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, head of the food center? The correct answer: neither.

The person with the most resources is Michael Chappell, Acting Associate Commissioner for Regulatory Affairs. In FY 09, he had primary responsibility for about $700 million, 1/3 of the agency’s appropriation. He also had management responsibility for 3700 individuals, more than 40% of the agency’s appropriated workforce. He is the uncrowned prince of FDA.

Few people know his name or much about the operational entity known as the Office of Regulatory Affairs (ORA). The Office’s funding is tucked into each center’s appropriation under the unremarkable line item: field. ORA does not even rate a link on the FDA home page. A description of ORA is two levels down:

The FDA’s Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports the five FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans.  http://www.fda.gov/AboutFDA/CentersOffices/ORA/default.htm

The relative invisibility of ORA appears to be intentional. For example, when the agency issues a press release about an enforcement action, the relevant center director gets the first quote; ORA is always quoted much further down.

Is ORA’s continued low profile a good thing? I don’t think so.

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 someone like him.

Well run, conscientious companies have little to fear. If you run a solid plant operation, import ingredients with care, use lots of 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 to consumer and patient risk, or stonewalling the agency, you deserve what you get from ORA, strengthened and visible or not.

Commissioner Hamburg intends to make the agency more scientifically knowledgeable, more innovation-oriented and a more reliable partner in its interactions with industry and other stakeholders. A year from now, she will have little leeway to accomplish these goals if she hasn’t taken the necessary steps to increase inspections and strengthen enforcement.

In doing so, it makes sense to take ORA out of the FDA shadows and make it a more visible force.

Steven

Post-script: While controlling a surprisingly large amount of the resources, ORA does not operate alone. Each center works with ORA to jointly develop work plans that direct inspection and enforcement priorities for the next fiscal year. My understanding is that this process is a serious endeavor that consumes an appropriately large amount of staff time and effort.

This entry was posted on Tuesday, September 15th, 2009 at 8:38 pm and is filed under FDA and Congress, FDA and Industry, FDA Leadership. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.