Is the FDA safe and effective?

According to today’s Washington Post, the FDA will soon approve a veterinary antibiotic for use in cattle even though (1) the American Medical Association and a dozen other health groups have told the FDA that use of this drug in cattle will foster the emergence of new microbes that are resistant to a class of “last-resort” antibiotics; (2) the FDA’s own panel of experts voted against approval; and (3) there are already more than a dozen different drugs on the market to treat the bovine condition at which the new drug is aimed. The Post‘s reporter, Rick Weiss, locates the root of the problem in the winningly titled and no-doubt scintillating FDA publication, “Guidance for Industry #152,” which seems to prevent the agency from taking any notice of the potential effect approval will have on resistance in humans until there is evidence of an actual human health problem. Unfortunately, agency experience suggests that by the time such evidence exists, it will be too late to do much about it.

Isn’t there something wrong when the agency’s own experts think a new drug will be bad for human health but the agency feels legally bound to approve it anyway? I have only a little experience with the FDA approval process, but I know from first-hand experience elsewhere how infuriating it can be when a regulatory agency makes ad hoc decisions without reference to any guiding principles, or worse yet, ignores the principles it has already laid down for guidance. At the same time, I also have some experience with the way documents like “Guidance for Industry #152” get created, and it contrasts instructively with the way courts decide legal issues.

In a typical court case, you have a conflict between real people over real events, and the people most directly involved are unable to resolve the conflict without the expense and trouble of going to court. The court solves the particular problem and leaves it at that. Then conflict #2 arises, and court #2 solves that problem. And so on, until the accretion of particular decisions resolving particular conflicts has created some general rules that courts subsequently treat as normative. In the Anglo-American system of justice, we’ve only been at this for seven or eight centuries, but so far it’s working pretty well.

In many bureaucracies, this process is turned upside down. Insiders who have in mind something they want to do recognize (or pretend to recognize) the appearance of an issue that makes what they want to do seem a little different than what has been done in the past. So they set about creating new general rules that will govern the way the particular case gets treated later. The general rules are drafted at a time when the number of interested participants is typically smaller, and when most of those participants may have no way of knowing exactly what particular conflict is about to arise for resolution under the general rules they are drafting. For the company that’s in the know about what’s coming down the pike, the process is a little bit like shooting an arrow and then drawing circles around it. Everyone else in the process is disadvantaged by the necessity of arguing about the placement of the circles without knowing exactly where the arrow will be. I don’t know if that’s what happened here, but it’s one of the more charitable and less cynical explanations I can come up with.

I am also struck by the fact that the drug in question here is designed for use against an infection that is already highly treatable with drugs that do not pose the same risk to human health. It puts me in mind of a criticism by Dr. Marcia Angell, which I first read in the New York Review of Books a few years ago:

[T]he pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). The great majority of “new” drugs are not new at all but merely variations of older drugs already on the market. These are called “me-too” drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it,

If I’m a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?

Notwithstanding my recent posts about Merck, I really don’t have anything against the pharmaceutical industry. Really, some of my best friends are in it. But does the law really require the FDA to approve cattle drugs that are bad for humans and superfluous for cattle?

Posted in Law, Public Policy. Comments Off on Is the FDA safe and effective?
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