1988 Product Approvals

by Food and Drug Administration (FDA)

One of the goals I set for myself and for FDA when I became commissioner was to hasten the agency's review of new drugs and medical devices. I believe this is particularly urgent in cases where the products represent a major therapeutic advance and where they may be life-saving.

So it is with a great deal of interest and satisfaction that I look back on 1988 to share with you what I feel to be our major progress toward this goal.

For 1988 was a year not only of important drug approvals, but also of major steps to improve the FDA drug review process. The most significant of these was developed at the request of the President's Task Force on Regulatory Relief, chaired by then-Vice President George Bush. It involves a major regulatory modification to reduce the time required for human testing of drugs for life-threatening diseases, such as AIDS and cancer, and diseases that cause permanent disability, such as infections that cause blindness. We are hopeful that it can reduce by as much as 50 percent the time required for human testing of these critically important drugs.

Among our most important product approvals last year were several for use in diagnosing or treating AIDS (acquired immune deficiency syndrome). Applications to approve AIDS therapies automatically are assigned 1-AA priority when they arrive at FDA. FDA classifies new drug applications to assign review priority on the basis of the drug's chemical type and potential benefit, and the 1-AA designation means AIDS drugs are processed with the greatest urgency by our reviewing offices. Among our 1988 AIDS approvals:

ALPHA INTERFERON, a biological originally marketed for hairy cell leukemia in 1986, was approved for additional uses. (A biological is a medical preparation made from living organisms or their products. Interferons, for example, are disease-fighting proteins found naturally in the body.) Versions of alpha interferon made by two companies were approved for treating Kaposi's sarcoma, a form of caner that afflicts many AIDS patients.

A 5-MINUTE SCREENING TEST (produced by recombinant DNA technology — that is, genetic engineering) was approved to detect antibodies to the AIDS virus in blood. The test will be particularly useful in areas that lack facilities to process other types of AIDS tests.

TRIMETREXATE, though not yet given final marketing approval, was allowed wider availability for use in treating Pneumocystis carinii pneumonia in patients with AIDS. The broadened availability was made possible through use of FDA's new Treatment IND (investigational new drug) procedures.

GANCICLOVIR also was allowed wider distribution under the Treatment IND procedures for use in AIDS patients with immediately sight-threatening cytomegalovirus (CMV) retinitis, a viral infection of the eye.

Of course, while AIDS is our most pressing public health concern, there are countless other diseases and disorders tha continue to demand our attention. And to help in the battle against these conditions — from cardiovascular disease to cancer — FDA's Center for Drug Evaluation and Research approved 20 totally new drugs — what we refer to as new molecular entities — in 1988. These are drugs that are distinctly different in chemical structure from those already on the market.

In many ways these drugs require the most careful review by FDA, since they are "totally new" in their chemistry. For these 20 drugs, the average FDA review time was just over 29 months. This average is the lowest in five years for new molecular entities; the average was over 39 months in 1984.

Four of these totally new drugs were classified "1=A," meaning they offer a potentially significant therapeutic gain over drugs already marketed for the same condition, or that they are intended to treat a condition for which no other drug is available.

The 1-A drugs approved last year are:

SANDOSTATIN (generic name: octreotide acetate) — to treat diarrhea associated with intestinal cancer;

CYTOTEC (misoprostol) — to prevent the ulcers sometimes caused by continual use of nonsteroidal anti-inflammatory drugs (NSAIDs) commonly prescribed for arthritis;

NIMOTOP (nimodipine) — to treat brain aneurysms (dangerous weakening of artery walls); and

IFEX (ifosfamide) — to treat testicular cancer.

Ifex is also one of a number of designated "orphan" drugs approved in 1988. ("Orphan" status is conferred on a drug when its therapeutic use is limited to a comparatively small number of patients. FDA usually gives special assistance and incentives to developers of orphan products.) Other "orphans" approved during 1988, all designated "1-B" because they offer potentially moderate therapeutic gains, include:

MESNEX (mesna) — to prevent hemorrhage from cystitis associated with ifosfamide treatment;

THIOLA (tiopronin) — to treat certain types of kidney stones; and

ETHAMOLIN (ethanolamine oleate) — to prevent bleeding from varicose veins in the lower esophagus.

FDA also approved several drugs that, although not classified 1-A or 1-B, offer important options to both patient and physician. These include:

CARDENE (nicardipine hydrochloride) — an addition to the new class of calcium channel blockers for treating high blood pressure and angina;

CARTROL (carteolol hydrochloride) — a once-a-day beta blocker for high blood pressure;

HISMANAL (astemizole) — an antihistamine for treating allergies tha is less sedating than similar products;

NAFTIN (naftifine hydrochloride) — the first in a new class of agents to treat fungal skin infections; and

VOLTAREN (diclofenac sodium) — a nonsteroidal anti-inflammatory drug for arthritis.

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.