Medical Device Link.

Originally Published MDDI April 2005

WASHINGTON WRAP-UP

Utah Medical Countersues FDA for Abuse of Process | Not-for-U.S. Device Data Not for FDA? | HHS Calls for Needs Assessment for Pediatric Devices | Cybersecurity for Networked Devices

President Bush’s choice of Lester Mills Crawford, 66, to lead FDA in a permanent capacity has been warmly welcomed by the industries the agency regulates. He is the first commissioner to come out of FDA’s own ranks since George P. Larrick (1954– 1965). Crawford cemented his goodwill in the medical device industry last year when he assured attendees of AdvaMed’s annual meeting that he has an “open-door policy.” He boasted that of all his procommunication predecessors, “I’m still the only one that ever has had a listed phone number. So give me a call!”

Bush’s February 14 announcement immediately drew praise from former AdvaMed president Pamela G. Bailey, who said in a statement that Crawford “understands the unique characteristics of the medical technology industry.” She stated that Crawford’s experience will be invaluable as Congress and FDA craft legislation this year regarding the medical device user-fee program. Similar welcoming statements came from food, drug, and biotech industry groups.

Crawford’s nomination, however, evoked backlash from lawmakers over recent FDA controversies—none of which involves medical devices. He was faulted for presiding over such embarrassments as prescription drug reimportation and the influenza vaccine debacle. He was also criticized for FDA’s slowness to act on antidepressant suicidality. Also mentioned was FDA’s suppression of dissident drug safety reviewer David Graham over the Vioxx withdrawal and continuing worries about other Cox-2 inhibitors.

Senate Finance Committee chairman Chuck Grassley (R-IA) has stepped outside his post to strongly criticize Crawford’s agency on these problems. Grassley issued a statement saying FDA “needs a permanent commissioner with the power and authority to reestablish that public safety is the overriding concern of FDA. We’ve seen evidence over the last year that the agency has become too cozy with drug companies. In some cases, FDA has disregarded important concerns and warnings from its own best scientists. During Senate consideration of Dr. Crawford’s nomination, I want to hear statements that prove he understands why public confidence has been shaken.” Grassley went on to say that he hoped to hear Crawford commit to enacting reforms inside FDA that focus on public health and safety.

The Senate Health, Education, Labor, and Pensions Committee has primary jurisdiction over the agency and the confirmation of its commissioner. Edward M. Kennedy is the ranking Democrat on the committee. He said the “credibility of FDA has been questioned due to recent serious controversies regarding drug safety and the possible intrusion of political decisions into agency decisions.” Many of these controversies arose while Crawford was acting commissioner. So, Kennedy believes it will be important for Crawford to lay out to Congress and the public specific plans to ensure the safety of prescription drugs as well as the food supply.

Notwithstanding such recent critics, unofficial FDA chief counsel emeritus Peter Barton Hutt (Covington & Burling) praised Crawford lavishly. “There’s no better candidate in the country,” he said. “Lester brings background and experience through his entire career in three entirely different areas,” he continued. In government, Hutt said, he’s not only been involved in FDA but also in USDA. In academia, he’s been chair of the department of pharmacology at Georgia and executive director of the Association of American Veterinary Medical Colleges. And he’s also been active in industry.

Crawford’s FDA career began in 1978, when he was appointed director of the then–Bureau of Veterinary Medicine. He held the post until 1985, though his tenure was interrupted for two years. During that time, he returned to the University of Georgia as its head of physiology-pharmacology. In 1986, he left FDA to join USDA’s Food Safety and Inspection Service as its administrator.

In 1991, Crawford became executive vice president for scientific affairs at the National Food Processors Association. After two years, he went on to serve as executive director of the Association of American Veterinary Medical Colleges. Later, he was director of the Center for Food and Nutrition Policy at Georgetown University and Virginia Tech. He also has served as an adviser to the United Nations’ World Health Organization. He is a member of the National Academy of Sciences’ Institute of Medicine and a fellow of the Royal Society of Medicine (UK). He earned his Doctor of Veterinary Medicine from Auburn University and his PhD in pharmacology from the University of Georgia.

A native of Demopolis, AL, Crawford closed his bio in the 1995 edition of Who’s Who In America with these words: “I have always predicated my own life on the certain knowledge that God is still at work in the world. I believe that every person carries a divine spark, and that the function of leadership is to ignite that spark. I furthermore believe that a Franciscan love of and respect for animals is a prerequisite for membership in the human race. And I believe that the true rewards in life are to be found in communion with family, friends, and colleagues.”

Utah Medical Countersues FDA for Abuse of Process

Utah Medical Products (Midvale, UT) believes that FDA decided to sue the company to secure a consent decree over manufacturing problems that posed no health risks. In doing so, the agency illegally abused its investigational process, the company alleges in a federal court countersuit. It asks the Utah federal court to amend FDA’s case in order to decide the abuse-of-process charges. Currently, the case is a permanent injunction complaint to close Utah Medical’s plant.

During the four-year-old dispute between Utah Medical and FDA, the company has complained that the agency has repeatedly refused to discuss quality system regulation (QSR) violations it says it found at Utah Medical. In discovery so far, FDA has conceded that no Utah Medical products have posed health risks, nor have they been shipped in defective condition.

McKenna, Long & Aldridge’s Larry R. Pilot filed the firm’s countersuit. It reminds the court that the Utah Supreme Court has described abuse of process as a “perversion of the process to accomplish some improper purpose.” It says evidence Utah Medical has gained from FDA in the discovery process is “more than enough” to fit FDA’s behavior to that standard.
First, the countersuit says, the lawsuit against Utah Medical is based on an FDA misrepresentation that allowed FDA investigators access to certain evidence. In other circumstances, the agency would have needed judicial permission to obtain such evidence. FDA’s lack of objectivity skewed the agency’s investigational process, the suit continues. In addition, it says, FDA used the investigational process for the noninvestigational purpose of pretrial discovery.

The countersuit charges FDA investigator Ricki A. Chase-Off with signs of “bias” and “lack of objectivity.” The suit quotes former FDA district director Edward J. McDonnell’s declaration that her executive intelligence review (EIR) “should not have been relied upon by agency decision makers.” When Utah Medical asked FDA Denver District director Belinda Collins to prevent Chase-Off from doing a second inspection, Collins characterized its purpose as a “routine follow-up.” The countersuit alleges that action was “a material misrepresentation” because the injunction case was approved by CDRH 45 days before the two-week inspection began.

“Such an inspection cannot legitimately be characterized as a ‘routine follow-up,’” the countersuit contends. “It is instead quite an extraordinary occurrence for FDA to undertake an inspection in direct support of an enforcement action that has already received the concurrence of FDA headquarters.”

Utah Medical’s contention cites two documents received from FDA. In two March 7, 2003, e-mail messages, CDRH QSR expert Kimberly A. Trautman complained to Denver District compliance officer Regina A. Barrell about the amount of time she was being allowed to advise on Utah Medical’s FDA-483 and the case’s priority with higher center management. “I was very upset and disappointed with the timing and lack of priority on this case last time from CDRH, and I am determined not to let that happen this go around,” Trautman wrote in one e-mail. In another, she said she “thought we had already arranged to review it before it was issued! Why can’t Ricki issue it Monday? If it is issued today without my review, I do not want any complaints if I do not support something because of the way it was written. This 483 is going to have to be dead-on, for me to support an observation with all the issues surrounding the inspections. I will not be able to massage it for the complaint like some cases because Pilot will kill us in court. I am willing to review it right now if I can get it electronically!”

The countersuit says these actions “constituted an abuse of process.” It alleges FDA personnel distorted the investigational process. In doing so, the lawsuit continues, it did not meet its fundamental purpose of assuring objectivity and fairness.
The countersuit says the evidence Utah Medical has obtained also indicates that Chase-Off and her colleague, Karen Coleman, engaged in misconduct. It says that Coleman omitted five Utah Medical quality documents from the EIR. Those documents were “the most significant to anyone reviewing molding documents and attempting to determine the adequacy of the company’s quality assurance practices.” These documents showed that Utah Medical’s procedures exceeded QSR requirements, the countersuit maintains.

In addition to the allegedly abusive 2003 inspection, FDA proceeded on yet another inspection in 2004, according to Utah Medical’s pleadings. The countersuit claims that investigation also abused the agency’s investigation process in the same way. “FDA abused its investigational process, creating collateral adverse impacts on the court’s discovery process, by using its investigational powers to conduct pretrial discovery,” it says.

The countersuit seeks damages that “include, but are not limited to, legal fees incurred by the company and derived from the abuse of process.”

Not-for-U.S. Device Data Not for FDA?

An advisory opinion on FDA’s authority to obtain information on medical devices not being sold in the United States has been requested by McKenna Long & Aldridge (Washington, DC). The request said FDA has no authority over medical devices not introduced in interstate commerce in this country.

“For example,” it said, “a device that is manufactured in another country, but not distributed in the U.S., cannot be seized or subject to a request for injunctive relief.…Yet, in particular during inspection of international device manufacturers, the authority of FDA inspectors relating to production of information about devices that are not in U.S. interstate commerce is not made clear to such manufacturers.”

Differences between devices that are sold in the United States and in other countries may include labeling or advertising materials and design features, the request said. Also included would be prescription or OTC sale, licensure requirements for those using the devices, and laws and regulations in the countries involved. The differences may affect the performance characteristics and expectations of devices. Such differences also prevent or significantly affect any possibility of country-to-country comparisons, the letter said.

According to attorney Larry Pilot, during FDA inspections of device facilities outside the United States, agency inspectors have been directed to demand production of information such as complaints relating to devices used in other countries. This happens even when there is no evidence that the device is or ever has been in U.S. interstate commerce. “Failure to provide such information for devices that have neither been nor are distributed in the U.S. has resulted in import detention or threats of detention by FDA,” Pilot wrote.

Pilot said his objective in asking for an advisory opinion is for confirmation of FDA’s jurisdiction. The agency’s authority over development, manufacture, distribution, and use of a device should be restricted to devices for which commercial distribution in interstate commerce has been established as a matter of fact and law. He also said there are no published court opinions that confirm FDA’s authority to access documents relating to items not offered for nor introduced into interstate commerce.

HHS Calls for Needs Assessment for Pediatric Devices

HHS says that while some barriers to developing pediatric medical devices have been identified, the issues are too complex for immediate substantive policy change recommendations. It says there should be a wide-ranging needs assessment to determine the scope of unmet needs. The potential barriers to bringing new pediatric devices to market should be dis-
cussed, along with the most promising solutions to address the unmet needs.

The department’s comments are included in a report to Congress on barriers to the availability of devices for treating or diagnosing conditions that affect children. The Medical Devices Technical Corrections Act of 2004 mandated the report. FDA prepared it after using the Federal Register to solicit comments from interested parties, including consumers, re-searchers, healthcare practitioners, the device industry, and professional and trade associations. The agency also compiled information after participating in a stakeholder meeting.

The comments from clinicians and patient advocacy groups stressed the need for pediatric devices in medical specialties, including pediatric cardiology, pulmonology, nephrology, orthopedics, and surgery. Many comments cited the widespread practice of modifying adult devices for pediatric use, that practice’s risks, and the need for data on long-term effects of device use as well as adverse events in children. Comments did not address whether adult device modification successfully addresses pediatric patients’ needs.

Numerous potential barriers to pediatric device development, approval, and widespread availability were cited, but FDA says respondents did not discuss the barriers’ relative importance or their urgency in relation to the unmet needs that were identified. Thus, FDA says, it is unknown how unmet pediatric needs are influenced by the small market for pediatric devices, in-sufficient reimbursement, difficulty in obtaining clinical data for FDA approval, or perceived liability associated with pediatric devices. Also, the report says, barriers actually contributing to the existence of unmet needs may not be the same for each device.

Many specific legislative, regulatory, research funding, financial incentive, and enhanced information gathering and exchange recommendations were made to foster development and availability of pediatric devices. FDA says one of the most frequently proposed incentives was to modify the humanitarian device exemption to allow profit-making and raise the limit on the number of patients who can be treated or diagnosed with such a device. Many respondents also suggested more interaction and communication between clinicians, the device industry, and FDA to identify and address unmet pediatric needs.

Given the issues’ complexity and the wide range of perspectives included in the comments, HHS says, what’s needed next is a systematic needs assessment. From that can come a prioritization of needs and an assessment of the potential barriers to bringing new pediatric devices to market. In addition, it can identify the most promising solutions to address the unmet needs. Three of the recommendations that can be integrated into the needs assessment and prioritization process, HHS says, are the following:

• Enhanced interaction and communication between pediatric clinicians and device manufacturers.
• Development of a network of children’s hospitals and healthcare facilities with expertise in pediatric diseases and conditions.
• Consideration of certain pediatric device issues by the Office of Pediatric Therapeutics or the Pediatric Advisory Committee.

Cybersecurity for Networked Devices

CDRH has prepared questions and answers to help explain the concerns outlined in its recently issued guidance Cybersecurity for Networked Medical Devices Containing Off-The-Shelf (OTS) Software. The center says it is worried about computer network security, because vulnerable OTS software can allow an attacker unauthorized access to a network. Such access would reduce the safety and effectiveness of medical devices that connect to such networks.

CDRH says its QSR requires manufacturers to examine sources of quality data and correct or prevent quality problems. This requirement includes OTS software that could be compromised by a hacker. “Ordinarily, FDA will not need to review software patches before a device manufacturer puts them in place,” it says. FDA considers most software patches to be design changes that manufacturers can make without prior approval.

To access the question-and-answer document about the guidance, visit www.fda.gov/cdrh/osb/1553faq.html.

Copyright ©2005 Medical Device & Diagnostic Industry