Originally Published MDDI May 2005

Q&A

Shaking Up FDA

It's not easy to effect change at FDA, but former chief counsel Daniel E. Troy and his special assistant Coleen Klasmeier did just that during their tenure. In a rare and exclusive interview, they reflect on some of the issues they took on.

Erik Swain

From the moment Daniel E. Troy joined FDA as its chief counsel in August 2001, he was not afraid to ruffle feathers to secure the agency on better legal footing. His mission was to get the agency to do a better job of considering the legal implications of its decisions. That caused some procedural and cultural changes to be made. Sometimes those developments caused trepidation for industry, which tends to get uncomfortable when uncertainty strikes the agency. But at the time of his departure in November 2004, FDA was faring much better in the courts than before.

Troy and his special assistant Coleen Klasmeier, who joined his office in June 2002 and left the agency at the same time as her boss, tackled a number of issues that caused controversy. They forced FDA to understand how the First Amendment restricts the agency's ability to regulate “commercial speech,” yet also toughened enforcement of certain provisions on advertising and promotion of drugs and devices. They implemented a policy of legal review for all warning letters and untitled letters and intervened on behalf of regulated companies in certain court cases. They prompted the different FDA centers to better communicate with each other to achieve better decision-making consistency.

Troy and Klasmeier are now in private practice at the Washington, DC, law firm of Sidley Austin Brown & Wood LLP, which they joined in January. Troy is practicing administrative and constitutional law and litigation and is providing strategic counseling on FDA-related matters. Klasmeier is handling policy, regulatory, and litigation matters affecting FDA-regulated industries. They spoke to MD&DI East Coast editor Erik Swain in March 2005.

What were your primary goals upon joining FDA, and how well were they accomplished?

Daniel Troy: My principal goal at the agency was to have the agency understand the need to preserve its legal credibility by making decisions that are not just science based, but are also resting on a firm legal foundation. In reviewing regulations, guidances, warning letters, and untitled letters, I wanted to consistently try to educate the agency about the authority Congress has and has not given it. I tried to instill a sense that striking out where Congress has not given you the authority to do so is a very risky proposition. The strategy should be to put the onus back on Congress to give the agency the authority, to say, “We share your concern about this, but we need you to give us the authority to do it.”

Separately, you have to provide information to consumers. As part of that, I wanted to ensure that the agency appreciates the fact that it is constrained by the First Amendment. The First Amendment should not be viewed as a problem or an impediment, but as an opportunity to give consumers better information to allow them to make better choices about the medical products they use.

I think the agency now has a better appreciation for where the courts are, what cases can be won, and what cases are better not fought.

Coleen Klasmeier: Since I was a special assistant and not a political appointee, my goals were more concrete in nature. First, I wanted to shore up FDA's relationship with the Securities and Exchange Commission. In the days just before I started, in June 2002, the ImClone scandal was in the news, and it was very much on my mind. I think those efforts raised industry's and FDA's consciousness about the importance of companies being truthful in their communications not only to patients and physicians, but also to the investment community. Capital is available to help companies grow, but it is finite. I wanted to help ensure that capital would be directed toward companies with real products, not companies that are lying about whether they have a real product. I hope that in the long term, this will reduce the instances of lying to the investment community to attract investments in products that will never come to completion.

I also thought CDRH misinterpreted the Doctrine of Intended Use. I thought the center was interpreting it too broadly and applying it to products that were not devices. I wanted to try to remind CDRH that the mere fact that a product is harmful or affects the structure or function of the body does not mean that it is a medical device.

Mr. Troy, when President Bush appointed you, some perceived you as “conservative” or “industry-friendly.” Were you able to overcome that perception and balance public health and industry concerns?

Troy: You do that by doing your job in a manner that is faithful to the law and to the agency. I tried to persuade the agency through reason and logic that what I was doing was best for it. An example of proof was in Hatch-Waxman cases [on generic drug availability], where we had a 13-1-1 record in my time at the agency. Being able to sustain programs in the courts was one way to show that I had the agency's best interest in mind. Every time the agency loses a case, it substantially constrains its ability to act. Also, cases such as taking on Abbott over diagnostics manufacturing persuaded people that I was out to do the best job possible to represent the interests of the agency.

How well has the agency adhered to “least burdensome” principles? What more can be done?

Troy: There is certainly more consciousness at the agency about the least-burdensome approach. The tough part is that it's not always clear what the least-burdensome approach is. The Office of Management and Budget has been vigilant about ensuring that regulations are the least burdensome possible. So, by and large, the regulations that come out of the agency are forced to adopt the least-burdensome approach.

Companies can help in this process by participating in rule making and commenting on draft guidances. What I found is that many often fail to understand the extent to which the agency takes their comments seriously.

Klasmeier: A lot of firms seem to have institutionalized the notion that we do take them seriously. The bigger companies, especially. They have more resources and can make sure to give input to every document that is relevant. In the device industry, however, things are highly diffuse, and there are a lot of smaller players with few resources. It can be hard for them to devote the resources to making sure they are heard. Trade associations can help communicate on their behalf, but even among them, there is not always a consistent voice. But there is a staff in FDA [the Division of Small Manufacturers, International, and Consumer Affairs] to help small businesses. Also, a company's input does not even have to be formal.

Troy: A message that I suggest everyone think about is that as hard as it may be to make the commitment to giving input, it is well worth it. It is much easier to give input on the front end of the process than to change the agency's mind once it comes to a conclusion. The old adage about an ounce of prevention applies here. The agency does keep track of what industry says.

Klasmeier: FDA frequently interprets silence as acquiescence. It's important to raise a matter early to justify fighting it later on.

When you resigned, FDA acting commissioner Lester Crawford said your legacy was “having instilled in the agency a deep and abiding respect for the rule of law” and “helping FDA achieve [its] public health mission with respect for the powers that Congress has—and has not—given us.” How was FDA lacking in that respect, and what did you do to change that?

Troy: I can give two examples. One, in the years before I arrived, the agency lost four or five cases in the Qualified Health Claims area on First Amendment grounds. When [former FDA commissioner Mark] McClellan arrived [in November 2002], he altered the agency's policy on Qualified Health Claims, and the agency stopped losing First Amendment cases there. The other was that the agency's record in Hatch-Waxman cases was not what I thought it should have been, and we improved it. The point is that we acted with respect to what the role of the courts was, and is.

Did that require a change in the agency's culture?

Troy: In some places, to some extent. The Office of Generic Drugs was skeptical at first. But aside from the first few months, my relationship with them was fabulous. They appreciated the Office of Chief Counsel's investing a lot of resources to help them make sure that they were making decisions that would not be overturned in court. Every time the agency wins in court, it wards off any number of other challenges about the same issue. So they began to see what an advantage this was. Success breeds success, and failure breeds failure.

What about at CDRH?

Troy: I had some very good relationships over there, though some people were skeptical. It's not productive to talk about the overall relationship with a center, because it's made up of so many different people and offices. While some agreed with me and some didn't, it was never personal.

How has the advent of combination products affected jurisdictional issues within FDA? How were you able to balance the interests of the centers?

Troy: I spent enormous amounts of time on combination products. I had a lot of input into the algorithm that sets forth how the agency makes a decision on which product area gets to review a combination product. Combination products are one of the most esoteric and intellectually fascinating issues that the agency faces. You can spend a lot of time arguing over a product's primary mode of action. The Office of Combination Products came to appreciate the amount of attention its issues got in the chief counsel's office. We did not always agree on everything, but most of the time we did end up agreeing. We wanted to make sure [its] decisions were as defensible as possible, and [its staff was] trying to make the right call without showing favoritism toward one center or another.

Klasmeier: To the extent that the combination product issues involved intended use, I had a lot of contact with industry about them. There seemed to be a bit of a disconnect. Industry wanted the agency to be more consistent with claims-based interpretations of the products' intended use. The centers needed to think more about the constitutionality of their decisions. They were not necessarily consistent with judicial opinions on the subject.

Troy: That issue came up more with compliance personnel. It was still difficult to determine the primary mode of action even when we knew everything about intended use. We spent a lot of time on those issues, but they were a lot of fun.

To what extent were you involved in the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) negotiations?

Troy: The Office of Legislative Affairs had more of a role than we did, but we helped the agency pull things together. Dr. Crawford was enormously important in consulting on the MDUFMA negotiations. He spent a lot of his time trying to close that deal.

How would you assess the results of the MDUFMA legislation to date?

Troy: There has been some frustration on everybody's part that the program has not been fully funded. Some have recognized that it is a problem and will continue to be. It's unfortunate that the agency does not have enough resources to do everything it wants to do. And industry has been frustrated because it is not getting the full benefits that were promised, and user fees have increased at amounts higher than expected. It has certainly not gone as smoothly as PDUFA [the Prescription Drug User Fee Act of 1992] did, and that was the case from the beginning when the program was not fully funded.

Are user fees here to stay, or can increased federal funding pick up the slack?

Troy: They have to be. Industry needs to understand that Congress will not step up to give the agency the resources to do everything it wants to do and industry wants it to do. User fees have to work; otherwise, the agency will not get the resources it needs to promote and protect public health.

Your office took some criticism for having FDA intervene on behalf of regulated companies that were being sued in court. Why was such intervention necessary?

Troy: We only became involved in those cases after considerable judgment by the agency and the Justice Department, and only when it was necessary to preserve and defend FDA's authority and decision-making process. For example, there's a pending case in Tennessee where FDA says the product requires a premarket approval (PMA) application and the plaintiffs say it's a partial PMA and partial 510(k). There's no such thing. The judge said he would submit the issue to a state panel. That position is not tenable. It is not sufficient to have FDA procedures decided on by a state jury.

We received tremendous support, from career staff up to the Solicitor General, for taking those kinds of positions. They understood that we were not doing this to help one company over another. The only point intended by doing this is to uphold FDA's regulatory authority. There were plenty of cases where we refused to get involved, because our authority was not in question. The point was not to help the companies.

One reform you helped implement was the vetting of warning letters and untitled letters by your office before they went out to firms. What sort of internal resistance to that did you face, and how did you deal with it?

Troy: That was an edict handed down by the deputy secretary of HHS. As a result, there was no internal resistance. John Taylor, who headed what was then called the Office of Enforcement, embraced the change. He recognized that it was an opportunity to get procedures in place to regularize [the letters'] flow and reconfirm their reasoning. The question was never about authority. Sure, some found it burdensome to suddenly have to send everything to our building, but soon they understood the value. Even when some objected to the idea that lawyers might rework the letters, it was about timeliness and resources, not authority. Looking at it from an objective eye, the letters got better.

And we approved the letters 95% of the time. The goal was to make them better, more legally sufficient, and consistent, rather than to engage in a censorship exercise. The idea of the agency making statements that have legal implications without legal review is incredible. Before the 1990s, these letters were always reviewed by lawyers. It was getting things back to the way they had been, not making a radical change. It just makes sense. If you talk to the average apolitical lawyer, he or she will tell you that it makes sense for lawyers to look at letters that imply legal threats before they go out. And that was the concern of the deputy secretary.

Klasmeier: I was one of the people who reworked the letters. I was assigned to the device team, in fact. I mostly reviewed QSR and Mammography Quality Standards Act letters. There were cases where someone in the field would deliberately try to get around the Office of Chief Counsel. That was extremely uncommon, but it did happen. That was a logical outgrowth of the frustration that one can feel when one has to take extra steps to get something done. Ultimately, the inspectors saw that legal review did have value. It wasn't like we were doing this just because we wanted to.

Has that change brought about the consistency that was hoped for?

Troy: We certainly had a lot of concern about different standards being applied by different district offices. [The vetting process] has certainly educated everyone about the legal facts of compliance issues. And it has strengthened our position in a couple of enforcement cases, such as Red Cross and Abbott. The end result was that it enhanced the agency's credibility. We were able to show that we acted because it was the right thing to do.

Were you able to improve the flow of the process?

Troy: Yes, thanks in large part to John Taylor's enforcement. Letters got sent out more quickly. We stopped seeing letters being sent out six to 10 months after an inspection. If a letter sat around for that long, it wasn't getting approved. So people moved with much more alacrity.

Another area where your office had an effect was in the regulation of promotional materials. How have your efforts there affected the device industry?

Klasmeier: We committed to evenhanded enforcement across all medical products. An example was the contact lens industry. Those are restricted devices, but for historical reasons, they had not had to deal with restricted-device advertising rules in the same way as others. We worked with those companies to help them understand that restricted-device rules would be applied across the board, and that there would be no exceptions.

Troy: We also tried to promote consistency across centers. There was not a lot of good interaction between the promotional staffs at CDRH and DDMAC [CDER's Division of Drug Marketing, Advertising, and Communications]. It's not good for the agency if its centers take different positions. That makes it easier for industry to say that agency decisions were arbitrary and capricious—and to get them overturned in court.

Does FDA have more respect for commercial speech than it used to?

Troy: I don't think it has any choice but to have more respect for it. That has little to do with us and more to do with the courts. Just before I arrived, the agency lost a case at the Supreme Court on First Amendment grounds. That was a signal that it had to take account of it. The agency was doing what courts hate most—sticking its head in the sand and pretending the rules do not apply. So, in certain cases, we did fairly extensive analyses justifying what the agency did under the First Amendment. And now, FDA is doing a better job of putting into rules its justifications under the First Amendment. That puts the agency in a better place than pretending it doesn't apply and not addressing it at all.

Is direct-to-consumer advertising appropriate for the device industry?

Troy: Absolutely.

Klasmeier: Why shouldn't consumers be informed? Why shouldn't they get information of value about their devices as well as their drugs?

What advice would you give to a device company that is not clear on what FDA expects in terms of advertising and promotion?

Klasmeier: It's important to read the statutes. That seems like a no-brainer, but you'd be surprised how many companies don't have a person specifically responsible for keeping track of the Food, Drug, and Cosmetics Act and others that relate to restricted-device advertising. We understand that the device industry has a lot of small players that may not have the personnel that the drug companies have. But they need to understand the value of proper communication with customers and that disseminating false and misleading information can be extremely harmful to the well-being of the company. There are significant product-liability issues that should prompt a company to become aware of these rules if FDA compliance isn't incentive enough.

How would you like to see the agency build upon your legacy?

Troy: With Dr. Crawford at the helm, the agency will be able to build on its successes of the past few years. He has a very steady hand at the tiller. I would not expect radical changes in the way FDA approaches things.

Now that you are in private practice, how will you interact with FDA and industry?

Troy: The rules about what we can and can't do are fairly well set. I can't talk to the agency for a year in a representative capacity, for example.

Klasmeier: If anything, we are maybe more conservative about interaction than we need to be. We take it very seriously.

Troy: When we are allowed to formally represent industry, we hope to help companies negotiate what's become a very difficult and challenging environment. And we hope to help people on both sides understand things from both public health and legal perspectives. The thing is, most companies just want to know what the rules are and how to follow them. Some at FDA, particularly in the Office of Compliance, don't take that view. But most of industry just wants to follow the rules and put out products that enhance public health while making a profit, which is not a dirty word.

Klasmeier: If you're a lawyer, you can't be in a better position than working for a fantastic firm representing companies you respect before an agency whose mission you believe in.

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