The FDA, it seems, is rejecting more new drugs. The agency approved only 61 percent of 2007 drug applications through mid-August, down from 73 percent in the same period last year. A new report by James Kumpel of Friedman, Billings, Ramsey & Co. shows that FDA approvals of drugs made from new chemical compounds are at their lowest level in a decade.
This should not be surprising. The FDA is still taking heat for its approval of Vioxx, which manufacturer Merck voluntarily withdrew from the market. The agency is thus flexing its protective biceps, being extra careful not to approve overly risky drugs.
The problem is, federal law forces all of us to live according to the FDA’s risk/benefit preferences, even though they may not mirror our own. Until the FDA determines that a newly discovered drug is, in its view, safe and effective — a process that takes, on average, 14.2 years — the rest of us aren’t allowed to have it.
This would be troubling enough if the FDA’s risk preferences mirrored those of the average person on the street. In reality, the FDA tends to be significantly more risk-averse than the general population. That’s because the consequences of FDA misjudgments are incommensurate. If the FDA approves a drug that’s “too risky” and people are hurt, the media are all over it and there’s a huge public outcry. By contrast, if the FDA errs in the direction of conservatism (i.e., it fails to approve a relatively safe and effective drug, thereby preventing currently sick people from getting drugs that could help them), there’s usually not much of a news story. (See here for a good explanation of the FDA’s incentives.)
And what about terminally ill people whose only hope is a drug the FDA has not yet approved? Too bad, so sad. The D.C. Circuit recently held that the Constitution does not protect those folks’ right to obtain even those drugs that have passed the first (but not all) stages of FDA approval. In the court’s words, there is no constitutional right for “a terminally ill patient with no remaining approved treatment options to decide, in consultation with his or her own doctor, whether to seek access to investigational medicines that the FDA concedes are safe and promising enough for human testing.”
I must say, I agree with Judge Rogers (and Judge Ginsburg) that
it is startling that the oft-limited rights to marry, to fornicate, to have children, to control the education and upbringing of children, to perform varied sexual acts in private, and to control one’s own body even if it results in one’s own death or the death of a fetus have all been deemed rights covered, although not always protected, by the Due Process Clause, but the right to try to save one’s life is left out in the cold despite its textual anchor in the right to life.
But such is our system — a system that diligently seeks to prevent market failure, with no apparent concern for government failure.