Tighten Foreign Inspections

A petition to FDA calls for clearer inspection policies. Until then, consumers may have to scrutinize such imported products as toothpaste.

 

While no injuries were reported in the United States, many have questioned how such imports could have been allowed, risking U.S. public health. In December, Alston & Bird LLP issued a citizen petition to FDA expressing concerns about FDA’s inspection program. “The red flags are all around us, whether it is Chinese fever medications containing diethylene glycol, or counterfeit Indian or Chinese methotrexate or Viagra,” wrote Marc Scheineson and Donald Segal for the firm. They pointed out that “FDA’s foreign inspection program has been predominantly a preapproval inspection program…there is no reason to assume that same level of compliance will be maintained in the years ahead. Routine surveillance is intended to address that issue.” In fact, 88% of foreign inspections between 2002 and 2007 were for preapproval applications.

The petition also pointed out that foreign firms are inspected less frequently than domestic ones. Scheineson and Segal wrote: “Certainly, recent recalls suggest that more scrutiny is needed.”

To shore up weaknesses in foreign inspections, the petition calls for a number of reforms. These include the creation of a publicly available database of foreign and domestic pharmaceutical-product manufacturing firms registered with FDA and selling product in the United States and therefore subject to cGMP inspection; a ranking of foreign and domestic manufacturing firms according to FDA’s risk-based approach; and criteria to determine frequency and circumstances of cGMP inspections.

It is unclear whether tighter foreign inspection policies could have caught potentially harmful or counterfeit toothpastes before they reached the United States. FDA’s current approach to protecting consumers includes encouraging them to look for Drug Facts panels on the labeling of imported drug toothpastes. “If a drug toothpaste does not show the ‘Drug Facts’ information, do not use it. It is not legally marketed in the United States,” FDA’s Web site says.

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