Preliminary injunction blocks Trump’s drug reimbursement plan

Over the break, a court issued a preliminary injunction in the lawsuit led by BIO against the Trump administration’s “Most Favored Nation” (MFN) drug reimbursement policy—blocking the administration from implementing this policy that would harm patient access and threaten innovation. Here’s what you need to know.

In November, President Trump announced the interim final rule to implement the Most Favored Nation drug pricing model, which would tie prices of Medicare Part B drugs to the lowest prices paid in Organisation for Economic Cooperation and Development (OECD) countries.

BIO led a lawsuit challenging the plan,joined by the California Life Sciences Association (CLSA) and BIOCOM California.

What’s the problem with MFN? We argued that Health and Human Services (HHS) was attempting to implement the plan without prior notice or opportunity for public comment while acknowledging that it cannot estimate the impact on patients and providers. In addition, HHS lacks the authority to make sweeping changes to statutory Medicare rules through administrative fiat.

Last week, the U.S. District Court of Northern California granted an injunction,blocking the government from implementing the rule until it proceeds with a formal notice and comment rulemaking. (Shoutout to BIO VP and Deputy General Counsel John Murphy, who led this effort.)  

What happens next? Currently, the interim final rule cannot be implemented until HHS decides whether to proceed with formal rulemaking or take some other legal action. Additionally, the Biden administration is expected to issue a “regulatory freeze” memo effective inauguration day to stop or delay regulations that have not yet taken effect or otherwise become final under the Trump administration. This regulatory freeze itself could impact the MFN rule, and BIO will work to ensure the Biden administration understands that this toxic proposal should not move forward. 

Dr. Michelle’s Diagnosis: 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. – BIO President and CEO Dr. Michelle McMurry-Heath

More Health Care News:

Biopharma Dive: 5 FDA approval decisions to watch in the 1st quarter
“Coronavirus vaccines will still be a major focus in 2021, with several others near completion of late-stage testing. But the agency has a full plate of drug reviews, too.” 

The Delaware News Journal (Opinion): COVID-19 vaccine underscores life-saving value of bioscience innovation
“Our Food and Drug Administration (FDA) sets the gold standard for approving new medicines and vaccines, carefully evaluating the cost-benefit ratio and safety profile of every product. That is why every American who meets the appropriate criteria should feel confident in getting the COVID-19 vaccine when it is made available,” says Michael Fleming, President of the Delaware BioScience Association.

President-elect Joe Biden has picked Tom Vilsack to lead the U.S. Department of Agriculture (USDA)—a job he held under President Obama, too. E&E News takes a look at what we can expect him to do when it comes to biotech.

Meet Tom Vilsack, former Governor of Iowa (1999-2007) and Secretary of Agriculture (2009-2017). Since 2017, he’s been president and CEO of the U.S. Dairy Export Council.

“Secretary Vilsack has been a leader in growing the bio-based economy,” said Dana O'Brien, BIO’s EVP for Food and Agriculture. 

In this role, Vilsack “worked to accelerate USDA’s work on biotechnology,” says E&E News, taking the average time for biotechnology approvals from 90 months to 18 months.

And he’s expected to support the “revamp of biotechnology regulations” started by the Trump administration,continuing to advance biotechnology and “potentially shortening the timeline for traits that help crops fend off insects or withstand drought and other effects of climate change,” continues E&E News. 

What he said: “It takes a long time—too long, too long—in this day and age of massive change and rapid change,” Vilsack recently told the Senate Agriculture, Nutrition, and Forestry Committee at a hearing on the industry’s role in responding to climate change. “We need to streamline the process without sacrificing the quality of their review.”

We agree.

More Agriculture and Environment News:

The Washington Post: EPA finalizes rule to limit science behind public health safeguards
“The Trump administration’s ‘transparency’ rule requires researchers to disclose their raw data. Opponents argue that the goal is to exclude important research on human health.” 

The Wall Street Journal (Opinion): Why we’re ending the EPA’s reliance on secret science
“Our rule will prioritize transparency and increase opportunities for the public to access the ‘dose-response’ data that underlie significant regulations and influential scientific information,” writes EPA Administrator Andrew Wheeler.

President Trump’s Wednesday: According to the official schedule, “President Trump will work from early in the morning until late in the evening. He will make many calls and have many meetings. The President will depart for the Ellipse at 10:50AM to deliver remarks at a Save America Rally.” 

President-elect Biden’s Wednesday: “Biden’s health agenda runs through Georgia,” says POLITICO. 

What’s Happening on Capitol Hill: Huge day. In the Georgia U.S. Senate runoffs, Rev. Raphael Warnock (D) defeated incumbent Kelly Loeffler (R), making history as the first Black U.S. Senator from Georgia and the state’s first Democratic Senator in 20 years. As of this writing, Jon Ossoff (D) is ahead of incumbent David Perdue (R) and his lead is growing. Meanwhile, Congress will begin the process of certifying the Electoral College result.