RALEIGH – Cindy Eckert, CEO of Raleigh-based Sprout Pharmaceuticals, says the next step in an ongoing debate with the Food and Drug Administration about the firm’s female sexual dysfunction drug Addyi is up to the regulatory agency.
“The FDA dictates that,” Eckert told WRAL TechWire Thursday afternoon when asked about what are the next steps in resolving the issue regarding warnings and labels.
“The FDA has had our new alcohol studies that are the basis of these changes for 400 days,” she added.
“We anxiously await implementation consistent with their statements.”
Eckert was reacting to an email update from a spokesperson at the FDA who had been asked for the latest news about the dispute which broke out after Sprout issued a press release last week saying the agency had moved to address labeling concerns regarding alcohol use with Addyi and less restrictive labeling.
The “FDA was concerned that Sprout’s original press release could lead to confusion among stakeholders, and accordingly we want to clarify that at this time FDA has not approved new labeling for Addyi and has not approved a supplement removing any element of the REMS,” the spokesperson said.
REMS refers to “Risk Evaluation and Mitigation Strategy.”
However, Eckert said her company was not out of step with what the FDA had told the company earlier this year.
“We issued a press release with same labeling language the FDA had issued to Sprout and the public on April 11th of this year.,” Eckert said.
“We additionally noted the decision we’d received on August 18th from the Director of the Office of New Drugs agreeing to remove the contraindication with alcohol as well as the ETASU, under REMS.
“It strikes me that the confusion in what is being reported is not if there is less restrictive labeling language coming for Addyi but rather when that is fully implemented by FDA.”
Eckert told Fortune that Sprout had spent $10 million on tests related to use of alcohol with Addyi.
ETASU stands for “elements to assure safe use.”
For related events to the story, including a timeline compiled by Sprout, see the following story: