MEDICINE:

The drug,which causes severe birth defects,would be sold under tight
restrictions.

WASHINGTONThe Food and Drug Administration says it is poised to approve
the sale of thalidomide,once the world's most infamous drug.

The FDA wrote to Celgene Corp. on Monday that thalidomide would be approved
to treat an agonizing inflammation in leprosy patients once the company
meets some final conditions, including tight restrictions aimed at avoiding
the birthdefect horrors of the 1960s.

Celgene said the FDA's "approvable letter" contained no surprise
conditions, meaning that final approval could come "in weeks rather than
months," said company spokesman Bob Butler.

Thalidomide was banned worldwide 35 years ago after it caused horrific
birth defects in 12,000 babies. It had been sold as a sedative for pregnant
women in 48 countries but never in the United States, because an FDA
scientist uncovered early signs of toxicity and blocked approval. Still,
some Americans got it overseas or in clinical trials.

No one knew then that just one pill in early pregnancy could result in a
baby with no limbs or with flipperlike arms and legs, and other defects.

Now thalidomide is making a comeback. Seventeen days ago, the FDA's
scientific advisers said thalidomide can alleviate the agonizing condition
called "erythema nodosum leprosum."

Leprosy is so rare in the United States that the FDA estimates only about
50 patients a year would need that therapy. But doctors are expected to
prescribe thalidomide for a wider range of conditions once it is on market
the drug is being studied for use against AIDrelated wasting and ulcers,
cancer, lupus, rheumatoid arthritis and autoimmune diseases.

The FDA and outside experts agree that all that use could result in more
thalidomide babies. So the FDA's advisers recommended that it be sold under
the tightest restrictions ever implemented for a U.S. drug, even demanding
that a photo of a child thalidomide victim be shown to every doctor who
prescribes it and every patient who takes it.