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Injunction Placed on Punitive and Political Maneuver by Administration
Patient Advocacy, Cost & Value of Biopharmaceuticals  •  Press Release  •  December 29, 2020
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…
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BIO Comments on FDA’s Public Workshop on Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation
Human Health  •  Letters, Testimony & Comments  •  December 23, 2020
On Wednesday, December 23rd, BIO submitted comments on the U.S. Food and Drug Administration (FDA)’s October 2020 public workshop titled, “New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation.” In its comments, BIO stated that the FDA’s new integrated review documentation is much improved from the older template as it is easier to navigate and provides greater clarity and transparency on key information considered in the review process. However, BIO requests that the Agency ensures any relevant information is not removed or omitted as the new documentation is implemented, and that this information remain publicly available. BIO also proposed additional strategies for the Agency to utilize in increasing transparency in the regulatory approval process. Lastly, given current technology, BIO encouraged the FDA to consider providing the information included in the integrated review in an electronic format that can easily be searched across products.  
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What you need to know about vaccine allocation
Good Day BIO Newsletter  •  December 23, 2020
Don’t put on your “out of office” message quite yet, because we have a few things you need to know about COVID-19 vaccine allocation. Plus, we close the year with a look at some of our newest members and why they decided to join. (863 words, 4 minutes, 18 seconds)    Good Day BIO is taking a holiday break—and we hope you do, too. We will resume normal publication on Monday, January 4, 2021, though we will pop in your inbox if there’s major news. Happy Holidays!
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A step towards modernized animal biotech regulation
Good Day BIO Newsletter  •  December 22, 2020
So much for a slow news week. Yesterday, USDA proposed a rulemaking regarding transferring authority over agricultural animal biotech from FDA to USDA—a welcome step towards a modernized animal biotech regulatory system (and a policy priority for BIO). We also catch you up on the COVID-19 vaccine news. (737 words, 3 minutes, 41 seconds)
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Modernizing Oversight of Animal Biotechnology Will Help Tackle Climate Change and Nutrition Challenges
Press Release  •  December 21, 2020
The Biotechnology Innovation Organization (BIO) appreciates the U.S. Department of Agriculture’s (USDA) longstanding commitment to food and agricultural innovation and looks forward to reviewing the Advanced Notice of Proposed Rulemaking (ANPR) aimed at restructuring the U.S. regulatory system for animal biotechnology. The following statement may be attributed to Dana O'Brien, BIO Executive Vice President for Food & Agriculture: “It’s essential for the U.S. Government’s oversight of animal biotechnology to be science-based and focused on the health and safety of animals, consumers, and the environment. “This system must also provide researchers and technology developers with clarity and predictability to foster scientific progress and restore investment in American innovation. Many of these discoveries are made possible by small and mid-sized companies based in rural communities, which provide jobs and help to boost our bioeconomy. “A modern U.S. regulatory system will pave the way for breakthroughs that can help prevent and respond to zoonotic diseases such as COVID-19, improve animal well-being, address hunger and nutrition, make our farming and food systems more sustainable, protect our environment, and bolster our resilience to climate change. “The new Food and Agriculture Climate Alliance, representing a broad spectrum of stakeholders in the agriculture, environmental, and food community, recognizes that improved animal genetics can help livestock adapt to a changing climate and contribute to reduced greenhouse gas emissions. “We thank USDA for its leadership and look forward to working with the FDA and USDA and the incoming Biden Administration to ensure appropriate safety measures remain in place, and that consumers are confident in the rigor of the system. BIO remains committed to improving public access to information about new agricultural technologies, and we are working with our stakeholder partners to drive transparency measures that…
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The frightening campaign to keep us unvaccinated
Good Day BIO Newsletter  •  December 21, 2020
Congratulations to BIO member Moderna on the emergency use authorization of your COVID-19 vaccine, the second vaccine to be authorized for use in the United States! These vaccines are safe and effective—but some Americans remain hesitant to get them. We discuss why and how we can tackle it, as well as take a look at what’s needed to grow the bioeconomy moving forward. (920 words, 4 minutes, 36 seconds)
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The payroll R&D credit, five years on
Good Day BIO Newsletter  •  December 18, 2020
Yesterday, an FDA independent advisory panel voted to endorse Moderna’s COVID-19 vaccine, clearing the way for emergency use authorization as soon as today. Meanwhile, we’re taking a look at the payroll R&D tax credit, Washington State’s plans for a low-carbon fuel standard, and whether the federal government will shut down tonight. (767 words, 3 minutes, 50 seconds)
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Survey on Payroll R&D Credit
BIO will soon be launching a survey on the Payroll R&D Credit. This Credit, which was introduced in the PATH Act in 2015, allowed pre-revenue innovators to take a portion of their R&D credit against their payroll tax obligation. The survey will help us assess the impact and usage of the Credit and will support our advocacy in the new Congress. To sign up to receive the survey when it is launched, please fill out the below form.
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Behind CMS' new data on health care spending
Good Day BIO Newsletter  •  December 17, 2020
The FDA Vaccines and Related Biological Products Advisory Committee meets today to discuss emergency use authorization of the Moderna COVID-19 vaccine. In other news, we look at new data on health care spending and the future of gene editing. (916 words, 4 minutes, 34 seconds)
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How Committees Work
Employees of member companies may be involved in committees as much or as little as they want to be. Committee members participate in committee calls to speak up about issues that are important to them, or simply network with peers. Here is a framework in which BIO can help support your objectives:
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