1988 Product Approvals : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Also, six new biologicals were licensed by FDA's Center for Biologics Evaluation and Research last year. In addition to the rapid screening test for detecting AIDS antibodies in blood, two others are of particular interest:

Blood screening tests for human t-lymphotropic virus type I (HTLV-1), which, though distantly related to the AIDS virus, does not cause AIDS but can transmit another disease, adult T-cell leukemia; and

A vaccine for childhood immunization against diseases, such as meningitis, caused by Haemophilis influenzae type b.

Also during 1988, FDA Center for Devices and Radiological Health cleared for marketing 11 products that represent advances in medical device technology. These include:

The cervical cap — the first contraceptive medical device approved since 1976;

Two diagnostic test kits using recombinant DNA technology to aid in detecting autoimmune disease, especially systemic lupus erythematosis;

A temperature-sensitive heart pacemaker, the first approved pacemaker to use the heart's temperature as an indicator of physiological stress for the purpose of regulating the heart rate;

A plasma immunoadsorption column to remove specific components from blood plasma;

A laser and catheter combination for use in treating circulatory problems;

DNA probes for speedier detection of Campylobacter, the number one cause of gastrointestinal infections in the United States; and

DNA probes for faster detection of herpes simplex viruses. (DNA probes are diagnostic products that use genetic engineering to simply, inexpensively and quickly detect specific infectious agents from patient specimens.)

As important as these approval are, they represent only a small part of FDA's total product review activities. In 1988, the agency approved 792 new and generic drugs and biologicals, completed review of 698 new devices or new uses of already approved devices, and took thousands of other actions that, in many cases, added new uses, warnings, dosages or directions to old products.

In addition to the 26 new molecular drug and biological entities, FDA approved 82 other drugs and biologicals that are chemically related or similar in structure to others already on the market. There were also 1,287 supplemental drug applications approved for additions or changes to uses of currently marketed products. Some of these actions — such as the approval of alpha interferon (already marketed for hairy cell leukemia) for AIDS-related Kaposi's sarcoma — are comparable in their therapeutic importance to new approvals. (One of the versions of alpha interferon was also approved last year for treating genital warts.) Among the other significant supplemental approvals:

ROGAINE, a topical form of the blood pressure drug minoxidil, was approved for treating baldness.

VASOTEC, previously approved for treating high blood pressure, was approved to also treat heart failure.

Also, trimetrexate and ganciclovir were just two of several investigational products that, though not yet receiving final marketing approval, were made more widely available for closely supervised use in certain patients under FDA's Treatment IND procedures. These procedures call for making experimental therapies available to more patients in cases of serious or life-threatening illness. These drugs include:

SELEGILINE — for use in treating Parkinson's disease;

CLOMIPRAMINE — for obsessive-compulsive disorder;

PENTOSTATIN — for hairy cell leukemia in patients who do not respond to or who cannot tolerate alpha interferon, and

TENIPOSIDE — for use in combination with the approved cancer drug cytarabine for acute lymphoblastic leukemia.

The sense of accomplishment that my colleagues at FDA and I share when reviewing these approvals is very rewarding indeed. Yet we feel there are challenges still t be met. With such programs as the administration's initiative to speed treatments to victims of AIDS and other serious illnesses, our treatment IND procedures, and other revisions in our approval process (which have helped reduce the size of the average new drug application by 50 percent), we have planted the seeds of increased responsiveness to the public's need for new therapies. As we move forward into 1989 and look ahead at the 21st century, we are confident tha the changes we have made will bear full fruit: We will make available to every American the newest therapies in the shortest possible time without sacrificing the safety and effectiveness for which this country's drug development and approval process is held in such high regard.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.