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Rx-360 Summary of US Legislation of HR 5470

Introduction: HR 5740 proposes to give the FDA mandatory recall authority for adulterated or misbranded human and animal drugs.  Currently, the FDA does not have this authority and depends on the company to make and execute recall decisions, albeit in communication with the local district FDA office.  This legislation was introduced on July 14, 2010 by Representative Edolphus Towns, Chairman of the House Committee on Oversight and Government Reform.  Chairman Towns mentioned that he would be introducing this legislation during the May 27, 2010 hearing conducted with regard to the several McNeil Consumer Healthcare recalls of their liquid pediatric formulations made in Fort Washington PA. This draft legislation provides for three recall options.
  • The company may initiate recalls as in the past
  • FDA may require a recall when “reasonable probability” exists that “…the drug will cause a threat of serious adverse health consequences or death…”
  • FDA may issue a recall order when they have “…credible evidence…that a drug…presents an imminent threat of serious adverse health consequences or death…" 
The sections that address non-delegation of these responsibilities are important to note.  In the situation described in the second bullet point, the responsibility may only be delegated to the district director, or their superior, where the drug involved is located.  In the third bullet, these responsibilities may only be performed by the Commissioner of Food and Drugs, the Principal Deputy Commissioner, or the Associate Commissioner for Regulatory Affairs of the FDA.  Thus, it appears that recall decisions made by FDA are not at the discretion of individual ORA inspectors who may uncover evidence that can ultimately lead to a recall.  In both cases where FDA exercises their recall authority, the company has access to appeal the decision within 24 hours of its issuance and petition for review at an informal hearing to be held within 5 days of the appeal. 

It is unclear if the bill will be considered by the full House of Representatives during 2010.  We will continue to track developments and provide additional updates, as warranted.

download / view the FDA's report click here

download / view the Rx-360 summary click here


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