by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jun 9, 2016 | Advocacy, FDA, Personal Drug Importation
I’m pleased to announce that the Prescription Justice Action Group (PJAG) has a new and improved website; and for those of you that follow PharmacyChecker.com’s advocacy efforts on these blog pages I believe you’ll like it! The site just looks a lot better, it’s easier to use and therefore more helpful.
As a reminder, last November we announced the formation of PJAG, a non-profit organization dedicated to defending Americans if the FDA refuses and threatens to destroy their personal drug imports and advocating for policies to lower domestic drug prices. The motivation to start PJAG was the passage of legislation back in 2012 giving new, potentially harmful regulatory powers to the FDA. Often referred to as Section 708, the law allows FDA to more easily destroy personally imported medication. The new rules went into effect on October 15th of 2015.
FDA may be seizing medications in larger numbers ordered from rogue online pharmacies but to date they have not greatly increased refusals of medication ordered internationally from PharmacyChecker-approved online pharmacies. I write “greatly” because I’ve heard that there have been some increases. Historically, over 99% of prescription drug imports ordered from international online pharmacies that require a prescription have reached the patient.
PJAG’s website provides guidance to show consumers how to submit a letter to the FDA to defend a medication they have ordered from an international pharmacy, if they get a letter that it’s being held by the FDA and subject to destruction. It’s not easy and it takes patience but following PJAGs guidance could be helpful: at a maximum to get your medication back in the unlikely event it’s taken, and at minimum to send a message to the FDA that they took medication from you and now you can’t afford it. PJAG blogs that it’s working to create a web form portal to make the submission process easier. We’ll report back when that’s up and running.
We also support the grassroots consumer advocacy efforts of RxRights and hope that you sign-on to its ongoing, multiple campaigns to contact your elected leaders about the high cost of medication.
Tagged with: 708, pjag, Prescription Justice Action Group, RxRights
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Nov 20, 2015 | Advocacy, Drug Importation, Drug Prices, FDA, Government
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!
Tagged with: affordable prescriptions, Drug Importation, FDA, Food and Drug Administration Safety and Innovation Act, international pharmacies, Online Pharmacies, pjag, Section 708
