Lisa SeachristWashington Editor

Contrary to popular opinion, outgoing FDA commissioner DavidKessler claims that the agency doesn't bring up the rear ininternational drug approval time, but is outpaced only by the U.K. inhead-to-head comparisons between four countries. Kessler broughtthe contentious issue of drug review times into the fore once againwith an article in the Dec. 11 Journal of the American MedicalAssociation.

In the article, Kessler looked at 214 new drugs introduced worldwidefrom 1990-1994 and compares the drug approval times for thesedrugs in the U.S., Germany, the U.K. and Japan. In comparisons ofthe 41 drugs mutually available in all countries, the U.K. was the firstto approve 16 products, the U.S. 15 products, Japan six and Germany4.

He and his colleagues concluded that in the head-to-headcomparisons looking only at drugs both countries have approved "theU.S. is consistently the first to approve more of the drugs that aremutually available."

In addition, Kessler maintained that of the drugs that the FDAconsiders "priority" agents _ those that have substantiatedtherapeutic value, offer at least a moderate advance to currenttherapies or offer treatment for conditions that have no alternativetreatment _ U.S. consumers "have been spared at least two productsthat proved to be ineffective or to be associated with serious adverseevents."

While Kessler et al. report a rosy picture of the outgoingcommissioner's first four years at the agency, some industryrepresentatives dispute the numbers in the article.

Gary Persinger, vice president of research and information sciencesat the Pharmaceutical Research and Manufacturers of America(PhRMA), pointed out that the FDA team excluded any drugs thathad been introduced prior to 1990 but received approval during thattime. "Overall, two-thirds of all drugs were first approved overseaswhen you look at all the drugs that were approved during the periodof 1990-1994," Persinger said.

Persinger also noted that the safety record of the FDA and the U.K.'sMedicines Control Agency were quite comparable. "The U.S. had a 3percent recall rate whereas the U.K. had a 4 percent rate," Persingersaid. "But, the U.K. approved 53 more products."

Carl Feldbaum president of the Biotechnology Industry Organization(BIO) told BioWorld Today the article "was an intriguing defense ofhis first few years, but we shouldn't distract ourselves with it. Thereis nothing in it for the industry or the FDA to go back to those yearsand relitigate them. It's a quagmire over whose facts are right."

However, the FDA and the industry can agree that approval timeshave been falling since Kessler took over. In the late 1980's, drugreview took on average 30 to 33 months which is "way off themandated six month review time," said PhRMA spokesperson JeffTrewhitt. By 1995, the approval time had dropped to 19.2 monthsand in 1996 it looks like review time will have dropped again to 15 to16 months.

"The primary motivating force behind the decline has been PDUFA[Prescription Drug User Fee Act of 1992]," Trewhitt said. "The FDAhas really kept up with program and hired new reviewers as well asequipment to complete reviews more quickly."

PhRMA and BIO currently are engaged in negotiations with the FDAto reauthorize PDUFA which expires September 1997. Trewhitt toldBioWorld Today that currently the major point of contention is overwhat the average user fee should be. "There is real determination onboth sides to come to an agreement," Trewhitt said.

While PDUFA reauthorization offers the opportunity to find ways tofurther reduce review times, it is not the only place to look forimprovements in drug review times, said Rick Burgoon seniordirector and patent counsel at Cephalon Inc., in West Chester, Penn."If the FDA can reduce the time for drug approvals it should doeverything in its power to do so," he said.

Burgoon pointed out that for patients waiting for a new acnemedication a two-year review time for a drug may not make much ofa difference in their lives, however for patients with a life-threateningdiseases a delay of one month may be fatal.

"Delays negatively affect the most vulnerable patients," Burgoonsaid. "And, none of us, not the FDA in drug review or the industry indrug development, should be satisfied with even a day's delay ingetting drugs to patients who desperately need them." n

(c) 1997 American Health Consultants. All rights reserved.