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Context of 'March 4, 2008: Judge Dismisses Lawsuit to Restrict Sales of ‘Morning-After’ Birth Control Pill'

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May 20, 1999: Vioxx Approved by FDA

The Food and Drug Administration approves Vioxx as a treatment for acute pain, dysmenorrhea, and osteoarthritis in adults, making the drug the second Cox-2 inhibitor available by prescription in the United States. [US Food and Drug Administration, 2005]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

The Food and Drug Administration holds an advisory meeting on the VIGOR study, a clinical trial for the drug Vioxx, to assess whether there is a connection between the drug and heart problems. Unlike the VIGOR study published in the New England Journal of Medicine (see November 23, 2000), this group includes heart attacks 18, 19, and 20 (see March 2000) in their analysis. The meeting’s members conclude that there is not enough data to draw a solid conclusion. [US Food and Drug Administration, 3/8/2001; National Public Radio, 6/8/2006] Notwithstanding, they do recommend that physicians be informed that the VIGOR study showed “an excess of cardiovascular events in comparison to naproxen.” [Office of Representative Henry A. Waxman, 5/5/2005, pp. 21 pdf file] On March 7, the agency publishes all of the VIGOR data on its website, as well as its analysis. [US Food and Drug Administration, 3/8/2001]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

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]

Entity Tags: Charlie Savage, Barr Pharmaceuticals, Bush administration (43), James Trussell, John Kerry, Food and Drug Administration

Timeline Tags: US Health Care, Civil Liberties

The Food and Drug administration approves Vioxx for children who are over the age of 2 and have symptoms of rheumatoid arthritis. [US Food and Drug Administration, 6/1/2005 pdf file] The approval is announced on September 8. [United Press International, 9/8/2004; Medical News Today, 9/9/2004]

Entity Tags: US Food and Drug Administration

Timeline Tags: US Health Care

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]

Entity Tags: Mark McClellan, Center for Reproductive Rights, Nancy Northrup, Food and Drug Administration, Scott McClellan

Timeline Tags: US Health Care, Civil Liberties

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]

Entity Tags: Association of American Physicians and Surgeons, Food and Drug Administration, Janet Crepps, Center for Reproductive Rights

Timeline Tags: US Health Care, Civil Liberties

According to media reports, the Obama administration intends to reverse the “right of conscience rule,” formally called the Provider Refusal Rule, for health care workers enacted by President Bush in the last weeks of his term. In December 2008, Bush issued an executive order allowing health care workers to deny care based on their personal beliefs. The order was issued to target doctors and nurses who do not want to provide abortions, even if they work in a facility that offers abortions to clients. Specifically, the rule denies Department of Health and Human Services (HHS) funding to institutions that do not allow workers to refuse care that goes against their beliefs. Now the Obama administration says President Obama will override that order. Seven states have already challenged the rule, claiming it sacrifices the health of patients in order to satisfy the religious or moral beliefs of medical personnel. The American College of Obstetrics and Gynecology has reported cases such as that of a Virginia mother of two who became pregnant because she was denied emergency contraception; in Texas, the group said, a rape victim had her prescription for emergency contraception rejected by a pharmacist. Obama has already overturned a ban on US funding for international aid groups that provide abortion services. However, administration officials say the administration may consider a rule that would clarify what health care workers can reasonably refuse. An HHS spokesman says: “We recognize and understand that some providers have objections to providing abortions. But we do not want to impose new limitations on services that would allow providers to refuse to provide to women and their families services like family planning and contraception that would actually help prevent the need for an abortion in the first place.” Dr. Suzanne Poppema of Physicians for Reproductive Choice and Health praises Obama “for placing good health care above ideological demands,” and says: “Physicians across the country were outraged when the Bush administration, in its final days, limited women’s access to reproductive health care. Hundreds of doctors protested these midnight regulations and urged President Obama to repeal them quickly. We are thrilled that President Obama took the first steps today to ensure that our patients’ health is once again protected.” Tony Perkins of the anti-abortion Family Research Council (FRC) counters: “Protecting the right of all health care providers to make professional judgments based on moral convictions and ethical standards is foundational to federal law and is necessary to ensure that access to health care is not diminished, which will occur if health care workers are forced out of their jobs because of their ethical stances. President Obama’s intention to change the language of these protections would result in the government becoming the conscience and not the individual. It is a person’s right to exercise their moral judgment, not the government’s to decide it for them.” [Chicago Tribune, 2/27/2009; CNN, 2/27/2009; New York Times, 2/27/2009] The liberal Center for American Progress (CAP) writes in April 2009: “Conservatives have criticized the Obama administration for infringing upon the conscience of health care professionals and ‘forcing’ them to provide abortion services.… Yet this assertion could not be further from the truth. President Obama’s proposal to rescind Bush’s last-minute rule restores the pre-existing compromise established through decades of debate.” CAP notes that Title VII of the Civil Rights Act disallows employers from firing or harassing workers who decline to fulfill assigned tasks due to moral or religious objections. “Obama’s proposal to rescind the Bush ‘conscience’ rule simply restores the prior balance that existed on matters of conscience,” CAP concludes. “It once again guides the health care system to value the consciences of health care providers and patients.” [Jessica Arons and Sarah Dreier, 4/28/2009] However, for reasons never made publicly clear, the Obama administration will never actually rescind the order. It is possible that Obama or HHS officials bow to pressure from a number of organizations such as the FRC and the Christian Medical Association, which have continually pressured the administration not to rescind the order. [Fox News, 4/8/2009; Time, 2/4/2010; Megan Sullivan, 7/13/2010]

Entity Tags: American College of Obstetrics and Gynecology, Family Research Council, Christian Medical Association, Barack Obama, Bush administration (43), Center for American Progress, Tony Perkins, George W. Bush, US Department of Health and Human Services, Obama administration, Provider Refusal Rule, Suzanne Poppema

Timeline Tags: US Health Care

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]

Entity Tags: George W. Bush, Bush administration (43), Center for Reproductive Rights, Food and Drug Administration, Susan Wood, Wendy Wright, Nancy Northrup, Edward Korman

Timeline Tags: US Health Care, Civil Liberties

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