Congress to Trump: Let’s Tackle Drug Pricing in User Fee Reauthorizations

Posted 15 May 2017 By Zachary Brennan

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As part of a bid to bring down the price of pharmaceuticals in the US, Reps. Jan Schakowsky (D-IL), Keith Ellison (D-MN), Rosa DeLauro (D-CT) and 33 other House members sent a letter to President Donald Trump on Monday seeking a way forward to meet the promises he’s made on the campaign trail and since taking office.

Among the suggestions is to attach drug price lowering provisions to the bill reauthorizing the US Food and Drug Administration (FDA) user fee agreements, which advanced in the Senate last week and has so far largely remained non-political.

"There is no shortage of possible reforms for us to pursue in the context of the UFAs [user fee agreements]," the representatives wrote. "For example, we could require Medicare to negotiate for the price of drugs, as you have called for. We can work to improve transparency around drug pricing so we can better understand how much drug corporations spend to develop and manufacture their drugs and how much they make in profits from those drugs."

Other examples of add-ons to the legislation proposed by the group include ensuring "that generic drug manufacturers, whose products help to lower the costs of prescription drugs through competition, have access to the materials needed to conduct studies essential for FDA approval."

The group also floated an idea recently offered by Mick Mulvaney, Trump’s appointed director of the Office of Management and Budget, which would require drug companies to provide rebates to Medicare when the cost of their drug exceeds a certain threshold, as they currently do for drugs covered by Medicaid.

In addition to the letter, Sens. Amy Klobuchar (D-MN), John McCain (R-AZ), and Chuck Grassley (R-IA) urged Mulvaney to use "existing statutory authority to quickly restore competition to the market with the introduction of cheaper, imported alternatives," such as those from Canada.

Another group of bipartisan senators is also planning to reintroduce a bill tomorrow to require pharmaceutical companies to justify their prices and provide manufacturing, R&D and marketing costs. Industry groups like PhRMA have lobbied against such transparency bills recently.

Letter

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Government affairs, Regulatory strategy, Regulatory intelligence, News, US, FDA

Tags: drug pricing, Trump, FDA user fees

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