Speaker Abstract: S-38
Overview of Ongoing Human Studies at the FDA Photosciences Facility
Janusz Z. Beer, M.D., Center for Devices & Radiological Health/FDA
FDA regulates a wide range of ultraviolet radiation (UV)-related products including UV-emitting devices (diagnostic and therapeutic devices, sunlamps), UV-transmitting products (sunscreens, cosmetics), and UV response-modifying products (photosensitizing drugs, cosmetics). There are numerous well-known risks from UV exposure. UV-exposed skin may develop cancer and undergo photoaging. Accelerated development of cataract or retinal damage may result from UV exposure to the eye. Immunosuppressive properties of UV are well known. The safety of UV-emitting devices used for diagnostics of mucosal tissue in the cervix, bladder, GI tract or oral cavity is a subject of concerns and analyses.
The number of new skin cancers diagnosed in the U.S.A. has been increasing and reached ~1,300,000 per annum (including ~50,000 of cutaneous malignant melanoma). Some of these cancers may be caused by the use of FDA-regulated products; some may be prevented by effective sunscreens. To modernize policies related to these products, FDA conducts clinical and animal studies as well as investigations in other experimental systems and risk assessments. The clinical studies are conducted in the FDA Human Photosciences Facility at CDRH in Rockville and involve researchers from CDRH, CFSAN, CDER, and NCI. These studies are coordinated with the NCTR Phototoxicology program of animal studies. The current Human Photosciences projects (1) explore methodologies for testing and standardization of UV responses, (2) investigate differences in UV responses of all U.S. racial/ethnic groups, (3) study UV tanning kinetics to improve the FDA and international standards for sunlamp products and to reduce the UV burden to the users of such products, and (4) investigate interactions between UV exposure and hydroxyacids (common components of cosmetics) to support new labeling guidelines. A recent NCI initiative led to the development of a protocol for studies on UV-induced changes at the gene expression level and on the preventive effects of sunscreens at this level. Scientific data generated in the FDA Human Photosciences Facility provide solid support for public health policies of the FDA in the area of UV-related products.
2004 FDA Science Forum | FDA Chapter, Sigma Xi | CFSAN | FDA
Last updated on 2004-MAY-28 by frf