FDA PLANS SAFETY PROGRAM AMID BID FOR THALIDOMIDE SALES.

Byline: Associated Press

Thalidomide, which became the world's most infamous drug after causing thousands of horrific birth defects more than 30 years ago, may soon be sold in the United States - perhaps as early as next year.

While the drug shows promise in fighting some AIDS-related disorders, leprosy and other devastating diseases, the Food and Drug Administration already is taking steps to protect women who could bear children with no limbs or tiny flipper-like arms and legs after taking just one pill in early pregnancy.

``We never thought there would be another generation of thalidomiders,'' said Canadian Randy Warren, his voice choked with emotion, who was born with no hips and malformed legs.

Thalidomide, once sold in 48 countries as a sleeping pill and morning sickness cure, was banned worldwide in 1962 after 12,000 babies were born with missing or malformed limbs, serious facial deformities and defective organs.

It was never sold in the United States because FDA scientist Frances Kelsey uncovered signs of toxicity that its manufacturer had denied. Some Americans, however, got it overseas or in research trials.

But last week, Kelsey, now in her 80s and still at the FDA, heard doctors explain thalidomide's unique ability to inhibit a substance that can spur immune-related diseases like lupus, leprosy and certain AIDS ailments.

Thalidomide also stops blood vessel growth - one reason for the birth defects - making it a possible future treatment for cancer and the incurable macular degeneration that blinds the elderly.

On Monday, Celgene Corp. of Warren, N.J., announced it will seek FDA approval by January to sell thalidomide to heal the most painful symptom, inflamed lesions, of the 200 people diagnosed with leprosy here each year.

Early next year, competitor Andrulis Inc. of Beltsville, Md., will seek approval for thalidomide to treat the excruciating mouth, throat and rectal ulcers that afflict AIDS patients. Then, Celgene also will seek permission to sell thalidomide to the 150,000 AIDS patients suffering from wasting, or severe weight loss.