In the News August 24, 2015

The Pink Sheet Quotes Marc Scheineson on FDA Approval Process

The Food & Drug Administration’s (FDA) approval of Sprout Pharmaceuticals Inc.’s drug, Addyi, known as the female Viagra, was met with controversy and skepticism.

The next phase of studies will be expensive and the alcohol interaction trials will be hard to enroll, said Marc Scheineson, partner in Alston & Bird’s Food Drug & Device/FDA Group and former FDA associate commissioner for legislative affairs.

“They stuck with it at great risk and great financial cost because it was potentially a very large market – that’s a very interesting lesson,” Scheineson said. “They jumped through lots and lots of hoops over the years. This was not a slam dunk.”

“The FDA is not immune to public pressure, certainly their advisory committees are not immune to public pressure,” said Scheineson, referring to Sprout’s public support from “Even The Score.”

Scheineson also highlighted the changing nature of the benefit-risk balance over time, saying that the risks were known and the benefits had to be lobbied for.

In addition, he pointed to the drug’s potential appeal as a treatment for sleeplessness – with boosted libido as a welcome side effect – but noted this would be unethical.

“Many companies have fallen into that trap,” said Scheineson.
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