FDA asks for comments on drug importation regulations by August 12

With 40% of drugs in this country coming from other nations and 80% of active ingredient manufacturers located outside the United States, last year Congress gave FDA new powers to oversee those products.

Among other provisions, Title VII of the FDA Safety and Innovation Act (FDASIA) requires commercial drug importers to register with FDA and allows the agency to require an importer to electronically submit information showing a drug complies with the law.

Now FDA is asking the public for advice on how to carry out Title VII. Among numerous other questions it is requesting comments on what information should be required at the time of entry to demonstrate a drug’s compliance, including information on homeopathic drugs for human use, articles for human or animal drug compounding, and drugs intended for research.

It’s also asking how a “commercial importer” should be defined to ensure the right entities are required to register and meet good importer practices. Another question is whether the regulations should require commercial importers to have safety management programs to ensure their products meet requirements of the US Federal Food, Drug and Cosmetic Act.

John Taylor III, acting deputy commissioner for Global Regulatory Operations and Policy at FDA, told attendees at a public meeting, Implementation Drug Supply Chain Provisions of Title VII of FDASIA, Friday at FDA headquarters that the “staggering increase” in imports “has really eliminated the distinction between domestic and imported products.”

FDA, Taylor said, had to be changed from “a domestic agency that is working in the international arena to an agency that is truly globally focused.”

The new authority from Congress, he said, allows the agency to collect more information in a more timely manner, to share it, and to treat domestic and foreign manufacturers similarly.

On the other hand Susan de Mars, senior advisor in the Office of Global Regulatory Operations and Policy, noted that unlike other provisions of FDASIA that are supported by user fees paid by industry, there is no funding attached specifically for Title VII, “so the resource challenges are certainly significant.”

Information on all the questions and how to comment is in a June 16 Federal Register notice. The deadline for comments is August 12, 2013.