The United States should set a goal of doubling the production of innovative new medicines that meet critical public health needs over the next 10 to 15 years.
This is what President Barack Obama's Council of Science and Technology Consultants (Pcast) hopes for. The Pcast analysis then makes a series of detailed recommendations aimed at strengthening the discovery and development of new therapeutic compounds; optimize the processes used by the FDA to evaluate the safety and efficacy of drug candidates; improve long-term monitoring of approved products and public understanding of the benefits and risks of medicines. All major components of the drug development ecosystem – basic biomedical research in universities and research institutes, clinical research in hospitals, and drug discovery and development in the biopharmaceutical industry – are increasingly facing challenges such as the time, complexity and cost required to develop a medicine. Rates of industry applications for FDA approval and new product approvals have remained relatively constant for 20 years, although there were 35 FDA approvals last year, among the highest figures in the last 10 years. years.
But experts highlight the critical need for new drugs. To meet it, they advise, the creation of a public-private partnership that helps identify and plan collaborative actions, accelerate drug development, balance the interests of competing stakeholders, reduce duplication of effort is essential..
Barbara Di Chiara – October 1, 2012 – PharmaKronos
