Medscape News: U.S. Regulators Needs New Authority
Posted Jan 04 2013 12:01am
Since the fungal meningitis health scandal that rocked the compounding pharmacy industry in 2012, there have been rumblings among legislatures and lawmakers to increase federal regulatory oversight of compounding pharmacies.
I have been following this issue because compounding pharmacies provide bioidentical hormones for hundreds of thousands of women going through perimenopause. It is an issue that I believe we need to be paying close attention. Medcape News Today has published this article and several others on this topic that I think might be of great interest to The Perimenopause Blog readers.
I do not have permission to reprint the articles in their entirety (simply because I did not request it) and so, instead, I thought I would link to the Medscape site and let you read them for yourself there. You have to open an account to have access to the articles, but it is free, and definitely something I recommend if you are interested in keeping up with medical news.
Click through below to go to Medscape for the rest of the article.
WASHINGTON (Reuters) Oct 29 – The U.S. Food and Drug Administration’s power to regulate compounded drugs similar to those linked to a deadly meningitis outbreak is legally nonbinding and lacks the authority of stringent standards imposed on drug manufacturers, according to a congressional report released on Sunday.
The report, compiled by the staff of U.S. Representative Edward Markey, a Massachusetts Democrat, drew an immediate response from FDA Commissioner Margaret Hamburg, who said the agency is committed to working with Congress and others to garner “the authority we need to help prevent tragedies like this from happening again.”
“Over the years, there has been substantial debate within Congress about the appropriate amount of FDA oversight and regulation of compounding pharmacies. But unfortunately, there has been a lack of consensus and many challenges from industry,” Hamburg said in a statement emailed to Reuters.
“As pointed out in the report from Congressman Markey, FDA’s authority over compounding pharmacies is more limited by statute than with drug manufacturers,” she added.