On Monday, May 9th, BIO submitted comments in response to the FDA’s recent draft guidance on Clinical Pharmacology Considerations for Antibody-Drug Conjugates. In the comments submitted, BIO acknowledged the challenge FDA faces in creating a regulatory guidance that is comprehensive yet adaptable, given the diversity and complexities of ADCs today. However, BIO noted that FDA’s inclusion of a broader range of ADC products in the final guidance would be valuable to sponsors and urged FDA to provide further detail when defining and referencing various components of ADCs and their byproducts. The comments also highlighted the current challenges sponsors face in considering the inclusion of organ impairment patients and patients with interacting concomitant medications, and requested the Agency provide additional guidance on when and how these patients should be included. Lastly, BIO encouraged FDA to provide additional examples and recommendations regarding the use of physiologically based pharmacokinetic (PBPK) modeling, and to consider opportunities where sponsors could leverage existing data on ADCs with the same linker-payload (if available).

We are writing on behalf of the Biotechnology Innovation Organization (BIO) to provide comments on the Federal Trade Commission’s (FTC’s or the Commission’s) Solicitation for Public Comments on the Business Practices of Pharmacy Benefit Managers and Their Impact on Independent Pharmacies and Consumers. BIO is the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology companies, state biotechnology centers, and related organizations across the United States and in more than 30 other nations. BIO’s members develop medical products and technologies to treat patients afflicted with serious diseases, to delay the onset of these diseases, or to prevent them in the first place. In that way, our members’ novel therapeutics, vaccines, and diagnostics not only have improved health outcomes, but have also reduced health care expenditures due to fewer physician office visits, hospitalizations, and surgical interventions.

Industrial biotechnology is enabling a dramatic paradigm shift in the production of fuels and chemicals. Modern biorefineries are converting domestic sources of renewable biomass, wastes, and residues into sustainable low carbon fuels, chemicals, and products, positioning the United States to reduce its dependence on foreign petroleum for these goods and to grow a robust biobased economy that creates high paying jobs, particularly in rural parts of the country where renewable biomass is grown and in manufacturing communities where carbon can be captured and utilized. For this growing sector of the economy to flourish, private sector investment is essential. Department of Energy programs that foster research, development, demonstration-scale activities, and deployment of renewable low-carbon energy technologies send positive signals to the investment community. Thus, we urge continued congressional support for a variety of key programs in FY 2023:

The value of science and agricultural innovation cannot be understated. The adoption of biotechnology in agriculture and the development of biobased technologies contribute to food security, sustainability, and climate change solutions. Over the past 25 years, it enabled shifts in agronomic practices that led to significant and widespread environmental benefits. BIO supports public policies centered on innovation to incentivize the adoption of cutting-edge technologies and practices and benefit rural economies. Further, it is crucial that the government establishes risk-proportionate, transparent regulations in a timely manner to maintain America’s global leadership in the life sciences while protecting health and the environment.

The Biotechnology Innovation Organization (BIO) is the largest biotechnology trade association, representing approximately 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. Our members are working every day to solve the greatest challenges facing society—whether it is finding a cure for cancer, protecting the public against bio-terror threats, feeding hungry people nutritious food, or generating renewable fuels, renewable chemicals, and other biobased products. We support public policies, including government funding for key agencies and programs that unleash our members’ scientific innovation potential and grow the biobased economy. BIO members urge you to actively support the following priorities as you consider the Fiscal Year 2023 Labor, Health and Human Services, Education and Related Agencies Appropriations Act: