Headlines: July 19, 2010

by Meg Larkin

            In health reform litigation news, the Obama Administration is taking the legal position that the individual mandate is a tax.  Although in the lead up to the passage of health reform the administration was adamant that the individual mandate was not a tax, the mandate is included in the tax code, and non-compliance does result in a tax penalty.  In response to legal challenges to the constitutionality of the health reform legislation, the Obama Administration has taken the position that the individual mandate is supported by the government’s power to lay and collect taxes.  Alternatively, the individual mandate could be found to be a legitimate exercise of Congress’s power under the commerce clause, but the Obama administration has called the tax argument a “lynchpin” of their legal strategy.

            In regulatory news, the FDA is questioning whether Avastin retain its approval to treat breast cancer.  According to the Washington Post, “The Food and Drug Administration approved Roche's blockbuster Avastin in 2008 based on a trial showing it slowed growth of tumors caused by breast cancer.”  This was part of an accelerated approval process that allows drugs for severely ill patients to be approved based on a surrogate end-point other than extension of life.  As part of the accelerated approval process, drug companies are expected to submit follow up studies that confirm the efficacy of the intervention on primary end-points such as extension of life.  According to the Post, “FDA reviewers said two follow-up studies recently submitted by Roche failed to show that Avastin significantly extended lives compared to chemotherapy alone.”  The FDA is convening an expert panel to determine whether Avastin should retain its approval for breast cancer.

            Finally, in international health news, India is using cash payments to encourage women to give birth in hospitals.  With 254 deaths per 100,000 live births, India has one of the highest maternal mortality rates in the world, and it is seen as an obstacle to India’s technological advancement.  By giving payments to mothers and increasing training of midwives in rural areas, the Indian government hopes to encourage women to give birth in slightly more expensive, but also safer locations.  According to the Boston Globe, “The government said it has no firm figures about the total number of women who have received cash or the total amount spent on the program, because it is administered by individual states. Under the plan, women receive a payment about two weeks after they deliver, and they are encouraged but not required to seek postnatal care.” 

Meg Larkin is a law student at Boston University.  Please feel free to email her with any questions, comments, suggestions or concerns.