The obvious question that the average citizen usually faces is, "When is my lifesaving product going to be approved?" However, a far larger foundational issue Mr. Volokh touched on merits a different discussion here.
The more paramount question is whether there will be any small medical manufacturing companies left in business by the end of the decade that will be in a position to manufacture these life-saving devices. The monolithic billion-dollar conglomerate medical manufacturers with the means and manpower will simply shuffle money, people, and plants across international borders at a faster and faster rate. Most of the rest of the medical manufacturing industry will likely be stuck in the United States, struggling to survive. The firms that are too small or too financially strapped will suffer and be eaten alive (i.e. acquired) by the multinational firms. Likewise for firms that may be too cautious--a very preventable but unfortunate trait of most American corporate managers today.
In the not-too-distant future, firms that require large masses of research will regularly conduct it in China, India, Korea, and other developing countries. These are countries with well-educated researchers and scientists who can conduct basic research at fractions of the prices in the United States.
Some of this may sound like overstatement and oversimplification, since there will almost certainly always be medical manufacturing companies in the United States. The total number of U.S. medical manufacturers has tripled since 1980, according to FDA statistics. Having reported on the medical industry since 1980, though, I can readily testify that the trend toward more companies is in critical danger of reversing at the same rate.
Another eye-opening experience is to read the list of products being exported overseas. Every month, several dozen are approved by the FDA for export, even though they have not been cleared by the FDA for sale in the United States. This totals many hundreds of products per year that are not available to U.S. medical practitioners and their desperate (but usually unaware) patients.
It is also worth noting that at least 95 percent of these products will at some point receive FDA "clearance," according to FDA officials and outside legal counsel, since they have to meet FDA requirements in order to be OK'd for export. Because of that level of certainty, Biomedical Market Newsletter now trumpets that it can predict which products the FDA will approve, months or even years beforehand. It is an embarrassingly simple but extremely accurate crystal ball that is only possible because the bureaucrats are so predictable.
However, to lay the blame for all of these incidents and others solely at the feet of the FDA, and claim that virtually all the troubles of U.S. medical manufacturers would disappear if the FDA were eliminated is not true. The FDA product-approval process is faster than it was two years ago and additional improvements were announced in recent weeks. It is a mistake to swallow the logic of those who claim the FDA can and should be replaced.
It cannot, and should not, be replaced. Improved? Absolutely.
This year? A must. Will it happen? A safe bet. Make a difference?
For sure. Save U.S. jobs? No question. Worth trying? Our future
depends on it.
David G. Anast
Publisher/Editor
Biomedical Market Newsletter
Costa Mesa, CA
While we agree with the thesis presented in Alexander Volokh's
article, we consider the statistics used at the beginning of the
article to be misleading at best.
The numbers provided are baseless within the context of the article. Without any sources accompanying them, they are no better than the endless litany of "scare" statistics for such things as the now-infamous Super Bowl domestic violence statistics. Even if the withheld products were available to those people cited in the "statistics," there is no evidence presented that all of the deceased people (or even a large percentage of them) would actually have benefited from those products.
It would have been better to focus the article on the simple fact that the FDA disallows our citizens and their selected health care providers freedom of choice in determining what's best for their individual health care needs. This simple fact is what can lead to preventing many tragic and preventable deaths. Numbers aren't important.
We also feel that for the purposes of the article, it would have been much more illustrative to focus on examples in which the FDA approved/licensed drugs or devices, and yet problems resulted anyway, showing that the FDA really doesn't make much of a difference, safety-wise, with its present level of excessive regulatory intrusion. One example would be the drug Felbamate, an initially promising anti-epileptic drug which was recommended for approval in late 1992 and actually licensed for use in July 1993. In mid-1994, scarcely a year following licensure of Felbamate, a warning was issued to physicians, noting that Felbamate was linked to risk of aplastic anemia, and that some fatalities had resulted.
The above example and others like it should be well documented
in medical and pharmaceutical journals, and would have proved a
much more solid argument for the author than his use of
"might-have-been" alarmist estimated statistics, like those used at
the beginning of the article. The misuse of statistics is not
needed to illustrate this case of government gone bad.
Alicia Oakley
Greenville, IL
Eric Tellefsen
Elberon, NJ
Alexander Volokh replies: For the benefit of Ralph Dreger and Gordon LaBedz, let me make clear that I, too, am not in love with drug and medical-device manufacturers. Neither the government nor industry is in the medical business for kindness alone. The true question, though, is how to avoid the FDA making an already risky situation worse.
Mr. LaBedz suspects that my estimated "lives saved" will be short and low-quality. I suspect that the folks whose lives are saved may think differently. Some of the treatments may cost hundreds of thousands of dollars, but I assure you that the FDA has quite other criteria in mind.
Mr. Dreger's question of drug patents is a thorny one, but FDA reform can proceed independently of patent law, and patent law can be changed regardless of what the FDA looks like. The two questions are connected, but independent. As for his second point, if all the FDA did was guard against fraudulent labeling, there would be no problem.
Editor's Note: We invite comments and request that they be civil and on-topic. We do not moderate or assume any responsibility for comments, which are owned by the readers who post them. Comments do not represent the views of Reason.com or Reason Foundation. We reserve the right to delete any comment for any reason at any time.
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