08 Jul 2016
The Personal Drug Importation Fairness Act
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About four million Americans import medication for personal use each year because of high drug costs, according to the U.S. Centers of Disease Control and Prevention. Their actions, under most circumstances, are technically illegal, but not something over which the government prosecutes individuals. The law, however, is unjust and unfair and should be reformed so that people who buy medication from a pharmacy in a different country are not, technically, criminally liable. Think about it. The medication you take is 90% cheaper in a different country and you can’t afford it domestically. It’s available for import by mail from a licensed pharmacy that you can access on the Internet. Why should the act of importing it be illegal?

The Personal Drug Importation Fairness Act of 2015 (PDIFA), H.R. 2623, expressly legalizes the importation and Reimportation for personal use of medications. Its passage would make it expressly legal to order a medication online and have it imported for personal use or simply bring it back into the U.S. by car or plane. The bill was introduced by Congressman Keith Ellison in June of 2015, and is cosponsored by Congressman Dana Rohrabacher (R-CA), Congresswoman Janice Schakowsky (D-IL), Congresswoman Raul Grijalva (D-AZ), Congressman Alcee Hastings (D-FL), Congressman Jerrold Nadler (D-NY), Congressman Collin Peterson (D-MN), and Congresswoman Rosa DeLauro (D-CT).

Under PDIFA, permitted imports would be drugs that have the “same active ingredients, route of administration, and strength” as those sold in the U.S. and sold in “qualified countries:” Australia, Canada, Israel, Japan, New Zealand, South Africa, Switzerland, a member-state of the European Union or a country in the European Economic Area. The qualified country must be considered to have “standards for ensuring the safety and effectiveness of drugs that are at least as protective as such standards in the United States” by the Commissioner of the FDA.

Past drug importation legislation has too often included poison pills that make it very difficult to actually change the regulations. In fact, even under current law, Section 804 of the Food and Drug Cosmetic Act (U.S. Code §384), prescription drug importation for personal use could be legal now if the Secretary of Health and Human Services certifies that the imports will “pose no additional risk to the public’s health and safety.” It’s very difficult to certify that there is no additional risk to importing medication from a different country but the FDA could do so with new safeguards and protocols.

The PDIFA, in contrast, looks to the FDA to simply certify that a qualified country has equally as protective pharmaceutical standards as the U.S. Luckily, there are other exceedingly competent and experienced drug regulatory authorities, such as Canada’s Therapeutic Products Directorate, the European Medicines Agency, and the UK’s Medicines and Healthcare products Regulatory Authority. The FDA could certify the equality of their standards.

While reforms to expressly permit drug imports from just Canada are welcome, the PDIFA reflects the reality of international trade and that Canada is too small a country to accommodate a sizeable increase in demand and – while not often discussed – Canada has the second highest drug prices on average. Also, for Americans, most personally imported medications already extend beyond Canada. However, there are political and practical reasons to support legislation focused on drug importation from Canada and we’ll address that in our next blog post.

Critics of expanding access to lower cost medications through personal drug importation, usually voices from the pharmaceutical and U.S. pharmacy industries, claim it’s not safe. What is not safe about buying medications from licensed pharmacies in a variety of countries throughout the world? If you go to Canada or the UK and need a prescription drug do you fear for your safety? No.

And what about rogue online pharmacies that intentionally sell counterfeit or otherwise bad medication, don’t’ require a prescription, or rip people off in other ways? Get rid of the rogues through online enforcement and regulate the safest international online pharmacies.  Bring on the prescription fairness!

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