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Several companies, including cigarette and smokeless tobacco manufacturers and sellers, had sued FDA regarding its rule on children and tobacco.
Judge William Osteen of the U.S. District Court for the Middle District of North Carolina ruled on April 25 that FDA may:
The government has appealed the court's finding that FDA lacks the authority to regulate the advertising and promotion of tobacco products.
"This is a fight we cannot afford to lose," President Clinton said on the day of the court decision. Each day, Clinton said, 3,000 young people become regular smokers, and 1,000 of them will have their lives cut short as a result.
According to the new recommendations:
Performed correctly, mammography is the most effective way to detect breast cancer early, often locating small tumors that cannot yet be detected by touch.
High-quality mammography can find 85 to 90 percent of breast tumors in women over 50. Widespread screening of women this age, followed by prompt treatment when needed, can reduce cancer deaths by up to 30 percent. Also, if the cancer is detected early enough, before it has spread, the woman may choose treatment that preserves her breast.
Because of concerns about inadequate mammography quality at some facilities, Congress in 1992 passed the Mammography Quality Standards Act. Facilities now must be certified by FDA as having met quality standards for x-ray images, equipment, and personnel and must be inspected annually. (See "Mammography Facilities Must Meet Quality Standards" in the March 1994 FDA Consumer.)
Legislation was introduced in April to reauthorize the act, which will otherwise expire this year.
FDA has certified more than 10,000 mammography facilities. For a list of their names and locations, go to FDA's Web site. Or call the National Cancer Institute's toll-free cancer information service at (1-800) 4-CANCER.
FDA cleared the erbium YAG laser system for marketing May 7 to remove tooth decay, prepare cavities for fillings, and roughen enamel to improve bonding of restorations. Previous dental lasers were cleared for use only on soft tissue like the gums, for curing restorations, and as the heat source in some bleaching systems. (See "Lasers in Dentistry" in the January-February 1995 FDA Consumer.)
In one study by the manufacturer, Premier Laser Systems, of Irvine, Calif., more than 500 teeth were treated for decay with the laser and then evaluated for damage to the tooth's nerve and blood supply. No adverse events were reported. A second controlled study by the firm involved some 125 patients with tooth decay. Half were treated with the laser, and half with a high-speed drill. The laser was as safe and effective as the drill in removing decay and preparing the teeth for fillings, but patients treated with the laser were less likely to need anesthetic for pain.
The laser system consists of a box-like laser console and a fiber-optic cable with a dental handpiece at the end resembling a standard high-speed drill. Like dental drills, the laser uses water or air to cool the tooth and clean the surface during treatment. Dentists and patients will need to wear goggles to protect their eyes.
FDA approved the Visx Inc. excimer laser April 24 for refractive surgery to treat mild to moderate astigmatism in people 21 and older who also have mild to moderate nearsightedness. Most nearsighted people also have astigmatism, which prevents correct focusing. It is caused by uneven curvature of the surface of the eye's cornea. The laser is not approved for severe cases of these disorders. (See also "Not a Cure-All: Eye Surgery Helps Some See Better" in the July-August 1995 FDA Consumer.)
FDA restrictions for the laser include:
The Nicotrol Inhaler (nicotine inhalation system) allows smokers to inhale the dose from a nicotine cartridge through a plastic mouthpiece. The nicotine is absorbed into the body through the mucous membranes of the mouth.
While the inhaler's ability to satisfy smokers' psychological needs for the ritual of bringing hand to mouth is unknown, quit rates in clinical trials with the inhaler were comparable to other smoking cessation products already on the market.
The Nicotrol Inhaler, approved by FDA May 2, is manufactured by Pharmacia & Upjohn Inc., Kalamazoo, Mich., and marketed by McNeil Consumer Products, Fort Washington, Pa.
Each year, about 51,000 Americans are hospitalized for serious burns, and 5,500 die. Covering wounds quickly with temporary skin substitutes can help prevent infection and minimize scarring and trauma.
The new Dermagraft-TC wound covering is grown in a laboratory from human cells, then frozen and packaged. To use, the surgeon unfreezes the temporary skin, then stretches it over the burn site. The surgeon removes the temporary covering when the patient's own skin is ready to be grafted, usually in 7 to 14 days.
Dermagraft-TC has not been tested in pregnant women or children under age 2, or on burns from electrical or chemical causes or on the head, hands, feet, or buttocks.
FDA's March 19 approval followed a recommendation from the General and Plastic Surgery Panel of the agency's Medical Devices Advisory Committee.
A study of 89 burn patients treated with Dermagraft-TC showed that it covered burns as effectively as frozen cadaver skin from tissue banks.
FDA's safety review focused on the risk of disease transmission because of the product's use of human cells. The cells met FDA guidelines for cell testing. The cells were tested for known disease-producing elements, such as bacteria, fungi and viruses. The final product was tested for bacteria and fungi.
Some data raised the possibility of a higher risk of infection from the Dermagraft-TC. At FDA's request, the manufacturer, Advanced Tissue Sciences of La Jolla, Calif., will conduct a postmarket study of 200 patients to evaluate this risk.
(For more information on skin substitutes, see "Second Skins" in the January-February 1997 FDA Consumer.)
Like other blood thinners, Coumadin is used to treat people with artificial heart valves, irregular heartbeat, and other conditions that lead to excessive blood clotting. These drugs have a "narrow" therapeutic range: Too much blood thinner can cause hemorrhage, while too little can allow clots to form and obstruct blood vessels, causing stroke or death.
Using the ProTime Microcoagulation System, a patient pricks a finger to draw a blood sample and runs the sample through a small, hand-held electronic device that displays results on a screen.
FDA previously cleared the test, known as a prothrombin time (PT) test, for use in doctors' offices, clinics, and nursing homes to check blood coagulation. The home prescription version will be for use under a doctor's supervision.
Previously, patients taking Coumadin had a PT test every one or two months during regular visits to their doctor. With the new kit, they can test themselves weekly, or as often as their doctor recommends. The system stores the 40 most recent results with a date and time stamp, enabling the doctor to review and interpret results and adjust the drug if needed. Doctors can program the appropriate upper and lower blood-clotting ranges for each patient.
FDA cleared the device after reviewing data on 84 patients at four clinics. The patients had the professional laboratory PT test at the clinics and also tested themselves with the home kit. Both types of tests showed comparable results.
International Technidyne Corp., Edison, N.J., makes the ProTime Microcoagulation System.
FDA's "New Use Initiative--Evidence for Primary and Supplemental Approvals," proposed March 13, gives industry clear guidance on when the agency can determine effectiveness for a new use without the usual standard of two new clinical trials.
In some cases, for example, FDA can rely on effectiveness information extrapolated from existing data. In others, the agency can accept evidence from a new single trial, as long as it is supported by existing related clinical data, or adequate evidence from a single study at more than one medical center.
The drafts, "Guidance for Industry: FDA Approval of New Cancer Treatment Uses for Marketed Drug and Biological Products" and "Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products" are available from FDA by calling (1-800) 835-4709 or by visiting www.fda.gov/cber/guidelines.htm on the agency's Web site.
The public can comment on the proposal, published in the April 17 Federal Register, until July 16.
If a food manufacturer determines a food substance is GRAS--that is, generally recognized as safe by qualified experts--the company does not need FDA approval before marketing. However, if a manufacturer wants FDA affirmation that the substance is GRAS, the company currently must submit a petition and go through lengthy rule-making.
Under FDA's proposal, a manufacturer would simply notify FDA of the GRAS determination and provide evidence to support this decision. FDA would evaluate the evidence and respond within 90 days. The proposal allows for FDA to reevaluate the notification if new information indicates a reason for concern.
The proposed simpler process would give manufacturers greater incentive to inform FDA of their GRAS determinations. This, in turn, would increase FDA's awareness of ingredients in the nation's food supply and the cumulative dietary exposure to GRAS substances. FDA also could redirect resources to food ingredient safety issues that may have a greater impact on public health, such as those posed by novel proteins, carbohydrates, fats, and oils.
Send written comments to the FDA Dockets Management Branch (HFA-305), 12420 Parklawn Drive, Room 1-23, Rockville, MD 20857-0001. The Federal Register is available in some public libraries, and the proposal is located at http://vm.cfsan.fda.gov/~lrd/fr970417.html on FDA's Web site.
Because generic drug makers do not have to repeat the clinical studies used to develop the brand-name drugs, they must ensure their products are as safe and effective by showing that the active ingredients are the same and that they are bioequivalent--that is, absorbed and used by the body in the same way as the original products.
Previously it was believed that two estrogens--sodium estrone sulfate and sodium equilin sulfate--were Premarin's sole active ingredients. New laboratory and clinical studies show this may not be the case. Other components in Premarin may contribute to its effectiveness. These and other findings, including a report by the agency's ad hoc working group on conjugated estrogens, underscore the lack of precise knowledge about Premarin.
FDA announced May 5 that Premarin must be better characterized before its active ingredients can be definitely identified and that the bioequivalence guidance for conjugated estrogens should be reexamined. The guidance describes how to measure whether the rate and extent of absorption in the blood of a generic version are equivalent to those of Premarin.
The agency encourages the start of studies that will permit scientific determination of the drug's active ingredients and provide a potential for approval of generic versions.
(For information about estrogen replacement therapy, see "New Attitudes Toward Menopause" in the March 1997 FDA Consumer.)
| 1989-91 | 3.9 servings |
| 1994 | 4.4 servings |
| 2000 Goal | 5 to 9 servings |
Adults' average daily intake of fruits and vegetables is closing in on five servings, according to the U.S. Department of Agriculture's Continuing Surveys of Food Intakes by Individuals. The National Cancer Institute, which recently reported this data, and the Produce for Better Health Foundation sponsor the National 5 A Day for Better Health campaign to increase consumers' consumption of fruits and vegetables. (See "Fruits and Vegetables: Eating Your Way to 5 A Day" in the March 1997 FDA Consumer.)
FDA Consumer magazine (July-August 1997)