Endocrine Society Tells FDA Testosterone Therapy Should Only Be for Men with Hypogonadism
The Endocrine Society testified at a September 17 meeting of the Food and Drug Administration (FDA) discussing the appropriate population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with its use. Th ough testosterone use has sharply increased among older men in the past decade, the Society told the FDA that testosterone therapy should be limited to men who meet the diagnostic guidelines for hypogonadism.
Testifying before the FDA joint meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee on behalf of the Endocrine Society, Ronald Swerdloff , MD, professor at the David Geffen School of Medicine at UCLA, said testosterone treatment should be limited to men who have clinical manifestations of hypogonadism and consistently low testosterone levels.
“The Endocrine Society also recommends that more data be collected on men of different ages to better establish the serum testosterone thresholds for specific organ-related symptoms and signs, and to determine which clinical manifestations will benefi t from replacement testosterone therapy,” Swerdloff testifi ed. Swerdloff was an author of the Endocrine Society’s clinical practice guideline, “Testosterone Th erapy in Adult Men with Androgen Defi ciency Syndromes.”
The Society further recommended that a large-scale, well-controlled study be conducted to assess long-term cardiovascular and prostate risks associated with testosterone replacement treatment.
Society Advocacy Prompts Coverage of Artificial Pancreas Technology
The Endocrine Society recently learned that several private insurers were proposing to eliminate coverage for lowthreshold suspend systems, which are the first devices to be classifi ed as artificial pancreas technology. In response, the Society contacted these insurers and strongly opposed the elimination of coverage for artificial pancreas device systems, which are FDA-approved and have been used in numerous countries for several years. Th e Society provided these companies with clinical evidence
On August 28, the Endocrine Society received a letter from Blue Cross Blue Shield Massachusetts (BCBSMA) stating that, due to our advocacy and that of other groups, BCBSMA has decided to cover low-threshold suspend systems effective December 1, 2014.
The Society has received responses from several other payers stating that they were reviewing their policies and would have a determination in the coming weeks. Th e Society will continue to advocate on behalf of coverage for the next generation of technologies that could pave the way for the artifi cial pancreas and will update its members when additional information becomes available.
Congress Passes Stopgap Funding Measure Before Elections; Advocacy Push for NIH Funding Needed During November “Lame Duck” Session
Although Congress is supposed to finalize funding bills by the start of the fiscal year, October 1, the House of Representatives and U.S. Senate left Washington for a seven-week recess on September 18 and will return following the mid-term elections in November for a “lame duck” session. Congress passed a temporary stopgap funding measure to keep the government running through December 11 at roughly last year’s funding levels. Th is means there is no increase for funding for the National Institutes of Health (NIH). The concern by many policy analysts is that Congress may continue to delay fi nal funding bills and simply pass another temporary measure in November, which would continue the negative impact on research funding.
Consequently, the Endocrine Society will increase its efforts to urge Congress to pass a funding bill that includes the NIH before the end of the calendar year. We urge Society members in the U. S. to share this message with their congressional delegations:
Congress needs to make appropriations legislation a priority in the “lame duck” session, and work in earnest to enact fi al spending legislation for fiscal year 2015 before the end of the calendar year. We are extremely disappointed in the breakdown of regular order in this year’s appropriations process and the resulting short-term Continuing Resolution to provide temporary funding for public health, health research, and other core government functions. We are also concerned that funding for emergent needs has been off set by an across-the-board cut. While relatively small, this cut compounds the impact of deep cuts already taken since 2010 due to federal austerity measures, including sequestration.
To learn more about the status of NIH funding and how you can participate in Endocrine Society advocacy, please visit www.endocrine.org