drug affordability specifically was the cause. In fact, the Gallup Poll lacks details about what kinds of medical treatments were too expensive. However, the poll identifies that a rising percentage of Americans are reporting going without prescriptions because of cost: from 18.9% in January to 22.9% in September of 2019. That would be about 58 million Americans who say they did not fill a prescription in the past 12 months because of cost. Since pharmacies in other countries charge much lower prices, and properly credentialed international online pharmacies make those drugs available, the veracity of the title of this blog post is undeniable.

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Canadian Ambassador Says Canada’s Too Small For America’s Drug Import Program. Now What?

There are few people more supportive than I am of prescription drug importation as one policy to help Americans access lower drug prices. But, since I accuse Big Pharma types and the FDA of ignoring reality about the safety of personal drug imports from licensed pharmacies in Canada and other countries, I won’t ignore reality! Canada is concerned about momentum on drug importation coming from the Trump administration and states, particularly Florida, citing its relatively small population and limited drug supplies. The answer is not to pull back on importation, but to expand the scope of countries in the supply network. 

As reported in Reuters earlier this week, the Canadian Ambassador to the U.S. stated that she is “sympathetic to U.S. concerns regarding affordable prescription drugs.” On the other hand, she said, “Not only are we too small of a market, Canada cannot increase its domestic pharmaceutical drug supply to meet U.S. demand…” It’s not incredibly cynical of me to suggest that drug company lobbyists, who work internationally, have spoken with Canadian diplomats and said, “Look, we’re not going to increase your supply of far less expensive medicine just so Florida’s state importation plan can work and Trump can get a political win.” 

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