FDA Wants Hormonal Products Assessed for Environmental Harm

June 5, 2015

Drugmakers seeking approval of products with hormonal effects should submit an assessment with their applications that evaluates whether they would be harmful if released into the environment.

The requirement, spelled out in April 28 draft guidance, would apply to drugs with estrogenic, androgenic or thyroid activity.

Sponsors should request a meeting with the FDA prior to starting clinical trials to clarify the kind of environmental assessment needed in the NDA. For example, a drug whose active ingredient shows up in local water sources at a concentration less than 1 part per billion would typically not require a full environmental assessment, the agency says.

Drugs derived from plants with endangered species protection, on the other hand, would require a full assessment unless the company can show that drug has no significant effect on the environment.

Third Such Guidance

To determine if a drug has estrogenic, androgenic or thyroid activity, firms should assess existing information such as nonclinical studies, pharmacology studies, developmental, reproductive and ecological toxicity studies and scientific articles on similar drugs, the question-and-answer guidance says.

This is the third environmental assessment-related draft guidance released by the FDA in the last year. A late March guidance on genetically engineered products followed one on gene therapies and vectored vaccines that came out last June.

Comments are due to regulations.gov, docket no. FDA-2015-D-1213, by June 30.

Get FDAnews’ Guide to FDA Pharma GMP Regulations - 2015 and gain access to all of the FDA’s GMP regulations for drugs, biologics and combination products with Federal Register announcements and hard-to-find background information, plus the guidance that helps you maintain compliance. These documents are a gold mine for anyone who has to determine whether they are complying with GMP rules.