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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 working group to examine how to safely import drugs that...

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More from Pricing Debate

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

US FDA Will Help States Apply To Import Cheaper Drugs From Canada

 
• By Cathy Kelly

The FDA is not currently signaling that stringent rules for the process will be relaxed, but the agency's change in approach is notable.

HHS Negotiating With Manufacturers On Most Favored Nation Drug Pricing

 
• By Cathy Kelly

MFN policy would would apply to all single source drugs in all insurance markets, according to HHS release. Secretary Robert F. Kennedy Jr. said the department is discussing the plan with drug sponsors.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.

More from Market Access

Spain Slashes Wait Between EU Drug Authorization And Financing Decisions

 
• By Francesca Bruce

Spanish authorities say that that timelines for drug reimbursement decisions can be improved further with the right submissions from companies.

Spain Beats England To Tevimbra Reimbursement Recommendations

 
• By Francesca Bruce

Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.

‘Tectonic’ Arkansas PBM Legislation May Upend Industry

 
• By Tim Casey

Industry will fight hard to prevent other states or the federal government from adopting measures similar to Arkansas' law preventing PBMs from owning pharmacies.