Consumers have won a rare, if possibly temporary, victory for their own freedom to take a drug that has worked for them even if its effectiveness has not been demonstrated to the FDA’s satisfaction.

“Two weeks ago,” writes the New York Times, “the Food and Drug Administration announced that it would remove the drug midodrine from the market because the drug's maker never confirmed that the medicine — approved in 1996 under an abbreviated process — actually worked against dizziness and fainting.”

The medicine had been approved for sale under a process called accelerated approval, whereby drugs for severe or life-threatening conditions are approved so long as their manufacturers promise to perform post-approval studies to prove that their drugs are working as advertised.

Midodrine’s manufacturer, Roberts Pharmaceutical, never did any studies once the drug was approved. Nonetheless, the nearly $257 million in sales the drug has generated might lead a reasonable person to believe that it has worked for quite a few people.

But this fact did not deter the FDA from deciding that the drug should be pulled. The Times indicates that this happened in part because of pressure from Congress, which did not like the idea that “more than a third of the 90 drugs approved under the [accelerated approval] program since 1992 never had studies done proving efficacy” — never mind that those drugs have been accepted by consumers and do not seem to have resulted in widespread illness or death. This is a matter of power.

What changed the FDA’s mind, at least for the time being, is the large number of midodrine users — about 100,000  — who “flooded the agency with calls,” according to the Times. The result: “Top F.D.A. officials announced that they had backtracked and would continue to allow midodrine to be sold.”

The paper quotes Dr. Joshua Sharfstein, principal deputy commissioner of the FDA: “In a different situation, we might act differently. But in this case, it does not make sense to pull access to the drug while we get better data.” That is, because of public outcry, the FDA will generously allow patients to get the drug they need; but if the manufacturer fails to satisfy the bureaucrats that the drug is efficacious, patients could be left high and dry again. (The report notes that users of Avastin, a drug for treating breast cancer, could end up in the same situation.)

The Times describes the predicament in which Congress has placed the FDA:

The agency’s flip-flop demonstrates the difficult choices regulators face in policing the nation’s drug market. Cracking down on drug makers sometimes means stranding desperate patients. And now that Congress has given the Food and Drug Administration greater powers to insist on better information about life-saving medicines, such disputes may become more common. [Emphasis added.]

Therein lies the problem with the FDA and, indeed, with all government regulators: Bureaucrats charged with protecting the public from every conceivable danger have no choice but to substitute their judgment for the judgment of individual consumers. Even though 100,000 Americans find midodrine effective for controlling their health problems, their judgment is insufficient for the FDA to permit the drug to be sold unless the manufacturer jumps through the bureaucracy’s hoops. Even if only one person were helped by midodrine, where would some government functionary get off telling that person he couldn’t buy the drug?

How, exactly, is midodrine’s maker (Shire Pharmaceuticals, which bought Roberts in 2000) supposed to prove that the drug is effective, anyway? A drug that works for one person may not work for another. A drug may work similarly for two patients, one of whom believes that the relief it provides is sufficient for his symptoms while the other thinks it’s not. Similarly, a drug that is safe for one person may cause illness or death in another. Safety is relative, too: Person A may be willing to put up with some negative side effects of a drug while person B is not. Proving either efficacy or safety to the FDA always comes down to satisfying the arbitrary whims of bureaucrats.

Midodrine’s users are fortunate that the drug was initially approved and that they were able to convince the FDA not to pull it from the market. Meanwhile, countless other patients go without helpful pharmaceuticals for years at a time, some of them dying from their illnesses, while the FDA delays approving new drugs. Those victims, of course, do not flood the FDA with phone calls or make the news since the not-yet-approved drugs are generally not known to the public.

Individuals should have the right to purchase and use whatever drugs they like. Each person’s judgment about the safety and efficacy of particular products ought to be determinative. The FDA — unconstitutional and a menace to Americans’ health — should be abolished.

TrackBack URI for this entry

Comments (5)

Subscribe to this comment's feed

Jonah said:

Abolishment of FDA I agree with most this article except the last point. The FDA provides information to consumers about the safety and the efficacy of a product. Surely one can't trust drug companies to provide an honest assessment of their drug. Perhaps the FDA's powers should be reduced ie if the drug is marginally effective the drug should be approved with an appropriate label but even that is an arguable point. Doctors don't have enough time to go through the clinical trial data for each drug so they prescribe a drug based on information provided by the FDA and the drug manufacturer. However multiple options should be made available to them and the FDA shouldn't prevent a drug from entering the market just because the efficacy signals weren't clear. Therefore the FDA shouldn't be abolished but their powers should be reduced. Consumers need an independent authority to assess drugs and this can't be done by a private entity either since this is not a for profit process.

September 04, 2010

Mikey Pinkie-Rings said:

I demur Surely one can't trust drug companies to provide an honest assessment of their drug. Who said that it would have to be the snake oil salesmen that we would be forced to rely upon? There are other solutions, for sure. I would urge you to consider that any unconstitutional agency like the FDA will grow until it is a burdensome beast. That is what bureaucracies do.

September 04, 2010

Flu-Bird said:

Do away with the FDA I read in a book that the FDA once delayed delivery of defibulators to hospitals becuase of paperwork and the countless victims that died becuase of the FDAs buracracy

September 06, 2010

L Miller said:

Let FDA comment, not veto Thank you for attention to this critical issue. Agencies gain more and more power while patients and doctors lose it. This is real, incurable suffering we are talking about. BTW don't bang the drum to approve Avastin and breast cancer. It's already a case study of the FDA's wrong direction but applied from the other side. It's rare that patient advocacy groups petition the FDA to NOT approve a drug, but it happened in 2008 with Avastin (for breast cancer specifically). For all its expense, the only improvements were in measured test results, with NO reduced suffering or extension of life by a single month! Please do look into Noscapine for prostate and ovarian cancer. A cough suppressant for decades in Europe, completely banned for all use. Who gets to say "Nope: someone might overuse and abuse it." So cheap, so promising. Not available in USA, Canada, or England. It would be a better world if we could take the FDA's veto power away. Perhaps there could be an age when citizens could be considered adults. If not 21, how about 51 or 71? When do you get to weigh the risks yourself? It's not like we can't get access to information these days.

September 06, 2010

Dan Tolleson said:

There is no constitutional authorization for the FDA. Used to be, if you went shopping for a product in the private sector, you looked for the UL (Underwriters' Laboratory) or "Good Housekeeping" seal of approval -- not government approval. Why not get the federal government out of the clearly unconstitutional regulation of food and drugs? If a manufacturer makes a dangerous product without a recognized private-sector seal of approval like UL of Good Housekeeping, and in spite of the "Buyer Beware!" caution that our grandparents taught us, we still buy and are injured by that product -- then the legal system is available for our recourse. A class-action suit can put a company out of business, or states may pass laws against such a product. The gradual development of such common-law solutions to these problems should supersede the unlimited regulations of an over-reaching, unconstitutional federal bureaucracy. History has shown us that there IS an undeniable need to regulate dangerous drugs -- but we don't need an all-powerful FDA using that as an excuse to regulate every aspect of our food supply! Once everyone recognizes this distinction, it should be possible for two-thirds of Congress and three-quarters of all the state legislatures to pass a constitutional amendment authorizing a restricted federal agency, with full Congressional oversight, to regulate only those dangerous drugs that the states unanimously agree should be regulated. As at the Founding, nullification and secession would have to be acknowledged as states’ rights. This may be one of the few instances in which Congress could legitimately exercise the much-abused “Commerce clause” – “To regulate Commerce . . . among the several States.” We need not be helplessly dependent on the federal government to protect us in every realm of life! We can get the FDA off our backs and then build a restricted, single-purpose federal agency in accordance with states' rights.

September 06, 2010