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Is the FDA Misleading Congress About the Safety of Imported Medicines?

FDA misleads Congress about drug importation

Properly licensed foreign pharmacies help Americans access medicines that they can’t afford here. Counterfeit drug makers and sellers, fentanyl and opioid dealers, and dangerous pharmacy websites are worthy targets of serious regulatory or criminal enforcement actions. There’s no gray there.

An article I wrote that was recently published in The Nation hopefully brings to greater public attention the FDA’s conflation of clearly safe channels for personal prescription imports with counterfeit drugs, the opioid crisis, and rogue online pharmacies. That conflation, one associated with the media relations work of the pharmaceutical industry – is used to justify FDA enforcement actions that exacerbate the crisis of high drug prices by threatening programs that facilitate prescription fulfillment from foreign, licensed pharmacies.

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NY State Authorizes Paper Prescriptions to Fill in Foreign Pharmacies

Good news for New Yorkers who want freedom of choice to fill their prescriptions at pharmacies located where they are more affordable: in other countries. There is now an explicit exception to the electronic prescription (e-prescribing) law in New York that permits paper prescriptions to be filled in other countries. I’m sorry we didn’t catch this earlier, but here it is now. As of January 2017, according to the NY State Department of Health, one exception to e-prescribing, which allows a provider to write a paper prescription, is when the medicine is: 

“…dispensed by a pharmacy located outside the state, outside the country, or on federal property, including and not limited to the following examples; Veterans Administration, West Point, Fort Drum, and Indian Reservations;”

When e-prescribing became mandatory in NY, people had a hard time obtaining paper prescriptions. This was not just an inconvenience. It was a threat to their access to affordable medicine. In our country, it’s sometimes imperative to shop around and find the pharmacy that charges the lowest price in our neighborhood – or in another country. This development should be very helpful to people looking to shop around.

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The Mike Enzi Foundation for Lower-Cost Imported Insulin Should Exist

Senator Mike Enzi

In my blog post about the Senate Finance Committee hearing on drug prices, I noted my surprise at Senator Mike Enzi’s (R-WY) comment that he knew about a foundation that helps people import lower-cost insulin from Canada. Sen. Enzi stated that a person referred to as his diabetes advisor had “found a way to work through a foundation to import insulin for a number of people at lower-cost. And I think he worked for a foundation so that it would be legal.” I had endeavored to look into it, but fortunately Jay Hancock from Kaiser Health News beat me to it and found, sadly, no such insulin import program exists. I think we can all agree that it should!

In researching the story, Jay asked me if I knew of such a program.

Nope.

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Senator Grassley on medication savings: “Have you considered Mexico or online”?

Grassley asks why not buy medicine online or go to Mexico

Senator Chuck Grassley (R-IA), who introduced the Safe and Affordable Drugs from Canada Act of 2019, may well emerge as a major champion for Americans who import medicine because the prices are too high here in the U.S.

An astounding thing happened during the Senate Finance Committee hearing on drug prices this past Tuesday. Committee Chairman Grassley asked one of the witnesses, a mother struggling with the cost of insulin for her young adult son, if she had considered importing medicine to afford it.

Think about that.

Under most circumstances, according to the FDA, it’s illegal to import medicine for personal use. And yet at a high-profile Senate committee hearing, the venerable Sen. Grassley seemed genuinely curious why Ms. Sego didn’t get lower-cost medication online from another country.

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Drug Importation Front and Center in 2019

Personal Drug Importation

In the first two weeks of January, the prospects for drug importation to help alleviate high drug prices in the U.S. are looking good. Before summarizing recent developments, I’ll just note that millions of Americans who can’t afford medicines and want to save money continue to use personal drug importation, despite the federal prohibitions. This includes physically traveling across the border to buy from Canadian or Mexican pharmacies, through international air travel, and ordering from international online pharmacies.

Last week, Lucia Mueller blogged about an important survey by the Campaign for Personal Prescription Importation in which 94% of respondents affirmed that cost is the #1 reason they rely on importation through international online pharmacies.

This week, the Philadelphia Inquirer reported on Americans with Medicare falling through the cracks on drugs dropped from formularies, particularly when they are prescribed off-label, facing high costs and looking internationally for relief. As reported, savings are even greater when Americans buy generic versions overseas, of drugs that are still under patent domestically.

There’s a lot of buzz in Congress, states, and the White House on the issue of drug importation right now. Hopefully, current laws will be amended this year to make importation expressly permitted instead of merely tolerated.

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Survey Shows Cost Top Reason Americans Order Medications from Canada

It’s no secret Americans are struggling to afford their medications. A quick skim of crowdfunding websites, such as GoFundMe.com and Fundly.com, sets the grim scene of rising prescription drug costs in the United States. As a result, many Americans are ordering from online pharmacies located in other countries that offer the price relief folks can rarely swing here at home without the aid of insurance or strategic use of discount coupons.

A 2019 survey conducted by the Campaign for Personal Prescription Importation shows that cost is the top reason more and more Americans are ordering their prescriptions from online pharmacies in Canada. 94% of Americans cite high drug prices in the U.S. as reason for ordering from abroad.

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