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Should Taxpayers Bear the Costs of Quality?

March 6, 2009 – 4:28 pm

Addressing the issue of salmonella-ridden peanut butter in his weekly message, Frank M. Torti, acting FDA commissioner, explained on March 2 that FDA and other government agencies are spending a lot of time looking for bad nuts. And probably money. “You should know that we at FDA as well as our colleagues in other branches of government are working tirelessly to make sure this outbreak is contained and understood,” he wrote. “For example, our inspectors are working day and night visiting sites across the country to be sure that the recalled products are actually being removed from the store shelves.”

Such inspectors marching into stores reminded me of the California State Board of Pharmacy’s 2008 search for recalled heparin. Last year the CA BoP inspected “all 533 licensed hospital pharmacies in California between late April and early June 2008. The board identified 94 hospitals where recalled heparin or Digitek was found in nonquarantined areas.”

We are in a national, if not global, economic crisis. Is this what taxpayers should be spending money on?

Don’t get me wrong. People have reportedly died from eating contaminated peanut butter as well as from adulterated heparin, so ensuring that all recalled product is actually recalled is vital.

But in the future, do we need to add money to FDA’s budget as well as to the budgets of other government agencies–i.e., pay more in taxes–just to be able to staff inspectors to find bad products?

Or should we instead be putting more money toward manufacturing inspections to catch violations before products are shipped? FDA has often based inspection decisions on the risk level of the product being manufactured. For instance, in drugs, FDA’s specialized team of experts, the Pharmaceutical Inspectorate, was intended to “focus a majority of [its] time on conducting human and animal drug quality inspections on high risk firms.”

But as I asked in a previous post–since when was peanut butter considered a “risky” product?

Shouldn’t FDA be funded and staffed enough to inspect every registered facility?

Or, better yet, should fines be higher to ensure that companies maintain adequate controls and quality procedures and never ever be tempted to ignore any problems?

In this economy in particular, manufacturers may be tempted to ignore test results that raise questions of product quality because it costs money to discard questionable product. Manufacturers may also be tempted to look for cheaper ingredients and raw materials and to ignore questions about their quality and authenticity, again, because the bargains may result in a better bottom line.

But the costs must be borne somewhere.

I called the California State Board of Pharmacy today to ask why its Scripts newsletter, which was due out in January and was to have a report on the heparin recalls, wasn’t available online. I wanted to ask just how much money California spent on these recalls. But the board’s receptionist wasn’t available today, March 6. Governor Arnold Schwarzenegger has issued an executive order to close state offices on the first and third Fridays of the month.

Again, the costs must be borne somewhere.

Daphne Allen

  1. One Response to “Should Taxpayers Bear the Costs of Quality?”

  2. Great question raised. Quite a debatable issue.

    By Medication Therapy Management on Feb 8, 2010

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