Injunction Placed on Punitive and Political Maneuver by Administration

Court sides with Scientists in a key decision

December 29, 2020
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A judge in the United States District Court for the Northern District of California yesterday issued a preliminary injunction blocking the Administration’s “Most Favored Nation” reimbursement policy for certain drugs administered by Medicare Part B providers.

The issuance comes weeks after the Biotechnology Innovation Organization (BIO), the California Life Sciences Association (CLSA), and BIOCOM California filed a challenge against the rule. 

Dr. Michelle McMurry-Heath, BIO President and CEO, made the following comments in response to the preliminary injunction:

“We are pleased with the court’s decision to grant a preliminary injunction on the president’s reckless scheme of foreign price controls on the very scientists working to end our current pandemic.

“Arbitrary government price setting creates unnecessary barriers for scientists and researchers ushering in the next generation of lifesaving cures, destroys the next generation of medical innovation, and eliminates hope for Americans desperately waiting for cures and treatments.”

Joe Panetta, President and CEO of BIOCOM California said the following:

“Biocom California applauds this preliminary injunction and stands firm with our partners in opposing a deeply-flawed plan to impose arbitrary foreign price controls on drugs and biologics that are administered in physicians’ offices. Models such as MFN reduce long-term investments in research and hamper the development of new treatments and cures – the wrong path to take when our patients, our economy and our whole nation are looking to the biotechnology industry for hope during our most deadly national pandemic in recent history.  

Biocom California looks forward to participating in future dialogues on drug pricing policies that include comprehensive stakeholder input and expand patient access.”  

Mike Guerra, President and CEO of CLSA, also commented:

“CLSA applauds Judge Chhabria’s order since this IFR seeks to implement a sweeping new rule that radically alters policy established by Congress for the reimbursement of certain drugs administered by Medicare Part B providers. It will harm America’s most vulnerable senior citizens and cause irreparable harm to the health care providers who serve this large patient population and could devastate the innovative life sciences ecosystem if implemented as proposed on January 1, 2021.

“Despite repeated concerns raised by patient advocates, the life sciences industry and others, HHS has proceeded with a flawed MFN model via an IFR that immediately threatens innovation and patient access because of this rushed implementation date. The mandatory and inflexible nationwide model would introduce a series of artificial price controls to reflect those of foreign "reference" nations. As a result, MFN will restrict access to medicines, stifle innovation, and disrupt the current distribution and reimbursement model established by Congress while doing little to make drugs more affordable or accessible."


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