Yes. Last week, the four most recent commissioners of the U.S. Food and Drug Administration sent an open letter to Congress declaring that an importation bill, The Affordable and Safe Prescription Drug Importation Act, introduced by Senators Bernie Sanders, Cory Booker, and Bob Casey, if passed, would jeopardize consumer safety. The bill, as described here, provides for an extensive oversight role for the FDA to help individuals and pharmacies import lower cost medications from Canada.
Don’t get me wrong: the former FDA leaders make pertinent points about regulatory issues implicated in reforming our importation laws, which should be noted – and then used to implement new regulations to expand importation from Canada – not used to pretend safe importation is impossible.
Thankfully, when the Washington Post covered this last week, they included something I said to the reporter: “The Internet has been a lifeline of affordable medicines, imported for personal use by using safe international online pharmacies that require valid prescriptions…” And if I had more to say… (more…)
Too many Americans are being kept in the dark by the very governing authorities and companies that are meant to protect their health. The FDA goes too far in telling Americans not to buy lower cost medication from outside the country, and Big Pharma spends big money on media relations to generate stories about rogue online pharmacies that wrongly conflate them with safe international online pharmacies.
If drug prices are going up, and Americans are fed up with prescription costs, wouldn’t you expect more people to be buying lower cost medications from outside the country? With fewer Americans buying medication internationally, potentially one million, how many of them are simply not taking prescribed medication? Are our most trusted authorities scaring Americans away from obtaining lower cost medications from other countries, or has affordable access improved over the past few years?
Today, as the Obama administration hosted a “public” forum (think invitation only) about pharmaceutical innovation, access and affordability, I announced the formation of a non-profit organization dedicated to helping Americans get justice when it comes to prescription drug prices: Prescription Justice Action Group (PJAG). Whereas the administration’s public forum ignored personal drug importation, PJAG is providing guidance to Americans on what to do if their prescription drug orders are refused import by the FDA so they can try to have their medications released.
For about fifteen years, tens of millions of Americans have purchased medication from outside the U.S. –usually ordering it online. They do it because they want to save money or they really cannot afford the medication here at local pharmacies. The fact is that it has become a lifeline of lower cost medications for Americans.
But a new law – Section 708 of the Food and Drug Administration Safety and Innovation Act – gives the FDA expanded powers to destroy your personally imported medications, whether bought from a Canadian, Indian, Turkish or U.K. pharmacy. That doesn’t mean they will. It just means that they can. That law became effective over a month ago, and we haven’t heard of increased FDA seizures and destructions of international prescription orders.
The FDA has stated, and we have re-affirmed on our blog and main website, that under most circumstances it’s technically illegal to import prescription medication for personal use. But is it really? Is it always?
Section 708 allows the FDA to detain and potentially destroy your prescription order if it appears to be misbranded, unapproved, counterfeit or adulterated. If they take your adulterated or counterfeit drugs then the FDA has done their job. Misbranded or unapproved drugs, in contrast, could be entirely safe and effective medications, the same or foreign versions of the ones you buy in the U.S., but much less expensive. Under Section 708, you must be notified by the FDA if they take your prescription drug import, and you have 20 days to challenge them on their action. PJAG, in consultation with legal advisers, believes that you can make a good case that FDA should not destroy the medication but instead send it to you.
There are many dangerous online pharmacies out there from which you don’t want to buy or import medication. We call them rogue online pharmacies. But if you import a genuine, safe and effective medication, one that was purchased from a PharmacyChecker.com-approved online pharmacy and you get a notification from the FDA telling you that your prescription drug order is subject to destruction…PJAG!
We issued a press release yesterday about our new drug price savings analysis, which shows that consumers can save 84% on average among a basket of 10 popular branded maintenance medications if purchased from verified international online pharmacies instead of local U.S. pharmacies. Many of the savings are over 90%! The greatest savings is 94% for the acid-blocking drug Nexium ($946.50 in the U.S. vs. $53.09 online for a three month supply of 40 mg pills) and the cholesterol-lowering drug Crestor ($803.89 vs. $51.40 – 20 mg pills). The greatest dollar savings is for the antipsychotic drug Abilify ($3,178.99 vs. $237.05 – 10 mg pills). The average annual savings per drug is $3,479. Despite this, last month, the U.S. FDA announced a “new rule” regarding its expanded authority to destroy personally imported medicine under Section 708 of the Food and Drug Administration Safety Act of 2012. Several members of congress have raised concern that FDA’s rules may impede access to affordable medication. 
The FDA says that its new regulation is meant to protect patients from unsafe medications and counterfeit drugs but the agency doesn’t seem to say how they will distinguish safe from potentially unsafe personal drug imports.
Sources: Local pharmacy prices based on prices at chain drugstores in New York City; International online pharmacy prices based on lowest prices listed on PharmacyChecker.com. All prices obtained on September 30, 2015.
*Medications dispensed by licensed pharmacies, verified by PharmacyChecker.com, in one of the following countries Australia, Barbados, Canada, India, Mauritius, New Zealand, Turkey, Singapore, or United Kingdom.
 U.S. Senator David Vitter, “Vitter Fights to Keep Prescription Drug Prices Affordable Through Reimportation,” July 9, 2014 [press release], see [www] vitter.senate.gov/newsroom/press/vitter-fights-to-keep-prescription-drug-prices-affordablethrough-reimportation [Last accessed 9/20/14]. 38 Representative JoAnn Emerson (MO), “Food and Drug Administration Reform Act.” May 30th 2012. See [www] votesmart.org/public-statement/702416/food-and-drug-administration-reform-act-of-2012#.UxVJN-co4s9 [Last accessed 9/22/14]. Letter to the U.S. Food and Drug Administration by Congressman Keith Ellison dated July 1st, 2014. See See [www] regulations.gov/#!documentDetail;D=FDA-2014-N-0504-0022.