NorthWest Biotherapeutics Inc (NWBO)

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Regarding the pending 21st Century Cures Act - here is a letter by Otis W. Brawley, CMO of the American Cancer Society to the Editor in the New York Times today...

To the Editor:

In “Don’t Rush Drugs to Market” (Op-Ed, June 11), Gregg Gonsalves, Mark Harrington and David A. Kessler suggest that the pending 21st Century Cures Act would open the door to lower standards for approval by the Food and Drug Administration for medical products.

The experience of recent years leads to a different conclusion, as Congress, responding to advances in science, has given the F.D.A. the authority to use multiple new tools and processes to make faster decisions about safety and efficacy.

This is especially true with cancer drugs, where the agency makes maximum use of regulatory flexibility to review new therapies quickly while maintaining rigorous scientific standards. That process has produced many breakthrough cancer drugs over the last decade, and it’s a strong reason there are now more than 14 million cancer survivors living in the United States today.

The Cures legislation will ensure that cutting-edge therapies are safe, effective and made available to patients ever faster.

OTIS W. BRAWLEY

Atlanta

The writer is chief medical officer of the American Cancer Society and a professor of hematology, oncology and epidemiology at Emory University.

http://www.nytimes.com/2015/06/23/opinion/a-bill-to-fast-track-drug-approval.html?_r=0