On the recordMay 22, 2012
Mr. President, the inappropriate overuse of antipsychotics--which are associated with a higher risk of death in frail elders--is a well-recognized problem that warrants new policy to ensure that these drugs are targeted to people suffering from serious mental illness, and not to curb behavioral symptoms of Alzheimer's or other dementias. Addressing these concerns requires additional transparency and accountability on how antipsychotics are being used today in older adults with dementia. I am pleased to be joined by Senators Grassley and Blumenthal in filing an amendment to S. 3187, the Food and Drug Administration Safety and Innovation Act S. 3187, which would require the HHS Secretary to develop standardized protocols for obtaining informed consent, or authorization, before administering an antipsychotic for a use not approved by the Food and Drug Administration. Authorizations would be provided by patients or, as appropriate, their designated health care agents or legal representatives. These informed consent protocols would provide valuable information to patients and their families, including possible risks and known side effects associated with the antipsychotic, as well as alternative treatment options that may be available. This bipartisan amendment also calls for a new prescriber education program to promote high-quality, evidence-based treatments, including non-pharmacological interventions.…





