Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Matthew M. Lowe
Don’t wait until something bad happens to make a change
Kari Miller
A lack of integration hampers quality compliance across a product’s life cycle
Etienne Nichols
A well-defined CAPA program is a framework for quality and effectiveness
Grant Ramaley
IAF CertSearch now mandatory for accredited certification bodies
Etienne Nichols
What’s the difference?

More Features

FDA Compliance News
Creates one of the most comprehensive regulatory SaaS platforms for the industry
Company’s first funding round will be used to accelerate product development for its QMS and MES SaaS offerings
Showcasing tech, solutions, and services at Gulfood Manufacturing 2022
Easy, reliable leak testing with methylene blue
Now is not the time to skip critical factory audits and supply chain assessments
Google Docs collaboration, more efficient management of quality deviations
Delivers time, cost, and efficiency savings while streamlining compliance activity
First trial module of learning tool focuses on ISO 9001 and is available now
Free education source for global medical device community

More News

Howard Sklamberg

FDA Compliance

Protecting the Global Drug Supply

Implementing Title VII of the FDASIA

Published: Wednesday, July 23, 2014 - 16:35

Since July 9, 2012, when President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA), a group of colleagues and I have had an urgent mission: implement Title VII of the statute. This section gave the FDA new authority to better protect the global drug supply chain, which is a critically important public health task in an increasingly global marketplace.

Title VII will advance the FDA’s transformation into a global public health agency, primarily by enabling it to better oversee the safety and integrity of drug ingredients and finished drugs in the supply chain. Thanks to this law, the FDA can become better informed about supply chain risks. This information allows the FDA to target its resources to higher-risk facilities, which makes us both more efficient and more effective in further ensuring the quality and safety of drug ingredients and finished drugs. The law also provides us with important new enforcement tools and facilitates our cooperation with trusted foreign regulators, which is essential in a global marketplace.

The FDA is working diligently to implement these authorities to better protect and promote the health of all Americans. During the past two years, the FDA has made many parts of Title VII a reality. These successful accomplishments include:
• A proposed and a final rule to extend the agency’s administrative detention authority to include drugs (Section 709, issued May 29, 2014). The rule prevents potentially adulterated or misbranded drugs from entering U.S. commerce while the FDA decides whether to take legal action, such as seizing the drug. Administrative detention is a particularly useful tool when there is a high likelihood that the drug will be moved before we can apply another enforcement tool. It aligns with FDA’s administrative detention authority for food and medical devices.
• A draft guidance defining what the agency considers to be actions that delay, deny, or limit an inspection (Section 707, issued July 9, 2013). In crafting this guidance, the FDA surveyed its field force to come up with the types of behaviors that were observed by investigators, based on real-life situations. This authority has already been used to warn firms of possible enforcement action in instances when the FDA was not allowed to inspect.
• A public meeting was held to discuss how the agency might implement certain parts of the FDASIA to protect the drug supply chain (Sections 713/714, held July 12, 2013). The FDA is dedicated to providing transparency and ongoing opportunities for stakeholder input and participation as it works to implement Title VII.
• A draft guidance specifying the unique facility identifier (UFI) system for drug establishment registration (Sections 701/702, issued September 5, 2013).
This data standard will improve our ability to identify drug establishments, both here and abroad, that make products for the U.S. market.
• The first annual report as required under section 705, outlining the number of domestic and foreign establishments registered and inspected in fiscal year 2013, and the percentage of the FDA budget used to fund such inspections (Section 705, issued January 31, 2014; this report provides a high-level overview of FDA inspection resources).
• A proposed rule regarding administrative destruction of imported drugs refused admission into the United States (Section 708, issued May 6, 2014). This authority will allow destruction of unsafe drugs valued at less than $2,500, rather than the current process that requires the return of these illegal products to the country of origin, which increases the risk that further attempts could be made to send them back into the United States.

Working together with stakeholders, the FDA will continue its strategic implementation of FDASIA Title VII by prioritizing its efforts based on the maximum benefit to the public health.

You can look up the current status of any FDASIA deliverable and sign up to receive Title VII updates using FDASIA-TRACK.

First published July 10, 2014, on FDAVoice.


About The Author

Howard Sklamberg’s picture

Howard Sklamberg

Howard Sklamberg is FDA’s deputy commissioner for global regulatory operations and policy, and he is the directorate comprising the Office of Regulatory Affairs and the Office of International Programs. Sklamberg provides executive oversight, strategic leadership, and policy direction to FDA’s domestic and international product quality and safety efforts, including global data-sharing, development and harmonization of standards, field operations, compliance, and enforcement activities. Sklamberg played leadership roles in global drug supply chain security, pharmacy compounding oversight, pharmaceutical quality, and expanded cooperation with international regulatory partners. Sklamberg has degrees from Harvard Law School, Yale University, and Fletcher School of Law and Diplomacy.