Having had the FDA remove their choice in types of breast implants, women now find that David Kesslers agency has taken away their choice in another area. All this with nary a feminist peep to be heard. Yet in fairness the removal of the Today Sponge contraceptive from store shelves was not demanded by the FDA, it just made it inevitable. The consequence, however, has been exactly the same.
The sponge often was used as an interim method while withdrawing from or beginning use of the birth control pill. It also provided some protection against the spread of sexually transmitted diseases. About 400,000 women used Today. As a contraceptive, Todays failure rate was relatively high, but the FDA ruled the sponge both safe and effective. It was certainly a lot more effective than using nothing, which may often be the alternative now that its gone.
Todays fate was sealed when FDA inspectors found that water in the sole plant that produced the sponge contained bacteria. Theres no evidence that the bacteria ever contaminated the sponge, according to FDA spokesman Don McLearn. Thats why the agency never ordered the product off the market. "They [Whitehall-Robins] have made the corporate decision to close this plant down," McLearn emphasized.
Ah, but the FDA had let Whitehall-Robins know that the bacteria was intolerable and the agency doesnt just make suggestions. Explained Whitehall- Robins spokesperson Ann Brice, "We tried diligently to improve and did [but] if we would have changed our manufacturing processes further, it would have required additional approval by the FDA."
It turned out the only way to meet the standards would be to set up the process at a new plant. But again, FDA regulations stood in the way. As McLearn explains, if you make "a product at a new site, its a totally new product."
That means the dreaded "NDA," or new drug application, the tortuous approval process for which the agency has become famous. This even though an inspection of the new product would reveal it to be identical to the old one.
Explains Henry Miller, formerly director of the Office of Biotechnology at the FDA and now a visiting fellow at the Hoover Institution in Palo Alto, California, the "new place, new product" rule is "an anachronism because you can now introduce stringent release specifications and look at whether products meets those specifications, as you do for a drug."
No matter, for rules are rules. Faced with a re-enactment of such a costly and lengthy procedure, Whitehall-Robins threw in the sponge.
Some people involved in the effort to prevent unplanned contraceptions were not pleased. Says Alan Guttmacher Institute spokesperson Susan Tew, "The point weve made is that women need different methods of birth control throughout their reproductive lifetime. Women spend three quarters of reproductive lifetime trying to avoid unplanned pregnancy. Any method found safe and effective should be available to U.S. women."
Dr. Robert Hatcher, Emery University professor of gynecology and obstetrics and editor of "Contraceptive Technology" was more blunt. "The delays and costs on companies are unconscionable," he told the Atlanta Journal and Constitution. "As far as Im concerned, the Food and Drug Administration is Disneyland. Its a mess." Hatcher was upset not just at the demise of the Today Sponge but at the FDA in general, at least as far as contraceptives go.
"It may look like were having a second contraceptive revolution," says Tew, "because in the past few years weve had the Reality female condom, injectable Depo-Provera and Norplant But the female condom is the only one of those that is new; the rest were available years ago in countries outside of the States." In the case of Reality, it was expected to have its product on the market in less than two years, while in actuality it took seven.
Such delays arent completely the fault of the FDA. The fear of litigation haunts practically any medical device or drug. But complying with FDA regulations and producing a safe (or relatively litigation-safe) product may have little in common. Thus the time delays and the expenses are piled on top of each other.
Criticize the FDA and you always get the same three responses: thalidomide, thalidomide, and thalidomide. Three decades ago, the agency held up this drug that later proved to cause major defects in some children born of European women using it. As a result that agency, according to Sam Kazman of the Competitive Enterprise Institute in Washington, D.C., causes thousands of premature deaths a year. It does so by delaying approval of drugs already available in the rest of the civilized world and much of the not-so-civilized world.
For all this, the FDA is no guarantee of safety. While on the subject of contraceptives, does anybody out there remember the Dalkon Shield, the intrauterine device that killed 15 women and injured hundreds more? FDA tested and approved? You bet. And while were dealing with womens nether regions, how about the tampons that caused toxic shock syndrome? Yes, FDA approved.
The FDAs reply to such assertions is that but for them, there would be even more such deaths. Thats true, if one only looks at one side of the equation. After all, a product that is forbidden to be sold cannot possibly cause harm. If delayed several years, it cannot cause harm in those years. But neither can it help. What the FDA has done is to force upon our nation a trade-off that for some strange reason the citizens of no other country seem to want.
As the Today incident shows, though, the full impact of such regulatory zeal isnt revealed just in deaths, but perhaps in unwanted births, as well.