Food and Drug Administration Hearings on Medication Guide Program

Statement to the Media by Anthony Ng, Board Member of Mental Health America

Contact:  Jason Halal, 703-797-1943 or jhalal@mentalhealthamerica.net

WASHINGTON, D.C. (June 13, 2007) - The Food and Drug Administration conducted hearings on June 12 and 13 to discuss recommendations for its medication guide program, which provides information to patients and their providers to communicate the safety of FDA-approved medications.  Mental Health America commends the Food and Drug Administration (FDA) for its efforts to ensure the safety of medications and believes that medication guide program offers the agency considerable opportunities to educate consumers on their potential risks. 

Mental Health America also believes that the medication guides should be used as a tool to support the decision-making partnership between the consumer and the provider.  Scientific research demonstrates that mental health treatments are highly individualized.  Therefore, medication guides should encourage consumers to review their health history and their treatment goals with their physician to weigh the risks - and benefits - of any medication choices. 

Mental Health America board member, Anthony Ng, M.D., a psychiatrist, testified at the hearing and provided the following recommendations to help the FDA craft medication guides that more effectively educate Americans and their providers about potential medications:

• Consumer preferences on potential side effects and physician expertise are critical components of the decision-making equation. While one individual may weigh the side effects and benefits of a medication with his or her provider and decide it is an appropriate treatment option, another may find the side effects too risky given other factors, such as other health problems or the medication's impact on day-to-day functioning.
  
  
• Consumers and physicians have a unique and essential perspective on treatment. The FDA must involve them in a meaningful way in the development of medication guides - indeed, all health care decision-makers must begin more meaningful inclusion of consumers. Consumer engagement might include participation in focus groups at the development stage of the medication guide.
  
  
• Guides should be accessible and relevant to individuals. In addition, medication information must be put into perspective to the relative risks for an individual. Blanket warnings taken out of context could likely dissuade people from seeking or receiving treatment from which they could benefit.
  
  
• It is important for the FDA to communicate both the risks and benefits of a medication. Warnings that fail to provide balanced information by focusing exclusively on risks could lead to consumers' discontinuation of treatment and to misinterpretation by the consumer which could subsequently lead to incomplete dialogues between consumers and providers.
  
  
• When communicating information about a drug's risks, the FDA and/or other federal agencies must also offer suggestions on mitigating that risk. For example, just as the FDA shares information about a treatment's possible risks, it must also provide the benefits of available treatments and the risks associated with no treatment at all - or it must work seamlessly with another federal agency to do so.

We believe that, if implemented, these recommendations would represent a significant step towards improving health outcomes, especially for the millions of Americans living with mental health conditions in our country.  

Mental Health America is the country's leading nonprofit dedicated to helping ALL people live mentally healthier lives.  With our more than 320 affiliates nationwide, we represent a growing movement of Americans who promote mental wellness for the health and well-being of the nation - everyday and in times of crisis.