[News] FDA to Tighten Standards for Generic Antiepileptic Drugs

[epileric]

I found this both interesting & exciting.

Most popular brand name products for epilepsy currently have generic equivalents, and some drugs have dozens. The agency says these alternatives are safe, but many have not been getting good reviews from patients and their physicians.

The AES opposes antiepileptic drug substitution without physician consent; its position is backed by the American Academy of Neurology.

"A single seizure represents a serious therapeutic failure," said town hall moderator Michael Privitera, MD, from the University of Cincinnati College of Medicine in Ohio.

Dr. Privitera told Medscape Medical News that he is encouraged by the FDA's response to these concerns, but he acknowledges that more work remains. "I'm eager to see the definition of a narrow therapeutic index drug and how new data are interpreted by regulators," he said.

Dr. Privitera is currently working on a new clinical trial comparing brand-name antiepileptic drugs with generics. "There are no adequately designed prospective studies, so we're looking to address that," he said. He is teaming up with investigators from the Johns Hopkins University School of Medicine in Baltimore, Maryland, and the University of Rochester School of Medicine and Dentistry in New York.

Prospective Clinical Trials

Tricia Ting, MD, from the University of Maryland School of Medicine in Baltimore, is also working to prospectively study this issue. "We're designing a test model to assess brand-name and generic antiepileptic drugs in epilepsy patients, not just healthy controls," she said at the meeting. This is a limitation of current studies.

As it stands now, the FDA looks at a small number of healthy people to establish bioequivalence. Dr. Davit says these studies typically include 24 to 36 people.

Measures of drug absorption or the area under the curve (AUC) are taken along with peak drug plasma concentrations (C-max). According to present standards, these values must fall within 80% to 125%.

All approved generic antiepileptic drugs currently on the market are well within current bioequivalence limits. The rows of data in Table 1, presented by Dr. Davit at the town hall meeting, demonstrate the highest and lowest point estimates and, in parentheses, the 90% confidence intervals.

http://www.medscape.com/viewarticle/754755

[Screamy]

Excellent post, also appreciate the link for medscape!

[epileric]

Excellent post, also appreciate the link for medscape!

Thanks Screamy.

I put the link up because the article was too big to quote but I wanted to give an idea what it was about.

[epileric]

Scott Gavura is a pharmacist who has a great explanation of generics, how they're made, controlled (at least in Ontario) and some of the facts and myths about them.

Generic Drugs: Are they Equivalent?