2004N-0115 - Prescription Drug Importation; Public Meeting
FDA Comment Number : EC63
Submitter : Mr. Tobias Fisher Date & Time: 06/03/2004 04:06:29
Organization : NAMImass
Health Care Association
Category :
Issue Areas/Comments
May 29, 2004

RE: Psychiatric Medications

Dear HHS Committee;

The National Alliance for the Mentally Ill of Massachusetts appreciates the state?s recent efforts to protect access to psychiatric medications. We also appreciate you need to look for cost effective strategies to curb costs. Yet, since we are all committed to insuring safe treatment for the chronically mentally ill, we should understand;

1. Medications to treat serious mental illnesses are essential parts of the already fragile treatment system. NAMI understands the need to cost contain and appreciates the motivation to save vital state resources. These are indeed very trying economic times.

2. The danger of importation programs is quality assurance, which even the FDA can not insure. These purchasing programs for mental health drugs can be dangerous. It places very vulnerable persons (adults, children and elders) with serious mental illness in the middle of a pricing battle between the pharmaceutical companies and state government. This is simply not acceptable. Placing life saving medications in an uncertain supply chain or entirely excluding them based on the willingness of the government and pharmaceutical company to negotiate places persons with serious mental illness in jeopardy and without vital treatment. The outcomes can be devastating. People can lose their jobs, homes, and at times their lives. The process can create a tremendous cost shift, which has been documented repeatedly. The use of ERs, jails, inpatient facilities and homeless shelters can increase significantly.

3. The value of a particular medicine cannot be measured by its price. It is measured by how well it treats a particular patient when delivered at the right time and at the right dose. Saving money in the pharmaceutical budget through shortsighted restrictions does not necessarily translate to reduce spending generally, as each change in treatment may require additional doctors? visits, medical testing and monitoring. Prescription medicines are a single component in the spectrum of health care services, and still account for only about 10% of the health care dollar.

People with mental illness and their families know that the lack of access to appropriate medications can quickly unravel and destroy lives. These treatments can mean the difference between hope and despair, recovery and struggle, and even life and death.


Tobias Fisher, Executive Director