Policy & Practice


Coalition Urges Quick Pick for FDA

The next Food and Drug Administration commissioner should be a proven manager who can rise above politics, according to a coalition of a patient advocacy groups. The group of more than 30 organizations, including the Society for Women's Health Research and Susan G. Komen for the Cure, wrote a letter to then-Health and Human Services secretary-designate Tom Daschle, calling on the Obama administration to fill the FDA post quickly. Candidates for the job shouldn't be excluded because of ties to the pharmaceutical or device industries, the coalition advised. “Diverse experience, including that with an FDA-regulated industry, should be viewed as a positive qualification,” the letter said.

ACOG Supports Abortion Access

The American College of Obstetricians and Gynecologists is calling on medical schools and ob.gyn. residency programs to integrate family planning and abortion education into physician training as a way to ensure that women have access to a full range of reproductive health services. Despite the continued demand for abortion services, training in these services is limited, according to a policy statement from ACOG's Committee on Health Care for Underserved Women, published this month in Obstetrics & Gynecology. For example, a 1998 survey by the National Abortion Federation found that only 46% of the 261 accredited U.S. obstetrics and gynecology residency programs offer first-trimester abortion training, despite requirements from the Accreditation Council for Graduate Medical Education to make experience with induced abortion part of residency training.

Consequences of EC Access

Some women with unrestricted access to emergency contraception (EC) will substitute it for their usual methods of birth control, according to data from a randomized, controlled trial. Women who had EC on hand were about three times as likely as were women who had to obtain EC to report that they had ever substituted emergency contraception for condoms or other methods of contraception, the researchers found. This effect was most pronounced among women who did not use a hormonal method at baseline and were not consistent condom users at baseline. The researchers analyzed data from more than 1,000 women aged 14–24 years who had been part of an earlier randomized trial on EC (Obstet.Gynecol. 2009;113:107–16). The study was funded by Family Health International, the National Institutes of Health, and the William and Flora Hewlett Foundation. The EC was provided by Barr Pharmaceuticals, which manufactures Plan B. One of the study authors has worked on studies funded by Barr Pharmaceuticals. The researchers did not report any other potential conflicts of interest.

FTC Alleges Price Gouging

The Federal Trade Commission has alleged that a pharmaceutical company acted illegally in buying the only two medicines approved to treat a deadly congenital heart defect in premature babies and then raising the prices for the drugs by nearly 1,300%. Ovation Pharmaceuticals Inc. bought the drug NeoProfen (ibuprofen lysine) in early 2006, when it already held the rights to Indocin IV (indomethacin). Both drugs are used to treat patent ductus arteriosus in lieu of surgical repair. After acquiring NeoProfen, Ovation raised the price of Indocin from $36 to nearly $500 per vial, and set a similar price when it launched NeoProfen in July 2006, according to the FTC, which has filed a civil lawsuit to force Ovation to divest itself of one of the drugs and forfeit some of the profits. Ovation said in a statement that NeoProfen and Indocin are not interchangeable and that it would fight the allegations.

Teen Health Care Reform Urged

Current health services for adolescents are fragmented and poorly designed to meet the needs of the nation's adolescents, according to a report from the National Research Council and the Institute of Medicine. Although most U.S. adolescents are healthy, many engage in risky behavior, develop unhealthy habits, and have physical and mental conditions that can jeopardize their immediate and future health, the report said. The U.S. health care system should foster better coordination between primary and specialty care and should include opportunities for adolescents to receive primary care services in “safety-net settings” such as schools, hospitals, and community health centers, the report said.

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