FDA, Adulterated Drugs And Industry Silence

FDA, Adulterated Drugs And Industry Silence

November 29th, 2011 // 1:39 pm @

The various scandals involving adulterated drugs and pet food in recent years prompted some members of Congress to ask the US General Accountability Office to review how the FDA oversees product safety to prevent and respond to economic adulteration. Not surprisingly, the GAO found that the increasing complexities of the global supply chain pose significant challenges – particularly, tracking ingredients back to their original sources.

But the GAO also noted that industry shares some of the blame. To wit, the report states that “gathering information from industry, such as information on potentially adulterated ingredients, presents challenges for the agency in detecting and preventing economic adulteration due to industry reluctance to share such information because it is proprietary.”

How so? During the heparin scandal, the FDA collaborated with scientists outside the agency to identify the contaminant and develop new tests for detection. The GAO notes that industry may be the “best source” of tests for detecting adulteration because these tests are specifically developed to monitor products received from suppliers. But “industry officials indicated that they are often reluctant to share such information because it is proprietary.”

And a fear of lawsuits is another factor. For instance, a company may be worried about provoking a lawsuit for reporting a supplier intentionally adulterating products if the accusation is later unfounded. Agency officials and industry execs told the GAO that “a wrongful accusation can have serious consequences, such as compromising the integrity of the company’s brands and products if certain information became public.”

For the record, economic adulteration can mean different things. As an example, this could involve adding material to increase product weight to more complex efforts to make substitutions or additions in order to avoid detection by tests. Also, the GAO points out that economic adulteration differs from other forms of intentional adulteration, such as bioterrorism or sabotage that is designed to cause harm. And since economic adulteration is intentional, this differs from unintentional adulteration, such as adulteration that results from failing to following good manufacturing practices.

How to cope? The report notes that the FDA does not currently have the authority to accredit or approve third parties to inspect entities that make drugs. If this were in place, the FDA workload would be diminished and could increase the number of facilities inspected. However, the GAO adds the FDA recently received authority to recognize, in certain situations, accreditation bodies that can accredit qualified third parties to inspect food establishments.

The FDA also has had the authority to accredit third parties to conduct inspections of certain domestic and foreign device makers since 2002, and while the agency implemented accreditation programs, which permit eligible establishments to voluntarily request inspections from third-party organizations, relatively few establishments have chosen to take advantage of this program, according to the GAO report.

One possible solution that was suggested is to create an information clearinghouse that would permit companies to share info about adulterated ingredients anonymously with the FDA and others. Industry officials maintain this approach could “enhance the FDA’s ability to disseminate information on adulterated products quickly, facilitate secure information sharing across industries, and enable FDA and industry to respond more rapidly to potential instances of adulteration”


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