According to the FDA, in 2017, 80% of the active pharmaceutical ingredients used to make our medicines are imported. I can’t remember how many times I’ve read (and written) that over the past decade or so. Almost every time I read that particular statistic in the news, it’s often a story about drug quality problems, in which foreign APIs are reported as a growing problem. Flashback to the FDA in 1998: as reported by the U.S. Government Accountability Office, the percent of active pharmaceutical ingredients used to make medicines for sale in the U.S. is about 80%.
In March 2019, Anna Edney, from Bloomberg News, wrote an
article called: “Tainted
Pills Force FDA to Tighten Drug-Safety Regulations.” The main focus of the
article is that there are drug quality problems caused by APIs that are not
meeting the required standards.
(more…)Tagged with: Anna Edney, bloomberg, FDA
Properly licensed foreign pharmacies help Americans access
medicines that they can’t afford here. Counterfeit drug makers and sellers,
fentanyl and opioid dealers, and dangerous pharmacy websites are worthy targets
of serious regulatory or criminal enforcement actions. There’s no gray there.
An article I wrote that was recently published in The Nation hopefully brings to greater public attention the FDA’s conflation of clearly safe channels for personal prescription imports with counterfeit drugs, the opioid crisis, and rogue online pharmacies. That conflation, one associated with the media relations work of the pharmaceutical industry – is used to justify FDA enforcement actions that exacerbate the crisis of high drug prices by threatening programs that facilitate prescription fulfillment from foreign, licensed pharmacies.
(more…)Tagged with: CanaRx, Counterfeit Drugs, FDA, fentanyl, The Nation
This week, I attended ASOP Foundation’s symposium titled: “Spotlight on Illegal Online Sales of Medicine.” ASOP is short for the Alliance for Safe Online Pharmacies. That organization, which started with funding from Eli Lilly and the National Association of Chain Drug Stores, has often received criticism on these blog pages. Like other Pharma-funded initiatives, its goals are aligned with the pharmaceutical industry and one of its main objectives is lobbying against personal drug importation. It often conflates, through its public education programs, safe international online pharmacies with dangerous rogue websites. However, a good part of its work is helping raise awareness and policy development to stop rogue sellers of counterfeit and substandard medicines from harming patients, and that’s something PharmacyChecker is 100% behind.
Much of ASOP’s work was the brainchild of LegitScript, a founder of ASOP. Truth be told, PharmacyChecker is the expert in safe international online pharmacies and providing consumers with useful guidance about them, but LegitScript/ASOP are the experts in rogue online pharmacies and pushing policies to shut them down. It’s disheartening that they seemingly refuse to separate safe importation from rogue online drug sellers. But I’ll put that aside for now.
I’m going to focus today’s post mostly on presentations by two high-ranking FDA officials. The first was the morning’s keynote speaker, Donald Ashley, JD, FDA’s Center for Drug Evaluation and Research Director of Compliance. His focus was the FDA’s efforts to combat illegal opioid sales online and those being imported through international mail facilities. I’ve written about how such actions can be used against safe personal drug imports. While that would be unfortunate, Mr. Ashley was meticulous in communicating that his efforts are strictly focused on opioids: shutting down fentanyl and other opioid-selling sites; detecting and stopping illegal opioid imports; and, through the Office of Criminal Investigations, charging and prosecuting these online opioid drug dealers.
Tagged with: ASOP, Donald Ashley, FDA, Michael Kopcha, Office of Pharmaceutical Quality