Topics:

FDA commish outlines plan to speed new drug development

Tools

That blast from the NVCA today is just the latest example of the growing chorus of criticism from lobbyists and political opponents over the regulatory process faced by drug and device developers. The regulatory burden had grown too cumbersome and too uncertain, they claimed, which was threatening to throttle innovation and cost the country some much-needed jobs. And yesterday FDA Commissioner Margaret Hamburg outlined a plan intended to appease the critics.

Innovative new drugs targeted at serious unmet medical needs, she said, will be provided an "expedited drug development path." A new deputy FDA commissioner will be charged with overseeing the regulatory process for drugs, biologics and cell-based treatments. Personalized meds will be given a top priority. And the country's top biotech entrepreneurs will be sought out to offer insights on how the agency can do better.

"The Obama Administration is committed to encouraging the entrepreneurs and businesses that are modernizing and strengthening our health care system," said HHS Secretary Kathleen Sebelius. "The innovation blueprint is another part of our effort to help businesses grow and keep Americans healthy."

Will it prove enough to satisfy the critics? Some are taking a wait-and-see approach on whether the FDA can walk the talk.

"Many in the private sector-especially investors in medical technologies-say America is beginning to lose its competitive edge in this arena, as many innovative start-up companies are choosing to commercialize, and hence create jobs, overseas," notes Timothy Hay, who writes the Venture Capital Dispatch for the conservative Wall Street Journal. "One of the most oft-cited reasons for the phenomenon is the unpredictability at the FDA."

- here's the press release
- check out the column from The WSJ

Related Articles:
Report: FDA readies release of long-awaited rules on biosimilars
FDA grants to boost manufacturing, regulatory science

Filed Under