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Food and Drug Administration Safety and Innovation Act--Motion to Proceed--Continued

Floor Speech

Location: Washington, DC


Mr. KOHL. 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. The prescriber education programs would be funded through settlements, penalties and damages recovered in cases related to off-label marketing of prescription drugs.

While the Food and Drug Administration--FDA--has approved antipsychotic drugs to treat an array of psychiatric conditions, numerous studies conducted during the last decade have concluded that these medications can be harmful when used by frail elders with dementia who do not have a diagnosis of serious mental illness. In fact, the FDA issued two ``black box'' warnings citing increased risk of death when these drugs are used to treat elderly patients with dementia.

Last year, the Health and Human Services Office of the Inspector General--HHS OIG--issued a report showing that over a 6-month period, 305,000, or 14 percent, of the Nation's 2.1 million elderly nursing home residents had at least one Medicare or Medicaid claim for atypical antipsychotics.

The HHS OIG also found that 83 percent of Medicare claims for atypical antipsychotic drugs for elderly nursing home residents were associated with off-label conditions and that 88 percent were associated with a condition specified in the FDA box warning. Further, it showed that more than half of the 1.4 million claims for atypical antipsychotic drugs, totaling $116.5 million, failed to comply with Medicare reimbursement criteria.

I hope this policy will send a strong signal that Congress is committed to improving the quality of treatment provided to millions of our most vulnerable Americans--older adults with dementia and the families who support them.


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