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
As we approach July 4th, a day to celebrate freedom in America, I urge you to stand up for your freedom to access safe and affordable medication!! Let’s face it: the global drug companies – big Pharma – would rather you pay higher prices for their medications because it makes them more money. In its infinite pandering to big Pharma, Congress included language in the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) – an otherwise pretty useful drug safety bill – expanding the authority of the U.S. Food and Drug Administration to destroy safe, personally imported medications. In the spirit of independence – life, liberty, and the pursuit of happiness – take this time to send a message to the Secretary of the Department of Health and Human Services (HHS) asking that she take the necessary actions to protect your prescription drug orders, ones ordered from safe international online pharmacies.
Thanks to RxRights.org for leading the charge on this effort!
The onerous language under discussion is found in Section 708 of FDASIA, which allows the FDA to destroy medication orders valued at $2500 or less that are refused import. The medications subject to refusal and destruction are those deemed “adulterated, misbranded or counterfeit.” Those words seem pretty scary but don’t be fooled. Unlike an adulterated or counterfeit drug, an imported ‘misbranded’ drug can be the same, safe and effective medication sold in a U.S. pharmacy but with a slightly different label. Seizing and destroying a person’s safe prescription drug order is immoral, anti-American, and dangerous to that person’s health.
There’s a catch in the law, which actually invokes the Spirit of 1776. Before Section 708 goes into effect, the HHS Secretary shall draft proposed regulations to provide consumers with due process to “challenge the decision to destroy the drug.” That means Americans should have an opportunity when their medication orders are seized to tell the government “don’t destroy my safe prescription drug order.” As the agency under HHS tasked with regulating the nation’s drug supply, it’s the FDA that leads the government in this process. FDA’s proposed regulations, which are open for public comment, were drafted and published in early May. While they fail to provide what the law requires – “appropriate due process” – I believe they leave the door open to amend what they have proposed. This weekend I’ll be working to submit PharmacyChecker.com’s public comments to try and assist (persuade?) the FDA to issue a more consumer-friendly final regulation that protects your access to safe and affordable imported medication.
I invoke the spirits of our Founding Fathers to guide us in this fight for independence from the tyranny of high drug prices.
Happy Fourth of July!
Tagged with: Due Process, Regulations, RxRights, Section 708
Section 708 of the Food and Drug Safety and Innovation Act of 2012 allows U.S. Customs and Border Patrol (CBP) to destroy your imported prescription orders. Even if the drug is the real deal, safe and effective, it can be destroyed. But wait! The law can’t take effect until the Secretary of Health and Human Services, Kathleen Sebelius, publishes regulations that provide Americans the opportunity to contest when their medications are seized by CBP. She is drafting those regulations right now, which will be followed by a period for public comment. Let her know that she is now responsible for protecting your access to affordable, imported medication. She should understand. As governor of Kansas, Kathleen Sebelius adopted a personal drug importation program by providing information online that helped residents find lower cost medications from licensed foreign pharmacies.
Sign the Petition!
Tagged with: Food and Drug Safety and Innovation Act of 2012, Kathleen Sebelius, Section 708