The US Food and Drug Administration Safety and Innovation Act of 2012

A look at the safety of the US drug supply chain, antibiotic drug development incentives and the government’s response to drug shortages.

August 28, 2012

This Q&A with Latham & Watkins partner Daniel Meron examines how the US Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA) of 2012 enhances drug supply chain requirements, expands antibiotic drug development incentives and strengthens FDA’s authority to respond to drug shortages in the United States.

What impact does this act have on the safety of the US drug supply?

Meron: One concern that FDA has expressed relates to the increasing complexity of the drug supply chain from raw source materials to finished products for consumers, and the many opportunities that exist along that chain for drugs to be contaminated, diverted or otherwise adulterated.

Under the new act, FDA is required to implement a new risk-based schedule for domestic and foreign drug facility inspections, including a unique facility identifier system, enhanced information requirements for facility registrations and a limited annual facility registration period from October 1-December 31. This replaces a standard bi-annual inspection regime.

Under a new provision in the act, which has the potential to increase the burden on manufacturers, FDA now will be allowed to require drug manufacturers to provide records for inspection — either electronically or in paper form — at their expense in advance of facility inspection. FDA is not limited to simply gathering records during the course of its own facility inspection.

Given the increase in global manufacturing, are drug imports a concern?

Meron: Yes and FDASIA grants FDA explicit extraterritorial jurisdiction over any violation of the federal Food, Drug, and Cosmetic Act (FDCA) for any article intended for import to the United States. This closed an existing potential loophole.

FDA also has the authority to destroy counterfeit or adulterated drugs that are refused for import and detain drugs during an inspection that it believes may be adulterated or misbranded. Commercial drug importers must register with FDA and obtain a unique identifier — and FDA may screen imported drugs using a risk-based approach.

How does the act expand antibiotic drug development incentives?

Meron: In the statute, Congress also addressed the increasing concern for the gradual rise of antibiotic-resistant diseases and the growth of deadly untreatable infection. The FDA realizes that new antibiotic development is not the entire solution to the problem, but that it’s an important part of it.

The Generating Antibiotic Incentives Now Act (GAIN Act) establishes incentives for developing antibacterial or antifungal drugs intended to treat serious or life-threatening infections, including those caused by antibacterial- or antifungal-resistant pathogens like MRSA.

How has the act changed the FDA’s ability to respond to drug shortages?

Meron: The statute requires drug manufacturers to notify FDA of any permanent drug discontinuance or manufacturing interruption that is likely to lead to a meaningful disruption in the drug supply — if those drug are life-saving, supporting or sustaining. In turn, FDA must widely notify healthcare providers and patient organizations and maintain an up-to-date list of drug shortages.

For More Information on FDASIA

To learn more about other aspects of the Food and Drug Administration Safety and Innovation Act of 2012:

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