by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Dec 13, 2018 | FDA enforcement
As announced on the Prescription Justice Blog, a person recently exercised their right to defend a prescription drug import that the FDA had detained and she won the case. The drug, Arthrotec, is available for sale at U.S. pharmacies. However, according to the patient, the drug was not affordable here in the U.S. This example shows the FDA exercising its enforcement discretion to permit medicine imports where the patient cited lower costs as the reason for the importation.
If personal drug importation is illegal under most circumstances, then what is behind this“right” to argue with the FDA?
It’s pretty straightforward:
U.S. law that affects personal prescription drug importation explicitly prevents the FDA from destroying a patient’s prescription drug import without “due process” to defend that order. That comes from Section 708of the Food and Drug Administration Safety and Innovation Act of 2012. The purpose of that law was to make it easier, ironically, for the FDA to refuse and destroy imported medicines for personal use. That can be helpful if the drugs are counterfeit or adulterated, but harmful if they are from licensed pharmacies and the patient importing them can’t afford them here—such as the case noted here.
(more…)Tagged with: Arthrotec, Due Process, Enforcement, prescription justice
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Jul 2, 2014 | Advocacy, Personal Drug Importation, Politics
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