SEC to pharma: Don't get cute with disclosing FDA dealings to investors
- U.S. Securities and Exchange Commission (SEC) enforcement director Andrew Ceresney had a simple message for pharmaceutical companies during a speech at the annual Pharmaceutical Compliance Congress on Tuesday: Don't mess around with investors when it comes to disclosing dealings and communications with the FDA.
- Ceresney emphasized that it's critical to let investors know where a drug or medical product stands in the regulatory scheme, and that correspondence with the FDA is the "lifeblood of [pharma's] business" and therefore needs to be disclosed in an honest and thorough fashion.
- The SEC official pointed to examples of companies that had tried to sweep negative dealings with federal regulators under the rug, including a company that was less than forthright about the status of "goat blood-derived" drug.
As Ceresney noted in his speech, deciding which information to relay to investors about FDA communications isn't really a pharma company's prerogative. "Accuracy of reporting in your dealings with the FDA is critical to getting investors the information they need," he said. [Y]ou need to be completely accurate in recounting your dealings with the FDA."
Properly disclosing communications can cut the other way, too. For instance, the FDA is making Orexigen do a second safety study of its obesity drug Contrave after the company shared positive data on heart safety with too many people before Orexigen was supposed to do so.