The Food and Drug Administration Safety and Innovation Act (FDASIA) turned two years old in July, marking the end of the second year of its three-year implementation plan. This act, which focused primarily on adding and improving regulation of drugs and medical devices, significantly increased the regulatory and documentation burden for industry. Specifically, the act created several proposed and final rules intended to increase FDA’s authority over what it refers to as an “increasingly global drug supply chain,” including
- increased User Fees for medical devices and prescription drugs
- added User Fees for generic drugs and biosimilar biological products
- increased information required for drug establishment registration and product listing
- more frequent inspection for foreign drug facilities
The act is specifically designed to enable FDA to become a global authority on public health, particularly as it relates to drugs. It extends FDA’s administrative detention authority to include drugs, outlines what it considers noncompliant behavior during investigation, officially designates DUNS numbers as FDA’s preferred unique identifiers for registered drug facilities, and proposes that FDA be allowed to administratively destroy refused imported drugs worth less than $1,500.
These provisions are allowing FDA to reach further and further abroad, to ensure global compliance with its standards. Industry members who don’t comply with or meet FDA’s standards may quickly find themselves shut out of the U.S. market. To learn more about FDASIA’s impact on your business, contact us today.
