Policy & Practice


Waxman: FDA Plan Is Flawed

The Food and Drug Administration is considering new guidance that would allow drug companies to use journal articles to promote “potentially dangerous uses” of drugs and medical devices without prior FDA review and approval, according to a top lawmaker. Rep. Henry Waxman (D-Calif.), who chairs the House Committee on Oversight and Government Reform, urged the FDA in a Nov. 30 letter to reconsider its draft guidance, which the congressman said was close to being finalized. “The draft guidance that I have obtained would, in effect, allow drug and device companies to short-circuit FDA review and approval by sponsoring drug trials that are carefully constructed to deliver positive results and then using the results to influence prescribing patterns,” Rep. Waxman said. “This undercuts the prohibition on marketing of unapproved uses of drugs and devices.” He asked the FDA to provide detailed information on the development of the new policy and how it would address his concerns.

N.J. Blocks Stem Cell Measure

New Jersey Gov. Jon Corzine (D) will press ahead with efforts to promote stem cell research in the state, even after voters rejected his proposal to borrow $450 million to fund research grants. Although the measure's defeat means there will be less state funding available for research, “the governor does expect they will be able to find additional dollars in the private sector,” said spokesman Jim Gardner in an interview. State lawmakers already have authorized about $20 million in funding for a new Stem Cell Institute of New Jersey and for research grants, and that money is not affected by the bond initiative's failure, Gardner said. The $450 million bond referendum would have provided financing for stem cell research grants to eligible institutions over a 10-year period. The grants would have been awarded after review by an independent research panel and after consideration of the commercial viability of the projects. Mr. Gardner said it's too early to tell if Gov. Corzine will attempt to bring a new bond initiative before the voters this year.

Woman-Specific Drugs in Pipeline

More than 700 medicines for diseases that disproportionately or solely affect women are currently in development, according to a report from the Pharmaceutical Research and Manufacturers of America. According to the PhRMA report, drugmakers are developing new products to treat arthritis, women-specific cancers, diabetes, obstetric-gynecologic conditions, and mental illnesses, among other things. The drugs in development include 135 medicines for cancers affecting women, including 95 for breast cancer, 47 for ovarian cancer, and 17 for cervical cancer. In addition, drug manufacturers have 125 medicines in the pipeline for arthritis and musculoskeletal disorders, which disproportionately affect women, and 106 drugs in the pipeline for autoimmune disorders, which collectively afflict 23.5 million Americans, the majority of them women. Other medicines in development include treatments for diabetes, glaucoma, irritable bowel syndrome, urinary tract infections, asthma, Alzheimer's disease, migraine, depression, anxiety and sepsis, all of which PhRMA said affect women more than men.

Report: Counseling Violates Ethics

Information that doctors in 23 states are required to provide to women either verbally or in writing before an abortion falls short of fundamental ethical principles because it is inaccurate or irrelevant, a nationwide analysis of state counseling requirements from the Guttmacher Institute found. The counseling required by these 23 states “in many cases appears to be designed more to influence rather than inform a woman's decision whether to have an abortion, for instance by exaggerating the physical or mental health risks of abortion, or by including information on certain abortion procedures that is irrelevant to most women,” according to the report in the Guttmacher Policy Review. Report coauthor Rachel Benson Gold said in a statement that the widespread misinformation is “particularly troubling” in light of a recent Supreme Court decision, Gonzalez v. Carhart, that defers to legislatures, rather than the weight of the evidence, in cases where there is medical disagreement on the potential consequences of abortion. “There is ample reason to worry that some state legislatures will view the Supreme Court's ruling as a green light to set up a new array of misleading counseling requirements that in reality are attempts by politicians to muscle their way into private medical decisions that should be between a woman, her family, and her doctor,” Gold said.

Maternal 'Toolkit' Developed

The National Business Group on Health, which represents large employers, in November released a new guide designed to help employers improve the health of pregnant women, children, and adolescents, as well as potentially reduce their health care costs. “Investing in Maternal and Child Health: An Employer's Toolkit” provides a model of a medical benefits package aimed at providing guidance on benefit design, employee cost-sharing recommendations, and actuarial cost-impact data employers can use to estimate the cost of adopting the recommended benefits. The toolkit also includes data on the cost of maternal and child health care services, and the business case for investing in healthy pregnancies and primary care services, along with educational materials for employees about maternal and child health topics.

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