The Food and Drug Administration (FDA) approved 16 new biotechnology based medicines and vaccines in 2001 and well as 8 new indications for previously approved biotech products, according to an analysis by the Biotechnology Industry Organization (BIO). The new products include treatments for leukemia, congestive heart failure, rheumatoid arthritis, and life-threatening sepsis, as well as a new combination vaccine for hepatitis A and B.
"Even though the number of approvals declined from 2000's record of 32, we are pleased that the past year has brought important new additions to the pharmacopeia that will save and enhance lives," says Carl B. Feldbaum, president of BIO. "More than half of the 133 biotechnology medications available today have been approved in the last 5 years, and another 350 products are in late-stage development."
"One factor in this increase has been the positive outcome of the Prescription Drug User Fee Act, which is up for renewal this year. The prospect of further refinement in the law's performance goals can only have a salutary effect on the drug approval process. That means, simply, more patients will get new drugs faster," Feldbaum adds.
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