You've heard it. The FDA is slowing down the introduction of new drugs through an overly cumbersome regulatory process -- or so charge the critics.
In a most recent example, the New Venture Capital Association cited a new survey that indicated that 39% of its members had decreased investment in the life sciences. Another 39% of VC groups plan to do so over the next few years which could result in a decrease of more than $500 M in venture capital aimed at biotech. The decrease they say is due to the unpredictability of the FDA regulatory approval process -- that results in delays and cost increases to the introduction of new drugs and lessens the ROI that can be achieved by VC groups. One third of the VCs surveyed say they will increase their investments in Europe, with 44% planning to spread their wings in Asia and only 13% planning to get more ambitious in North America.
In response, the FDA pledges to speed up the process -- particularly for new drugs targeted at serious unmet needs. Thes drugs will receive an "expedited drug development path". The new path will be overseen by a new deputy commissioner who will govern the regulatory process for biologics and cell based medicines. Personalized medicines will receive top priority under the new plan.
"The Obama Administration is committed to encouraging the entrepreneurs and businesses that are hmodernizing and strengthening our health care system," said HHS Secretary Kathleen Sebelius.
Posted by Bruce Lehr Oct 8th 2011.
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