by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Mar 6, 2020 | Politics and policy
The window for public comments on the FDA’s
notice on proposed rulemaking about drug importation under Section 804 of
the Food, Drug, and Cosmetic Act is closing on Monday March 9th – and I’m not
done writing! So, this post will be short and sweet but highly relevant. Of
course, lower drug prices in foreign countries are on my mind today – as they
often are. And they were also on the minds of the truth-sleuth masters over at
Politifact yesterday. The title gives away the answer already so go take a look
at how Politifact
checks out U.S. Rep. Gwen Moore’s (D-WI) statement: “Prescription drug
companies are charging Americans prices that are on average 4x higher than
what’s charged in other countries.” Or read on for the super quick explanation.
(more…)Tagged with: Congressional House Ways and Means Committee, Rep. Gwen Moore
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 28, 2020 | Online Pharmacies
Yesterday, I was asked by Ed Silverman of STAT NEWS’ Pharmalot
for my thoughts about a report by the Office of Inspector General, Department
of Health and Human Services (OIG). The report is an audit of companies in the
drug supply chain to test compliance with regulations called for by the Drug
Supply Chain Security Act of 2013 (DSCSA). In short, as reported
in STAT, OIG found that seven out of 44 drugs audited could not be traced
back to the manufacturer in the manner required under the DSCSA. Add to that,
the physical locations of 21 drugs could not be determined. Since most drugs
subject to DSCSA are made overseas and imported, Mr. Silverman wanted to know
if this audit impacted drug importation proposals and plans in the works to
lower drug prices. The answer is probably no. The report appears to be a
worthwhile effort to test compliance with DSCSA. However, use of the word
“legitimate” is found in the DSCSA, and that word is often misused by opponents
of drug importation and international online pharmacies – and that got me
thinking. I’m sick of that word.
(more…)Tagged with: ed silverman, Eliquis, LegitScript, NABP, OIG
by Gabriel Levitt, President, PharmacyChecker.com and Prescription Justice | Feb 21, 2020 | Drug Importation
On behalf of Prescription Justice, I submitted comments to
the FDA in response to its request for public comments on its draft guidance
called: “Importation
of Certain FDA-Approved Human Prescription Drugs, Including Biological
Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic
Act: Draft Guidance for Industry.”
I published the comments in their entirety on Prescription
Justice here: https://prescriptionjustice.org/resources/blog/opportunities-safe-personal-drug-importation-under-section-801-public-comments-prescription-justice.
I have a different story to tell here about the new, or
newish reimportation law.
(more…)Tagged with: reimportation