Regulatory Issues in Drug Delivery to the Eye

Research and Development, Allergan, Irvine and Department of Ophthalmology, Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, California, U.S.A. 

In order for a drug product to be marketed in the United States, it must be approved by the U.S. Food and Drug Administration (FDA). The authority for the FDA was established by the Federal Food Drug and Cosmetic Act (FD C Act). The Act requires FDA to approve new drug products that are the subject of a New Drug Application (NDA) containing adequate data and information on the drug s safety and substantial evidence of the product s effectiveness. 

FD C Act leaves it to the interpretive and discretionary power of the FDA to determine the legal requirement that a sponsor present substantial evidence of effectiveness prior to a drug s approval. Pharmaceutical companies should work closely with the FDA to assure that the development program they are pursuing will meet FDA s expectations and criteria (1,2). 

Most drug products are not developed for a single market such as the United States, but with the intent of marketing the product worldwide. A difficulty for pharmaceutical companies has been the differing requirements from Health Authorities around the world. In an effort to harmonize worldwide requirements for the approval of drug products, the International Conference on Harmonization (ICH) was established. 

The ICH has published a collection of guidelines attempting to standardize the requirements for establishing the safety, efficacy, and quality of pharmaceutical products. These guidelines currently have been adopted not only by the ICH participating countries (the European Union, Japan, and the United States) but also by countries that are monitoring the ICH process including Canada and Australia. 

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