PhRMA calls for 'critical path' support

Medical Marketing and Media, Nov 2004 by Dickinson, James G

PHARMACEUTICAL Research and Manufacturers of America (PhRMA) says one of the most important things the Department of Health and Human Services could do to further medical innovation is to fully support and adequately fund PDA's critical path initiative

PhRMA said that despite significant success in the last decade in developing innovative medicines, "the scientific and regulatory barriers have also grown."

Because FDA stands between researchers and patients, said PhRMA, the agency is uniquely positioned to understand the scientific and regulatory hurdles associated with bringing innovative medicines to market and PhRMA supports PDA's initiative to join with its stakeholders to think creatively about transitional and critical path research and its potential impact on pharmaceutical development and the regulatory review process.

PhRMA also urged HHS to:

* Facilitate collaboration on biomarkers and surrogate endpoints in clinical trials.

* Stimulate National Institutes of Health basic research into the mechanism of action of diseases that are not well understood such as osteoarthritis and Alzheimer's.

* Facilitate research into diagnostics and treatments for primary prevention.

* Establish payment policies that support innovation.

* Educate the public and policymakers on challenges to innovation.-J.G.D.