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Profile: Food and Drug Administration (FDA)
Food and Drug Administration (FDA) was a participant or observer in the following events:
The Supreme Court rules in INS v. Chadha that Congress has no right to issue what it calls “legislative vetoes,” essentially provisions passed by Congress giving the executive branch specific powers but with Congress reserving the right to veto specific decisions by the executive branch if it does not approve of the decisions made by the executive. Congress had relied on such “legislative vetoes” for years to curb the expanding power of the president. The Court strikes down hundreds of these “legislative vetoes” throughout federal law. Congress quickly schedules hearings to decide how to respond to the Court’s ruling. White House attorney John Roberts (see September 29, 2005), a young, fast-rising conservative, is one of a team of lawyers assigned to review the administration’s upcoming testimony before Congress. Some of the lawyers want to push Congress to place independent agencies such as the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) under White House control—part of the evolving “unitary executive” theory of presidential power (see April 30, 1986). Roberts writes: “With respect to independent agencies… the time may be ripe to reconsider the existence of such entities, and take action to bring them back within the executive branch.… I agree that the time is ripe to reconsider the Constitutional anomaly of independent agencies… More timid souls may, however, desire to see this deleted as provocative.” [Savage, 2007, pp. 256-257]
Upon learning that the Food and Drug Administration (FDA) has decided not to require special regulation for genetically engineered foods (see May 26, 1992), FDA scientist Dr. Louis J. Pribyl blasts the decision in a memo to his colleagues. “This is the industry’s pet idea, namely that there are no unintended effects that will raise the FDA’s level of concern,” he writes. “But time and time again, there is no data to back up their contention.” Pribyl, one of 17 government scientists who have been working on a policy for genetically engineered food, knows from his own research and studies that the introduction of new genes into a plant’s cell can produce toxins. [New York Times, 1/25/2001]
The Food and Drug Administration (FDA) announces that it will not permit pharmacies to sell the emergency contraception drug “Plan B” without a prescription. The drug is a “morning-after” birth-control drug that prevents fertilization and the implantation of the embryo. The agency explains to the manufacturer of the drug, Barr Pharmaceuticals, that the government is worried about the possibility that teenaged girls might not understand how to correctly use the drug without a doctor’s advice. The FDA’s decision is in direct contradiction of a federal advisory panel’s 23-4 decision to recommend approving the drug for over-the-counter sales, including to teenagers, without a doctor’s approval. The FDA’s staff recommended that the agency follow the panel’s recommendation. In 2007, author and reporter Charlie Savage will write, “Normally, agencies such as the FDA base their decisions on the information provided by their expert advisory panels—but, strangely, not this time.” A spokesman for the presidential campaign of John Kerry (D-MA) says: “By overruling a recommendation by an independent FDA review board, the White House is putting its own political interests ahead of sound medical policies that have broad support. This White House is more interested in appealing to its electoral base than it is in protecting women’s health.” James Trussell, director of the office of population research at Princeton University and a member of the advisory board, says, “The White House has now taken over the FDA.” Numerous women’s groups accuse the FDA’s political appointees of overruling the experts in order to please social conservatives who believe that the “Plan B” drug encourages promiscuity and is a form of abortion. In the following months, a lawsuit will be filed to have the FDA’s decision overturned (see January 21, 2005 and After). [New York Times, 3/7/2004; Savage, 2007, pp. 300-301]
The Center for Reproductive Rights (CRR) files a lawsuit against the Food and Drug Administration (FDA) asking that the courts reverse a recent FDA decision not to allow the so-called “morning-after” birth-control drug “Plan B” to be sold without a prescription (see May 6, 2004 and After). The CRR says the FDA’s decision was made based on politics and not science. CCR president Nancy Northrup will say that the FDA’s decision “broke its own rules, held Plan B to a higher standard than other over-the-counter drugs, and [as a result,] women have suffered the consequences.” Testimony and depositions gathered indicate that the FDA indeed placed politics over science in its decision. One scientist says that a deputy FDA commissioner told her that the over-the-counter (OTC) application for Plan B had to be rejected “to appease the administration’s constituents,” and that it could later be quietly approved for adults only (see March 4, 2008). Another scientist testifies that he learned before the 2004 decision was issued that then-FDA commissioner Mark McClellan—the brother of White House press secretary Scott McClellan—had already decided to disapprove the drug even before the FDA’s advisory panel had completed its analysis. However, McClellan will deny the accusation. [Center for Reproductive Rights, 11/14/2005; Savage, 2007, pp. 301-302]
A federal judge dismisses a lawsuit seeking to halt sales of the so-called “morning-after” birth control pill, the only such drug available in the US without a prescription. In 2006, the FDA reversed its 2004 decision not to allow the drug to be sold over the counter (see May 6, 2004 and After) to anyone 18 years of age or older. The suit was brought by the Association of American Physicians and Surgeons and a number of anti-abortion and social conservative groups. The US District Court in the District of Columbia finds that the plaintiffs failed “to identify a single individual who has been harmed by Plan B’s OTC [over-the-counter] availability.” The ruling is widely considered to be a victory for advocates of reproductive rights. “They still don’t have any evidence in terms of why they think it is harmful,” says Janet Crepps of the Center for Reproductive Rights (CRR). “This is the right decision for women.” A lawsuit filed by the CRR to force OTC sales of the drug to girls under 18 is still pending (see April 22, 2009). [Reuters, 3/4/2008]
The Food and Drug Administration (FDA) announces that, in line with a judge’s recent ruling, it will approve the sale of the so-called “morning-after” emergency contraception pill to 17-year olds without a doctor’s prescription. A judge recently ruled in favor of the Center for Reproductive Rights (CRR) in a lawsuit against the FDA (see January 21, 2005 and After). Under the Bush administration, the FDA ruled that the pill, called “Plan B,” could not be sold without a prescription (see May 6, 2004 and After), a decision partially reversed in 2006. Conservative groups say the decision will make it more difficult for parents to supervise their teens; women’s rights groups say the decision strengthens the rights of women. District Judge Edward Korman ruled that the FDA’s political appointees placed politics over science in its decision to restrict over-the-counter (OTC) sales of the drug; he wrote that evidence showed White House officials pressured the FDA to reject the drug’s OTC sales. His ruling orders the FDA to allow OTC sales to 17-year olds, and to evaluate whether all age restrictions should be lifted. CRR’s Nancy Northrup says, “It’s a good indication that the agency will move expeditiously to ensure its policy on Plan B is based solely on science.” Wendy Wright of the conservative action group Concerned Women for America says, “Parents should be furious at the FDA’s complete disregard of parental rights and the safety of minors.” In 2008, a judge ruled that conservative groups had failed to prove that the drug posed a risk to anyone (see March 4, 2008). Former FDA official Susan Wood, who resigned in 2005 over the issue, says the battle over Plan B came to symbolize just how politicized the agency became under President Bush. “The FDA got caught up in a saga, it got caught up in a drama,” she says. “This issue served as a clear example of the agency being taken off track, and it highlighted the problems FDA was facing in many other areas.” [Associated Press, 4/22/2009; Washington Post, 4/23/2009] “We need to have a very strong and science-based agency, and this is one of those steps that will help strengthen it,” Wood says. [USA Today, 3/23/2009]
Graphic of Frank VanderSloot, appearing on Fox News. [Source: Fox News Insider]Salon’s Glenn Greenwald reports that Idaho billionaire Frank VanderSloot, the CEO of Melaleuca, Inc. and a prominent donor for the presidential campaign of Mitt Romney (R-MA), apparently objects to media reports about his financial and corporate practices, issuing threats against those who report on him and his company. VanderSloot is the national finance co-chair of the Romney campaign and a longtime Republican donor. Like Romney, he is a devout Mormon and an active member of the Church of Jesus Christ of Latter-Day Saints.
Accusations of Wrongdoing - VanderSloot and Melaleuca have donated at least $1 million to the “independent” super PAC supporting Romney, Restore Our Future (ROF—see June 23, 2011). Melaleuca, which manufactures and distributes dietary supplements and cleaning products, was described by Forbes magazine in 2004 as “a pyramid selling organization” comparable to Amway and Herbalife. Melaleuca has been sanctioned by Michigan regulatory agencies, and agreed to refrain from “engag[ing] in the marketing and promotion of an illegal pyramid” in that state. It entered into a separate agreement with the Idaho attorney general’s office after that office found that some Melaleuca executives had broken Idaho law. And the Food and Drug Administration (FDA) has accused Melaleuca of deceiving customers about its supplements.
Threats of Lawsuits - VanderSloot counters media reports of Melaleuca’s alleged wrongdoing with what Greenwald calls “chronic bullying threats to bring patently frivolous lawsuits against his political critics—magazines, journalists, and bloggers—that makes him particularly pernicious and worthy of more attention.” His threats have forced Forbes, Mother Jones, and a gay blogger in Idaho to remove material that was critical of his political and business practices, though Mother Jones reposted its article after revisions were made. Greenwald reports: “He has been using this abusive tactic in Idaho for years: suppressing legitimate political speech by threatening or even commencing lawsuits against even the most obscure critics (he has even sued local bloggers for ‘copyright infringement’ after they published a threatening letter sent by his lawyers, and demanded the public outing of some bloggers’ identities). This tactic almost always succeeds in silencing its targets, because even journalists and their employers who have done nothing wrong are afraid of the potentially ruinous costs they will incur when sued by a litigious billionaire.” Greenwald reports that VanderSloot’s tactics have had a chilling effect on Idaho journalists and bloggers, who routinely refuse to write critically about VanderSloot’s fundraising for conservative causes. And now that VanderSloot is a senior official in the Romney campaign, Greenwald writes, he is expanding his tactics beyond Idaho. “To allow this scheme to continue—whereby billionaires can use their bottomless wealth to intimidate ordinary citizens and media outlets out of writing about them—is to permit the wealthiest in America to thuggishly shield themselves from legitimate criticism and scrutiny,” he writes. “It’s almost impossible to imagine any more thuggish attempts to intimidate people from speaking out and criticizing VanderSloot,” he adds. “The effect, if not the intent, of these frivolous threats, pure and simple, is to intimidate those who cannot afford to defend themselves from criticizing the very public, politicized acts of Frank VanderSloot and his company. That’s why one no longer can even read most of the criticisms that prompted these warnings.”
Anti-Gay Activism - Greenwald writes that VanderSloot has a history of anti-gay activism, citing his funding of a billboard campaign that condemned Idaho Public Television for showing a documentary that reported on the effects of addressing lesbian and gay issues inside elementary classrooms. Though the documentary reported that working with such issues in an age-appropriate fashion was generally positive, VanderSloot accused IPT of promoting a threat to children, saying, “[I]f this isn’t stopped… little lives are going to be damaged permanently.” His wife Belinda donated $100,000 to California’s anti-gay marriage Proposition 8 campaign in 2008. And when the Idaho Falls Post Register reported on a pedophile preying on local Boy Scouts, a Mormon bishop’s alleged complicity in the matter, and the network of pedophiles that was behind the original allegations, VanderSloot attacked the newspaper and the principal reporter, Peter Zuckerman. (The six-part series won the Scripps Howard Award for Distinguished Service to the First Amendment.) VanderSloot bought full-page ads in the Post Register attacking the story and outing Zuckerman as “a homosexual,” a fact that Zuckerman had not advertised since moving to Idaho years before. VanderSloot’s ads asked if Zuckerman’s sexual orientation made him hostile to the Boy Scouts and the Mormon Church. The damage to Zuckerman’s professional and personal life was severe, including physical threats and his longtime partner being fired from his job. [Salon, 2/17/2012]
Response - VanderSloot responds in a subsequent interview with local Idaho reporter Marissa Bodnar. After the Greenwald report, MSNBC talk show host Rachel Maddow devotes a segment to VanderSloot based largely on Greenwald’s article. According to VanderSloot, Greenwald “quotes what others have wrongfully said about us and then taunts us to do something about the fact that he repeats it.” Idaho independent journalist and blogger Jody May-Chang, who has also been threatened with lawsuits by VanderSloot’s lawyers, says in response: “Mr. VanderSloot is a public political figure. They’re fair game… especially when you’re talking about behaviors and actions and things done in public light that are well known.” VanderSloot denies harboring an anti-gay agenda, saying, “I have never spoken out against gays or against gay rights,” though Bodnar notes, “[S]ome said money speaks louder than words.” VanderSloot admitted to contributing money to a group that challenged a pro-gay marriage documentary aired on Idaho public television in 1999; May-Chang says, “I’m not sure how anyone else could not characterize those as anti-gay.” For his part, VanderSloot says, “I believe that gay people should have the same freedoms and rights as any other individual.” His main objection to the Idaho Public Television program about addressing gay issues in schools, he says, was that it was being aired during prime time, “when it would attract the most children,” and the use of tax dollars to fund the program. He contends that his status as a “billionaire” is “greatly exaggerated,” and though he owns a controlling interest in Melaleuca, he is not “cash-rich.” He defends his attacks on the Idaho Falls Post Register, saying that he deplores the pedophiles who were preying on children but found the story to be “unfair” in its coverage. He was merely defending people who had been unfairly portrayed as being involved in the affair, he says, and notes that he “would use a much different approach were this to happen again.” He denies outing Zuckerman as a gay man, claiming that Zuckerman’s sexual orientation was public knowledge, and saying that contrary to Greenwald’s reporting, he defended Zuckerman in the Post Register advertisements. He denies that Melaleuca’s business model is anything like those used by Amway or Herbalife, and says Melaleuca does not employ a “pyramid scheme” to make its profits. VanderSloot says Melaleuca “will continue to use whatever legal means are available to us to defend the truth and to request corrections where false allegations have been made.” He is strongly critical of Greenwald’s article, and accuses Greenwald of deliberately repeating “the original false allegations” against him and Melaleuca. He concludes: “We can disagree on issues and argue those issues in honest and open debate. You can count on us to not smear or attack the messenger. We will defend their right to disagree. But we do ask even those who disagree with us to tell the truth about who we are and what we do. We will continue to ask that of people. That is not going to change.” [KIFI Local News 8, 3/1/2012]
Entity Tags: Idaho Public Television, Idaho Falls Post Register, Frank VanderSloot, Forbes magazine, Food and Drug Administration, Willard Mitt Romney, Restore Our Future, Rachel Maddow, Peter Zuckerman, Melaleuca, Inc., Mitt Romney presidential campaign (2012), Marissa Bodnar, Jody May-Chang, Mother Jones, Glenn Greenwald
Timeline Tags: Civil Liberties
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