Sunday, May 13, 2012

FDA's 2012 Enforcement Priorities

At the recent December 2011 Food and Drug Law Institute (FDLI) conference on Enforcement, Litigation and Compliance Conference in Washington, DC, Howard Sklamberg, Deputy Associate Commissioner for Regulatory Affairs, ORA, FDA at U.S. Food and Drug Administration, gave a speech on ORA 2012 Enforcement Priorities.  The slides from that presentation can be viewed here.  Sklamberg's conclusion included these points:
  • Enforcing the laws and regulations is one of the Agency’s highest priorities.
  • Effective enforcement ensures that businesses 
    • remain vigilant about their corporate responsibility to comply with the laws enforced by FDA; 
    • firms invest in quality systems that prevent harm to the public; and
    • those who do comply with the law are not unfairly disadvantaged.
  • FDA needs to transform from a domestically-focused safety agency operating in a globalized world to a truly globally-focused agency that is fully prepared for a regulatory environment in which national borders are less relevant to product safety than they have been in the past.
  • FDA intends to build international coalitions of regulators who have the capability and technology to rapidly share public health information and protect those they serve.
  • Advantages for industry may include: fewer inspections, stream-lined regulation, level playing field between foreign and domestic producers, elimination of the competitive advantage of non-compliance.
  • This monumental effort will take a long-term investment in time and resources, but the pay off will be added safety and security for American consumers.

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