Thursday, October 23, 2014
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The FDA continues to play a vital role

Today, although the FDA reflects some inefficiency inherent in any large organization, it remains as necessary for a modern pharmaceutical industry as Merck, Pfizer or the most scientifically inventive biotech.

The FDA continues to play a vital role

Last year, as reauthorizing legislation for the Food and Drug Administration was nearing ratification, the Obama administration urged the agency to speed its approval process for new drug candidates. It appears uncertain whether the administration was buying the pharma line that stringent regulatory review costs jobs or if the White House staff counseled bending over backwards for hostile Republicans by favoring a policy of lax regulation.

Despite the administration's election season posturing, Democrats have traditionally encouraged a rigorous FDA. Democratic congressmen such as Henry Waxman and John Dingell in the House, together with their party colleagues elsewhere in Washington, generally held the FDA's feet to the fire by demanding careful reviews. But Republicans have also come down on both sides of favoring tough versus lenient drug regulation. Charles Grassley, Republican senator from Iowa, remains one of the staunchest legislators in terms of demanding that the FDA not act as the drug industry's pet.

The example of Grassley notwithstanding, conservatives generally favor public policies that emphasize "values."  Typically, this means a combination of repressive Victorian morality and a despotic Christian theology. But the term they prefer to use in connection with their animating regulatory principle is "freedom," defined as a lack of government restrictions. In practice, they pursue freedom as it permits wealthy individuals and corporations to exploit advantages in the market.

Sabeel Rahman of Harvard makes the point that over the past 100 years, progressive reformers in the U.S. have also opposed dangers to freedom that come from sources beside arbitrary state power. Powerful private entities such as corporations pose an even more intrusive threat to individual freedom. In this progressive vision, "government is not an obstacle to freedom that must be dismantled; rather it is a vital tool that can help expand individual freedom."  

As conceived by reformers such as Louis Brandeis and John Dewey, freedom requires enacting public policies that protect individuals from private exploitation and harm. Toward that end, regulation and oversight are necessary means because they check the power of large corporations to dominate workers, harm consumers and corrupt the political process.

When Congress first passed the Pure Food and Drug Act in June 1906, it was precisely to protect the public from patent medicines that contained narcotics, poisons, excessive caffeine, alcohol and morphine. That vision persisted through several revisions and organizational changes, involving at various times the Bureau of Chemistry, the Bureau of Chemistry and Soils, and finally the Food, Drug, and Insecticide Administration that in 1930 was renamed the FDA. 

Today, although the FDA reflects some inefficiency inherent in any large organization, it remains as necessary for a modern pharmaceutical industry as Merck, Pfizer or the most scientifically inventive biotech. 

In reality, the agency is just a surrogate for two things that contemporary conservatives despise. The first is a scientifically based view of mankind and the world. Their second bugbear consists of efforts that support an individual's right to freedom from corporate supremacy. The FDA, in short, is more than another political bureaucracy. It is a symbol that serves as a basis for thinking about the political economy.

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About this blog

Check Up covers major health events in our region and offers everything from personal health advice to an expert look at health reform. Read about some of our bloggers here.

For Inquirer.com. Portions of this blog may also be found in the Inquirer's Sunday Health Section

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