Series - Policy

The FDA has established the Split Real-Time Application Review (STAR) pilot program. The purpose of this program is to shorten the time from the date of a complete submission to the action date, in allowing earlier patient access to therapies that address an unmet medical need.

In this webinar, FDA staff will give an overview of the program, including the eligibility criteria for the pilot, and will answer your questions about participating in the program.

View this conversation highlighting how BIO member companies are strengthening food security and addressing climate change through biotechnology innovations in crop protection and efficient food production. Learn how regulation and policy can support agricultural innovation to protect our environment and our food supply.

View this conversation highlighting how BIO member companies are leveraging biotechnology innovations to enable advances in climate adaptation, mitigation, and resilience. Hear how diverse feedstocks and manufacturing processes are targeting emission reduction breakthroughs in hard-to-reach sectors. Learn how regulation and policy can better incentivize innovation and be structured to support new and emerging technologies throughout research, development, demonstration, and deployment.

​It's been one year since the passage of the IRA. The Centers for Medicare & Medicaid Services has moved forward implementing the law's various provisions, including the new Medicare negotiation program and the redesign of the Medicare Part D benefit. Learn the latest developments from our panel of experts, including how the IRA is impacting biopharmaceutical companies today. Panelists delve into other important issues beyond the IRA, including new developments in Medicaid, 340B, and the emergence of Prescription Drug Affordability Boards in a number of states.  

Following reauthorization by Congress of the SBIR/STTR Programs in 2022, there are new rules companies should familiarize themselves with concerning required disclosures of foreign affiliations or relationships with foreign countries. In addition to mandating disclosures prior to receiving SBIR awards, companies must also regularly update NIH following any changes to a disclosure. View this webinar organized by the Biotechnology Innovation Organization (BIO) for a comprehensive discussion on how to effectively navigate these new rules as you apply for SBIR awards.

This webinar is co-hosted by the National Institutes of Health (NIH) Seed Office.

View this important webinar for those invested in the broader biotech industry, "Understanding the Business Implications of Global Access and Benefit Sharing Policies." Tailored for members of BIO and a diverse community of stakeholders, this high-level session focuses on understanding the impact of recent developments in the global policy arena that will affect industry’s access to vital biologic materials and information. These policies have implications for the way industry will need to share the potential benefits that flow from their use of these physical and digital resources worldwide. Through interactive discussions led by seasoned experts across the Biotech ecosystem, explore the intricate relationship between national and global concerns, while uncovering the potential implications for your company. This webinar will equip you with the knowledge and insights essential to thriving in an ever-evolving global biotech landscape for an empowering dialogue that promises to shape the future of biotechnology.

U.S. Department of Justice (DOJ) statistics suggest that enforcement will be a top government priority in 2023, including for pharma/life sciences. Warning or untitled letters from the U.S. Food and Drug Administration (FDA) will serve as ammunition for DOJ cases. Statements about product safety will be heavily scrutinized.

Do you know what to watch out for? Has your company trained its employees and marketing agencies on how to appropriately implement the requirements for promotion? What activities require extra vigilance? The prior downturn in enforcement can be linked to the development of a response to COVID-19, which diverted government resources across the board. Now trends suggest the FDA, DOJ, and Office of Inspector General (OIG) will return to active healthcare enforcement in 2023 for violations of the Food Drug and Cosmetic Act (FDCA), False Claims Act and the Anti-Kickback Statute in part attributable to the goal of obtaining additional financial recoveries.

This webinar hosted by the Biotechnology Innovation Organization (BIO) has these learning objectives:
—Understand the current trends for government enforcement
—Dissect the compliance implications of increased enforcement on the industry
—Identify specific cases that are clear examples for company concern
—Isolate the key principles for avoiding violations

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In 2021, the United States government launched multiple international initiatives focused on issues at the intersection of climate, agriculture, and sustainable food systems. These initiatives are housed under the U.S. Department of Agriculture (USDA) and involve a cross section of government and non-governmental partners.

As part of the 2021 UN Food Systems Summit, the United States launched a Coalition for Sustainable Productivity Growth for Food Security and Resource Conservation (the SPG Coalition) with a goal to accelerate the transition to more sustainable food systems through productivity growth that optimizes agricultural sustainability across social, economic, and environmental dimensions.

Agriculture Innovation Mission for Climate (AIM for Climate/AIM4C) is an initiative launched at COP 26 and led by the United Arab Emirates and the United States. AIM for Climate is focused on addressing climate change and global hunger by increasing investment in, and other support for, climate-smart agriculture and food systems innovation over five years (2021–2025) and enabling greater public-private and cross-sectoral partnerships.

This webinar hosted by the Biotechnology Innovation Organization (BIO) provides an update on the status of the initiatives including a look ahead to COP 27 and beyond. In addition, USDA staff helping to lead this work discuss ways for private sector partners to engage in, support, and amplify the work of the SPG Coalition and AIM for Climate.

On August 16, 2022, President Biden signed the Inflation Reduction Act of 2022, which includes a number of significant prescription drug-related provisions, including a new drug price negotiation program in Medicare, inflation rebates in Medicare Part B and Part D, and a redesign of the Medicare Part D benefit, with a new patient out-of-pocket cap of $2,000.

Leaders from the Biotechnology Innovation Organization (BIO) as well as experts from the Hogan Lovells Life Sciences & Health Care team provide detailed overviews with Q&A on these newly enacted provisions.

The webinar covers the new drug price negotiation program, inflation rebates in Medicare, the Medicare Part D benefit redesign, and new out-of-pocket cap, as well as other important provisions that will reduce patient cost sharing.

• Introduction and Context [0:00:00–0:03:53]:
  John Murphy, Chief Policy Officer, BIO
• Inflation Reduction Act Background [0:03:54–0:07:26]:
  Crystal Kuntz, VP Health Policy and Research, BIO
• Drug Price Negotiation Program [0:07:27–0:44:07]:
  Ken Choe, Partner, Hogan Lovells
• Medicare Part B and Part D Inflation Rebates [0:44:08–1:18:29]:
  Alice Valder Curran, Partner, Hogan Lovells
• Medicare Part D Redesign [1:18:30–1:53:05]:
  Melissa Bianchi, Partner, Hogan Lovells
• Conclusion and Next Steps [1:53:06–1:58:02]:
  John Murphy, Chief Policy Officer, BIO Downloadable webinar slides at https://bit.ly/BIO-IRA-slides