Congress and FDA Working Together to Ensure Drug Safety and Security: FDASIA

Based on the Sessions “50,000 ft. View – Sphere of Influence” and Steve Lynn’s “FDA International Initiatives from the 2012 FDA/Xavier University Global Outsourcing Conference

The Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law by President Obama on July 9, 2012. While many associate this act only with reauthorization of user fees for brand pharmaceuticals and the addition of a user fee program for generics and biologics, there are many additional provisions contained within this act that members of the industry must be aware. The primary goal of FDASIA was to ensure that FDA had the resources to ensure a global supply chain, as the number of drug products from overseas coming into the U.S. has more than doubled since 2001. The following provides highlights of FDASIA with respect to ensuring the pharmaceutical supply chain (Title VII):

• Requires all companies that import products into the U.S. to register, including excipient and commercial products (Sections 701, 702, 703, and 714). Excipient manufacturers are also required to list all establishments used for production as well as the drug associated with the excipient (Section 703). Each facility will be assigned a Unique Facility Identifier (UFI) that will also include additional information about foreign establishments (Section 702). All information will be contained in an electronic database that is linked to other FDA databases (Section 704).
• Changes inspection requirements to a risk-based system dependent on product risk, recalls, and inspection history (Section 705). This system replaces a minimum inspection frequency system. Also, agreements may be formed with foreign governments and regulatory agencies in order to share inspection information and reduce the frequency of audits (Sections 710 and 712).
• The FDA now has the authority to detain suspect products or destroy adulterated, misbranded, or counterfeit drugs imported into the U.S. (Section 708 and 709).
• Products from foreign facilities that refuse FDA inspections or provide sufficient information will be denied entry into the U.S. (Sections 707 and 713).
• Requires that all members of the regulated industry (including wholesale distributers) notify the FDA if they are aware of products that are stolen, counterfeit, or could cause harm (Section 715).
• There are also enhanced penalties to hold criminals accountable for intentional adulteration and counterfeiting (Sections 716 and 717), including up to 20 years in prison and $5 million in fines.

In addition to these provisions, Title 11 discusses global cooperation for drug, device, and biologic clinical trial standards and operations.

Together, these provisions will allow the FDA to focus resources where they are most needed and allow the U.S. government to have leverage over foreign establishments that will level the playing field between domestic and foreign facilities. FDASIA will also shift the burden to importers from solely being on the FDA by establishing these domestic requirements. Over the next year, the FDA will create guidance documents on these provisions to assist the industry with compliance for these changes.