FDA Deputy Director Sklamberg

FDA Deputy Commissioner Howard Sklamberg, keynote speaker at Interchange 2014, has offered a clear explanation of FDA’s implementation of the Food and Drug Administration Safety and Innovation Act Title VII drug supply chain provisions.

On July 9, 2012, President Barack Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) in to law. Since that time, the FDA has been working to implement the title VII provisions affecting drug supply chain security. Deputy Commissioner Sklamberg explains in his latest post to FDA Voices, “Title VII will advance 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.”

In his testimony before Congress on February 27th of this year, Deputy Director Sklamberg explained why this is so important: “Counterfeit drugs raise significant public health concerns because their safety and effectiveness is unknown. A counterfeit drug could be made using ingredients that are toxic to patients and processed under poorly controlled and unsanitary conditions. Substandard drugs are also a major public health concern, especially regarding infectious disease drugs, such as anti-HIV and anti-malarial drugs. In the United States, a relatively comprehensive system of laws, regulations, and enforcement by Federal and state authorities has kept drug counterfeiting incidents in the United States relatively rare, and FDA continues to believe—and works to ensure—that Americans can have a high degree of confidence in the drugs that they obtain through legal channels. Nonetheless, with the dramatic increase in the complexity of the global supply chain, FDA and its regulatory and law enforcement partners around the world face enormous challenges regarding supply chain security.”

The implementation of FDASIA’s Title VII provisions is aimed primarily at protecting the health of the American consumer, by implementing a series of globally-aimed enforcement and inspection changes in how the FDA operates. Deputy Director Sklamberg goes on to describe just how much the FDA has managed to accomplish:

  • a proposed and a final rule to extend the agency’s administrative detention authority to include drugs, (Section 709, issued 5/29/2014). The rule prevents potentially adulterated or misbranded drugs from entering U.S. commerce while FDA decides whether to take such legal action 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 7/9/2013) In crafting this guidance, 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 FDA was not allowed to inspect.
  • a public meeting was held to discuss how the agency might implement certain parts of FDASIA to protect the drug supply chain. (Sections 713/714, held July 12, 2013). 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 9/5/2013) 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 1/31/2014. This report provides a high level overview of FDA inspection resources.
  • a proposed rule regarding administrative destruction of imported drugs refused admission into the U.S. (Section 708, issued 5/6/2014) 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 U.S

Please join us September 18th at Washington D.C.’s Newseum for Interchange 2014, and hear more from Deputy Director Sklamberg about what the FDA is doing to protect the secure U.S. drug supply chain.

By S. Imber