NCHR Testimony at FDA on Restylane

Before the General and Plastic Surgery Advisory Panel, Food and Drug Administration

Good morning. My name is Elizabeth Santoro. I am a registered nurse and hold a Master of Public Health with a concentration in health policy. I am a Health Policy Fellow at the National Center for Policy Research for Women & Families. This morning I will be reading the testimony of our President, Dr. Diana Zuckerman, who regretfully could not be here today.

Our Center is a think tank that translates scientific research findings into meaningful information for the public. We use that research information to advocate for policies that benefit the health and safety of women, children, and families.

It is clear that both women and men alike continue to search for the fountain of youth. We know that these products are widely used, and that’s why they should be carefully studied. They should be approved if they are safe and effective.

Of course, it’s difficult to make a statement before the data are presented, but based on what was made available on the FDA website yesterday, these are our concerns:

Our main concern about Restylane is the lack of data for African Americans and Asian Americans. Only two of the patients are African American and only two are Asian American.

Research clearly shows that African Americans and Asian Americans are more likely to produce keloids and can respond differently to procedures involving the skin. In addition, African Americans are more likely to develop autoimmune diseases than white women. The company has not studied a reasonable number of African Americans or Asian Americans to approve the product for those populations.

Our Center has joined with the National Medical Association to express our very strong concerns on this issue to the FDA Commissioner. It is a great concern for all products of this type, not just the products under review today.

The FDA has suggested one solution – postmarket studies. We strongly believe it is not appropriate to require studies of minority populations on a postmarket basis, since the FDA does not have the authority to enforce such requirements. The company should be required to do the studies before the product is approved.

It is similarly inappropriate to label the product “For Whites Only.” I am sure that I am not the only person in the room who believes it would be inconsistent with the values of our country to approve products only for white people, unless there was a compelling reason – for example, if a product was found to be safe for whites but unsafe for other racial or ethnic groups. Such a label is not appropriate as a way around a sponsor’s failure to conduct research on people of color. Moreover, if there are no data on people of color, it is likely that the product will be used off label by them anyway, and that could potentially be dangerous. Research is needed, it won’t take long to do it, and it should be done.

Another shortcoming of the research on Restylane is the relatively small sample size. The sample starts with only 138 people and only 125 are still in the study after 12 months. Since this is a cosmetic procedure that is likely to be used by hundreds of thousands – perhaps millions– of people, the product should be tested on a larger sample to determine if there are rare adverse reactions that are serious enough to consider before approval.

Our final concern is the lack of long-term follow-up and the lack of research on women who undergo the procedure multiple times. It is clear from published reports that women who have a good outcome the first or second time they use this product may have serious adverse reactions after the third or later procedure. This needs to be studied before approval since it is clear that the product will be used more than once or twice.

We want to make a final comment about the risks and benefits of this product. According to the company’s own data, the product is not necessarily better than the comparison product, Zyplast. For that reason, we believe rushing this product to market without gathering the additional data listed above is unwarranted.