Medical Device & Diagnostic Industry Magazine
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Originally Published October 2000

WASHINGTON WRAP-UP

With experience in academia, hospital administration, and industry consulting, new director of device evaluation Bernard Statland vows to keep his focus on patients.

James G. Dickinson

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FDA has broken new ground in its selection of the next director of device evaluation at CDRH. Its choice, Bernard Statland, MD, PhD, has an extensive industry background, having served in a consulting capacity—often helping with product-review submissions to the office he now heads—with Beckman Instruments (now Beckman Coulter), Technicon Co. (now Bayer Diagnostics), Corning Co., Diametrics Medical, Boehringer Mannheim (now Roche Diagnostics), and National Reference Laboratories (now Lab Corporation of America).

But that doesn't mean that Statland, a biochemist, will be "industry's man" in the sensitive gatekeeper slot he now fills. As he made clear in a recent interview with the author, Statland is just as highly patient oriented as his predecessors. His industry background is balanced by an almost equal amount of time in academia and hospital administrative positions.

Statland says he understands industry's positions, but he tries to look at everything from the patient's viewpoint. "There is one way I have always evaluated how well a device does its job," Statland says, "and that is as if I am the patient and the device is going to be given to me, or I am a patient that's going to have a laboratory test on my specimen—what degree of assurance do I want to have? What guarantee do I want to have that when that device is inserted or the laboratory test is done, it really has been shown to be safe and effective? I think that is the way one has to evaluate all this business—to make it personal, try to imagine yourself as the patient, and then it becomes easier."

Statland also admits to a healthy respect for FDA's police power, offering an analogy that compares the role of his Office of Device Evaluation (ODE) to that of an obstetrician overseeing the birth of a baby. After premarket approval, it is the Office of Compliance and the Office of Surveillance that performs in the pediatrician role as the compliance and monitoring side takes over and the new product matures.

"I think that even if we bring down the PMA turnaround times, the 510(k)s, and all the rest," Statland continues, "and we do a really good job of delivering the baby, it is very important to monitor the newborn and to see what is going on during infancy, childhood, and adulthood."

"This is where I think it is very important that industry sees the value [of FDA]," he adds. "FDA is not just a police force [in place] to monitor things. There is a real opportunity for industry and FDA to work together, and there is value in seeing how a product evolves." It could be that at times some of the scrutiny of a 510(k) or a PMA application is not warranted, Statland admits. Or, alternatively, a problem might surface during the evaluation period, and become significant afterwards. "I think that being able to watch the life cycle of a particular device is very valuable," he continues. "You can learn tremendously whether your predictions were correct."

Statland said he is not planning to bring his own people into the office, or to make any immediate changes—other than to relieve some of the workload already being borne by the two deputy directors, Kimber Richter and Phil Phillips. Two of the deputies will be responsible for ODE's six clinical divisions and the third deputy will focus on policy and regulations.

Statland says that as someone who is still fresh from the outside, he has three "very important initial observations" to make about ODE. First, he says he is "very impressed with the commitment and the dedication of the people here." The staff, he says, make a "tremendous effort" to try to do the right thing. "Obviously, it is not for the money alone," he adds.

The second thing Statland says he has observed at ODE is the considerable intellectual resources available. "I am in charge of about 350 people, many of them MDs, PhDs, engineers, bioengineers, biostatisticians, and so on," he says. "There are as many MDs and PhDs as one would find in a small medical school."

Third, Statland says, "There is a far better relationship than there may have been in years past between industry and FDA. I think people on both sides are really working very hard to make it a good interaction, a positive give-and- take."

Expanding on the third observation, Statland says that after several interactions and his attendance at an AdvaMed meeting, he believes that "industry is realizing that FDA, to some extent, plays a consultative role as well as a regulatory one. Not that it is officially a consultant," he adds, but that "when the ODE looks at an application, asks questions, and makes suggestions for more data, the product becomes a better product—the claims and indications for use become much more substantiated. I think that is better for industry, for the provider, and for the patient." Statland says that in every government area, "in the beginning there is bound to be a kind of adversarial relationship between government and industry. But I think as things evolve, people get to see one another as human beings who are trying to do the best job that they possibly can, and then they tend to work together," he says.

Statland received both his MD and PhD in biochemistry from the University of Minnesota. He is a board-certified clinical pathologist trained at the National Institutes of Health, the State University of Copenhagen Hospital, the University of Minnesota, and the University of California, San Diego.

According to his biographical sketch posted on the CDRH Web site, Statland has enjoyed an evolving career as a laboratory-oriented pathologist working in all sectors of the field: academics, hospital, and industry. In academia, he was a professor at the University of North Carolina in Chapel Hill, the University of California at Davis, and Boston University Medical Center. In the hospital setting, he chaired the Department of Pathology at Methodist Hospital of Indiana and consulted for the laboratory industry. In the industrial sector, Statland was the CEO and president of National Reference Laboratory (NRL) in Nashville, TN, a specialized testing laboratory performing advanced diagnostic evaluations for National Health Laboratories. For 16 years he has edited the "Tips for Technologist" column in the Medical Laboratory Observer. His last major role before beginning at FDA was as CEO and president of the North Shore–Long Island Jewish Consolidated Laboratory network in Lake Success, NY.

Record $3.8 Million Fine for Fresenius

The wheels of government move slowly, even when they move massively. It took FDA nearly 10 months to announce in the September-October issue of FDA Consumer that it had won a $3.8 million federal court fine against NMC Medical Products (Waltham, MA). The fine was imposed last December for misdemeanor violations of the Food, Drug, and Cosmetic (FD&C) Act involving adulterated blood lines.

Now a division of Fresenius Medical Care North America, NMC pleaded guilty in the New Jersey federal court to two misdemeanor charges: one, distribution in interstate commerce of devices that were adulterated because they were not manufactured in accordance with CGMPs; and two, the failure to file medical device reports.

In FDA Consumer, the agency said NMC admitted that between December 1992 and October of the following year it released into interstate commerce adulterated blood lines—tubes that carry a dialysis patient's blood to and from a dialyzer. According to the report, NMC released the blood lines even though the firm's own tests showed the devices were prone to develop potentially excessive levels of air bubbles as they carried patients' blood. After it released the adulterated product, the company received four reports of serious injury caused by the devices, with 108 malfunctions during dialysis. The company also admitted that it failed to report in a timely manner 1196 incidents in which its devices—such as dialyzers, blood lines, and related products—may have caused or contributed to a death or serious injury or may have malfunctioned. The company admitted that it made those reports only after receiving a federal grand jury subpoena calling for a halt in the company's production.

FDA said the $3.8 million fine was the highest ever imposed for a misdemeanor violation of the FD&C Act.

Sponsors to Share PMA Data

CDRH says it will allow product sponsors to use data contained in approved PMAs dating back to November 28, 1990, as part of the center's implementation of a FDAMA provision. In a just-released document, Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997, FDA indicates that it will only allow use of data prior to November 28, 1990, if the data were made available in published studies.

The FDAMA provision allows use of data in PMAs that have been approved for six years in order to: one, approve another PMA; two, determine whether a product development protocol has been completed; three, establish a performance standard or a special control; or four, classify or reclassify another device. Information available for the agency to use would include clinical and nonclinical tests or studies in the application that were used to demonstrate safety and effectiveness. The FDAMA provision replaced section 520(h)(4), which was added by the Safe Medical Devices Act of 1990 and set FDA's "four-of-a-kind" rule for use of data in PMAs. Under that rule, approved PMA data could be used in any filed PMA one year after FDA had approved the fourth device of a kind.

FDA's guidance points out that the agency will exclude use of trade secret information such as manufacturing methods or device composition. The guidance also sets forth procedures for identifying and using data available under the provision.

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