No Drug Approval Lag, "At Least Not In The USA"

There is no US drug lag, Food and Drug Administration Commissioner David Kessler told the Food and drug Law Institute's annual meeting. If there is one, it is not in America, he said, using three reports to back this statement and support his thesis that the USA is a world leader in reviewing and approving new drugs rapidly and efficiently.

AIDS drugs are one of the best examples, since the USA was either first or tied for first in approving these antivirals compared with the UK, France and Germany, he said, but the improvement has come for all drugs. He pointed to Bristol-Myers Squibb's Taxol (paclitaxel), Schering AG's Fludara (fludarabine) and Betaseron (interferon beta 1b) and Genentech's Pulmozyme (dornase alfa), and announced approval of Rhone-Poulenc Rorer's Rilutek (riluzole) for Lou Gehrig's disease, which is being approved in the USA first. The research infrastructure means the USA is a world leader in development of AIDS therapies, but the review of all new drugs and biologics for other than serious or life-threatening conditions has also been speeded up, he said.

1994 User Fee Study Shows Performance Goals Exceeded The third annual performance report on FDA user fees, just submitted to Congress, shows that 96% of all new drug and biologic applications in the most recent review cycle were reviewed "on time" (eg FDA action within 12 months, plus three more months if the maker submits a major amendment late in the process), notably higher than even 1997's goal of 90% (1994's was only 55%), but science and safety are not being sacrificed for speed. The speed in reaching these goals is due to incremental changes over many years, including better FDA management and staff dedication. Goals of 55% were set for on-time review for efficacy supplements sent in fiscal 1994, manufacturing supplements and action on resubmissions; the actual rate for these was 74%, 69% and 81% respectively. The FDA acted on all backlogged new drug and biologic applications by the July 1, 1995 deadline, with 21 of 34 approved, four rejected as not approvable and five withdrawn by the firms.