Acheson Sees Recent Food Problems As "Eye-Opener" For Bumpy Road Ahead

In his more than six years at FDA, David Acheson frequently saw the ugly side of the food industry. He was chief medical officer in the Center for Food Safety and Applied Nutrition when then-Commissioner Andrew von Eschenbach appointed him the first assistant commissioner for food protection in May 2007 as FDA responded to widespread pet food contamination.

Later designated associate commissioner for foods, Acheson oversaw responses to salmonella found in peppers and in peanut butter ingredients sourced from Peanut Corporation of America ( ¹ "The Tan Sheet" Feb. 16, 2009 ).

Acheson left the agency July 31 to consult on food and import safety at Leavitt Partners, a new Washington-based firm founded by former Health and Human Services Secretary Mike Leavitt. Acheson says his new role gives him the chance to "continue to have a positive impact on public health."

In an Aug. 10 interview, Acheson reflected on his accomplishments at FDA and why it was time to move on, as well as what lies ahead for food safety.

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"The Tan Sheet": Did the announced FDA reorganization - which includes Michael Taylor's appointment as senior advisor to the commissioner and possible appointment as deputy commissioner of food - play a part in your decision to leave the agency (² (Also see "FDA Creates Food Czar In Agency-Wide Reorganization" - Pink Sheet, 13 Jul, 2009.))?

David Acheson: I'd been looking at this opportunity for a while. I could see that coming down the pike, and I would have no problem working for a political appointee as a deputy commissioner for food if that was what the decision was. ... I would be being less than honest to say that I was hoping that I would be able to have a lead position in the agency. But not having that and recognizing the way that politics work, if they feel they need a political appointee to do that job, then so be it and I can understand that.

I think the obvious next question, which I'll answer for you right upfront is, OK then, why did I leave? I think the key answer to that is probably, to use a sports analogy, that I saw myself as somebody who had a lot to offer the agency and a lot to offer public health and food safety. And what I found was that, with a new administration, I was essentially sitting on the bench and being excluded from important policy discussions, excluded from the White House Food Safety Working Group, excluded from opportunities to provide my expertise and input as a career [federal employee] with a lot of experience in food safety and public health. And I simply wasn't prepared to be sitting on the bench when I felt I've got a lot of good years left in me, a lot of good games left in me. So I needed to move on and find new challenges.

TS: What are your expectations for the food safety legislation that has passed the House and now awaits action by the Senate (³ (Also see "House Passes Food Safety Bill That May Not Be Appetizing To Senate" - Pink Sheet, 3 Aug, 2009.))?

DA: I think it will pass. I think the Senate will - essentially what they've got to do is take [Illinois Democrat] Dick Durbin's bill, S. 510, and merge it with H.R. 2749 [the Food Safety Enhancement Act of 2009]. ... It's not all that different from the House bill; the basic principles are the same. If I had a crystal ball, I would say in the fall they'll get together, they'll figure out the areas where there's a bit of contention and deal with it through conference. But that before the end of this session, we will see a new food safety bill that's for real, and I think [the bills] move the ball forward significantly, either one of them do.

A concern that I have is that this process is raising expectations among consumers that deserve to be raised, but I do worry that those expectations may be a little unachievable. If people think that this food safety bill is going to, in a matter of months or a year, have a significant impact on the number of recalls or the number of illnesses, it won't. It's going to be a much slower burn than that.

I think the PCA example in Georgia was a wonderful eye-opener to the impact that a small manufacturer has on the domestic food supply of anything with a peanut in it. I mean it really brought that whole industry to a screeching halt in all kinds of ways. ... Unfortunately, I think we might see more of that as the system improves. But you've got to go through that, you've got to get there.

TS: Do you expect a PCA-level outbreak will happen again?

DA: Yes. Oh yeah. I don't see how it can't because I think the ability to find these things will increase. The industry is no better to respond to that today than it was in January. Or at least marginally.

Obviously, there are going to be small firms who are going to say, 'Oh boy, if we test a product and we find a positive, we've got to make sure we don't ship it.' There will have been some impact there. But legitimately things go wrong, and product gets out into the food supply, and people do get sick. And our ability to be able to track it quickly is no better now than it was six months ago. That's clearly an area that needs some work because it's problematic when a manufacturer doesn't know that they've sourced from PCA until maybe two months, three months into an outbreak, and then they're suddenly issuing recalls. And not only is that prolonging consumer exposure and illness, but it's also undermining the whole food process and consumer confidence in the system.

TS: Do you consider dietary supplements a disproportionate part of the food industry's safety problems?

DA: I don't have any data - this is just my gut reaction from having worked at the agency for a while. I think like any of these industries there is a broad spectrum of some good players who pay a lot of attention to GMPs, produce a safe product. And then there are a bunch of bad actors who are working the system because it's full of holes.

To me, many of the dietary supplements behave like drugs. And I'm speaking from there as a physician, not as a regulator. These are dietary supplements, botanicals, whatever you want to call them, that have drug-like properties about them, one way or another, in that they can have impacts on a human's physiology. And they're just simply not regulated like that.

People can market something that can have a profound impact with little control. And then unfortunately, FDA is left in the position of having to prove there's a problem. And what does that take? That takes demonstrating that there are people that died or got sick. And the reporting systems are so inadequate that it's really hard to track.

TS: So do you think the adverse event reporting system for supplements is adequate?

DA: I think in as much that it's capturing what's reported, yeah. And that's a heck of a lot better than it was, because it was really ad hoc before. But how often is a primary care physician going to realize that somebody's arrhythmia or renal failure or liver failure or stroke or whatever may have been contributed by dietary supplements?

It's not so much that the reporting systems per se as they're set up are not functioning. I think they are, and I think they're doing a better job at capturing what little there is to capture. It's just such an ethereal kind of world, the dietary supplement world, that it's just really hard to get your fingers around to figure out there's truly a problem.

TS: What do you think the food industry needs to be doing better on its own to improve safety?

DA: Developing partnerships is probably one of the key areas. Solving these problems of the global food supply is going to require industry to build partnerships in areas that they haven't typically done. It's a strange partnership with regulators, I recognize that. But I think the industry needs to find a way to be able to dialogue with the regulators in a more constructive fashion. And I would point that out equally to the regulators.

Probably another angle with industry, and this doesn't typically apply to the multinationals, is the recognition from small- and medium-sized food industries that they have a huge responsibility and a major role to play. And once again you turn to the PCA example of how a pretty small firm had such a huge, negative impact on the peanut industry in the U.S. And also made 600 people sick and killed a bunch.

So this is not all about the big guys, this is about the small and medium guys. And given that everybody's out to make a profit, it's probably going to be a bit of a stretch to ask the multinationals to help the little guys. But how are we going to help the little guys? ... It's often a low-margin business and how can you reconcile that without pushing food prices through the roof with producing a safe product?

I think industry needs to think about how do we address that, because one thing we've learned is that when a small and medium guy screws up and makes 600 people sick, the whole industry suffers.

TS: Talk of separating food safety out of FDA was popular for a few months during all the peanut product recalls (⁴ (Also see "U.S. Needs FDA Food Safety Czar Now, Separate Agency Later, Group Says" - Pink Sheet, 30 Mar, 2009.)). Do you see that as happening in the near future or being at all necessary down the road?

DA: I don't see it in the near future, to be honest with you. I think it got some traction end of 2008, early 2009. I think the view right now is, let's try to make foods work within the Food and Drug Administration. And maybe it will and maybe it won't.

I think the fact that FDA has now got another huge demand put on it in the form of tobacco has the potential to further dilute the leadership's attention on foods (⁵ (Also see "Commissioner Hamburg Speaks On Claims, A Global Footprint And Tobacco" - Pink Sheet, 22 Jun, 2009.)). I'm not saying it will, but it certainly has that potential, because there is a public expectation that there's going to be some changes and stuff will happen that will improve the situation around smoking cessation. The agency's going to need to come through on that, and there's only so much ability to be able to drive multiple huge initiatives at any one time.

I think in the short term, foods will stay put. I think that the administration is committed to trying to make it work in the Food and Drug Administration. I think the agency has got a shot at making it work. And if they don't, then the argument and the ammunition to say we need to move it will be almost overwhelming.

It's not without its problems to pull foods out of FDA. It's simple if you just pull out CFSAN, it's simple if you pull out [the Center for Veterinary Medicine]. It's not at all simple how you would deal with the field, because essentially the field is structured around a district director and a series of senior positions and a cadre of inspectors who really are built to do both. So the district director is dealing with medical products and he's dealing with foods. And so it works all the way down, even to the point where you may have an inspector who does predominantly foods, they may go off and do a medical product inspection and vice versa when the need arises. Which [the Office of Regulatory Affairs] likes because it gives them lots of flexibility.

At the end of the day, I'm not sure that that's really serving public health in the optimal fashion. But that would require a lot of thinking through. Would you create a duplicate ORA that's essentially a foods ORA? How would you deal with that? Would that mean opening another 20 district offices for foods only? I don't know. Logistically it would be a bit of a challenge.

TS: It sounds like under the right set of circumstances, though, a separate food safety agency is something you'd be willing to get behind.

DA: Oh yeah, definitely. I personally feel that it's got a lot of attributes, but it would be the right set of circumstances where you'd need to think through the legislation, you'd need to think through the funding, you'd need to think through the logistics and the leadership and the management and the vision. But yeah, I think, at the end of the day, it's very doable.

TS: Do you foresee an update of current good manufacturing practices for foods at any point in the near future (⁶ (Also see "Salmonella Outbreak Reveals “Gaping Loophole” In Food GMPs – Sen. Harkin" - Pink Sheet, 9 Feb, 2009.))?

DA: I should sincerely hope so. That's long overdue, those are old. I think 1986 they were last updated. That's something that the industry's been calling for. I think the agency should have done it 10 years ago.

I think part of the reason it hasn't happened has been the erosion of the people within CFSAN who could actually do it. When the budget started to drop and people began to leave through retirements and weren't replaced, there just simply wasn't the depth of expertise to be able to deal with all the day-to-day issues and the crises and the outbreaks, as well as roll up your sleeves and figure out how to modernize cGMPs. It is a real need because it's a fundamental baseline to food safety.

I think on top of that you need other levels of preventive controls for certain types of foods, but you need that sort of foundation of good manufacturing practices across the board. So it is a priority for FDA to update. FDA's been saying that for a long time, it just hasn't happened yet. And I suspect that the new administration will push that because it's important.

- Interview by Dan Schiff ( ⁷ [email protected] )