Tuesday, October 2, 2012

PCAST Releases Report

 According to the report, “Propelling Innovation in Drug Discovery, Development, and Evaluation” produced by the President’s Council of Advisors on Science and Technology (PCAST), challenges remain in translating scientific advances into practical solutions derived from biomedical sciences.

The report makes a number of detailed recommendations aimed at bolstering the discovery and development of new therapeutic compounds such as optimizing processes used by FDA to evaluate the safety and efficacy of candidate drugs.

 Recommendation (Number 6) in the report wants the FDA to require improved tools to assess and communicate about the uncertainty, benefits, and risks for drugs. The thinking is that Congress should provide an initial line-item appropriation of $40 million per year to the FDA to expand post-marketing surveillance capability using the Sentinel System to evaluate the potential benefits and risks of medical products and populations at the highest risk for adverse events. The appropriation should increase over time, and be indexed to the use of EMRs in the U.S.

In addition, the FDA should work with academic researchers, communications experts, patients, prescribers, drug sponsors, payers, and the Risk Communication Advisory Committee to develop and evaluate new tools and approaches for effectively communicating risks and benefits to patients and the public at large. The FDA could administer prize competitions for such tools and approaches.

The report also emphasizes that FDA’s IT systems need to be overhauled and brought up to 21st standards. The overhaul should develop an integrated platform to manage all drug-regulatory activities, including workload tracking and management, provide data management and data aggregation tools, develop strategies for mobility and connectivity, and provide for appropriate data sharing.

FDA should develop within six months, a clear, feasible, and accountable plan to achieve IT modernization. The modernization plan should identify workforce transformation needs and explore external cloud computing and other transformational approaches to managing data. The plan should also identify systems architecture needs to reduce the cost and complexity of the technology management lifecycle to ensure long term adaptability.

The report also recommends that FDA should improve communication to the external community by creating web-based communication tools and a white paper process to rapidly update sponsors and other stakeholders about policy and technical standards relevant to drug development.

To download the full report released September 25th, go to www.WhiteHouse.gov/ostp/pcast.