- Email: [email protected]
Clinton nominates FDA chief
POLICY AND PEOPLE
Clinton nominates FDA chief
O
More than a year after the departure of David Kessler, President Clinton has nominated Jane E Henney to head the FDA. Henney is currently
n June 24, the US House of Representatives voted to bar the FDA from testing, developing, or approving “any drug for the chemical inducement of abortion”. If the measure were to become law, it would effectively block final approval of mifepristone, the French abortifacient pill. The 223 to 202 vote came at the instigation of Oklahoma Republican, Thomas Coburn, a physician and anti-abortion activist who argued that federal funds should not be used “to facilitate the death of children”. Advocate for abortion rights, Republican Nita Lowey (New York) vainly argued that the vote—the first ever directly blocking FDA approval of the drug—“is about whether politics or science will govern the drugapproval process”. In September, 1996, the FDA wrote to the non-profitmaking Population Council, which was assigned the rights to mifepristone by the French pharmacutical firm that developed the drug, Roussel, saying that the drug was “approvable”. However, the FDA asked for more information regarding proposed labelling and manufacture of
the drug before an official approval could be issued. Meanwhile, the House has continued to move forward on legislation making it a crime to take an underage girl across state lines for an abortion if her home state has a law requiring parental notification. After more than 15 hours of debate—a long time even by congressional standards—the House Judiciary Committee approved the bill. Sensing that the measure will become an issue for the autumn elections, all the Republicans present voted for the measure, and all Democrats against. Republicans are trying to make abortions by teenagers a political issue, but new statistics from the Centers for Disease Control and Prevention (CDC) show that adolescent pregnancy is becoming less and less common. In April this year, the CDC reported a reduction in abortion rates for teenagers and new data show that pregnancies have declined as well—between 3% and 20% for 1991–96 for each of the 42 states for which data were available. Julie Rovner
Associated Press
US House votes to bar “abortion drugs”
Jane Henney and Bill Clinton
vice-president of health sciences at the University of New Mexico. Henney, 51, a cancer specialist, joined the FDA in 1992 and served as one of Kessler’s deputies until 1994. But Henney, whose nomination must be confirmed by the Republicancontrolled Senate, could face some problems. First, she has the backing of Senator Edward Kennedy, who opposed the 1997 FDA-overhaul bill. Such backing has raised concerns among Republicans who pushed the bill through Congress. Henney also faces questions about her role in FDA’s encouragement of US approval of mifepristone. Julie Rovner
News in brief
US Court rules HIV infection confers disability
UK research “crisis” On June 30, the UK government Select Committee on Science and Technology published a report reaffirming its stance that the government must make a “substantial real terms increase” in research funding. In addition, the government must treat with “utmost priority” the crisis in research infrastructure in UK universities. (Third Special Report. Available at: http://www.parliament.uk/commons/ selcom/s&thome.htm)
he US Supreme Court ruled on June 25 that people infected with HIV, even if they do not yet have HIV-related symptoms, are protected by a Federal law that bars discrimination against the disabled. The law is the Americans with Disabilities Act. By favouring a broad definition of disability, the five-to-four decision is expected to help the cases of people with other conditions, such as diabetes and epilepsy, who want to sue under the terms of the act. The decision came in response to a case in which a dentist had refused to treat an woman because she was infected with HIV. The woman sued the dentist, claiming that she was entitled to the protection of the Americans with Disabilities Act, which defines a disability as an impairment that “substantially limits” one or more “major life activities”. The woman argued that reproduction is a major life activity that she could not engage in because of the risk of mother-to-child transmission
FDA approves new TB drug On June 23, the US FDA granted accelerated approval for rifapentine for the treatment of pulmonary tuberculosis. This is the first US approval for this indication in 25 years. Although the relapse rate for rifapentine is higher than for rifampicin, the regimen is easier to follow so the FDA believes that compliance will be better and that this should help prevent drug resistance (http://www.fda.gov/ opacom/hpnews.html).
THE LANCET • Vol 352 • July 4, 1998
T
of HIV and because it was likely that her illness would eventually make her unable to rear any offspring. The Supreme Court agreed that reproduction was a major life activity covered by the Americans with Disabilities Act. “We have little doubt”, wrote Justice William M Kennedy, who held the majority opinion, “that had different parties brought the suit they would have maintained that an HIV infection imposes substantial limitations on other major life activities”. Jennifer Middleton of the American Civil Liberties Union said that the court’s decision reverses a series of lower court decisions that had increasingly narrowed the definition of major life activities making it difficult to sue under the act. The “tenor” of the Supreme Court decision should allow more people with disabilities to sue under the act, Middleton said. “But they’ll still have to make their case that they were discriminated against”, she added. Michael McCarthy
45
Clinton nominates FDA chief
O
More than a year after the departure of David Kessler, President Clinton has nominated Jane E Henney to head the FDA. Henney is currently
n June 24, the US House of Representatives voted to bar the FDA from testing, developing, or approving “any drug for the chemical inducement of abortion”. If the measure were to become law, it would effectively block final approval of mifepristone, the French abortifacient pill. The 223 to 202 vote came at the instigation of Oklahoma Republican, Thomas Coburn, a physician and anti-abortion activist who argued that federal funds should not be used “to facilitate the death of children”. Advocate for abortion rights, Republican Nita Lowey (New York) vainly argued that the vote—the first ever directly blocking FDA approval of the drug—“is about whether politics or science will govern the drugapproval process”. In September, 1996, the FDA wrote to the non-profitmaking Population Council, which was assigned the rights to mifepristone by the French pharmacutical firm that developed the drug, Roussel, saying that the drug was “approvable”. However, the FDA asked for more information regarding proposed labelling and manufacture of
the drug before an official approval could be issued. Meanwhile, the House has continued to move forward on legislation making it a crime to take an underage girl across state lines for an abortion if her home state has a law requiring parental notification. After more than 15 hours of debate—a long time even by congressional standards—the House Judiciary Committee approved the bill. Sensing that the measure will become an issue for the autumn elections, all the Republicans present voted for the measure, and all Democrats against. Republicans are trying to make abortions by teenagers a political issue, but new statistics from the Centers for Disease Control and Prevention (CDC) show that adolescent pregnancy is becoming less and less common. In April this year, the CDC reported a reduction in abortion rates for teenagers and new data show that pregnancies have declined as well—between 3% and 20% for 1991–96 for each of the 42 states for which data were available. Julie Rovner
Associated Press
US House votes to bar “abortion drugs”
Jane Henney and Bill Clinton
vice-president of health sciences at the University of New Mexico. Henney, 51, a cancer specialist, joined the FDA in 1992 and served as one of Kessler’s deputies until 1994. But Henney, whose nomination must be confirmed by the Republicancontrolled Senate, could face some problems. First, she has the backing of Senator Edward Kennedy, who opposed the 1997 FDA-overhaul bill. Such backing has raised concerns among Republicans who pushed the bill through Congress. Henney also faces questions about her role in FDA’s encouragement of US approval of mifepristone. Julie Rovner
News in brief
US Court rules HIV infection confers disability
UK research “crisis” On June 30, the UK government Select Committee on Science and Technology published a report reaffirming its stance that the government must make a “substantial real terms increase” in research funding. In addition, the government must treat with “utmost priority” the crisis in research infrastructure in UK universities. (Third Special Report. Available at: http://www.parliament.uk/commons/ selcom/s&thome.htm)
he US Supreme Court ruled on June 25 that people infected with HIV, even if they do not yet have HIV-related symptoms, are protected by a Federal law that bars discrimination against the disabled. The law is the Americans with Disabilities Act. By favouring a broad definition of disability, the five-to-four decision is expected to help the cases of people with other conditions, such as diabetes and epilepsy, who want to sue under the terms of the act. The decision came in response to a case in which a dentist had refused to treat an woman because she was infected with HIV. The woman sued the dentist, claiming that she was entitled to the protection of the Americans with Disabilities Act, which defines a disability as an impairment that “substantially limits” one or more “major life activities”. The woman argued that reproduction is a major life activity that she could not engage in because of the risk of mother-to-child transmission
FDA approves new TB drug On June 23, the US FDA granted accelerated approval for rifapentine for the treatment of pulmonary tuberculosis. This is the first US approval for this indication in 25 years. Although the relapse rate for rifapentine is higher than for rifampicin, the regimen is easier to follow so the FDA believes that compliance will be better and that this should help prevent drug resistance (http://www.fda.gov/ opacom/hpnews.html).
THE LANCET • Vol 352 • July 4, 1998
T
of HIV and because it was likely that her illness would eventually make her unable to rear any offspring. The Supreme Court agreed that reproduction was a major life activity covered by the Americans with Disabilities Act. “We have little doubt”, wrote Justice William M Kennedy, who held the majority opinion, “that had different parties brought the suit they would have maintained that an HIV infection imposes substantial limitations on other major life activities”. Jennifer Middleton of the American Civil Liberties Union said that the court’s decision reverses a series of lower court decisions that had increasingly narrowed the definition of major life activities making it difficult to sue under the act. The “tenor” of the Supreme Court decision should allow more people with disabilities to sue under the act, Middleton said. “But they’ll still have to make their case that they were discriminated against”, she added. Michael McCarthy
45