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FDA, the national Centers for Disease Control and Prevention, and the National Institutes of Health developed the guideline to reduce public health risks while not impeding medical innovation.
People may send comments to FDA's Dockets Management Branch, HFA-305, Room 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
The recommendations include:
The guideline was published in the Sept. 12, 1996, Federal Register. [Note (Jan. 15, 2002): The information that originally appeared in this article about obtaining this guideline is no longer current. To obtain this guideline, write to the Division of Communication and Consumer Affairs, OCTMA, HFM-43, Center for Biologics Evaluation and Research, 1401 Rockville, Pike, Rockville, MD 20852-1448 or phone 1-800-835-4709 or 301-827-1800. Also see the final PHS Guideline on Disease Issues in Xenotransplantation on this Website.]
A copy of an FDA backgrounder, "Fact Sheet on Xenotransplantation," may be ordered by writing to FDA, HFI-40, Rockville, MD 20857, or faxing your order to (301) 827-5308. Include the publication number: BG 96-6. [Note (June 5, 2003): This document is no longer available.]
Before, patients in a life-threatening situation could not take advantage of experimental therapies if they were unable to provide the required informed consent or did not have a family member or other legal representative readily available to provide it. But in the new rule, published in the Oct. 2 Federal Register, FDA establishes the criteria under which such patients may receive, without consent, treatment with promising experimental drugs and medical devices.
The new policy is expected to offer critically ill, unconscious patients who cannot be successfully treated with conventional therapies the benefits of experimental intervention.
FDA's rule allows patients to be enrolled in clinical trials without their consent provided that an independent doctor and an institutional review board, or IRB, agree that the clinical trial addresses a life-threatening situation and that other criteria are met. An IRB is a committee of experts and lay people established to review research.
Also, patients may receive the experimental therapy only if:
The NIH companion document, "Emergency Research Consent Waiver," applies to all agencies in the Department of Health and Human Services. Both FDA and NIH are part of the department. NIH's document reaffirms the government's policy of protecting human research subjects. It contains the same criteria as FDA's final rule.
The BAK Interbody Fusion System was approved only for people who need surgical fusion of adjacent vertebrae above and below a diseased disc. The device is a hollow metal cage about an inch long that is implanted into disc space between two vertebrae to stabilize the spine and to allow for fusion of the vertebrae. The device is not intended for people with general back pain.
In degenerative disc disease, discs between the vertebrae break down and cause lower back and leg pain. Conventional treatments include back braces, physical therapy, and, in some people, surgery to remove the disc. Fusion with hooks and rods has been used in some cases.
When implanting the BAK system, the surgeon removes bone from the patient and packs it inside the implant. Over time, the bone can grow through the holes in the wall of the cage and around the outside of the cage, fusing the vertebrae and often reducing back pain.
In a clinical study, the device was implanted in 947 patients aged 21 to 65 who needed spinal fusion surgery for degenerative disc disease.
After two years, 254 patients were evaluated. The device was successful in 184 patients (72 percent). For this group, the spine had fused, pain was decreased, and there was no loss of muscle strength or function--the ability to sit, walk, or put on shoes. Complications were similar to those reported from conventional surgery and included damage to the nerve and blood vessels, infection, and the need for more surgery to further stabilize the spine.
As a condition of approval, the manufacturer must conduct postmarketing studies to determine the device's long-term effectiveness and to examine any devices removed from patients for any reason. The company also must provide information that would help potential patients make informed decisions about the surgery.
Spine-Tech Inc., of Minneapolis, makes the BAK Interbody Fusion System.
Gliadel wafers were approved by FDA on Sept. 24 to treat glioblastoma multiforme, an aggressive type of brain cancer in the malignant glioma class of cancers. Glioblastoma multiforme, which occurs mainly in adults, has been extremely difficult to treat effectively with cancer therapies such as surgery, radiation, and traditional chemotherapy.
Implanted into the cavity of the brain created when a tumor is removed, the wafers--seven or eight of them, depending on the cavity's size--deliver the anticancer drug BiCNU (carmustine) directly to the affected area of the brain. The direct delivery lessens the exposure of the rest of the body to the drug.
In a study of 222 patients with recurrent malignant glioma who had been initially treated with surgery and radiation, the six-month survival rate in those with glioblastoma multiforme who received Gliadel was 56 percent, compared with 36 percent for those who received a placebo. In patients with diagnoses other than glioblastoma multiforme, Gliadel did not affect survival rates. A small 32-patient study supported these results.
Patients should be monitored closely after implantation for possible complications such as seizures, infections, abnormal wound healing, and brain swelling.
Approval followed a June 15, 1996, recommendation for approval by FDA's Oncologic Drug Advisory Committee. Since October 1995, Gliadel had been available under a Treatment IND to patients with recurrent malignant glioma.
Gliadel is manufactured by Guilford Pharmaceuticals Inc., of Baltimore.
The Xillix Life-Lung Fluorescence Endoscopy System uses a tube inserted through the mouth into the bronchi (tubes leading from the trachea to the lungs) to deliver a blue laser light to the bronchial tissue. The laser light elicits a fluorescence from the tissue, which projects an image on a video monitor. Normal tissue appears green; abnormal tissue appears reddish-brown. A biopsy of suspicious tissue can then identify cancer or another abnormality.
The system was approved last Sept. 19 for use with conventional white light bronchoscopy, in which a white light is used to illuminate lung tissue to help physicians identify abnormalities. The new system detects more tissue changes than can be seen with the white light alone.
The manufacturer, Xillix Technologies Corp., of Richmond, British Columbia, sponsored a study that examined 700 spots on the bronchial tubes of 173 patients at seven medical facilities in the United States and Canada. Patients first underwent white light bronchoscopy and then, with the bronchoscope still in place, the fluorescence endoscopy. The patients either had symptoms or x-ray findings indicating possible lung cancer or had previously had the disease.
Subsequent biopsy of all 700 suspicious lesions found that 75 patients had one or more abnormal spots. Of those, 28 patients, or 37 percent, were correctly identified by white light bronchoscopy as needing biopsy. The fluorescence system combined with white light correctly identified 56 patients, or 75 percent, as needing biopsy--twice as many as white light alone.
Few adverse effects were associated with the new system. However, the fluorescence exam generated 196 additional biopsies, of which only 60 proved to have significant cellular abnormalities.
As a condition of approval, which was based on the study data and on the recommendation of FDA's Ear Nose and Throat Devices Panel, the manufacturer must conduct a postmarketing study to see if doctors will generally agree on which images are positive and which are negative.
The recalled lot is P72304, with an expiration date of April 12, 1998. It was recalled in early October as a precautionary measure. At press time in October, FDA had not received any reports of illness associated with this product.
Individuals or institutions who have any vials of the recalled lot should return the product immediately to the manufacturer. The company's customer support telephone number is (1-800) 683-1288.
The recall of the lot of Monoclate-P was prompted by the possibility that it had been damaged and possibly contaminated as a result of a manufacturing problem. Similar manufacturing problems may be related to reports linking one lot of Centeon's human albumin, Albuminar-25, to septicemia, a life-threatening blood infection. This lot was recalled by the manufacturer last Sept. 23, followed by the recall of nine other lots.
On Oct. 9, as a precautionary measure, Centeon L.L.C. voluntarily recalled all Albuminar brand human albumin and Plasma Plex brand plasma protein products, distributed under the Centeon and Armour labels. Because these products are typically administered in hospitals and other health-care facilities, it is unlikely that consumers have any. Health-care professionals with questions may call the company's medical information line at (1-800) 551-0210.
FDA is asking health professionals to report any adverse events associated with these products to MedWatch, the agency's adverse event reporting program, at (1-800) FDA-1088, and to the company.
The quality system rule, published in the Oct. 7, 1996, Federal Register, requires that manufacturers:
For example, when designing defibrillators for emergency use in hospitals and ambulances to restart the heart, firms must consider all aspects of use in the ambulance as well as in the hospital. Firms must consider such ambulance-related factors as storage temperature, road shock and vibration, two-way radio interference, and electrical noise generated by the siren. They must review their design throughout development to make sure it is meeting all requirements.
In a review of medical device recalls over six years in the 1980s, the Government Accounting Office found that design defects accounted for about 44 percent of the products' quality problems and that proper design controls could have prevented the problems. Design-related defects have been found in critical products such as heart valves, catheters, defibrillators, pacemakers, ventilators, patient chair lifts, and laboratory tests.
The quality system rule will make standards for U.S. medical devices consistent with quality system requirements worldwide. The rule's standards closely follow the international standard, ISO 9001, fulfilling a mandate of the Safe Medical Devices Act of 1990 to harmonize these requirements. The rule also includes purchasing and manufacturer servicing controls and clarifies requirements of FDA's current good manufacturing practices. Firms may develop their own methods for meeting the objectives of each control tool.
The rule takes effect June 1, 1997, but FDA will not enforce the design control provisions until after June 1998, when equivalent provisions become mandatory in Europe.
A subsequent proposal and final rule will cover firms that service or refurbish devices outside the original manufacturer's control.
The Office of Consumer Affairs at FDA has a new free telephone number for consumer inquiries: (1-800) 532-4440 (in the D.C. metropolitan area, call (301) 827-4420). Inquiries about breast implants, previously directed to the breast implant information line, should be directed to this number.
[Note (June 17, 2003): The information that has been grayed-out above is no longer accurate.]