For more than a year, FDA Matters has talked about the position of Associate FDA Commissioner for Regulatory Affairs (ACRA), who is the agency’s chief officer for inspections, enforcement and compliance. Of FDA’s appropriated (non-user fee) budget, the ACRA oversees one-third of the agency’s monies and more than 40% of the staff. It is FDA Matters that dubbed the ACRA the “uncrowned prince” of FDA.
Because of the importance of ACRA and the level of resources it receives, we have been awaiting a new appointee to this long-vacant position. This has now occurred, but the announcement was so unassuming as to raise concerns.
Dara Corrigan, JD, will be the new ACRA and run the Office of Regulatory Affairs (ORA). She is a veteran of the HHS Inspector General’s office and has also held policy positions at HHS. We wish her well. We also hope that she and the Commissioner can return this position to the visibility it needs.
Congressional and media attention are increasingly focused on FDA’s capacity to perform effective inspections and rigorously enforce the law. The agency’s good name and public credibility are tied to success in these areas.
Since the Commissioner has so many roles, she needs someone to be the highly-visible, public face of tough enforcement at FDA. Two decades ago, when I worked at HHS, the Inspector General was a former professor who had become the supervisor of the organized crime units in the FBI’s Chicago Office. He was a good, smart man and a friend…but you knew immediately that you didn’t want to be a target of one of his investigations.
FDA needs Ms. Corrigan to perform this function on behalf of ORA and FDA.
Well run, conscientious companies have little to fear. If you run a solid plant operation, import ingredients with care, use multiple system controls, and renew your commitment to pedigree and chain of custody, you are unlikely to be affected by a stronger ORA. If you have an inspections or enforcement problem: cooperate with FDA and correct it quickly.
On the other hand, if you are cutting corners, heedless of consumer and patient risk, or stonewalling the agency, you deserve what you get from FDA.
Commissioner Hamburg is working to make the agency more scientifically knowledgeable, more innovation-oriented and a more reliable partner in its interactions with industry and other stakeholders. She doesn’t have the leeway to accomplish these goals if she doesn’t continue to strengthen inspections and enforcement.
It makes sense to take ORA out of the FDA shadows and make it a more visible force. The initial announcement did not live up to this.
Commissioner Hamburg’s Most Important Personnel Decision
February 21st, 2010
With due respect to the many fine individuals that Commissioner Hamburg has recruited, FDA Matters thinks the most important appointment needs to be made soon: choosing the right person to be Associate Commissioner for Regulatory Affairs. Read the rest of this entry »
The Uncrowned Prince of FDA
September 15th, 2009
Which FDA line manager has the most appropriated resources to work with in FY 09? Is it Janet Woodcock, head of the drug center or Stephen Sundlof, [then]head of the food center? The correct answer: neither. Read the rest of this entry »