u.s. drug approval system takes too long

1
Government U.S. drug approval system takes too long GAO study finds both FDA, industry contribute to delay in new drug okays, which are generally slower than those of other developed countries Witnesses from the General Ac- counting Office gave Congress a pre- view of its long-awaited "drug lag" study late last month and they didn't paint a glowing picture. Begun at the request of Rep. James Scheuer (D.-N.Y.) two years ago, the study was undertaken by GAO (Congress' investigative arm) to find out whether there are inordinate de- lays in approving new drugs in the U.S., and, if so, whether these delays are depriving the public of important therapeutic advances available in other countries. GAO also compared the U.S. drug approval system with those of foreign countries, particu- larly the industrialized Western Eu- ropean nations. Presenting the findings of the study to a House Science & Tech- nology Subcommittee, director of GAO's human resource division Gregory J. Ahart noted that the U.S. drug approval system is generally slower than those of other developed countries, and lengthier scrutiny of U.S. drug applications doesn't guar- antee that drugs sold in the U.S. are any safer than those sold in, say, West Germany. In answer to a question by Rep. Scheuer about whether there is a drug lag in the U.S., Ahart conceded that "in the sense that a number of im- portant drugs have been approved elsewhere or have been approved here later, yes." Ahart admits, too, that the GAO study could find "no identifi- able benefits of delay" on the part of FDA. The GAO study concludes, moreover, that "the statutory 180-day review time is generally not met." The GAO analysis finds, for ex- ample, that the average approval time for 132 original new drug applications (NDA's) submitted in 1975 was about 20 months. Even worse, Ahart suggests, was that FDA's own analysis of 80 NDA's submitted in 1978 re- Kennedy: research avenues exhausted suited in an average approval time of 34 months. The NDA's studied by GAO, Ahart insists, were for drugs that FDA considered therapeutically important and "some were available in other countries before they were available in the U.S." By comparison, Ahart says, the average new drug approval time in other developed countries was from seven to 12 months shorter than the 20-month U.S. average. There are two major exceptions, though, Ahart ad- mits: Norway, where approval times took from one to three years, and Sweden, where drugs were approved in an average of 27 months. But pra- zosin hydrochloride, for example, was approved 40 months after an NDA was submitted to FDA here, whereas in the U.K. it was given the go-ahead after six months. Prazosin is used to treat hypertension. Ahart says that GAO was unable to determine why drugs are approved more quickly abroad than they are in the U.S. because the organization did not have access to drug application records in those countries. But GAO does find a number of differences between FDA and foreign drug ap- proval agencies. A major difference noted in nine countries GAO sur- veyed was the use of committees of medical experts in drug approval. The major advantage to this system, Ahart believes, is that drug approval deci- sions are generally "made by experts in their fields whose decisions are more likely to receive acceptance." To determine why drug applica- tions take as long as they do in the U.S., GAO investigators interviewed industry officials as well as FDA staff members. In addition, Ahart says, the work load of FDA application re- viewers also was analyzed. According to industry officials, GAO says, NDA approvals are slow because FDA guidelines are imprecise and subject to different interpreta- tions; FDA often changes reviewers during the course of an NDA, which slows things down; disagreements between industry and FDA are not easy to resolve; and there are long periods of delay after a company submits an NDA before it is notified by FDA of deficiencies. But GAO finds that industry also contributes to the delay by submit- ting incomplete NDA's and not quickly correcting deficiencies singled out by the agency. FDA doesn't take so gloomy a view of the drug approval process as GAO. Defending the agency, commissioner Donald Kennedy argues that the so- called drug lag is actually a worldwide problem stemming from an exhaus- tion of fruitful areas of drug research. And even if there is a drug lag pecu- liar to the U.S., Kennedy insists, it is a very short one, and it is acceptable. Here Kennedy waxes eloquent: "The regulatory requirements that grow out of societal attitudes toward drug safety in this country confer indis- putable benefits that bear certain costs in terms of slower drug ap- provals." One expert witness whose testi- mony followed Kennedy's took vig- orous exception the commissioner's defense of the U.S. drug approval system. Matthew Connolly of the University of California, Los Angeles, medical school dismissed Kennedy's assertions as "sheer sophistry." Connolly adds, "Quite frankly the American therapeutics scene is the laughing-stock of the world. I'm ap- palled at the drugs that are not available here." As to Kennedy's claim that a drug lag is due to an exhaustion of basic research avenues, William Regelson of the Medical College of Virginia says that such a statement is "abso- lutely idiotic." Chris Murray, C&EN Washington 16 C&EN July 9, 1979

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Page 1: U.S. drug approval system takes too long

Government

U.S. drug approval system takes too long GAO study finds both FDA,

industry contribute to delay in

new drug okays, which are

generally slower than those

of other developed countries

Witnesses from the General Ac­counting Office gave Congress a pre­view of its long-awaited "drug lag" study late last month and they didn't paint a glowing picture.

Begun at the request of Rep. James Scheuer (D.-N.Y.) two years ago, the study was undertaken by GAO (Congress' investigative arm) to find out whether there are inordinate de­lays in approving new drugs in the U.S., and, if so, whether these delays are depriving the public of important therapeutic advances available in other countries. GAO also compared the U.S. drug approval system with those of foreign countries, particu­larly the industrialized Western Eu­ropean nations.

Presenting the findings of the study to a House Science & Tech­nology Subcommittee, director of GAO's human resource division Gregory J. Ahart noted that the U.S. drug approval system is generally slower than those of other developed countries, and lengthier scrutiny of U.S. drug applications doesn't guar­antee that drugs sold in the U.S. are any safer than those sold in, say, West Germany.

In answer to a question by Rep. Scheuer about whether there is a drug lag in the U.S., Ahart conceded that "in the sense that a number of im­portant drugs have been approved elsewhere or have been approved here later, yes." Ahart admits, too, that the GAO study could find "no identifi­able benefits of delay" on the part of FDA. The GAO study concludes, moreover, that "the statutory 180-day review time is generally not met."

The GAO analysis finds, for ex­ample, that the average approval time for 132 original new drug applications (NDA's) submitted in 1975 was about 20 months. Even worse, Ahart suggests, was that FDA's own analysis of 80 NDA's submitted in 1978 re-

Kennedy: research avenues exhausted

suited in an average approval time of 34 months. The NDA's studied by GAO, Ahart insists, were for drugs that FDA considered therapeutically important and "some were available in other countries before they were available in the U.S."

By comparison, Ahart says, the average new drug approval time in other developed countries was from seven to 12 months shorter than the 20-month U.S. average. There are two major exceptions, though, Ahart ad­mits: Norway, where approval times took from one to three years, and Sweden, where drugs were approved in an average of 27 months. But pra­zosin hydrochloride, for example, was approved 40 months after an NDA was submitted to FDA here, whereas in the U.K. it was given the go-ahead after six months. Prazosin is used to treat hypertension.

Ahart says that GAO was unable to determine why drugs are approved more quickly abroad than they are in the U.S. because the organization did not have access to drug application records in those countries. But GAO does find a number of differences between FDA and foreign drug ap­proval agencies. A major difference noted in nine countries GAO sur­veyed was the use of committees of medical experts in drug approval. The major advantage to this system, Ahart believes, is that drug approval deci­sions are generally "made by experts in their fields whose decisions are more likely to receive acceptance."

To determine why drug applica­tions take as long as they do in the U.S., GAO investigators interviewed industry officials as well as FDA staff members. In addition, Ahart says, the work load of FDA application re­viewers also was analyzed.

According to industry officials, GAO says, NDA approvals are slow because FDA guidelines are imprecise and subject to different interpreta­tions; FDA often changes reviewers during the course of an NDA, which slows things down; disagreements between industry and FDA are not easy to resolve; and there are long periods of delay after a company submits an NDA before it is notified by FDA of deficiencies.

But GAO finds that industry also contributes to the delay by submit­ting incomplete NDA's and not quickly correcting deficiencies singled out by the agency.

FDA doesn't take so gloomy a view of the drug approval process as GAO. Defending the agency, commissioner Donald Kennedy argues that the so-called drug lag is actually a worldwide problem stemming from an exhaus­tion of fruitful areas of drug research. And even if there is a drug lag pecu­liar to the U.S., Kennedy insists, it is a very short one, and it is acceptable. Here Kennedy waxes eloquent: "The regulatory requirements that grow out of societal attitudes toward drug safety in this country confer indis­putable benefits that bear certain costs in terms of slower drug ap­provals."

One expert witness whose testi­mony followed Kennedy's took vig­orous exception the commissioner's defense of the U.S. drug approval system. Matthew Connolly of the University of California, Los Angeles, medical school dismissed Kennedy's assertions as "sheer sophistry." Connolly adds, "Quite frankly the American therapeutics scene is the laughing-stock of the world. I'm ap­palled at the drugs that are not available here."

As to Kennedy's claim that a drug lag is due to an exhaustion of basic research avenues, William Regelson of the Medical College of Virginia says that such a statement is "abso­lutely idiotic."

Chris Murray, C&EN Washington

16 C&EN July 9, 1979