June 1, 2012
By Allison Cohen*
User Fee Bill Passed by the U.S. House of Representatives
MedPage Today (5/31) reports that the House bill to reauthorize U.S. Food and Drug Administration (FDA) user fee programs passed by a vote of 387-5. Since the Senate passed a similar version of the bill a week ago, the bills will go through the conference committee process and be sent to President Barack Obama by July 4.
University of Illinois Medical Center Support Staff Strike
A Chicago Tribune (5/30) story says that members of the University of Illinois at Chicago's support staff are striking because they have not had a contract since 2010. According to union representatives, their demand is for market wages for support staff who are not doctors or nurses at the hospital.
Hormone Replacement Therapy Risks Are Highlighted in New Study and Recommendations
According to the Los Angeles Times (5/29), the U.S. Preventive Services Task Force issued a new recommendation based on a new analysis finding that the benefits do not outweigh the risks of using hormone replacement therapy for women who are post menopause and healthy, but are trying to ward off dementia, bone fractures, and heart disease.
New Data Does Not Provide Strong Support for Medicare Reimbursement Causing Prescription Drug Shortages
Health Affairs (5/29) reports that the prescription drug shortage crisis continues and numerous reports and articles have explored its causes. New data from a study supported by a grant from the National Cancer Institute does not provide support for the role of Medicare reimbursement policies and calls for more research to understand the causes of prescription drug shortages.
Bone Meds and Esphogeal Cancer Were Linked by Adverse Event Study
MedPage Today (5/30) reports that more cases of esophageal cancer were found to be associated with bisphosphonate use than previously findings suggest, according to a recent adverse event surveillance study. The analysis suggests that "[i]ncreased awareness and vigilance is needed for patients receiving oral bisphosphonate therapy."
According to New FDA Guidance, pCR May Be Used As a Breast Cancer Trial Endpoint
MedPage Today (5/29) reports that the FDA released a draft guidance explaining how pathologic complete response (pCR) can be used as a surrogate endpoint to demonstrate a study drug's efficacy in clinical trials. Based on randomized neoadjuvant trials that approve the same treatment administered pre-operatively and post-operatively, pCR may predict disease free survival or overall survival in patients who have early stage breast cancer.
Rep. Pelosi Believes That the Healthcare Reform Law Will be Upheld by the U.S. Supreme Court
An article in the Los Angeles Times (5/31) states that Representative Pelosi (D-CA) publicly expressed that she expects the U.S. Supreme Court to rule in favor of the Patient Protection and Affordable Care Act of 2010 by a vote of 6-3.
*We would like to thank Allison M. Cohen, Esquire (Washington, DC), for providing this week's update.
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.
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