Here’s an example from the article - “When Siga complained that contracting specialists at the Department of Health and Human Services were resisting the company’s financial demands, senior officials replaced the government’s lead negotiator for the deal, interviews and documents show.”
WE need to go to the public hearing in December - will try ot find info. More outrage from the article:
“In a June 2010 email, Gary Disbrow, a virologist in HHS’ biomedical unit, shared with colleagues his assessment of where the FDA stood on the smallpox drugs being developed by Siga and Chimerix, the North Carolina company: “My interpretation of their current position is that there is NO foreseeable path to licensure.”
The problem was the inherent limits of animal testing in determining whether the drugs would be safe and effective in fighting smallpox in humans. Researchers are prohibited from infecting humans with the virus.
In May of this year, Robert G. Kosko Jr., a manager in the FDA’s antiviral-products division, wrote that there was “no clear regulatory path” for approving antiviral drugs for smallpox — again because of the uncertainty surrounding proof of effectiveness.
The FDA has scheduled a public meeting in December to discuss Siga’s and Chimerix’s drugs. Siga’s contract requires it to conduct additional studies to seek the agency’s approval.
Lurie said she hoped the FDA would ultimately approve ST-246. “We would not have gone ahead with a procurement unless we thought there was a pathway,” she said.