FDA Seeks to Tighten Drug Import Regulation

August 9, 2013

In 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). Title VII of the FDASIA provides the FDA with new authority to ensure the safety, effectiveness and quality of drugs imported into the United States. Currently, the FDA is seeking public comment regarding the implementation of Title VII of the FDASIA. Click here for a link to the FDA request for public comment.

The FDA demonstrates the need for Title VII implementation by acknowledging that nearly 40 percent of the drugs Americans take are imported into the United States and nearly 80 percent of the active ingredients for the drugs Americans take come from overseas sources . Furthermore, a growing number of clinical trials are moving overseas, making FDA oversight of the clinical trials more complicated due to trial design concerns, data validity concerns and jurisdictional reach of the FDA. Finally, the United States is not immune to the proliferation of substandard and counterfeit drug products, and online pharmacies pose further supply chain monitoring challenges beyond monitoring the traditional supply chain.

The FDA held a daylong public meeting in July 2013 to discuss the implementation of the Drug Supply Chain Provisions of Title VII of FDASIA, particularly Sections 713 and 714.

Under Section 713:

  • FDA can require that an importer electronically submit information demonstrating that the drug complies with the applicable requirements of the federal Food, Drug & Cosmetic Act (FD&CA).
  • FDA can expedite clearance for those importers that volunteer to participate in partnership programs for highly compliant companies and pass a review of internal controls.

Under Section 714:

  • Commercial drug importers are required to register with the FDA.
  • FDA must issue regulations establishing good importer practices that specify the measures an importer shall take to ensure that imported goods are in compliance with the FD&CA.

During the July meeting, industry commenters suggested that FDA:

  1. establish risk-based standards for submission of information by importers to demonstrate that drugs offered for import comply with FDA requirements;
  2. adopt different supply verification or other good importer practices or requirements based on the type of drug being offered for import;
  3. implement an electronic portal for the submission of information by importers; and
  4. harmonize the FDA definition of importer.

The FDA is accepting comments until Aug. 12, 2013, on the implementation methods for Title VII and to specific questions regarding Sections 713 and 714 of the FDASIA.

If you have any questions regarding Title VII of the FDASIA or the importation of drugs into the United States, please contact one of the authors.