- The Washington Times - Sunday, April 20, 2003

Few doubt that the federal drug-approval process is in trouble: It costs too much and takes too long. While the reasons are myriad, the bottom line is that needed medicines are not being approved as quickly as they could be.
While the Food and Drug Administration should not sanction any elixir without regard to its efficacy, a balance must be found between safety and speed; between the danger of a drug-approval process which accounts for all toxic possibilities but paralyzes innovation (and possibly kills patients); and the danger of too short an approval process, where humans become inadvertent guinea pigs. New medical technology must walk the same tightrope. This is not to suggest that all the problems in the process are of the FDA's making. However, where the agency can speed the process and reduce its cost without sacrificing consumer safety, it should do so.
FDA Commissioner Dr. Mark McClellan has recently put forward a number of innovative solutions to that end. He has launched initiatives in several different areas of the drug-approval process, including avoiding multiple-cycle drug reviews; speeding the availability of generic drugs; improving the efficiency of drug reviews; hastening the approval of new medical devices; and setting up reforms in several other areas related to the drug-approval process.
Avoiding time-consuming multiple-cycle drug reviews for new medications (and new medical devices, see below) is high on the commissioner's list, and for good reason. Only about 50 percent of new medicines are approved the first time through the review process, and a study by the Tufts Center for the Study of Drug Development (CSDD) suggested that companies could save $100 million on their costs of developing a new drug either by reducing development time by nearly 19 percent or improving the clinical success rates by more than 25 percent. Earlier this year, Dr. McClellan instituted a "root cause analysis" to determine the reasons for multi-cycle reviews. One of the preliminary findings was that greater transparency and clear communication of approval requirements could help. So, Dr. McClellan followed up by instituting pilot programs to study the benefits of intensive early communications with drug manufacturers and the benefits of reviewing drug applications as they are sent in component by component, rather than waiting for (and possibly rejecting) the entire application.
Dr. McClellan also hopes to reduce the number of review cycles that generic drugs go through. Less than 10 percent of generics are approved on their first review cycle the average applicant takes 20 months to be approved. To do better, Dr. McClellan has proposed more collaboration between generics makers and generics reviewers. He has also asked for a $13 million increase in funding for the generic drug office in next year's budget, which he hopes will permit the agency to hire more inspectors. Dr. McClellan also hopes to reduce the review time for generics (and new medications, for that matter) by applying new performance standards to the approval process.
Imposing new performance standards for the review process could improve the efficiency of drug reviews. At the commissioner's behest, the FDA is attempting to develop "quality systems" for the reviews, so that the best management practices will be applied and will be measured against a reasonable performance baseline. In an effort to produce the best results from the process, Dr. McClellan has properly engaged the expertise of consultants from outside the FDA.
The commissioner's initiatives to speed the approval of new medical technology combines elements of the other three initiatives it's critical, since new medical devices can be just as vital as new medicines in curing ailments or relieving suffering. The three-part initiative combines a "root cause analysis" for multi-cycle product reviews, the development of quality systems for review processes and the publication of better product approval guidelines by using outside experts.
In addition, Dr. McClellan is also pushing for reform in other areas related to the drug-approval process. He hopes to update the FDA's guidelines for good manufacturing practices, which haven't been revised in a quarter-century. To limit adverse events from wrongly prescribed pharmaceuticals, he's proposed a universal bar-coding system. He's even pushing for pharmaceutical package inserts to be written more intelligibly.
Another important part of safely speeding the drug-approval process, particularly for encouraging the development of new treatments against agents of bioterrorism, is guaranteeing that pharmaceutical companies will have a market for them. However, that is more the business of Congress than the FDA commissioner.
In the next editorial in this series, we'll examine some ways that Congress could speed the drug-approval process, as well as a few other proposals to the same end that Dr. McClellan might also want to consider.

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