FDA’s Emerging Global Drug Safety Role

Title VII of the FDA Safety and Innovation Act (FDASIA) will advance FDA’s transformation into a global public health agency, says Deputy Commissioner Howard Sklamberg in his recent FDA Voice blog entry, primarily, by enabling it better oversight of the safety and integrity of drug ingredients and finished drugs in the supply chain. “Since July 9, 2012, when President Obama signed FDASIA, a group of my colleagues and I have had an urgent mission: implement Title VII of the statute.” This section, says Sklamberg, gives 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, says the Agency, lets the regulator become better informed about supply chain risks. “This information allows 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,” says Sklamberg, and “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.”

FDA says it is working diligently to implement those enforcement tools and over the past two years, FDA has made many parts of Title VII a reality. Its accomplishments, say the Agency, include:

  • Drafting 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.
  • Crafting draft guidance defining what the agency considers to be actions that delay, deny, or limit an inspection. (Section 707, issued 7/9/2013) In drafting 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.
  • Holding a public meeting to discuss how the agency might implement certain parts of FDASIA to protect the drug supply chain. (Sections 713/714, held July 12, 2013).
  • Issuing draft guidance specifying the unique facility identifier (UFI) system for drug establishment registration.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.
  • Delivering 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.
  • Submitting 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.

“Working together with stakeholders,” says Sklamberg closing his post, “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.

See more at: http://blogs.fda.gov/fdavoice/#sthash.3SFibGfT.dpuf

 

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