Updates

Significant Devices Approved Faster

Faster reviews, significant new products approved, and streamlined operations highlight FDA's medical device evaluation in fiscal year 1996.

FDA cleared for marketing 4,501 medical devices that were similar to existing products. This category, called "510(k)" for the section of the rule governing such devices, covers about 98 percent of all devices sold in the United States. Average review time was 110 days, down from 137 days in fiscal year 1995 and the peak average of 184 days in fiscal year 1994. In the first three quarters of fiscal year 1996, FDA made decisions on 93 percent of reviews in 90 days or less, compared with 81 percent in fiscal year 1995.

FDA approved 43 premarket approval applications (PMAs) in fiscal year 1996, 16 more than in fiscal year 1995. Half of these devices are new technologies for diagnosis and treatment. By contrast, products like contact lenses, lens care solutions, intraocular lenses, and sutures made up the bulk of the approvals in the years leading up to 1990. Along with other streamlining, earlier and more frequent communication with manufacturers at the clinical study stage enabled this progress.

The agency reviewed eight PMAs in a year or less in fiscal year 1996. Average review time was 568 days, down from 606 days in fiscal year 1995.

Key PMA approvals in fiscal year 1996 include:

the first blood test to monitor patients for possible breast cancer recurrence
new use of ultrasound to help doctors decide if a breast biopsy is needed when a lump is found
a spinal fusion implant, the first of its kind, to treat degenerative disc disease
a fiber-optic bronchial device that uses blue-light wavelengths to detect abnormal lung tissue
an automated Pap smear scanner to help laboratories detect cervical cancer more reliably
a system to remove harmful cholesterol from the blood in people who have a genetic disorder of extremely high cholesterol levels and are at very high risk of heart attack early in life
a microwave device to treat symptoms of enlarged prostate
the first permanent implant to relieve urinary obstruction in men
two lasers that use breakthrough technology to treat nearsightedness
a product to help stop urine leakage in women with urinary incontinence.

Agency changes in fiscal year 1996 to speed and otherwise improve review include:

Third-party review--This pilot program allows third-party review of certain 510(k) devices to test whether private evaluation will save time. So far, seven organizations qualify to review.
Exemption of 125 types of low- and medium-risk devices from premarket notification--This frees FDA time for review of more critical, life-saving products.
Orphan device program--The program fosters development of devices for rare, or "orphan," diseases--those affecting fewer than 4,000 people annually. It does not require extensive clinical studies to establish effectiveness, provided manufacturers show their products are safe and have a probable benefit.
Faster review of applications for exemption to study investigational devices--More than 70 percent of these applications were approved within 30 days.
Fewer overdue PMA supplements--Only 17, down from 49 in fiscal year 1995 and the peak of 173 in fiscal year 1993.
Testing faster review of PMA supplements--Pilot-testing of "real time" (two weeks or less) review of PMA supplements reduced some times to only five days.
Testing fewer inspection requirements--FDA pilot-tested a program to reduce inspection requirements when manufacturers of new, investigational devices change manufacturing sites.

New Drug Approved for Interstitial Cystitis

The first oral medication to relieve the pain and discomfort of interstitial cystitis (IC), an inflammatory disease of the bladder wall, has been approved by FDA.

The agency approved the drug, Elmiron (pentosan polysulfate sodium), last Sept. 26 under its orphan products program, which encourages development of treatments for rare diseases.

About 450,000 people in the United States are believed to have IC. But true numbers are hard to come by, because many cases are either undiagnosed or misdiagnosed. While most cases are in women, at least 10 percent of cases are in men.

No one knows what causes IC. Although bacteria, fungi or viruses are not found in patients' urine, many researchers believe the cause may be an infectious agent that hasn't yet been identified. Another theory holds that the inner lining that protects the bladder wall from toxic effects of urine may be "leaky," allowing substances in the urine to penetrate the wall and trigger IC symptoms.

In clinical studies, at least 38 percent of IC patients responded to treatment with the new drug. How Elmiron relieves the bladder pain associated with IC is not known, but the hypothesis is that the drug improves the bladder's defective lining.

Some patients see results in weeks. A few patients may take as long as six months before getting relief. If pain is not relieved in six months, the benefits of continuing treatment are unknown.

Elmiron is a weak blood thinner; therefore, patients should tell their doctors if they are taking other drugs with a similar effect, such as anticoagulants, or high doses of aspirin or other anti-inflammatory drugs, such as ibuprofen. A package insert for patients includes information on side effects, how to take the drug, and who should take it.

IC symptoms are similar to those of a urinary tract infection. Most people have some of the following symptoms:

urgent need for frequent urination both day and night
reduced bladder capacity
feelings of pressure, pain and tenderness around the bladder, pelvic and genital area, which may increase as the bladder fills and decrease as it empties
painful sexual intercourse
in men, discomfort or pain in the prostatic area.

Elmiron is marketed by Baker Norton Pharmaceuticals Inc., Miami, Fla. At FDA's request, the firm will conduct postmarketing studies.

(For more information, see "Interstitial Cystitis: Progress Against Disabling Bladder Condition" in the November 1995 FDA Consumer.)

Breath Test for Ulcer Bacterium

A simple, new breath test--the first of its kind cleared by FDA--is as good as biopsy in detecting the bacterium associated with the development of peptic ulcers in people who have developed such ulcers.

The Meretek UBT Breath Test Collection Kit accurately detects H. pylori bacterium, a common bacterium thought to infect the stomachs of 35 percent of American adults, about 10 percent of whom develop peptic ulcers. The test is administered in doctors' offices.

Previously, the only accurate way to diagnose H. pylori infection was by endoscopy with stomach biopsy. In this procedure, the patient is sedated, and a tube is inserted into the mouth and down into the stomach, where a sample of stomach lining is removed for analysis. Blood tests also have been used to detect H. pylori, but with less dependable results.

With the breath test, the patient drinks a new nonradioactive diagnostic drug solution and then exhales into the collection kit--all within about 30 minutes. The solution contains the drug Pranactin, which determines the presence or absence of active H. pylori infection. The collection kit is sent to the product's manufacturer, Meretek Diagnostics Inc., of Nashville, Tenn., and results are available within two days.

In studies of 499 U.S. and Canadian patients with duodenal ulcer, the breath test detected H. pylori in 95 percent of cases confirmed by biopsy.

FDA cleared the test for marketing Sept. 17, 1996.

(See also "Surprise Cause of Gastritis Revolutionizes Ulcer Treatment" in the December 1994 FDA Consumer.)

Mammography Info on Internet

Women can now turn to FDA's web site on the Internet to find the nearest certified mammography facility. Facilities are listed by state and include the name, address, and phone number. FDA updates the list periodically to reflect the most up-to-date information.

High-quality mammography is currently the most effective technique for early detection of breast cancer. Because of concerns about variations in mammography quality, Congress passed the Mammography Quality Standards Act in 1992, requiring certification and annual inspection of mammography facilities. To be certified, facilities must meet quality standards for x-ray images, equipment and personnel.

(See "Mammography Facilities Must Meet Quality Standards" in the March 1994 FDA Consumer.)

Antimicrobial Drugs
Related to Tendon Problems

At FDA's request, makers of fluoroquinolone antimicrobial drugs are adding warnings to the package inserts about possible tendinitis and tendon rupture.

Fluoroquinolones are used to treat bladder, respiratory and other infections. Under the precautions section in the inserts, the following information for patients is being added: "Patients should be advised to discontinue treatment and inform their physician if they experience pain, inflammation, or rupture of a tendon, and to rest and refrain from exercise." Another warning will alert doctors to the risk. It states that ruptures of the shoulder, hand, and Achilles tendons have been reported and that they required surgery or led to prolonged disability.

The affected drugs include Cipro (ciprofloxacin), Penetrex (enoxacin), Maxaquin (lomefloxacin), Noroxin (norloxacin), and Floxin (ofloxacin). Tendon rupture can occur during or after therapy with the drugs.

New Law for Animal Drugs

A new law that lends flexibility to the way FDA regulates animal drugs and medicated feeds is designed to increase the number of animal drugs without compromising the agency's mission to protect the public health.

The Animal Drug Availability Act (H.R. 2508), supported by FDA's Center for Veterinary Medicine and animal industry groups, amends the Federal Food, Drug, and Cosmetic Act to:

Allow for more flexibility in studies required to show a new animal drug's effectiveness.
Provide for greater interaction between drug sponsors and FDA during drug development. The law requires a presubmission conference to ensure a common understanding about the data needed to establish safety and effectiveness and the types of studies needed to provide the data.
Create a new category of drugs, Veterinary Feeds Directive Drugs, that allows approval and use of sophisticated new animal drugs in feed, while incorporating safeguards to ensure the drugs' safe use.
Provide for flexible labeling that permits a range of acceptable or recommended doses on animal drug labeling, rather than one optimum dose.

The new law also directs FDA to propose other changes that would, for example, broaden the approval process to make more animal drugs available to treat minor species.

President Clinton signed the law Oct. 9, 1996.

Free Pubs

An FDA Consumer reprint about health information on the Internet and a low-literacy brochure in Spanish about choosing medical treatments are available free from FDA. Their titles and publication numbers are:

Health Information On-Line (FDA) 96-1253
Sea Cuidadoso Al Escoger Los Tratamientos M»dicos (FDA) 96-1248S.

To order single copies, write to FDA, HFI-40 , Rockville, MD 20857. To order 2 to 100 copies, write to FDA, HFI-40, at the same address, or fax your order to (301) 827-5308. Include the publication number.

FDA Consumer magazine (January-February 1997)