CDER enforcement actions will continue to rise in the foreseeable future, warned Center Office of Compliance director Deborah Autor in Washington, DC 4/23. Speaking at the Food and Drug Law Institute’s annual conference, she said the best way to avoid an enforcement action is by “thorough corporate accountability” and staying proactive about compliance.
Recent CDER enforcement has seen “swift aggressive actions,” Autor told the conference. For example, KV Pharmaceuticals had only a four-week window from the time FDA’s inspection ended and the signing of a consent decree (see earlier story). “If you are a company your head should be spinning,” she said, adding that the agency is committed to finding expeditious ways to approach enforcement. Coast IRB’s Warning Letter was another swift action that was taken within three weeks after a congressional hearing documented problems with the company (see story). The company has now announced 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,” advised Autor. Recent enforcement cases reinforce the need to establish systems to assure sustainable compliance. “What we see over and over are firms getting into trouble that don’t have systems-based approaches for dealing with deficiencies and those that don’t have upper management commitment to assure compliance… You can see this in the applications they submit, in the meetings we have with them, in the Warning Letter responses submitted, and in their lack of data integrity.”
CDER’s Division of Scientific Investigations has increasingly been issuing Warning Letters to clinical investigator and trial sponsors, Autor told FDLI. Last year, the division issued 18 such Warning Letters, which are considerably up since 2004 when none were issued. “Routine data audits have found problems with clinical investigators and that leads us to ask the question ‘what about the quality management systems of the sponsor?’ What it says to me is that if you are overseeing clinical trials you should have your quality system in place, so when we go look you can prove to us that this was an isolated incidence. This goes back to the company and you can’t outsource your responsibility… you need to be adequately monitoring throughout.”
Joining Autor on the FDLI podium was University of Cincinnati professor James O’Reilly, who predicted more “alternative punishments” as FDA escalates its enforcement posture. Instead of seizures, injunctions or Park case criminal procedures, there are going to be monitors — “enforcement cases in which the government t puts a monitor inside your corporate office and that results in mandatory retraining” of employees, he said. “Monitoring of conduct will be much more impactful on the entire organization long term, and that is what I as a scholar in the food and drug law field see as the likely outcome.”
“Industry needs FDA to be an effective regulator,” former FDA attorney Robert Spiller told the conference. He believes the agency, with the help o f the Obama Administration, is coming out of a period where industry saw less regulatory and compliance activity, which led some companies to cut corners. FDA seizure cases are not being sought and this needs to reverse, he said. The lack of enforcement cases over the past few years is not a reflection of industry’s compliance. As evidence, he offered a 146% increase in adverse events being reported since 1996 — from 191,000 reported back then to 471,000 reported in 2006. And look at the rise in convictions since 2003, he added, when the Office of Criminal Investigations won 206 cases. That number has been steadily rising and reached 369 convictions in 2008.
Spiller believes FDA civil enforcement has been starved for many years, and so it lacked resources and the will to be an effective cop. “Now comes another new day because Congress and the Administration bring the climate and resources for increasing compliance and enforcement activity.”
The best way to avoid enforcement action is to comply with the law, maintain a state of control, and to recognize your obligations to patients, concluded Autor. “Complacency is not an option… I do predict continued swift aggressive action, and continued emphasis on good clinical practices, data integrity, unapproved drugs, supply chain integrity and much more. Please, now is the time to do it right.”
