Month: August 2011

The number of patients sitting on AIDS Drug Assistance Programs (ADAP) wait lists, denied the life-saving treatment they need, have risen dramatically over the past two years. ADAPs are critical in providing HIV/AIDS treatment to low-income, uninsured, or underinsured patients within the United States and its territories. As noted in an earlier KEI blog, in January 2010, 361 individuals were on ADAP waitlists; that number grew to 7,873 across eleven states as of May 5, 2011 (a 2100% increase over less than sixteen months).

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In the first seven months of 2011 (January 14 to July 20) , the US FDA has already approved 18 new molecular entity drugs. These are some notes on the approvals:

• All of the NME products are considered pharmaceutical drugs, and received approval under FDA procedures for New Drug Applications (NDA).
• Despite the trends indiciating shifts to biologic products from pharmaceutical drugs, none of the 2011 products introduced to date were biologics.
• One third (6 of 18) received Priority review status. 12 of 18 received Standard review status.

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