On a wall in his office at the Food and Drug Administration laboratories in Rockville, Md., Donald Marlowe has a bulletin board covered with slide rules. He’s been collecting them in various shapes and sizes for some years, and enjoys the reminder of his origins as a scientist trained in the days when NASA “went to the moon on the slide rule.”

A scientist and administrator since his career began with the National Bureau of Standards in 1963, Marlowe has successfully navigated the changing tides in technology, regulatory agendas, and standardization, and brings his knowledge to bear in this, his year as ASTM’s chairman of the Board.

In this interview with SN, Marlowe talks about the regulatory and standards-developing mandate of his FDA branch, the Center for Devices and Radiological Health, as well as upcoming challenges for ASTM’s technical committees and the Society’s future.

You work for the U.S. Food and Drug
Administration’s Center for Devices and Radiological Health. What important areas of public health and safety does the CDRH regulate?

FDA regulates about one dollar in five of the Gross National Product—foods, drugs, medical devices and veterinary drugs. Medical devices, which the CDRH regulates, are a comparatively small part of the total. However, virtually everyone in the population can relate to a medical device of some type. Many of us wear eyeglasses or use a hearing aid. Many also know someone who has an implant such as a total hip or intraocular lens. In addition, virtually all of us own televisions and microwave ovens. Many of us have had dental x-rays, mammograms or other forms of diagnostic x-rays. The safety of all of these types of products is regulated by FDA/CDRH. So, in general, the Center for Devices and Radiological Health thinks of our responsibilities as promoting and protecting the public health by ensuring the safety and efficacy of medical devices and the safety of radiation emitting electronic products.

The National Technology Transfer and Advancement Act of 1995 requires that all federal agencies utilize private-sector voluntary consensus standards. How has FDA responded to the NTTAA since its implementation in the mid-1990s?

One of the things we’re quite proud of at CDRH is that our whole program relating to standards, dating back to the late 1970s, has been based on the premise of using consensus standards to describe how devices should perform. The Medical Devices Amendments of 1976 required that more than half of medical devices meet performance standards. To manage the risks from this majority of devices, the original concept was for government to write regulatory standards for these products. It was quite apparent to us that it was an impossible task for the government to write regulatory standards for about 1500 types of medical devices. So we adopted a consensus standards pattern very early on, and started weighing heavily into medical device standards work in both national and international venues.

Just within ASTM, the FDA is heavily involved in Committees F29 on Anesthetic and Respiratory Devices, consumer product Subcommittees of D11 on Rubber, F04 on Medical and Surgical Materials and Devices, and more. And we are also active in other standards developing organizations, primarily the Association for the Advancement of Medical Instrumentation and NCCLS, which develops standards for the clinical healthcare community. The Tech Transfer Act enabled us to strengthen the message we were trying to convey to the medical device manufacturers about the inherent benefits of developing performance standards through the consensus process.

Under your direction, the Office of Science and Technology within the CDRH conducts research in support of FDA regulatory decisions. What kind of research is conducted there and how does this research translate into standards development?

The Office of Science and Technology (OST) is the laboratory of CDRH. OST supports the scientific basis for the agency’s regulatory policies through development of independent laboratory information for regulatory and other public health activities of the CDRH. OST accomplishes this mission by managing, developing, and supporting standards used for regulatory assessments; performing laboratory evaluations and analyses in support of CDRH pre-market and post-market activities; developing data needed for current and future regulatory problems; and performing research and anticipating the impact of technology on the safety, effectiveness, and use of regulated products.

Specifically, OST develops and conducts research and testing programs in the physical, life, and engineering sciences related to the human health effects of radiation and medical device technologies. It provides expertise and analyses for health-risk assessments. The Office also develops new or improved measurement methods, techniques, instruments, and analytical procedures for evaluating product performance and reliability. OST provides innovative solutions to public health problems through the development of generic techniques to enhance product safety and effectiveness.

How do standards support the regulatory mission of FDA?

The appreciation on our part that we might best manage the risks of products through the development of consensus standards is key to our ability to manage the expenditure of resources it takes to get the products through the approval process to market. Standards are used to support every regulatory requirement of the Center. All manufacturers may declare conformance with a “recognized” consensus standard in lieu of submitting data to fulfill a regulatory requirement. Since our first list of recognized consensus standards was published in February of 1998, FDA has recognized more than 650 consensus standards. Another direct application of standards by FDA is in the area of quality systems. The Quality Systems Regulation is largely based on consensus standards.

You are active in the Association for the Advancement of Medical Instrumentation. AAMI has recently committed itself to the development and use of ISO standards only. Can you comment on how decisions such as AAMI’s impact SDOs such as ASTM?

For our program, the work of the two organizations is very complementary. Each has developed areas of expertise and competence that are independent of the other. We could not accomplish our program without the contributions of both. It’s a very symbiotic relationship, and it works very well.

In a larger sense, wherever the industry looks for answers in the standards world, that’s who we’ll work with. Ten years ago, I was one of the strongest proponents for using U.S.-developed technology as the basis for international standards. I thought that the best way of getting the best technology into the standards was to use that approach, simply because the United States tends to have more resources available to solve a problem, and historically has been more willing to contribute those resources to develop the standards than anyone else in the world.

Today, I’m not so sure. In fact, I think I would say I have changed my emphasis on the international standards. I think that they have not demonstrated the necessary value-added to make them the only source. So a best-technology approach is how we want to go. From the FDA’s perspective we want to recognize the best standards, and if you look at the standards that the agency has recognized, I think that’s the approach you’ll see playing out.

When and how did you first become involved in ASTM?

I first attended ASTM Committee Week meetings in 1965. At the time, I was working at the National Bureau of Standards, now the National Institute of Standards and Technology, in the areas of force measurement and measurement of the physical properties of materials. I joined ASTM in 1968 as a member of then-Committee E09 on Fatigue when I became interested in the fatigue behavior of aircraft materials and parts. Today, I still have friends on the committees I joined back in the 1960s.

Your primary ASTM committee affiliation is with Committee F04 on Medical and Surgical Materials and Devices. What are some of the significant challenges Committee F04 has confronted in standards development?

I suspect the challenges that face F04 are not much different from those that face other product committees of ASTM. The combined impacts of the globalization of the marketplace and the economics of mergers have yet to be fully measured.

Another challenge for these committees is to build, or rebuild, an academic base in the committee membership. I’m not proposing a shift in the balance of the membership of a committee but I am suggesting that, without a viable academic presence, the technology used by the committee tends to go stale. Participation by academics and, in the case of the committees developing standards for medical devices, clinical experts is very hard to come by. No one pays their way to meetings or other expenses. It is very hard for them to justify days away from their institutions to work on standards.

Committee F04 has helped ensure public health and safety through its standards development. What are some accomplishments of F04 in this regard in which you or members of your staff have taken part?

FDA has been a significant player in F04 since it was formed, and it would be hard to single out individual accomplishments that FDA initiated. However, the current standards development effort in tissue engineering is one area spearheaded by FDA players.

The people at FDA who participate in ASTM have all been very active in committee work and hold a lot of leadership positions on ASTM committees. In the development of medical device standards, very often, FDA has the only public-sector data to bring to the discussion. Manufacturers generate information and data that comes to the standards table, but often FDA is the only public sector participant with the resources to develop new data. Consumers don’t have the resources to develop this kind of work. FDA is committed to the development of standards through the consensus process and that’s been the case for 25 years with no change.

In your more than 30 years of participation in the Society, how have you seen ASTM change? How do you feel the Society is situated for the business and standards development challenges of the future?

ASTM has adopted the concept of the “information economy.” Fortunately, we did it early in the development of the technology. I’ve watched and participated as ASTM worked through several generations of equipment and software to support the new technology requirements. While it was painful and expensive, let me assure you that ASTM is now the envy of many of our colleagues in the standards world. I was complimented just recently week on our ability to publish and distribute information in ways that are unrivaled. Several societies have been or are thinking about approaching ASTM to do their distribution of information.

What are the challenges you see for ASTM in the coming years?

Well, I addressed some of this earlier in the interview with regard to maintaining academic and clinical participation. In addition, I have not been able to assess the impact of electronic publication on the overall funding stream of the Society. The growing trend in technical information is to make such information free to the user. This could threaten standards developing organizations that depend on the publication of information for income. The secret will be the ability of the Society to sustain the quality of the information and the value it provides to the user.

Regarding ASTM’s place in the international arena, I’m a strong believer in market-driven international standards. ASTM has a high- quality product technologically. This fact is recognized in those industries and communities that come to ASTM to develop their standards, the building community and the petroleum industry, the environmental community, and so many others. So I think that our standing internationally is based on our ability to produce the best standards in a timely way. And as long as we continue to do that, we will fare well internationally.

Is there anything else you want to add?

I hope that 2001, the first year of the new millennium, is a good year for all our members and the committees they serve on. If there is any way that the Society staff or leadership can be of assistance in accomplishing your goals, we’re here to help.

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Copyright 2001, ASTM