In its annual review of new drug approvals, the PharmaceuticalManufacturers Association criticized the continued slow pace ofthe Food and Drug Administration in the area of biotechnology.
"We are seeing a bottleneck" of biotech drug approvals, saidPMA spokeswoman Judith Shuler. The rate of new biotechproducts coming out is not keeping up with the rate going infor approval, Shuler said.
"During the past nine years, 14 biotechnology drugs have beenapproved -- an average of only about one and a half approvalsper year," the PMA said.
Each year the drug company trade organization evaluates thenew drugs approved by the FDA.
Robert Allnutt, association vice president, said the level ofstaffing to review new biotech drugs is still insufficient.
Allnutt noted that a PMA survey showed there are 132engineered drugs in development, 21 of which are underreview at the FDA.
"It is difficult to put management strategies in place withouthaving their leadership in place," Shuler said, referring to thelack of a permanent director at the agency's Center for BiologicsEvaluation and Review, which receives the majority of newbiotech drug applications. -- RF
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