Caution needed in helping the FDA
By Boston Herald editorial staff
Sunday, June 25, 2006
The top Republican and Democratic members of the Senate committee dealing with health, Sens. Michael Enzi of Wyoming and our own Ted Kennedy, have begun preparing a bill that would give the Food and Drug Administration new powers over drug safety.
Some new powers are needed, but we fear Congress may go too far.
Senators are reacting to the withdrawal of Vioxx and similar drugs after the discovery that these stomach-friendly painkillers increased the risk of heart attack when taken for 18 months.
The FDA would get the ability to order changes in a drug label after it goes on sale and the power to force manufacturers to live up to any promises to conduct post-approval safety studies. Experience shows these are needed improvements.
But the bill reportedly (a text is not yet available) sets up dispute resolution procedures and requires the FDA to publish formal plans for evaluating and mitigating risks of every new drug, complete with schedules and timetables. All this would just augment the agency’s “avoid mistakes” culture. Its bureaucrats know they will be pilloried for approving a drug that later reveals problems, but will be left alone if overcaution delays the sale of something useful.
Caution has costs. Approval of Erbitux, a new treatment for colon cancer, was withheld in 2001 because not all the study patients had failed conventional therapy. The drug was approved 27 months later. Colon cancer strikes about 8,700 people every month; Erbitux (used with another drug) halts tumor growth for 4.1 months. The delay thus cost about 80,000 person-years of tumor arrest.
The FDA has improved its once-draggy performance. Average time to approval of new drugs fell from 22 months to 14 from 1993 to 2003; time to approval for promising drugs in fast-track review fell from 13 months to six. Congress should do nothing to slow it down.
Frank Lichtenberg of the Columbia Business School has estimated that on the average each new drug approved in 1970-1991 saved 11,200 person-years of life in 1991 alone, and presumably each year thereafter. New drugs yielded a return to society of 40 percent per year on the cost of development, he calculated.
All drugs have side effects. The senators would do well to encourage the taking of worthwhile risks, perhaps by mandating the use of sound cost-benefit analysis in surveillance of drug safety.