Why Is the Best Sunscreen Blocked by FDA?

We think of July and August as the peak of summer, but when it comes to sunburn, now is the peak. Next Tuesday, June 21st, is the longest day of the year, when the sun is highest in the sky, so it's now that the sun does the most damage. Like most people, you probably think you know what to do about it. You slather on the sunscreen when you're out in the sun.

Our suntan lotions are good at screening out the sun's UVB rays - the ones that cause sunburn and skin cancers - but most people don't realize their sunscreens don't offer much protection against UVA rays, the ones that put wrinkles in your skin. "Ultraviolet A light ages your skin. And the reason it does that, it's a longer wavelength, so it can penetrate deeper into the skin, and instead of attacking the upper layers of the skin where skin cancer often forms, it attacks the layers that give your skin its tone, its elasticity, as we call it. . You get the lines, the wrinkles, all the things associated from aging," said Dr. Darrell Rigel, clinical professor of dermatology at New York University

But there's good news. Lotions that contain the ingredients Oxybenzone, Titanium Dioxide or Parsol 1789 block out some UVA rays. Doctors say a chemical called Mexoryl offers even better protection. "It produces a product which gives us almost perfect protection against sunshine," said Dr. Vincent DeLeo, chairman of dermatology at Columbia University. People are happily protecting themselves with Mexoryl on the beaches of Rio de Janeiro, the streets of Paris, in Canada, Mexico and Australia. Mexoryl "is the No. 1 individual ingredient in terms of protection from Ultraviolet A radiation," Rigel said.

But even though dermatologists say Mexoryl is the best, you cannot legally buy it in the United States. It's illegal, because the Food and Drug Administration won't approve it. They won't even say why. The FDA is charged with making sure no drug is sold unless the government is convinced it's safe and effective. Dermatologists think it's just stuck in the bureaucracy. It routinely takes 12 to 15 years for a drug to get approval. After an approved drug - Vioxx, for example - gets bad publicity as a health risk, the FDA gets particularly cautious.

But is there no common sense here? All drugs have risks as well as benefits. Mexoryl has been in use in other countries for 13 years. It's passed many safety tests. Why won't our FDA even talk about it? Although buying or selling sunscreens with Mexoryl is illegal in the United States, that doesn't mean sunscreens with Mexoryl aren't bought and sold here. We found it at some pharmacies. It was expensive - $30 to $50. "People really want this stuff. People go to pharmacies and they keep it under the counter, like it's a secret ingredient, like prohibition or something and people will still buy it," Rigel said. I don't fault the pharmacies, they're serving their customers.

Everyone is always telling us, protect yourself from the sun, but then the government won't give us permission to have the best sunscreen?

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Theory, Evidence and Examples of FDA Harm

To obtain permission to market a drug, the manufacturer must satisfy the FDA that the drug is both safe and effective. Additional testing often enhances safety and effectiveness, but requiring a lot of testing has at least two negative effects. First, it delays the arrival of superior drugs. During the delay, some people who would have lived end up dying. Second, additional testing requirements raise the costs of bringing a new drug to market; hence, many drugs that would have been developed are not, and all the people who would have been helped, even saved, are not.

In addition, because FDA approval is mandatory, industry and medicine must heed FDA standards regardless of their relevance, efficiency, and appropriateness. Not all testing is equally beneficial. The FDA apparatus mandates testing that, in some cases, is not useful or not appropriately designed. The case against the FDA is not that premarket testing is unnecessary but that the costs and benefits of premarket testing would be better evaluated and the trade-offs better navigated in a voluntary, competitive system of drug development.

Three bodies of evidence indicate that the costs of FDA requirements exceed the benefits. In other words, three bodies of evidence suggest that the FDA kills and harms, on net. First, we compare pre-1962 drug approval times and rates of drug introduction with post-1962 approval times and rates of introduction. Second, we compare drug availability and safety in the United States with the same in other countries. Third, we compare the relatively unregulated market of off-label drug uses in the United States with the on-label market. In the final section, before turning to reform options, we also discuss the evidence showing that the costs of FDA advertising restrictions exceed the benefits.

Comparison of Pre- and Post-1962

Sam Peltzman (1973) wrote the first serious cost-benefit study of the FDA. He focused his attention on the 1962 Kefauver-Harris Amendments to the Food, Drug, and Cosmetics Act of 1938, which significantly enhanced FDA powers. The amendments added a proof-of-efficacy requirement to the existing proof-of-safety requirement, removed time constraints on the FDA disposition of NDAs, and gave the FDA extensive powers over the clinical testing procedures drug companies used to support their applications.

Using data from 1948 to 1962, Peltzman created a statistical model to predict the yearly number of new drug introductions. The model is based on three variables, the most important of which is the size of the prescription drug market, lagged two years. The idea is that if the prescription drug market were large two years ago, manufacturers would invest more money in research and development, which would pay off two years later in a new drug. (Prior to 1962, it took approximately two years to develop a new drug.) Despite the model's simplicity, it tracks the actual number of new drug introductions quite well....

Because Peltzman's model tracks the pre-1962 drug market quite well, we have some confidence that if all else had remained equal, the model also should have roughly tracked the post-1962 drug market. Peltzman's model, in other words, estimates the number of new drugs that would have been produced if the FDA's powers had not been increased in 1962. Thus, by comparing the model results with the actual number of new drugs, we can draw an estimate of the effect of the 1962 amendments. The model predicts a probable post-1962 average of forty-one new chemical entities (NCEs, or new drugs) approved per year.

The average number of new drugs introduced pre-1962 (forty) was also much larger than the post-1962 average (sixteen). Thus, whether one compares pre- and post-1962 averages or compares the results from a forecast with the actual results, the conclusions are the same: the 1962 Amendments caused a significant drop in the introduction of new drugs. Using data of longer span, Wiggins (1981) also found that increased FDA regulations raised costs and reduced the number of new drugs.

Even if FDA regulations have not improved safety, they might be redeemed if they have reduced the proportion of inefficacious drugs on the market. Using a variety of tests, however, Peltzman (1973) found little evidence to suggest a decline in the proportion of inefficacious drugs reaching the market since 1962. Thus, he concluded, "(the) penalties imposed by the marketplace on sellers of ineffective drugs prior to 1962 seem to have been enough of a deterrent to have left little room for improvement by a regulatory agency." (1086) Similarly, in their survey of the literature, Grabowski and Vernon (1983) conclude, "In sum, the hypothesis that the observed decline in new product introductions has largely been concentrated in marginal or ineffective drugs is not generally supported by empirical analyses" (34).

The costs of FDA regulations do not vary with the number of potential users of the drug, so the decline in drug development has been especially important in the treatment of rare diseases. By definition, each rare disease afflicts only a small number of people, but there are thousands of rare diseases. In aggregate, rare diseases afflict millions of Americans: according to an AMA estimate (AMA 1995), as many as 10 percent of the population. Thus, millions of Americans have few or no therapies available to treat their diseases because of increased costs of drug development brought about by stringent FDA "safety and efficacy" requirements. In response to this problem, in 1983 the Orphan Drug Act was passed to provide tax relief and exclusive privileges to firms developing drugs for diseases affecting two hundred thousand or fewer Americans (AMA 1995). It would be better to reduce or eliminate FDA regulations for all drugs and patient populations.

The Grisly Comparison

The delay and large reduction in the total number of new drugs has had terrible consequences. It is difficult to estimate how many lives the post-1962 FDA controls have cost, but the number is likely to be substantial; Gieringer (1985) estimates the loss of life from delay alone to be in the hundreds of thousands (not to mention millions of patients who endured unnecessary morbidity). When we look back to the pre-1962 period, do we find anything like this tragedy? The historical record-decades of a relatively free market up to 1962-shows that voluntary institutions, the tort system, and the pre-1962 FDA succeeded in keeping unsafe drugs to a low level. The Elixir Sulfanilamide tragedy, in which 107 people died, was the worst of those decades. Every life lost is important, but the grisly comparison is necessary. The number of victims of Elixir Sulfanilamide tragedy and of all other drug tragedies prior to 1962 is very small compared to the death toll of the post-1962 FDA.

Much more here

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For greatest efficiency, lowest cost and maximum choice, ALL hospitals and health insurance schemes should be privately owned and run -- with government-paid vouchers for the very poor and minimal regulation. Both Australia and Sweden have large private sector health systems with government reimbursement for privately-provided services so can a purely private system with some level of government reimbursement or insurance for the poor be so hard to do?

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