Sen. Grassley Raises Concerns About Safety Of Medications Manufactured In Developing Nations

Main Category: Pharma Industry / Biotech Industry
Also Included In: Public Health
Article Date: 08 Feb 2008 - 7:00 PDT

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The small number of FDA inspections of facilities that manufacture medications in developing nations might place U.S. residents at risk, according to Sen. Chuck Grassley (R-Iowa), the Washington Post reports. In a Feb. 1 letter to FDA, Grassley wrote that the number of agency inspections in China decreased from 18 in 2004 to 11 in 2007. However, FDA conducts a large number of inspections in nations such as Germany, Switzerland, Italy and Canada, he wrote.

The disparity has resulted "largely because the FDA can allocate 'user fees' provided by brand-name drug companies to pay for inspections of their plants, many of which are in Europe," but lacks the "money to pay for inspections for low-cost generic drugs," whose manufacturers often operate in developing nations and "do not pay such fees," according to the Post. Grassley wrote, "Since the beginning of FY 2002, the FDA conducted approximately 1,379 inspections of foreign pharmaceutical facilities, often focused in countries with few reported quality concerns." He added that "this seems to be a misplacement of limited FDA resources."

According to FDA officials, medications manufactured in other nations are safe, and the agency has required improvements in the production processes of such treatments and does not rely completely on inspections to ensure their safety (Kaufman, Washington Post, 2/7).

Editorial
FDA "cannot meet its responsibilities if it has to protect itself from politicians," a Washington Times editorial states. The editorial criticizes recent opposition from House Appropriations Committee Chair Rosa DeLauro (D-Conn.) to the Reagan-Udall Foundation, which Congress established to support collaboration with academic and private-sector researchers to improve the development of medications and medical devices. According to the editorial, her opposition "reflects poorly on both her political and scientific judgment."

The FDA Science Board recently concluded that the agency cannot meet responsibilities to "both police and improve the public health" because Congress "adds new responsibilities but not the corresponding resources, even as it blames the FDA for falling short of the new regulations it must enforce," the editorial states, adding, "When politicians even drive away the agency's private support and voluntary participation, you know that at the heart of the FDA's problem are pols willing to attack the agency for political gain" (Washington Times, 2/7).

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