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Viewpoint |

Innovative New Drugs for Serious Nonlethal Diseases The Cost to Develop and the Cost to Buy

William H. Eaglstein, MD1
[+] Author Affiliations
1Department of Dermatology and Cutaneous Surgery, Miller School of Medicine, University of Miami, Miami, Florida
JAMA Dermatol. 2016;152(2):139-140. doi:10.1001/jamadermatol.2015.4903.
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This Viewpoint highlights that studies using unvalidated surrogate end points has led to the availability of many new anticancer drugs and that adopting similar standards for drugs aimed at nonlethal diseases might produce more drugs for these conditions.

Recent changes in US Food and Drug Administration (FDA) approval requirements for cancer and other serious life-threatening diseases have resulted in many new cancer drugs, including drugs for skin cancer. This success suggests that adjusting the requirements for life-disrupting but nonlethal diseases often treated by dermatologists might also stimulate the development of many new drugs for such conditions. However, the American public and the US Congress are alarmed by the high cost of these new drugs.1,2 For example, the price of anticancer drugs has more than doubled, from $4500/mo to over $10 000/mo over the past 10 years,3 and the 21st Century Cares Act that was recently introduced in the US House of Representatives reflects this concern.4

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