Regulatory agencies, says Encyclopedia Britannica, are a uniquely American institution. Though conceptualized as mere advisory bodies at the time of their emergence in the late 19th century, federal regulatory agencies have since acquired comprehensive legislative powers and even quasi-judicial powers — exercising “social control through rulemaking” with “almost no supervision by other branches of government.”
As legal scholars tamely explain, “unique pressures and influences … invariably push [regulators’] actions, and their decisions on policy questions, in a direction favored by regulated firms.”
In the crowded field of captured agencies, the U.S. Food and Drug Administration (FDA) is one of the standouts. FDA gets 45% of its budget from the pharmaceutical industry, and fast-tracks more than 50% of the drugs it approves.
Consumer watchdog groups accuse the FDA of having evolved from a “hard-charging tiger of an agency” a century ago, to a “pliant pussycat” today.
FDA states that drug recalls are initiated either “by FDA request” or “on a company’s own initiative.” According to the consumer website Drugwatch, however, FDA “can only recommend” but not force a recall.
Vaccine recalls, too, are “almost always initiated voluntarily by the vaccine manufacturer.” In 1976, public outcry forced the government to pull the plug on a dangerous swine flu vaccine after just 10 weeks, but only after 40 million Americans had received it.
Although manufacturers do withdraw dangerous drugs, vaccines and consumer products from the market from time to time (sometimes after FDA has obligingly looked the other way for decades), many observers believe such recalls represent the tip of the iceberg — a placatory bone thrown to persuade the public that the nation has a functional oversight system.
Is the FDA at least scrupulous about which drugs and vaccines it lets out of the starting gate?
The still timely tale of thalidomide
Thalidomide never received FDA approval, but the saga illustrates how, even 60 years ago, the FDA had already cast its lot with industry.
In the late 1950s, German firm Chemie Grünenthal (now Grünenthal) developed thalidomide with the help of former Nazi scientists (including Hitler’s IG Farben adviser on chemical warfare), promoting the drug for nausea and other discomforts of pregnancy.
In some countries, thalidomide was an ingredient in children’s cough syrups. Chemie Grünenthal sold thalidomide in 46 countries for five years before admitting the drug posed risks of severe birth defects, including missing or deformed limbs and injuries to major organs.
In the U.S., Chemie Grünenthal gave two pharmaceutical giants (companies that dominate the American market to this day) permission to manufacture thalidomide: first Smith Kline & French (now GlaxoSmithKline) and then Richardson-Merrell (now Sanofi).
Richardson-Merrell expected smooth regulatory sailing, but after it ignored repeated requests for pregnancy safety data from Dr. Frances Kelsey — a newly minted FDA employee with untarnished integrity — Kelsey “took a bold stance against inadequate testing and corporate pressure” and refused to approve thalidomide’s U.S. release.
Mistakenly confident that “corporate pressure” would eventually bear fruit, the company went ahead and distributed, “in an uncontrolled fashion,” more than 2.5 million doses of thalidomide to 20,000 pregnant women under cover of “clinical trials.”
When Kelsey still would not approve the drug, the company was forced to give up, but threatened to sue Kelsey after she tried to track down thalidomide babies. Neither the FDA nor the U.S. attorney backed up Kelsey.
In 1962, President John F. Kennedy shone a light on Kelsey’s efforts by giving her a President’s Award for Distinguished Federal Civilian Service. Even so, thalidomide survivors allege the FDA and Richardson-Merrell kept the full story of thalidomide buried for decades.
In fact, not only did FDA squelch efforts to locate thalidomide victims, but it produced a whitewashed report stating that Richardson-Merrell’s “unauthorized marketing program” had produced just 17 thalidomide babies — a bogus estimate emphatically denounced by survivors.
At some point, FDA appears to have quietly changed its tune. In an undated presentation on its website, the agency states: “By late 1961, it was obvious that thalidomide had caused serious birth defects in thousands of children.”….