US Government Report on Innovation in Pharmaceutical Development

The President's Council of Advisors on Science and Technology (PCAST) has published a report to the President on propelling Innovation in Drug Discovery, Development and Evaluation.

The Council points out that, despite increasing investments in R&D, the number of new drugs on the market "remained constant for several decades". PCAST has therefore held a lot of discussions with various stakeholders including senior leaders from the pharmaceutical industry, patient advocacy groups but also FDA and the National Institutes of Health. The goal was to identify and develop constructive solutions. As a result, a set of recommendations was made, summarised in the report.

Two major concerns were identified:

1.) A gap between scientific knowledge between research and commercial projects and a mismatch between advances in research and the technologies needed for the development of the drug.

2.) Inefficiency in clinical trials caused for example by complex requirements.

Possible improvement could for example be achieved by:

• Enforcement of post approval studies
• Accelerated approvals
• Certifications in the approval process
• Enhanced communication between FDA and R&D departments

To achieve the goals, several recommendations were made:

• Supporting federal initiatives to improve drug discovery and development
• Creation of a broad-based partnership
• Facilitate accelerated approval
• Create a new pathway for initial approval of drugs shown to be safe and effective
• Exploring approaches for adaptive approval via pilot projects
• Promote innovation in drug development.

Source: Report to the President on propelling Innovation in Drug Discovery, Development and Evaluation

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)