Former Epilepsy Foundation Board Chair and Congressman, Tony Coelho, Delivers Resonant Personal Remarks to an FDA Panel

Esteemed politician and longtime supporter of disability rights shares his personal story of life with epilepsy to underscore the Foundation’s commitment to protecting all people with epilepsy from repercussions caused by medication switching.

SILVER SPRING, MD, Aug 4—Former Epilepsy Foundation board chair and congressman, Tony Coelho, delivered compelling remarks today at an FDA Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. The committee convened to discuss the bioequivalence recommendations for a drug, vancomycin. The Foundation took the opportunity to present its longtime position on the broader subject of public health and safety as it pertains to medication switching.

Coelho underscored the Foundation’s longtime stance that this is not a “brand versus generic issue,” but rather a “switching issue.” The distinction involves different manufacturers’ versions of the same drug; a switch from generic to a brand-name drug; or a switch from a brand-name drug to a generic. Complications can also arise from a switch from one manufacturer’s formulation of its antiepileptic (AED) drug to a new formulation of its AED to a new formulation of the same drug.

In order to provide a face to the sometimes confusing scientific explanations involved in medication switching, Coelho revealed a deeply personal but resonant story of his own recent experience with medication switching.  Just as recently as May 2009, his pharmacist, unbeknown to him or his doctor, switched his prescription from a brand-name AED, Topamax, to a generic, topiramate. He immediately began experiencing side effects of lethargy and—more concerning—depression. His intrinsic knowledge of the repercussions involved with medication switching led him to question his current drug and brought him back to Topamax.

Coelho acknowledged the strains of an unwanted and unwarranted return to the depression he experienced in his youth, but said he was grateful he did not experience more serious side effects sometimes endured by victims of medication switching, such as breakthrough seizures. He said, “Slight changes in the amount of medication received by a person with epilepsy can mean the difference between a fully-controlled condition and breakthrough seizures.”

Coelho went on to urge the FDA to remember its promise of preserving the public safety of all Americans: “The Foundation believes that short-sighted cost considerations should never be allowed to trump efficacy or take precedence over patient welfare.”

Significantly, former FDA commissioner, Frank E. Young, M.D., Ph. D., also appeared before the advisory committee for the first time since he left the FDA two decades ago. He noted that “we are at a critical juncture in our scientific understanding and regulation of bioequivalence . . . it is time to convene another comprehensive bioequivalence hearing.”

The advisory panel ultimately voted 16-0 in favor of the FDA’s rules regarding the evaluation of generic versions of the drug it had convened to discuss, vancomycin.

This is not a defeat, however.  It is another step in the struggle the Foundation has tirelessly championed to illuminate, which involves the concerns and personal stories of people whose lives have been affected by medication switching.  

Our presence at such a precedent-setting discussion also reinforces our position that the government agency charged with public health safety—the FDA—needs to take notice of its core responsibilities, sooner rather than later.

Learn more about the Epilepsy Foundation’s outreach on medication switching and find resources that can help you, your physician and your pharmacist understand the concerns with switching and the importance of communication and consent of patients and physicians when epilepsy medications are changed at our web site:  http://www.epilepsyfoundation.org/medicationswitching/

You can read Tony Coelho’s remarks by clicking here.