New prescription growth rates in the U.S. appear to reflect a drop-off in the number of new drugs clearing FDA, IMS VP-Industry Relations Doug Long told the Pharmaceutical Care Management Association annual meeting Oct. 14 in Henderson, Nev.

The low number of drug approvals in 2001 "may be one of the reasons...why new prescriptions are not as strong as they have been in the past," Long said.

According to IMS data, total retail prescription growth was 7% over the last 12 months. Refill prescriptions were up 9%, but new prescriptions were up only 5%.

"I believe this has a lot to do with the FDA slowing down approval of drugs," Long said.

Long attributes the change to FDA becoming "a lot more cautious" in its drug reviews following the withdrawal of a number of drugs over the last several years. "You're going to see probably, if this holds true, the fewest number of new molecular entities approved by the FDA since before 1990," Long said.

FDA has approved 14 NMEs so far in 2001. At that pace, the agency would clear fewer than 20 NMEs, unless it reverts to the pre-user fee pattern of a large end-of-the-year approval rush.

The last time FDA approved fewer than 20 NMEs was in 1983, when the agency cleared 14. The low year since then is 1988, when FDA approved exactly 20. FDA approved 27 NMEs in 2000 and 35 in 1999.

Since the user fee program took effect in 1993, FDA has averaged 29 NME approvals per year. The average number of NME approvals over the past five years is even higher (37), helped by an all-time high of 53 in 1996.

There is a chance that FDA will have a significant number of NME approvals over the final two months of the year. There are at least 19 pending NMEs that have been recommended for approval by an FDA advisory committee and/or deemed "approvable" by the agency.

Long predicted that the average NME approval time in 2001 will exceed 20 months, continuing a recent trend toward lengthening approval times.

It is "surprising that the market is holding up as strongly as it is considering only a few new products have been introduced this year," Long added.

Long predicted that, for the full-year 2001, retail and mail order prescriptions will increase by 5%-5.5%, to more than 3 bil. Dollar sales are expected to increase 15%-17% and top $160 bil. for the year.

American Pharmaceutical Association CEO John Gans suggested that the apparent change in FDA's tolerance for risk should encourage drug manufacturers to support pharmacist care services.

Pharmacists are the missing element in the current risk management system, Gans suggested.

FDA is "getting hammered on these drugs being pulled off the market because Congress and the public that look at and monitor FDA are wondering whether or not they're doing their job," Gans declared.

"The reality is that most of those products could and should still be on the market and the reason they're not is that...pharmacists are not doing the job."

For example, he said, pharmacists allowed refills of Wyeth's pain reliever Duract for patients who should have had only one prescription; "didn't check to see if people on [Warner-Lambert's antidiabetic] Rezulin had a liver function test"; and did not "confirm the diagnosis with [Glaxo's] Lotronex to ensure that that patient had the right kind of irritable bowel syndrome."

"The system isn't set up to work and the American public isn't even close to dealing with the issues of quality drug use today," Gans declared.

"We've got a shutdown in the FDA approval process because the system that we have is broken and it can't manage the risk," he said. FDA "can't afford the risk and they're not about to take the heat."

"We're still prescribing and dispensing medicines like we did 150 years ago," Gans noted. However, he said, studies and health projects show pharmacist involvement in patient counseling can significantly increase appropriate use of drugs.

U.S. Rx Trends Showing Impact Of Fewer Drug Approvals, IMS Data Suggest

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