Pharmacy Checkers

NOVEMBER 21, 2019

The Food and Drug Administration (FDA) is just one agency out of the many that make up the United States Department of Health and Human Services and, from PharmacyChecker’s relatively small (non-regulatory) role of helping verify online pharmacies to protect public health, I’ve learned just how insanely massive its mandate is.

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Pharmacy Checkers

JANUARY 4, 2020

The FDA has drafted a proposed rule to facilitate wholesale importation of lower-cost drugs from Canada, pursuant to Section 804 of the Food, Drug and Cosmetic Act. It’s a major milestone that the FDA is willing to and on the cusp of finally providing that certification – but that’s only for wholesale importation.

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Pharmacy Checkers

FEBRUARY 21, 2020

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behalf of Prescription Justice, I submitted comments to the FDA in response to its request for public comments on its draft guidance called: “Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry.”.

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FDA Law Blog

FEBRUARY 12, 2023

Department of Health and Human Services (HHS) to block a rule that would allow the importation of Canadian prescription drugs (see our blog post on the complaint). Despite the apparent green light, it will be a while before we see Canadian drugs on our pharmacy shelves. Last week, the D.C.

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FDA Law Blog

JULY 12, 2021

Among the Order’s mandates for DHHS are several relating to prescription drugs. DHHS is also called upon to implement existing laws and initiatives supporting the development, approval, and Medicare and Medicaid payment for generics and biosimilars. The Executive Order places the Biden Administration firmly behind drug importation.

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Pharmacy Checkers

AUGUST 2, 2019

This week, the Trump administration formally announced support for not only state prescription drug importation programs, but also HHS Secretary Alex Azar’s own importation plan. These drugs, as explained below, are safe and effective foreign brand versions of the same drugs sold here. Now, there is real movement.

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Pharmacy Checkers

JANUARY 30, 2020

No, not for raising a drug price – otherwise the jails would overflow with pharma execs – but for financial fraud related to his work as hedge fund manager. Pasted from the AG’s press release : Attorney General James Sues ‘Pharma Bro’ Martin Shkreli And Vyera Pharmaceuticals For Illegally Monopolizing Life-Saving Drug.

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Pharmacy Checkers

MARCH 11, 2020

Below is a copy of Gabriel Levitt’s comments on the FDA Notice of Proposed Rulemaking titled “Importation of Prescription Drugs” that were submitted Monday, March 9th, 2020. Comments on Notice of Proposed Rulemaking titled “Importation of Prescription Drugs, FDA-2019-N-5711, 84 Fed. counterparts.

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Pharmacy Checkers

DECEMBER 20, 2019

The FDA has done something that prescription drug importation advocates had possibly given up on. The agency drafted a new proposed rule to allow importation from Canada of lower-cost drugs and industry guidance for drug manufacturers to import their FDA-approved foreign drug versions, for which they can charge lower prices.

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