US pharma lobby launches legal action against the Trump administration over drug pricing proposals

pharmafile | December 8, 2020 | News story | Manufacturing and Production, Sales and Marketing Drug pricing, PhRMA, Trump, US 

US industry organisations including the Pharmaceutical Research and Manufacturers of America (PhRMA) have launched legal action against the Trump administration over its plans to lower drug prices in the US.

The Association of Community Cancer Centers (ACCC), the Global Colon Cancer Association (GCCA) and National Infusion Center Association, among others, joined PhRMA in denouncing the Trump administration’s Most Favored Nation (MFN) rule, which would the price tags for certain drugs in the US would be tied to the lowest price paid by developed nations elsewhere in the world.

Around 50 drugs are covered under the proposals, which account for 73% of Medicare Part B’s total spend and could generate as much as $85 billion in savings for patients over the next seven years, according to the Office of the Actuary of the Centers for Medicare and Medicaid Services.

The outgoing president signed the proposals under an Executive Order in the run-up to the US election; they have since been finalised and are due to take effect on 1 January.

The lobby groups attacked the new proposals on the basis that they are illegal, as they do not take into account any consultation with key stakeholders.

“The Most Favored Nation Interim Final Rule is bad policy that is contrary to law and that the administration expressly admits will disrupt patients’ access to medicines,” remarked James C Stansel, PhRMA Executive Vice President and General Counsel. “By pushing through a nationwide, mandatory policy change, the administration is essentially rewriting the Medicare statute. It is circumventing Congress entirely, ignoring the roles assigned to the executive and legislative branches. The US Constitution is clear: The administration does not have the legal authority to write new laws or override existing laws through regulations. Laws must be passed by both chambers of Congress and signed by the president.

“By proceeding with an interim final rule, the administration has also deprived the American public of their right to provide input on these drastic changes before they are implemented,” he continued. “Alarmingly, they have used COVID-19 as a baseless pretext for skipping normal rulemaking, having delayed the issuance of a proposed rule for nearly two years. The MFN Interim Final Rule should be stopped from moving forward immediately before it can cause irreparable harm.”

Matt Fellows

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