Last week, the President’s Council of Advisors on Science and Technology (PCAST) released their “Report to the President on Propelling Innovation in Drug Discovery, Development, and Evaluation.” The report recommends that the United States set a goal of doubling the number of new medicines “that meet critical public health needs” over the next ten to 15 years.
PCAST, which was formed in April 2009 by President Barack Obama, is an advisory group consisting of leading scientists and engineers which makes science and technology policy recommendations to the President and the Executive Office of the President.
For the report, PCAST analyzed trends and challenges in biomedical research and development over recent years, finding that scientists need better methodologies and tools for translating discoveries and pharmaceutical developers and regulators need to incorporate efficiencies into clinical trials.
The report includes eight recommendations for “bolstering the discovery and development of new therapeutic compounds; optimizing processes used by the Food and Drug Administration (FDA) to evaluate the safety and efficacy of candidate drugs; enhancing long-term monitoring of approved medicines; and enhancing public understanding about the benefits and risks of medicines (Administration’s press release)”. The recommendations include:
Support Federal initiatives to accelerate therapeutics.
- Catalyze the creation of a broad-based partnership to accelerate therapeutics.
- Expand the use in practice of FDA’s existing authorities for accelerated approval and for confirmatory evidence.
- Create a new pathway for initial approval of drugs shown to be safe and effective in a specific subgroup of patients.
- Explore approaches for adaptive approval via pilot projects under existing pathways but do not create new adaptive approval pathways through legislation.
- Improve FDA’s tools for monitoring and communication of clinical benefits and risks.
- Reform management practices at FDA.
Study current and potential economic incentives to promote innovation in drug development.