The FDA’s drug center is increasing and speeding up its enforcement actions, according to compliance director Deborah Autor. Addressing the Food and Drug Law Institute’s annual conference in April, she said the best way to avoid an enforcement action is by “thorough corporate accountability” and staying proactive about compliance.
Among recent examples of “swift aggressive actions,” Autor cited an action against KV Pharmaceuticals, where there had been only a four-week window from the time the FDA’s inspection ended and the signing of a consent decree under which the firm’s Ethex and Ther-Rx subsidiaries were shut down pending FDA confirmation of their good manufacturing practices.
“If you are a company your head should be spinning,” Autor told the conference, adding that the agency is committed to finding expeditious ways to approach enforcement. A warning letter issued to Coast IRB was another swift action, she said, noting that it was sent within three weeks after a congressional hearing documented problems with the company. The company announced in April that it’s going out of business. “These are instances of serious noncompliance and serious consequences,” she said.
“When you find a problem that needs to be solved, solve it fast,” said Autor. Recent enforcement cases reinforce the need to establish systems to assure sustainable compliance.