The federal Food and Drug Administration seems to be everyone's favorite whipping boy these days and is going to be the object of a congressional investigation extending into "the foreseeable future." What that means is a litany of complaints and critical stories about the FDA that may continue for years.
Yet it is possible to feel a certain sympathy for the FDA because much of the criticism aimed at the agency is contradictory in nature.On one hand, the agency is regularly blasted for failing to stop the sale of products that are ineffective or dangerous. On the other hand, the FDA is just as regularly castigated by the White House, industry and angry patients because of the time it takes to get new drugs and medical devices on the market.
In other words, the FDA is being asked to be more careful, meticulous, vigilant, thorough and safer in giving approval to new products, while simultaneously being pressured to be quicker, prompter and to engage in less lengthy tests, nit-picking and delays.
The FDA recently has wrestled with the problem of silicone gel breast implants. The implants have been on the market for decades and now are the center of charges that they can rupture and cause cancer and other diseases.
But congressional investigators this week are looking at other problems. They include a jelly injected into the eye to hold it steady for surgery and a family of machines that beam radiation at tumors.
The jelly supposedly caused blindness in some patients. And the machines mistakenly gave patients such high doses of radiation that several people died. The jelly has been withdrawn from the market. The radiation machines, built by a Canadian government-owned firm, are no longer produced, but spare parts are still shipped to those in use.
As far as the eye jelly is concerned, the FDA approval process appears to have been flawed. The radiation machines are part of a bigger problem in which FDA investigators are failing to adequately inspect factories that make medical devices.
The House Energy and Commerce subcommittee on investigations this week noted that the FDA doesn't even know how many manufacturers it is supposed to be inspecting. The agency put the figure at 4,000 to 5,500. That's quite a spread.
In any case, inspections are supposed to take place every two years, but only 60 percent get regular inspections on time.
Clearly, there is a certain amount of bureaucratic inertia and failure in the FDA. But if the agency is going to do all that people demand of it, more resources must be devoted to the cause. But the FDA cannot be faster, make products available more quickly, and still be more thorough and detailed in catching every flaw.
If a choice must be made between speed and safety, then safety should take precedence, if only because the consequences of failure with medicines and machines that have been approved can affect people's lives in tragic ways.
Let's not ask more of the FDA than it can possibly do.