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Drug Importation Can Be Triggered By 'Excessive' Price Increases; Now US FDA Has To Decide What That Means

 
• By Michael Cipriano

Did FDA Commissioner Scott Gottlieb and HHS Secretary Alex Azar have a change of heart on importation? Or are they being pressured from above?

Chair on Fire

The move by the US FDA and the Department of Health and Human Services (HHS) to explore the creation of a temporary, narrow drug importation program targeting sole-source products that are off-patent and off-exclusivity generates questions both practical and philosophical for drug sponsors.

According to a July 19 statement from HHS, Secretary Alex Azar has directed FDA Commissioner Scott Gottlieb to form a...

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EU Pharma Reform: Council Wants Strengthened Member State Powers On Drug Supply

 
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Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
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The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

BIO Notebook: MFN Pricing, Obesity R&D, US FDA’s Rare Disease Hub And Reaction To Review Program

 
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Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.

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New Drug Procurement Rules Aim To Drive Pharma Investment In Mexico

 
• By Francesca Bruce

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Crosstalk On Drug Pricing: Conflicts In Trump Team Rhetoric And Policy

 
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The Trump Administration’s rhetoric and policy approaches illustrate the confusion that often arises between efforts to cut drug prices and cutting spending.

Price Inflation Rebates: Biden Policies Add Teeth To Trump’s Pharma Tariff Threat

 
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Companies with significant exposure to Medicare and Medicaid have fewer options for passing along higher costs to consumers because of price controls in the programs.