Let me start out by saying that I am not advancing here any position on the legal, political, or moral grounds for banning or approving the abortion drug, Mifepristone. I am, however, fascinated by the multitude of reactions to the decision by US District Judge Matthew Kascmaryk to suspend the FDA's approval of the pill. In particular, the reaction by the biopharma industry was the most fascinating. It has immediately claimed that reversing a decision made by the FDA would stifle innovation in the industry and would lead to more lawsuits challenging the FDA's decision-making process as it relates to existing and future pharmaceuticals. Tossing out the pills' FDA approval by judges reversing that decision could potentially deter investments in the development of life-changing drugs. Drugmakers rely on the FDA's regulatory framework involving an expensive and lengthy process of developing medications. Over 200 biopharma companies in an open letter emphasized that “adding regulatory uncertainty to the already inherently risky work of discovering and developing new medicines will likely have the effect of reducing incentives for investment, endangering the innovation that characterized our industry.”  The number of companies supporting this argument has grown to over 600 and includes the giants Pfizer, Biogen and Merck.

I fully support the biopharma industry's claims and the precedent this decision would have in overturning the regulatory authority of the FDA in assessing the safety and efficacy of drugs in the USA. However, I wonder why this furor over suspending FDA approvals of the drug Mifepristone was not expressed when Hawaii banned two ultraviolet “drug” filters. In fact, the state of Hawaii has usurped the authority of the FDA by unilaterally requiring physician prescriptions to use those filters. The state of Hawaii has gone even further by demanding that only the two GRASE UV filters (zinc and titanium oxides) should be allowed in the state in the future, potentially banning all UV absorbing molecules from the sun care industry. Maintaining a $1.8 billion sunscreen industry in the US with only zinc oxide and titanium dioxide as UV filters is a nightmare—if not downright impossible! Why then was there a lack of public outcry or biopharma industry protestations that the FDA's role in dictating the efficacy and safety of sunscreen has been usurped?

I have a few suggestions to explain this inconsistency. First, it seems to me that the role of sunscreens in eliminating the risk of skin cancer has not been fully solidified in the minds of the public—and even scientists and biopharma. Despite all the efforts of the skin cancer foundations and melanoma treatment organizations in the US, the message that not using sunscreens, is a matter of life or death. We could blame the lack of real academic scientific, dermatologic, or epidemiologic studies demonstrating the absolute need for sunscreens for protection. We could blame the sun care and cosmetic industries for not promoting reliable and effective marketing campaigns extolling the value of sunscreens in preventing the skin cancer diseases that afflict several million individuals annually in the US. Sunscreens are barriers that only protect the individual from receiving the damaging UV radiation that causes skin cancer. This is a physical phenomenon, not a drug action. Why then does the FDA insist that sunscreens are drugs? Shirts, clothing, umbrellas, sunglasses or “avoiding the sun altogether,” do not require FDA approvals!

Second, the biopharma industry submits hundreds of applications to the FDA each year hoping to get approval for a drug that cures a particular disease, spends hundreds of millions of dollars, and is willing to wait up to a dozen years to get approvals, even though only one in ten applications ever yield a new approved drug. The reason is obvious: the rewards are in the billions of dollars! This is NOT the case in the ultraviolet filters market.  A brand-new novel UV filter, WHEN and IF it is approved by the FDA, will garner the creator of this drug—at best—a few hundred million dollars a year. When was the last time you heard that a new UV filter was approved by the FDA? None that I recall recently. L'Oreal's Mexoryl, the trade name for ecamsule, was approved 20 years ago after being developed and patented in 1982!  Zinc oxide and avobenzone were approved 25 years ago!  There is no serious economic incentive in pursuing FDA approvals for a UV filter or in securing funding and incentives for basic research.

Is there a solution to this dilemma? My answer is simple. First, note that neither the FDA nor biopharma companies were outraged when FDA-approved drug UV filters were banned by Hawaii. The FDA did not make a big fuss when Hawaii required a physician prescription if the individual wishes to use those sunscreens containing UV filters already approved by the FDA. They all, however, were incensed that Mifepristone was banned by a judge in Texas. The case has already been elevated to the Supreme Court and biopharma companies are crying bloody murder while they await the Supreme Court's final ruling on that case. Ultraviolet filters, in my opinion, should not be considered drugs as is the case in most of the other countries in the world. When applied properly on the skin, sunscreens aid only in the reflection and absorption of the harmful UV radiation, thereby reducing or eliminating the potential that solar radiation can cause cancer to the individual exposed to the sun. Ultraviolet filters do not reverse skin cancer. They only assist in the dissipation of solar radiation, the agent that causes cancer. That is not drug action! Individuals should use sunscreen for protection, stay in the shade whenever possible, use hats and umbrellas, also wear shirts and proper clothing, especially while being exposed to the sun from 11am to 3pm. The money that would be spent by biopharma or the sunscreen and cosmetics industry to get a new UV filter approved by the FDA as a drug, would be better spent on education, proper protocols for effective application of sunscreens on the skin, basic research to design superior UV protectant molecules and also to study the effectiveness of sunscreens and, most importantly, to develop new protocols and drugs to combat skin cancer when individuals are inflicted with the disease.

This saga will continue until the FDA acknowledges this basic fact that UV filters are not drugs but only agents of absorbing or dissipating harmful UV radiation.