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
Yesterday, the Florida House Legislature voted
93-22 passing HB 19. The bill creates programs and processes for importing
prescription drugs from Canada, as well as from other countries. HB 19 actually
calls for the creation of two programs, which I have summarized below. For a
deep dive, you should read the Staff
Analysis from the Florida House of Representatives.
Prescription Drug Importation Program (CPDIP)
If HB 19 becomes law, the Florida Agency for Health Care
Administration (AHCA) will create processes that meet the safety protocols
called for in the bill, which include inspections and testing of drugs, to
allow registered wholesale pharmacies to import from Florida-registered
Canadian wholesalers. In this program, lower drug prices will save taxpayers
money for government funded-entities, such as county health departments, free
clinics, and the Department of Corrections.
(more…)Tagged with: Florida
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 Purdue Pharma settled with the state of Oklahoma for $270 million to avoid a trial charging the company with what I call opioid drug dealing. Purdue Pharma and members of the Sackler family–founders and managers of the company–are enmeshed in 1,600 cases throughout the U.S. They are accused of illegal marketing activities that led to over-prescribing and rampant distribution of Oxycontin, which paved the way for millions to the addiction of opioids, with hundreds of thousands dying over the last decade.
It was not just Purdue but many drug companies—and the entire
drug supply chain—that fueled the opioid death spiral. As drug companies and
their allies in the drug supply chain continue to use the opioid crisis as a
means to oppose prescription drug importation to lower drug prices in the U.S.,
we can only look on with amazement at their audacity.
(more…)Tagged with: New York Times, Purdue, Sackler family
Earlier this week, a report (the
“FGI Report”) opposing prescription drug importation proposals was released
by the law firm of Freeh, Sporkin and Sullivan LLP and the Freeh Group International.
Both organizations are headed by former FBI Director, Louis Freeh. I’m hesitant
to criticize reports authored by dedicated Americans who spent years in public
service protecting the safety of the American people in federal law enforcement.
On the other hand, the intent of tacking the name of a venerated American
patriot on a report that mirrors
the lobbying agenda of the pharmaceutical industry is clearly being used to
deter voices opposed to that agenda.
Summing it all up: this report was commissioned, I believe, by the drug company-funded group Partnership for Safe Medicines or a similar organization. As noted in the report’s title, it’s an addendum to an earlier report published in late 2017, one that was promoted at a Partnership for Safe Medicines media event at the National Press Club.
(more…)Tagged with: Alex Azar, FGI report, Louis Freeh, Partnership for Safe Medicines
Back in 2008, Consumer Reports recommended PharmacyChecker to Americans looking to save money on prescription drugs at foreign pharmacies. An article in the Los Angeles Times stated: “Consumer Reports Best Buy Drugs advises checking online prices, for U.S. and foreign pharmacies, at pharmacychecker.com.”
That was then. This is now.
When Consumer Reports’ Lisa Gill testified before the Senate
Special Committee on Aging hearing on drug prices last week, she was silent
in her prepared remarks about what she knows well: millions of Americans,
readers of Consumer Reports, buy medicine online internationally. Her silence
did not surprise me because Consumer Reports does not currently recommend
buying medicine online from Canada or other countries, although many of its
readers believe it should.
(more…)Tagged with: American Enterprise Institute, Consumer Reports