FDA re-examines hot flash drugsCompiled from Times wires
© St. Petersburg Times
published April 12, 2003
WASHINGTON -- Federal health officials are taking a second look at a treatment for menopausal hot flashes, saying their approval of a hormone combination 27 years ago was not based on substantial evidence.
The Food and Drug Administration said in a statement Thursday that the combination of estrogen and androgen is included in two marketed products, Estratest and Estratest H.S., sold by Solvay Pharmaceuticals of Marietta, Ga.
The FDA said neither of those products has ever received formal approval, although both have been on the market for several years. The company is being asked to submit data to support sale of the drugs.
The agency said it was acting because it "does not believe there is substantial evidence that androgens contribute to the effectiveness of these combination products."
Androgens are male sexual hormones, such as testosterone.
The FDA will allow the products to remain available while it undertakes the re-examination of its 1976 approval, the statement said.
Red Cross settles blood safety fines
WASHINGTON -- The Red Cross, accused by the government of "persistent and serious violations" of blood safety rules, promised in a court settlement Friday to meet all safety requirements and pay substantial fines if it fails to do so.
The Food and Drug Administration said the consent agreement settles concerns stemming from inspections during 17 years.
Two years ago, the FDA went to court seeking a contempt citation against the Red Cross for not following a 1993 agreement to meet blood safety standards.
Under the new settlement, fines for various violations could total up to 1 percent of the Red Cross's $1.9-billion in annual revenues -- or $19-million -- in the first year, increasing to a maximum of 4 percent by the fourth year, the FDA said.
"The new financial penalties in the consent decree create an important new incentive for (the American Red Cross) to improve the processes and controls necessary for making safer blood products," said FDA Commissioner Dr. Mark B. McClellan.
Red Cross officials could not be reached for comment on the agreement.
The Red Cross provides about 45 percent of the nation's blood supply. Another 45 percent is collected by independent blood centers and the rest is collected at hospitals.
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From the Times wire desk
From the AP