BIO submitted comments on the Food and Drug Administration’s (FDA) Draft Guidance, Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials. The draft guidance is an important step towards ensuring stakeholders understand FDA’s expectations regarding the inclusion of adolescents in clinical trials for oncology products. BIO asks the FDA to consider reviewing and discussing the draft guidance with other global health authorities during pediatric cluster calls and asks for educational efforts directed towards institutional review boards (IRBs), which will be critical for successful implementation of the draft guidance. In addition, BIO asks for clarification on how the draft guidance relates to the Pediatrics Research Equity Act (PREA) and the FDA Reauthorization Act of 2017, Section 504, Development of Drugs and Biological Products for Pediatric Cancers. BIO requests case examples demonstrating circumstances in which adolescents have different physiology and/or psychology relative to adults. BIO’s comments include general suggestions as well as line edits.

As the U.S. Environmental Protection Agency (EPA) begins its work to develop the proposed 2019 Renewable Fuel Standard (RFS) Renewable Volume Obligation (RVO), we encourage the agency to take a renewed look at commercial-ready cellulosic biofuels.

BIO sent the following letter to Representative Barbara Comstock following her introduction of H.R. 6390, the “Study of Underrepresented Classes Chasing Engineering and Science Success Act of 2018” or the SUCCESS Act  

First and foremost, this is an extraordinary time for biotechnology. The therapies in development and coming to the market are unlike any we have seen in the history of medicine. We have entered into a new era of medicine, and BIO members are making discoveries that were unimaginable a decade ago. The days of traditional chemical drugs that treat broad classes of patients in blunt ways are giving way to the development of entirely new ways to treat and ultimately cure disease for targeted patient populations using living organisms, including a patient’s own cells. We have already seen the first wave of these advances reach the marketplace, with many more already in the Food & Drug Administration (FDA) regulatory process.However, BIO and our members recognize that too many patients – even those with insurance – cannot afford the life-saving cures and treatments that biopharmaceutical companies are developing. We stand with the Trump Administration in our shared commitment to addressing this serious problem. To accomplish this, we must harness – not abandon – the free market that has delivered amazing innovations for patients and made America first in the world in biomedical innovation. That’s why BIO has joined with stakeholders across the healthcare spectrum – including insurers, Pharmacy Benefit Mangers (PBMs), employers, and patient groups – in a coalition that developed and supports consensus, market-based reforms to lower drug costs without harming innovation.

BIO’s comments on the Proposed Rule are focused on the following areas:  Proposed changes to the IPPS for coverage and payment of Chimeric Antigen Receptor T-cell (CAR T) Therapy and other Transformative Therapies;  Updates to the Medicare Severity – Diagnosis Related Groups (MS-DRG) to appropriately account for care delivered, including for patients with rare diseases;      Applications for FY 2019 New Technology Add-On Payments (NTAP) and the process for determination of receipt of NTAP status;  Improving patient outcomes and reducing burden through meaningful measures and expanding access to vaccines through appropriate quality measures; and  Requirements for hospitals to make public a list of their standard charges via the Internet.