Series - Policy

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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The CCC eLearning System has set an unmatched standard for confirming regulatory competency through engaging mastery tests and expert education content across more than a dozen course options.

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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

BIO, CSBA, and AdvaMed hosted a special briefing to discuss the success of SBIR/STTR programs, their economic impact, and the important next steps to Federal reauthorization.

The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs are highly competitive award-based programs that encourage domestic small businesses to engage in Federal Research/Research and Development with the potential for commercialization.

Federal funding for the SBIR/STTR Program will expire on September 30, 2022, and we need your support to ensure timely reauthorization! Hear from successful SBIR/STTR grantees and technical experts on these vital programs. After this webinar, you will be able to effectively advocate for Federal SBIR/STTR program reauthorization.

• https://action.bio.org/X8gCA7U
• https://www.advamed.org/takeaction/?vvsrc=%2fcampaigns%2f96142%2frespond%3futm

Biotech Intellectual Property Law in Focus: Webinar Series

Navigating Parallel BPCIA and PTAB Proceedings – Recent Developments and Strategic Considerations

This panel hosted by the Biotechnology Innovation Organization (BIO) discusses relevant case law and trends in BPCIA litigation and related PTAB proceedings, followed by a “roundtable” on the factors that may influence litigation strategy, early case resolution, and market entry.

Accepting the Status Quo: Subject Matter Eligibility Nearly a Decade after Mayo  

This Biotechnology Innovation Organization (BIO) webinar discusses the reality that almost a decade after the Supreme Court’s decision in Mayo v. Prometheus, the current subject matter eligibility standard has become the status quo with little prospect for change. Speakers will discuss how innovators can best protect their technology under these circumstances, how subject matter jurisprudence has impacted the patent process, and whether incremental changes could improve the situation.  

Calculating the Benefits of Biotechnology Climate change is a clear and present danger to society. Industries and governments are taking action to confront this crisis, committing to sustainability goals that reduce environmental impact and improve the health and well-being of communities. To be confident in sustainability claims, it is critical to accurately calculate the environmental benefits of biotechnologies and how that value transfers through complex supply chains. Our BIO Impact webinar will explore efforts to promote consistent sustainability accounting, as well as highlight BIO members’ transformative innovations and the partnerships & collaborations that are leveraging the demands of climate mitigation and propelling a resilient biobased economy of the future.

Join the Biotechnology Innovation Organization (BIO) for an expert discussion on Section 112, focusing on the enablement of functional language. We'll review how this is playing out in district court litigation and in the PTAB and also discuss potential prosecution strategies. The discussion will focus on recent enablement-related cases, including Amgen v. Sanofi and the cases that led to that landmark decision.