A league of their own? Federal govt. wants to enter drug development sector

Dissatisfied with the pace of new drug development by the pharmaceutical industry, the federal government is establishing a research center devoted to expediting drug discovery beginning this October. The new center, to be named the National Center for Advancing Translational Sciences and housed within the National Institutes of Health (NIH), is receiving an initial investment of more than $700 million — a meager investment when compared to the nearly $46 billion spent annually by the drug industry — to initiate research on drugs that have not been successfully developed by the pharmaceutical industry. The aim is that the government might discover a new therapy that will then be picked up by private-sector drugmakers. In order for the new center to be established, one of the current 27 centers within the NIH must be closed down.

Even in the midst of budget cuts, NIH director Dr. Francis Collins persisted and was able to get his vision funded. “There are some people that would say this is not the time to do something bold and ambitious because the budget is so tight, but we would be irresponsible not to take advantage of scientific opportunity, even if it means tightening in other places.”

ACSH’s Dr. Elizabeth Whelan believes that this initiative is a little more than ironic given the FDA emphasis on the precautionary principal in assessing drug safety and its effect on slowing the drug approval process.

“Perhaps Dr. Collins should tell the precautionary FDA regulators to pay more attention to benefits and reduce their focus on ‘safety above all’,” adds ACSH’s Dr. Gilbert Ross, who has written multiple op-eds on the chilling effect of the precautionary principal on pharmaceutical research and development. “The New York Times reports that research has been ‘pared back’ because the industry has been unable to discover new drugs. Don’t they have it backwards?”

ACSH’s Dr. Josh Bloom thinks the government would do better to increase the patent life of new drugs to make them more profitable for the drug companies and therefore encourage more investment in drug development. “It takes 14 years to discover and develop a new drug. That leaves about six years of patent protection for the company to try to recoup their investment and make a profit. At 20 years plus one day, a generic company will be selling the same medicine.”

This writer, on the other hand, wonders why the federal government isn’t investing the money into developing genome-based technologies that can better predict the success of potential drugs in clinical trials.