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An MD&DI April 1997 Column

WASHINGTON WRAP-UP

Congressman Joe Barton still distrusts FDA's own reform efforts. He calls for legislative reform before a new commissioner comes on board.

As the new Congress assembled in January, there were plenty of signs that its attitude toward industry complaints about FDA was more realistic--which is to say, more sober--than it was during the last Congress. During its last term, Congress appeared close to passing sweeping FDA reform legislation and even considered removing device approval from FDA's jurisdiction.

One new sign was the general reluctance of returning lawmakers to say anything specific about FDA, apparently out of fear of hindering bipartisan efforts that are expected to take a second shot at passing FDA reform legislation this year.

If such passage is to be achieved, the acrimony that accompanied so much of last year's eventually unsuccessful negotiations must not occur again. Reformers need to minimize public grandstanding on any issue and maximize consensus-gathering, especially at the staff level, that needs to involve all interested parties, including FDA.

One congressman who seemed less hesitant than others to engage publicly in FDA specifics was former industrial engineer Joe Barton (R­TX). A six-term representative from the Dallas­Fort Worth area, Barton has served for two years as chairman of the House Commerce Committee's subcommittee on oversight and investigations and has proved to be a quick and adept study regarding this complex, potent, and controversial agency.

During an interview with this columnist at the end of January, almost exactly 12 months after an earlier discussion, Barton explained his approach to FDA reform for this term. In just under a year, he has moved from seeking the abolition of FDA's good manufacturing practices regulation to, in his own words, being "a little bit wiser this year than last year! I still don't see the need for such regulation in an open market as long as you guarantee the quality that's coming out. But that's not a big battle I'm going to fight."

In other ways, too, a year of Capitol Hill­FDA skirmishing on a variety of medical device issues (e.g., leaking Visx documents to Summit Technology, home drug-test kits, conflicts of interest among clinical investigators, bias in FDA advisory committees, Commissioner David Kessler's expense irregularities, etc.) had obviously seasoned Barton.

Barton now has hopes, stronger than last year, for FDA reform legislation, and he is skeptical that FDA is effectively reforming itself. He agrees with the Indiana Medical Device Manufacturers Council (IMDMC) that FDA shows contempt for outside input on guidance development, and he calls for a restructuring of FDA and a new FDA commissioner selected from outside the agency. His interest in the biomaterials crisis is waning, and he supports FDA efforts to informally resolve regulatory disputes with companies.

Highlights of the interview follow.

Has there been much progress in the past year in the way FDA performs?

I don't think so, no. I think it has responded to a lot of pressure by doing some high-profile things. But it's done them under pressure, and in some ways it hasn't done anything at all. I think it's much more visible in its actions because of our congressional hearings. FDA is more aware that it's not going to get a free ride.

Would you then say that there hasn't been any change in FDA's culture? A lot of people inside the agency think there has been.

Really? That surprises me. I don't see how anyone could objectively say that.

Well, perhaps agency personnel are not objective. They feel, though, that their jobs have changed, that the things they're asked to do have changed, that they're asked to be more responsive to industry now, and that anything they want to do they have to seek outside input on. These are radical changes in the way a lot of people think. Brad Thompson of IMDMC recently responded to FDA regarding public input on guidance development. He thought a lot had been said and done by FDA, but he was disturbed that pockets inside FDA seem to regard public comment as akin to junk mail. He conceded, though, that there had been changes, despite the fact that when FDA received 57 comments on two proposed guidances on journal dissemination, it managed to dismiss them in two sentences.

Yes, that's the FDA we all know and--I wouldn't say "love"--but know and expect. I think that until it gets a new commissioner who's from outside the agency and we enact legislation to restructure it and give it a new mission statement, things won't change. I'm not going to say it hasn't made any improvement--that would be unfair --but it's been under real pressure. I think there's more of a hunker-down-and-cover-your-rear kind of attitude right now, with FDA hoping these things go away. But we'll see. One thing I think we've got a great chance to do fairly early in this Congress is to pass real bipartisan FDA reform. People like Ron Klink (D­PA) and Anna Eshoo (D­CA) and those on the oversight subcommittee this term are, I think, pretty well convinced that the agency needs reform.

Do you think that reform should await the appointment of a new commissioner?

We might want to do the reform legislation before FDA gets a new commissioner. It may take a long time for the Clinton administration to appoint a permanent commissioner.

Do you think an omnibus bill reforming the entire agency at once is still viable, or should reform efforts tackle one FDA center at a time?

I think the broad approach is still preferable. We had a task force chaired by Jim Greenwood (D­PA) during the last Congress, and beginning with the new one we've tentatively decided to keep the task force but broaden it and make it more bipartisan, and we're working with some of the coalition Democrats, like Gary Condit (D­CA) and his group. I've had one real good conversation with [Michael] Bilirakis (R­FL), and he really wants to try to move it ahead this year. [The "Blue Dog" Coalition is a group of moderate-to-conservative Democrats who have committed to working with Republicans on passing middle-of-the-road legislation.]

Do you think its priority is as high this year as it was last year?

FDA reform a priority, Barton says.

With me it is. It's higher with me because we did so much work during the last Congress. If we get an agreement with the president on Medicare or Medicaid reform, that would take immediate precedence over FDA, but other than those two issues, I think in the health area FDA reform would be a higher priority than anything else.

You had a medical device bill, and it wasn't clear whether that was going to be folded into a single bill or go on its separate track. What's the strategy this year?

We haven't determined one yet. Again, that's going to depend on some of the bipartisan leadership. We're serious about moving a bill, or bills, and we're serious about doing it with Republicans and Democrats helping to put the bill together from the beginning. Condit told me that his group wants to be involved. Eshoo, who was on my subcommittee last year, has agreed to be my lead Democrat on the medical device bill.

Do you feel your staff has enough expertise in FDA matters, or are you thinking of hiring anyone?

Well, I've got one on the committee staff, Alan Slobodin, who is really good. John Cohrssen is also very knowledgeable on some of the policy issues. But I think it would be nice to have some more expertise.

Are you looking for someone now?

Yes, I am.

Will there be hearings on FDA's third-party review pilot?

Probably.

Do you have any idea when?

It wouldn't be among the first hearings we do on FDA, but it could come in June or July.

What about biomaterials hearings?

Less likely. I've asked all my subcommittee people to give me a list of their priorities. My oversight and investigations subcommittee has jurisdiction over 43% of the federal government and I do intend in this Congress to do more than just look at the EPA and FDA. We are planning a first hearing on FDA about their home drug-testing policy, and then we'll probably have a hearing about the general management of the agency. After that, we'll take a look at what the subcommittee wants to do, and see what our situation is on the bipartisan FDA reform bill.

What are your concerns on the home drug tests? Hasn't FDA more or less fixed that?

I don't think so. I don't think it has jurisdiction. I don't accept the view that a sample collector is a medical device. FDA has approved a company that markets a home drug-test kit--which is positive, I'm glad it's approved it--but I think it keeps finessing the whole issue of what a medical device is. It's just trying to maintain jurisdiction, and it's coming up with all these convoluted definitions. We've got the legislation on the books for the laboratories where the home tests are sent. If the Consumer Product Safety Commission wants to issue some sort of regulation on how to label or interpret the tests, that's fine--but I don't see that FDA has any right at all to require approval for urine sample jars or hair bag pouches.

What is your interest regarding FDA management?

I'd like to see good management at the agency, and I don't think it has it. I think part of the problem is structural and part of it has been Kessler. He's gone, but the lack of structure is still there.

Whom could you get to testify on matters like agency structure?

Well, you could start with the people who are supposed to know what's going on in the agency, like the acting commissioner, who's in charge of operations. He would be a good one, and I'm sure they've got some midlevel people. I know we can get some people from outside, maybe even some consultants who are knowledgeable about large organizations and not necessarily experts on FDA.

You're aware that they've had four or five external expert panels examine the agency extensively, yet nothing has really come from any of them.

There you go. You've got to have a willingness from the decision makers. I told Dr. Kessler face-to-face several times that I just didn't think he was a good manager. My master's degree, although it's 20 years old, is in industrial administration. I've been a plant manager. I'm not an expert on it, but I'm certainly more than a novice on running organizations.

Is there anything you see, just looking at FDA from that background, that seems wrong?

Well, the first thing I'd say is that, at least under Kessler's direct leadership, they seem a lot more interested in covering things up than in getting to the bottom of obvious problems. An example of that is the Visx investigation, in which someone within the agency sent a complete package of materials to Visx's competitor, and FDA did nothing internally, other than say the behavior wasn't acceptable and that it had referred the issue to the FBI. The FBI is glacially investigating. But if I were the commissioner of FDA, I would have had an immediate, top-to-bottom investigation of everybody who had any contact. I would have found out who did it and turned them over to the appropriate authorities for prosecution. That's not what the agency has done. It has just tried to sweep it under the rug, cover it up, and hope it goes way.

Almost every issue that I looked at in any detail during the last Congress where there was obvious wrongdoing by someone within FDA, FDA's immediate reaction, and generally its continuing reaction, was simply to hunker down, cover it up, try to say as little as possible, and just hope it would go away. It didn't happen every time--there were one or two exceptions in which Kessler went the other way, but they were exceptions.

Aside from Summit and Visx, which I think constituted a bizarre, standout example of what you're talking about, what were some others?

Well, there were several companies that were scheduled to testify [about FDA irregularities] and, lo and behold, they had surprise inspections. That has happened at least twice.

Do you think those inspections were intimidatory?

You could speculate that they were.

Is FDA the only government agency that, when confronted by public embarrassment over something that has gone wrong inside, covers it up and hunkers down to avoid it?

Oh, they're not alone, no. But they certainly seem to be a more willing practitioner of it.

Are there any other government models that you could cite that handle these sorts of situations in a more upfront, well-managed way?

In the immediate past, the Pentagon and the Defense Department confronted such problems much better. They would be one example--but there aren't a lot, no.

It seems to be endemic in the federal government, and perhaps in government in general. It seems to be the way government behaves. What hope do you have of changing this at FDA?

By getting a commissioner who's a lot more open. You set up a system within the agency to flush out problems, and act according to some sort of mechanism. That's one reason I'm so strong on third-party review. It would give applicants the option to go outside the agency. Such possible competition, I think, would help a lot. The marketplace forces private-sector companies to do lots of things that, if they were monopolies, they wouldn't do. The same principle would apply at FDA. And within FDA, staff need an attitude change, or a real structural change, or both, about how they police themselves, how they find out about wrongdoing, and how theyfollow up on it. Their Office of Internal Affairs just does as little as possible for as long as it has to and then doesn't do anything. That needs to be beefed up, somehow.

Is FDA retaliation against industry still a concern to you?

Yes, it is.

Are you going to hold hearings on that?

I don't know. I haven't decided yet--but it is a concern.

You won't get to have a say on it, I guess, but you'd prefer that the new commissioner not come from inside the agency?

Right, I'm very strong about that. Not that there are not good people within FDA. There are good people. But I really think you need to get somebody from outside the agency to come in with a new attitude and a fresh objective.

James G. Dickinson is a veteran reporter on regulatory affairs in the medical device industry.

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