BB&T Washington Editor

Timothy Ulatowski is the director of the Office of Compliance (OC) at FDA's Center for Devices and Radiological Health (CDRH). He manages four divisions that are tasked with promoting consumer health and safety, and enforcing the medical device and radiological health laws and regulations. Ulatowski started with the agency in 1974 and took a position with the Office of Compliance in January 2003.

Prior to his recent appointment as the director of OC, Ulatowski served as director of the Division of Anesthesiology in the General Hospital, Infection Control, and Dental Devices office at CDRH. He also served as the U.S. government's representative for Study Group 1 (Premarket) of the Global Harmonization Task Force and on several cross-cutting FDA committees dealing with such topics as reuse of single-use devices, user fee implementation, and international standards implementation.

Ulatowski holds a bachelor of science degree in microbiology with honors from Pennsylvania State University (University Park, Pennsylvania), which he complemented with additional undergraduate study in engineering and computer science. He earned a masters of science in biomedical engineering in a program run jointly by Georgetown University School of Medicine and the department of engineering at Catholic University (both Washington).

BB&T: The news has been out for some time about the government-wide action plan for import safety. Can you tell us about how that's going to affect your office and what you'll have to do to fulfill your responsibilities in that area?

Ulatowski: The government-wide plan has been translated to an FDA-level action plan, and the agency as a whole – each center, the commissioner's office, ORA, the inspections office – is working on implementing the plan where we're discussing the details of each element, the procedures, the statutory and regulatory changes, these things will become clear as parts of that plan emerge.

BB&T: Import detention is periodically practiced for devices that are suspect, and the detention issue came up toward the beginning of the decade when a consulting group alleged that foreign companies are more likely to be targeted for detention than domestic firms are for seizures. Is the customs service in a position to be more active on that front?

Ulatowski: That's one of the tools we have available to us. We consider in terms of, for example, warning letters for foreign establishments. When there is a finding of official action for an establishment and we generate a warning letter, in each and every case we consider import detention for the products that are associated with that facility. It's a very effective tool.

The import action plan I mentioned is discussing other aspects of import detention that may be applied. I know it can be a burden on companies if they're solely foreign or if they're international and U.S. based, but I think that for the most part, these detentions are clarified and are lifted as soon as the warning letter findings are corrected, which in most cases is in due course.

BB&T: Will your office feel compelled to exercise a lower threshold of evidence for imposing detention because of all the things that have gone on, such as the heparin situation, or do you feel that the threshold for detention has been adequate?

Ulatowski: The threshold for detention is dictated by statute, so we abide by the criteria explained therein. Again it's based on evidence of significant violations related to facilities. We have not at this point in time sought to lower the threshold in regard to that, but in the import action plan, there are proposals that may be considered. There may be other considerations, but at this time, no.

BB&T: Have you been in contact with officials at China's State Food and Drug Administration regarding their enforcement work?

Ulatowski: We're actively engaged in implementing the agreement we reached with them in regard to specific products and training, so that's moving forward. In regard to training, we have had several FDA folk, including myself, provide training to SFDA, and that will continue and will be expanded. The individuals we have on staff in our Chinese office are there also to provide a resource to SFDA in regard to how we regulate products as well as explore areas of mutual interest and continue training. This is all going to continue over the next months and years to come. We are engaged with them very actively.

BB&T: Do you expect that your operations in China and India will make it easier for you to let device makers in those nations know earlier on in the process that their production processes or other GMP requirements are growing problematic?

Ulatowski: Certainly I think that the availability of FDA staff in China, India, Europe, Central America and the Middle East, is going to facilitate the conversation we have with manufacturers in those countries and those regions. That's one big reason why our people are there, to provide an available resource for the combined interests of our country and their countries to produce good products for export and to use domestically. I think it's going to lead to more active engagement. And typically, that active engagement, when done right, produces a more knowledgeable manufacturing staff, more knowledgeable management, and hopefully better quality products.

BB&T: Given that the staff you're placing in these overseas posts, do you anticipate that you're going to have a difficult time with your domestic staffing situation?

Ulatowski: I think FDA has been, because of the efforts of our previous commissioner, that we were provided resources that in my experience is unprecedented. We have been provided resources as an agency to hire needed staff to conduct not just foreign inspections, but also domestic inspections. This staff for our inspections group, ORA [Office of Regulatory Affairs], is actively engaged in getting up to speed all the people they brought on board. It will take a little time to get them trained properly, but the result will be much improved coverage, foreign and domestic, of the facilities that are in our inventory.

It will mean better coverage and in some cases, more enforcement action because of more activity with inspections. Because of that, the centers, CDER and CBER included, have staff that are being applied to imports, evaluations of enforcement actions, and recalls. FDA as a whole is ramping up and we appreciate the resources that have been provided and we're putting them to good use.

BB&T: Are a significant number of your investigators old enough that they're liable to retire over the next 10 or 15 years?

Ulatowski: I don't know the profile of the average hire yet. If I look back at years past to look at what my office has done in regard to hiring – we've hired a number of additional staff at the Office of Compliance – we've tried to identify the best people, [those] with the skills, the background and education that are necessary to do the job. If that means younger folk or older folk, so be it.

As I recall, our hiring profile at the Office of Compliance, we have a spectrum of people, from people right out of college to people who have a good deal of experience as investigators, in quality systems in industry, just a great bunch of people we've brought on board. It's a variety but it's a good core of people based on their knowledge, skills and abilities.

BB&T. Industry has been agitated for some time over the agency's use of the word "recall" because it encompasses class I, II and III recalls. As we know, a class I recall is a very different animal from a class III recall. Is there any movement at all within the agency to come up with a different kind of nomenclature for these kinds of actions?

Ulatowski: The agency as a whole initiated a recall communications effort to look at how the agency deals with communicating with the public on actions such as recalls. Although I have not seen the final outcome of that communications initiative, in the Center for Devices, we understand that there can be instances – for implantable devices particularly – where the term recall, depending on how the communication is structured, can provide some public angst. We've been concerned about making sure that industry, the healthcare community and the public are aware of important messages when they come out. So if you begin to dilute the message by using terms that are not as striking to people, that do not get their attention such as the term "recall" can provide, I think you run into problems.

We have considered with industry and their notifications terms such as "corrections" and "removals." These are legitimate regulatory terms and they've been used in public notices. My point is that we have to be sure that people pay attention to these public notices, however they are characterized, and take action as indicated. There are other elements of communication that are just as important as the title you slap on a communication. It's what you tell the doctor or patient what they're supposed to do. What is the problem? Whom do I contact if I have a question? These are all important things that in certain communications are insufficient. We're looking at the whole package.

BB&T: In 2008, there were a fair number of warning letters that dealt with contract device manufacturing. Is there anything that you're looking at for 2009 that you feel needs special attention from your office?

Ulatowski: First of all, what is getting a high degree of attention, if not the highest, is our emphasis on implementing the import action plan. That's where we're putting a lot of time and effort – in regard to training and staffing – in our office.

In terms of enforcement actions, a lot of things continue in regard to identifying facilities at risk and taking action accordingly. As people know, we've taken a number of enforcement actions in the past that we need to continue to manage. Every injunction, every seizure and every warning letter that we issue needs to be followed through and worked to completion. So we build this inventory of activity that we have to take care of. So for any new actions that come forward, we have to have sufficient resources and time to do what we need to do on those actions.

We do have additional actions moving forward from our district offices and on foreign facilities. We are continuing to look at corporate activities as we've done in the past. We're looking at particular areas of industry that based on the history of actions – not just warning letters but other activities – may be an indicator of problems. We're trying to be more responsive to signals that we're seeing rather than just a typical surveillance sort of attitude. We're trying to focus on where the problems really exist based on medical device reports (MDRs), on clinical reports, inspection history, and information from foreign sources. That is new that we're looking at.

We're trying to get a profile on segments of the industry, areas that are potentially problematic. We're examining new techniques to identify these areas at risk. We're looking not just looking at our own inspection history and information technology databases and things like that, but also at information like that provided by publications such as Dunn and Bradstreet. We're utilizing economic information and other information that may be an indicator of a facility or company at risk that might lead to quality systems issues.

BB&T: Toward the beginning of the decade, the policy regarding warning letter publication was changed so that the Office of General Counsel at FDA would review warning letters before publication. In your view, did that provide a more consistent threshold for warning letters?

Ulatowski: It's my philosophy that people checking people is not the way to run a process, but you have to establish a program based on procedures and quality, just the way we expect the companies to have, so that there's a system of making decisions, of generating letters, of ensuring that those letters are consistent with the law and regulation, and that they have a high degree of quality in regard to background supporting documentation. If those ducks are in order, then the quality of those letters and their legal sufficiency fall out on their own as adequate.

So get the systems and procedures in place and you solve the problem, not adding people upon people checking letters in an endless chain of review. What we've seen because of some changes made over the past few years – and thankfully so – we've put into place boilerplate letters and procedures for evaluations.

We're making improvements all the way from the front-line investigators through the centers, improving quality, and as a result, the evaluation you talked about by the chief counsel's office has been rolled back. We're on an audit program where all the letters are not evaluated. We do spot-checks. We do constant evaluation of quality, and I think that's going to expand and be improved further.

BB&T: The post-approval study requirements for PMAs and even some 510(k)s these days are getting more demanding. Is your office responsible in some part whether the sponsors are following through and/or enforcing that follow-through?

Ulatowski: Yes. In terms of the post-market study requirements and surveillance, of course that's in the purview of our office and the Office of Surveillance and Biometrics (OSB). Also the Office of Device Evaluation collaborates with OSB to create an appropriate protocol, and OSB then monitors the progress on that, and there's an extremely improved database on post-market studies now. Based on where we were a few years ago, this is a dramatic improvement. So we know where these studies are in terms of their compliance and reporting requirements.

The Office of Compliance is the office that would generate warning letters if necessary to a post-market study company if need be. We have generated and sent one letter to a company on a post-market study. It was a shot across the bow. People have to attend to these studies and you have to report as necessary or else you're going to be warned. And action will be taken according to regulation regarding that.

BB&T: Are you using untitled letters to try to get people on board before firing off a warning letter?

Ulatowski: No, we won't send an untitled letter and a warning letter. Fortunately I think all the people know we've been monitoring compliance.

BB&T: What are your enforcement alternatives to warning letters?

Ulatowski: Warning and untitled letters are notification letters, and are not in and of themselves enforcement letters, they're advisory letters indicating that there is a problem and FDA may be taking action. Enforcement actions themselves are withdrawal of approval or injunctions or seizures.

There are criteria for when you should send a warning letter or an untitled letter. If the agency is prepared to take action and there's a serious violation, we send a warning letter. I think these post-market studies are very important, so when this new IT system was set up and when as a center we worked on the post-market study program, we said we're serious about this and we're going to take action.

BB&T: What sort of message do you have for device makers that we haven't covered here?

Ulatowski: I guess one message is that no matter how big or small your company is that it's been proven time and time again that compliance with quality systems leads directly to the bottom line for the company. You can have a short-term view or long-term view on that and be half-hearted about quality systems and suffer consequences for poor-quality products and problems with your company down the road.

So it's "pay me now or pay me later" where quality systems are concerned and I'd rather they made an appropriate effort to maintain compliance, because it really is good for them.

BB&T: CAPA citations in warning letters really do not seem to have gone down over the past eight or 10 years. In the case of a well-established company, it's a rather conspicuous finding. In the case of a start-up company, you might chalk it up to a lack of experience among quality control or regulatory affairs staff or as just a decision to forgo it, thinking they'll be able to stay under your radar screen. What in your opinion is the most conspicuous thing about companies that routinely run into these CAPA problems?

Ulatowski: Running a medical device business is not an easy task whether you're a big company or a small company, and CAPA is a window into the company's attentiveness to doing things right. Again, it's good for the bottom line for the company that you deal with problems and correct problems, create the best product you can create for your customer and are responsive to your customer.

These are all things that are lead to goodwill and to customer support and public support for companies. It something that deserves attention every day in companies, and unfortunately in some cases these things are thrown by the wayside for one reason or another. I think that on FDA's part, we're not there to try and play "gotcha" in regard to CAPA issues. We're there to work with the companies to try and solve these problems because we're all looking out for the public's welfare and benefit. We want to work together in identifying and correcting these issues serves the public benefit.

BB&T: Medical device reports also are still conspicuous in warning letters. Is this largely a question of there being a gray sort of threshold for MDRs or are companies just dropping the ball?

Ulatowski: MDR reports – and OSB can comment on this much more eloquently than this because this is really their area of responsibility – are an important aspect of regulation and one of the key signals FDA relies on to understand whether there are issues going on. It's not the only area of signal generation, but it's one of the key areas.

We see things wax and wane in regard to compliance with MDRs. We're trying to make things easier and trying to get in people's faces regarding MDR regulations. We're trying to make it easier with electronic MDR reporting and by increasing the tempo of education about MDRs. I was at a conference last week where we talked about complaints, MDRs and drug reports quite extensively. It's an area we have to pay a lot of attention to and I think the agency is devoting a lot of time to this.

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