A Word to the Unwise - Pharmaceutical Technology

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A Word to the Unwise
After a spate of industrial disasters, the public seeks greater oversight of corporations—so does FDA.


Pharmaceutical Technology
Volume 34, Issue 7, pp. 12


Michelle Hoffman
Maybe with summer around the corner, corporations are getting spring fever and losing focus. But it seems that a lot of them are becoming distracted (again), and the quality of their products and operations are suffering.

For example, as I write this, newspapers, TV, radio, the Internet, and the blogosphere are dominated by reports of BP's failed attempts to plug its catastrophic oil spill in the Gulf of Mexico (as well as BP executives' clumsy attempts to apologize for their mess). A few months ago, Toyota—a leader in quality control—issued massive recalls of its cars and trucks, stemming shockingly from lapses in quality control.

And in a series of quality breaches that hit closer to home, we are learning more details about an ongoing succession of recalls by Johnson & Johnson of over-the-counter products, including a bizarre "phantom recall," in which the company contracted people to buy tainted Motrin off store shelves rather than formally recall the product. (In an article published on June 11, the New York Times quoted a company spokesperson as saying that the objective was "to remove the affected product from a unique distribution channel, mainly convenience stores and gas stations, with as little disruption and consumer confusion as possible." In that same article, the US Food and Drug Administration begged to differ. The article cited an email from one of FDA's recall coordinators as saying to J&J, "It seems that your company is doing a recall even though you are calling it a 'retrieval' ... your company should do a voluntary recall of the product since it appears to be that you are already doing a recall of the product." (The company did later institute a formal recall, according to the Times article.) We are also learning that Pfizer dragged its heels in reporting adverse events associated with its cholesterol-lowering drug Lipitor and its antiseizure medication Lyrica, prompting FDA to issue a Warning Letter.

In theory, the specters of legal liability and/or public disapproval (along with declines in sales and stock prices) are supposed to check corporate temptation to cut corners on quality or to be otherwise negligent. Nevertheless, recent events seem to indicate that neither liability nor public disapproval is adequate to ensure good corporate citizenship.

So it should come as no surprise that after each of these incidents, the public looked to the government to increase its oversight of the affected industry. As a result of BP's fiasco in the Gulf of Mexico, there is strengthened public support for a moratorium on off-shore drilling and for greater government regulation of the petroleum industry. In response to the recent financial crisis, a bill is now wending its way through Congress that calls for greater regulation of the financial industry, banks, hedge funds, and mortgage lenders. And, in spite of the well publicized role of FDA in regulating drug safety, a recent poll indicates most people feel pharmaceuticals ought to be better regulated.

Of the more than 2500 adults responding to a Harris poll, conducted in May 2010, 70% felt that the government should impose even stricter regulations on the pharmaceutical industry than it does now. Surprisingly, even a majority—61%—of respondents self-identified as Republican, who usually oppose government intervention in industry—felt that pharmaceuticals required more regulation than they now receive. (In contrast, 80% of self-identified Democrats supported stricter oversight of pharmaceuticals.)

The American public is not alone in feeling that corporations—specifically their executives—need to be monitored a little more closely. Brian Hasselbalch in FDA's Division of Manufacturing and Product Quality, Office of Compliance, at the Center for Drug Evaluation and Research addressed the agency's enforcement role in promoting corporate responsibility at a recent meeting held jointly by FDA and Xavier University in Cincinnati, Ohio. The agency seeks to ensure that poor practices are not rewarded, and will take "swift, aggressive, and effective" enforcement action when needed, he said.

Corporations are operating within a quality vacuum, and the public, as well as nature, abhors a vacuum. Ultimately, if corporations are unwilling or unable to regulate themselves, someone will do it for them.

Michelle Hoffman is editor-in-chief of Pharmaceutical Technology. Send your thoughts and story ideas to
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