Biomedical Innovation in Trouble

The time and cost of developing new drugs are rising, venture capitalists make no return on investments in biopharma R&D, and other countries are boosting support in this area while U.S. policy makers propose funding cuts for the National Institutes of Health (NIH). This bleak picture of the “state of biomedical innovation” was painted by experts at a seminar in June sponsored by the Brookings Institution Engelberg Center for Health Care Reform.

There is a “relentless decline” in biopharma R&D productivity, as measured by the number of new drugs approved compared to spending on R&D, pointed out Jonathan Leff of Warburg Pincus. He and others noted a drop in first-time venture capital financing for new life sciences companies, along with ever-increasing product development times.

NIH director Francis Collins warned that the U.S. faces erosion of its scientific leadership and competitiveness as visionary scientists find research funding increasingly difficult to obtain. NIH’s new National Center for Advancing Translational Sciences (NCATs), he noted, provides a means for cutting the current 14-year development timeline for new therapies.

FDA commissioner Margaret Hamburg cited the impact that reimbursement and immigration policy on innovation, and that FDA strives to serve as a gateway, and not a barrier, to advancing the development of new medical products.

U.S. Still Dominant

Amgen chairman Kevin Shearer sounded a more optimistic tone, noting that the American biotech industry continues to “dominate the world,” and that no other country “is even close” to the U.S. in providing the financial support and scientific infrastructure for biopharma innovation. If you develop an innovative medicine in America, he stated, “you’ll be rewarded.”  Leff similarly acknowledged a positive effect from increased scrutiny on the cost of medical innovations because it supports a system where “real innovations that make a difference to get paid for.”

The main strategy for the research community, said Shearer, is to continue investing in NIH, which he termed “a national treasure,” and to “leave FDA officials alone” by de-politicizing the agency.