President Bush's nomination in March of FDA acting commissioner Andrew C. von Eschenbach for permanent commissioner is unlikely to result in an early confirmation. Although it was welcomed by medical device and other regulated industries, many believe it simply won't happen.
The reasons have been well aired in the mass media. They include the immediate hold placed on the nomination by two senators, Hillary Clinton (D–NY) and Pattie Murray (D–WA), over stalled approval of the Plan B emergency contraceptive for nonprescription sale. Also in the air is the question of the perceived conflict of interest in von Eschenbach's dual role as National Cancer Institute (NCI) director, even if he surrendered the position.
The White House announcement prompted an array of endorsements and condemnations from the usual Washington sources. Predictions from informed observers also abounded.
Norman Ornstein, a scholar at the American Enterprise Institute, predicted that the Bush administration would rather allow von Eschenbach to remain unconfirmed for years than approve the Plan B application. Antiabortion Bush supporters oppose the Plan B drug. “The [administration is] not going to enrage its base,” Ornstein told the New York Times.
Senator Enzi will preside over the confirmation hearings. He has promised prompt action.
Senate Health, Education, Labor, and Pensions Committee chairman Mike Enzi (R–WY) will preside over confirmation hearings when they are held. He promised early action on the confirmation. But the senior Democrat on the committee, Senator Edward M. Kennedy (D–MA), spoke more cautiously. “I expect the administration will have to address the Plan B issue fair and square before he can be confirmed,” Kennedy said.
Public Citizen Health Research Group director Sidney Wolfe sourly predicted that if von Eschenbach is confirmed, he will have gotten the post for the wrong reasons. He “will become yet another Bush appointee whose main reason for being selected is that he is a family friend, someone who has been warmly embraced by the regulated industries—especially the pharmaceutical industry—and someone who has been and will continue to be loyal to the White House agenda,” Wolfe said.
Von Eschenbach's background will behoove him, said Foti.
“Von Eschenbach continues to exhibit extraordinarily bad judgment, a lack of being in touch with reality, and insensitivity to the hopes and fears of cancer patients and their friends and families,” Wolfe continued. He pointed to von Eschenbach's oft-stated plan to eliminate the suffering and death from cancer by 2015. Doing away with cancer in 10 years is not “realistic,” Wolfe said, adding that von Eschenbach is raising false hope. “He is a very poor choice to head this critical agency, and his nomination must be defeated.”
The American Association for Cancer Research, however, said it “enthusiastically” supports the nomination. In a statement, its chief executive officer, Margaret Foti, said that von Eschenbach “brings enormous medical and administrative expertise and experience to this post. This background will be vitally important in his new, challenging role of FDA commissioner.”
Claude Alexander Allen, a former HHS employee and Bush adviser, was arrested at his Gaithersburg, MD, home on March 9. He has allegedly stolen more than $5000 from retail stores by way of receiving 25 fraudulent refunds since January 2. His lawyer told the Washington Post that the incidents were “a series of misunderstandings.” Allen, a Bush HHS appointee, slashed FDA's issuance of warning letters by as much as 70% in 2001.
Last year, Allen became the highest-ranking African-American on the White House staff as domestic policy adviser to the President. He left HHS after three years as deputy secretary. In that post, he issued a directive in 2001 that the Office of Chief Counsel vet all FDA warning and untitled letters before issuance. At that time, newly appointed Daniel Troy headed the office. Allen's order reversed an earlier order by then-commissioner David Kessler in 1992 that gave district offices direct authority to issue warning letters.
At the time, Allen said he did not intend for the directive to have “a chilling effect on enforcement” as critics had been complaining. However, it did have such an effect. It added more than a month to FDA's letter-issuance time and drastically curtailed the number of letters issued. Industry's rate of product recalls, traditionally seen as an inverse barometer of FDA enforcement, soared 42% after warning letters were reduced.
Allen said he started looking into industry complaints about inconsistency in warning letters. Then-secretary Tommy Thompson had asked him to bring about changes that would allow FDA to increase its effectiveness in fulfilling its mission. While doing so, Allen said, he noticed some letters come through that raised questions. “In the course of a meeting that we had, I raised the question as to what these things were and why they were going out in such a hodgepodge fashion.” Many letters addressed issues that had broad implications but may not have been a high priority for the agency or the department, according to Allen.
Although his effort had the opposite effect to the one he said was sought by Thompson, Allen's star continued to rise in the Bush administration. He was nominated twice, unsuccessfully, to the 4th Circuit Court of Appeals in Richmond, VA, while at HHS. When Democrats blocked Allen the second time, citing his lack of legal experience, President Bush brought him to the White House as senior domestic policy adviser.
A March 11 Washington Post report on his arrest said Allen worked in a small office on the second floor of the West Wing, shaping administration policy on such issues as healthcare, space exploration, housing, and education. He resigned February 9, saying he wanted to spend more time with his family. Five weeks earlier, police had cited him for a theft of less than $500 at a Target store in Gaithersburg, MD. There, the Post said, employees had spotted him putting merchandise in a shopping bag. “He then walked over to the guest services desk, produced a receipt and received a refund for the items,” the newspaper reported. He was stopped leaving the store, police were called, and he was charged. But prosecutors “dropped the misdemeanor charge, which is not unusual in cases in which detectives are considering filing more-serious charges.”
A police spokesman told the Post this was not an isolated incident; Allen is alleged to have received 25 fraudulent refunds for items. Items returned include a home theater system, stereo equipment, clothes, a photo printer, and items worth as little as $2.50.
A March 12 Post article quoted Bush as saying on March 10 that “If the allegations are true, something went wrong in Claude Allen's life, and that is really sad. When I heard the story last night I was shocked, and my first reaction was one of disappointment, deep disappointment.”
Allen was released on his own recognizance after being charged on two felony counts of theft and the purported fraudulent refunds scheme. Both charges carry maximum penalties of a $25,000 fine and 15 years in prison.
A CDRH bulletin for laboratories gives information on differences among C-reactive protein (CRP) assays. Included are conventional CRP assays, high-sensitivity CRP assays, and cardiac CRP assays. It also addresses the regulatory need to designate a CRP assay specifically for cardiovascular risk indications for use. FDA says the tip sheet is needed because there may be confusion in the laboratory community on the indications for use for different CRP assays. And, it says, the confusion may stem both from clinicians and from manufacturers.
The difference between cardiac CRPs and high-sensitivity CRPs is not in the analyte itself. Rather, it is in the analytical performance documented through submitted evidence, the posting says. When device specifications say a device can be used for multiple clinical purposes—for example, to diagnose two distinct diseases—FDA requires proof to support each purpose.
To access the guidance, visit www.fda.gov/cdrh/oivd/tips/crp.html.
Openings in a bed rail should be small enough to prevent the head from entering. A loosened bar or rail can change the size of the space. HBSW and IEC recommend that the space be less than 120 mm, representing average head breadth.
FDA has issued a guidance for industry and agency staff called “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.” It includes ways to reduce life-threatening entrapments associated with hospital bed systems. FDA says the guidance names the body parts at risk for entrapment, identifies hospital bed openings that are potential entrapment areas, and recommends dimensional criteria for these systems.
Manufacturers, FDA says, may use the guidance when designing new beds to help ensure compliance with regulations such as the quality system regulation. They can also use it to provide labeling and instructions for use and to help ensure that devices are safe when used as labeled. FDA says it encourages manufacturers to provide data to medical device distributors, clinicians, patients, and families on mattress dimensions, compatible components, and entrapment issues.
The agency has received some 690 entrapment reports over the 21 years from January 1, 1985, to January 1, 2006. In those reports, 413 people died and 120 were injured. The other 158 were near-miss events with no serious injury as a result of intervention. The events have occurred in openings within the bed rails, between the bed rails and mattresses, under bed rails, between split rails, and between the bed rails and head- or footboards.
Not all patients are at risk for entrapment, the agency says, and not all hospital beds pose an entrapment risk. Most vulnerable to entrapment are elderly patients and residents, especially those who are frail, confused, or restless, or who may have uncontrolled body movement.
The guidance provides a scientific basis for the limits derived from a review of international anthropometric data, a review of historical entrapment data, and a retrospective study to verify the proposed limits. The guidance provides information about reporting entrapment adverse events as well. In addition, it provides a copy of the Hospital Bed Safety Workgroup (HBSW) test methods for assessing gaps or openings in hospital bed systems.
To access the guidance, visit www.fda.gov/ohrms/dockets/98fr/04d-0343-gdl0002.pdf.
FDA has become aware of additional serious injuries and deaths associated with using the Gambro Prisma Continuous Renal Replacement Therapy device. FDA said in a February 27 updated public health notification that these deaths surfaced after the release of an advisory last August.
“We want to emphasize again that special caution must be used when operating the Prisma system to prevent excessive fluid removal from patients,” FDA said. “Caregivers must adhere strictly to the labeled operating instructions.” In particular, caregivers must pay particular attention to the ‘incorrect weight change detected' alarms, the agency said. Those alarms are designed to alert the user of a potential fluid imbalance that has occurred during the course of continuous renal replacement therapy. “If treatment is continued without resolving the cause of these alarms,” the notification continued, “excessive fluid may be removed from the patient, and this can result in serious injury or death.”
FDA and the company are investigating whether device design issues may contribute to the problem.
Recommendations for dealing with the weight change alarms are included in the notification. It can be accessed at www.fda.gov/cdrh/safety.html.
AdvaMed has authorized use of an AdvaMed Code logo by device manufacturers that adopt compliance policies consistent with AdvaMed's Code of Ethics and maintain a robust compliance infrastructure.
Under the new system, companies that meet eight items in a Conditions of Use agreement will be able to display the logo on their corporate Web site, business cards, displays, and other marketing materials. AdvaMed said the eight elements align with the HHS Office of Inspector General Compliance Program Effectiveness Standards. They also outline specific programs and processes that firms must maintain to ensure effective compliance.
To reinforce a company's commitment, ethical practices must originate at the highest levels. AdvaMed requires that the Conditions of Use certification be signed by a high-ranking corporate executive.
“Development of the code logo and self-certification program is the latest example of our industry taking a leadership role when it comes to ethical practices and compliance,” said AdvaMed president and CEO Stephen Ubl. “Now, at a glance, healthcare professionals can know they are dealing with a company that is committed to the highest ethical standards and that has solid compliance programs in place.”
Guidant Corp. has alerted physicians and FDA about lower-than-expected battery voltage measurements detected in preimplanted Contak Renewal 3 RF and Renewal 4 RF defibrillators. A letter from Guidant says 39 devices had low battery voltage prior to implant; none were implanted. The firm claims that the observed decline in battery voltage is related to “an unexpected sustained low-level current” that can occur only during storage and shipment prior to implant.
More than 4000 of the devices have already been implanted. However, Guidant says it has received no reports of abnormal battery voltage related to this issue. “Engineering investigation has confirmed that this internal low-level current may occur transiently in normal use postimplant, with negligible impact on longevity (less than two weeks over a device lifetime) and no impact on device function,” the letter adds.
FDA typically classifies a communication like this to physicians as a recall.