I like beauty products – well, it may be more accurate to say that I am interested in beauty products, since most days I only wear a swipe of mascara and concealer to work. However, there are some drawbacks to being interested in beauty; unlike for pharmaceuticals, there are no promises that any product will work, and the perceived improvement in my appearance is just that. Importantly, the FDA does not have significant power to regulate the cosmetics market. Pharmaceuticals, on the other hand, are currently required to demonstrate both safety and efficacy in tightly controlled clinical settings, with well-defined endpoints. Despite certain requirements for safety in cosmetic products, the relative lack of FDA regulation can result in significant consequences to consumers, especially for niche or “indie” brands. With Donald Trump championing the removal of FDA requirements that drugs prove efficacy, also called progressive approval, could the market for pharmaceuticals begin to bear an unfortunate resemblance to that for cosmetic products?
Although Scott Gottlieb beat out Jim O’Neill for the final nomination, if confirmed, the FDA commissioner may be under some pressure to cooperate with the Trump administration’s stated goal to “slash the restraints” currently contributing to the perceived “slow and burdensome approval process at the Food and Drug Administration.” While the passed-over Jim O’Neill is a known champion of progressive approval, Scott Gottlieb has avoided explicitly stating his position on this issue, leaving open the question of what, if any, changes will be implemented in the current FDA approval process. However, the strong stance taken by the chief executive continues to loom over the debate.
Currently, U.S. law requires only that cosmetics be unadulterated and correctly branded. Unadulterated, under the law, should also ensure the safety of such products, prohibiting the inclusion of any “poisonous or deleterious substance” in the cosmetic. There is no evaluable beauty standard that a product could claim to achieve, making any regulation based on efficacy impossible – my own opinion that mascara makes my eyes brighter is completely subjective. Importantly, individual companies are responsible for evaluating the safety of their products, and the FDA does not have authority to issue a recall for cosmetics. This lack of oversight has allowed several potentially injurious products to stay on the market. In a relatively famous example, over 20,000 clients have complained that indie-brand Wen haircare has caused itches, rashes, or even hair loss.
I was also unfortunate enough to witness firsthand the emergence of a possible link between the popular Mentality nail polish and itching, sensitivity, and even nail loss. Initially, a few instances of these complaints were reported on social media, with select bloggers noting these reactions after Mentality changed the base for their colors. However, Mentality failed to react appropriately, and in fact appeared to go into damage control mode, launching additional promotions of their product with sale codes on the same social media where adverse side effects were noted. Eventually, additional reports piled up and the scandal snowballed to such an extent that the company was forced into launching an FDA registered Class 2 recall (May 6, 2016, accessed March 6, 2017), but not until nearly a year had passed since the original reports.
Under current regulation, customers affected by harmful cosmetic products have limited legal recourse. Unlike pharmaceuticals, there is no reporting mechanism for so-called adverse events within the cosmetics market. In contrast, there is a rigorous structure in place for reporting of severe adverse events linked to pharmaceutical products, which is given teeth with the FDA’s statutory authority to recall products. Instead of reporting adverse events to the FDA, viral complaints on social media appear to be the only way such stories gain traction. A bill was introduced in the most recent congress to expand the FDA’s regulatory regime to include cosmetics but was not able to clear both houses before the swearing-in of a new congress in January of 2017. This bill would have moved the cosmetic regulatory regime closer to that governing pharmaceuticals by setting up a fee structure wherein proceeds from sales would be used to ensure safety. It would also have created a pathway for adverse event reporting, making such data collection mandatory.
Instead, several individuals tied to the current administration, including HHS secretary Tom Price, have promoted a regulatory regime for drugs called “progressive” appeal. Under this scheme, pharmaceuticals are only required to demonstrate safety, not efficacy, before they are made available to consumers – this would be slightly more rigorous than regulations for cosmetics. Currently, there are no plans in the works to eliminate the FDA’s safety regulations for pharmaceuticals, and it is along this line that my analogy breaks down. Demonstrating safety would be mandatory, but it still leaves open the possibility that inefficacious medicines would be sold to patients. In fact, this is where the beauty analogy becomes even more disturbing; similarly to how I simply like the way I look with a bit of mascara, would subjective endpoints be sufficient to help a drug gain traction? Social media is already becoming a major marketing platform for pharmaceuticals; in a regime where untested medicines are made available, would patient testimonials drive viral engagement and promote use of pharmaceuticals that may or may not be efficacious?
Any details of a progressive drug-approval regimen would most likely be worked out in Congress, but in addition to the cases highlighted by members of DRG’s therapy-area teams, the beauty market provides a chilling example of the possible consequences of reforming the pharmaceutical approval process. In fact, I may forgo my mascara tomorrow.