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FDAnews Drug Daily Bulletin

Lawmakers Call for White House Action, User Fee Legislation to Lower Drug Prices

May 23, 2017

A bipartisan trio of senators urged the Office of Management and Budget to take administrative action to lower prescription costs — while 36 House Democrats asked President Trump to consider using FDA user fee legislation as a vehicle to cut drug prices.

In a letter to OMB Director Mick Mulvaney, Sens. Amy Klobuchar (D-Minn.), John McCain (R-Ariz.) and Chuck Grassley (R-Iowa) called for the White House and HHS to certify the importation of medicines from Canada, allowing the FDA to permit pharmacists and wholesalers to purchase the drugs, as well as issue waivers to individuals for personal use.

The FDA currently has this authority, under a 2003 Medicare law — but only if the HHS secretary officially certifies that importation would pose no additional risk to health and safety. The three senators previously wrote to HHS Secretary Tom Price advocating for the move, saying that importation of off-patent and sole-source drugs should be permitted from validated facilities.

Four former FDA commissioners have warned Congress that imported drugs can carry risks of being substandard, adulterated or fake.

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