GSK vs FDA - Let battle commence?

Looks like GSK are squaring up to the FDA over the propsed changes to their respiratory blockbusters labelling.

“Patient safety is of paramount concern to GSK which is why we disagree with the FDA's proposed labeling changes,” (for Advair and Serevent) said Dr. Kathy Rickard, GSK Vice President Clinical Development and Medical Affairs, respiratory medicine in the US.

Always good to diss the opposition, Kathy. Like, duh, what would the FDA know about patient safety, right?

“These proposed labeling changes would reserve the most effective asthma treatment - the combination of inhaled corticosteroids and long-acting beta agonists - until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations and potentially death.”

But wait, is this a hand of friendship and cooperation.....or just a right hook?

GSK believes sufficient safety information about these medicines is already in the labels to help guide physicians about their appropriate use. However, we will work with FDA to address the differences of opinion about how best to communicate the benefit risk profile of these medicines for optimal patient care.

So, that's alright then.

http://www.medicalnewstoday.com/medicalnews.php?newsid=33838

PS Insider had to giggle at the above report. The Medical News Today link to "asthma" in the middle of the GSK press release takes you to a site where you get details about AZ's asthma treatments!! LOL!