Category — Pharma

Feb. 3, 2012 – The FDA’s long-awaited draft Guidance for Industry on social media provides non-binding recommendations regarding how manufacturers and distributors of prescription drugs and medical devices can respond to unsolicited requests for off-label information, but does not provide guidelines for appropriate responses to other consumer inquiries or comments posted on Facebook and other electronic media.  [Read more →]

Dec. 1, 2011 – Regular blog contributor Brian Fowler has co-authored an article with Troutman Sanders partner Dabney Carr concerning the implications of the Supreme Court’s recent decision in Pliva v. Mensing.  The article appears in the November issue of the International Association of Defense Counsel Product Liability Committee’s newsletter, which can be found here.  Please check it out.

Aug. 20, 2011 -  Facebook recently decided to require pharmaceutical companies to enable commenting on their Facebook pages.  With the new “open walls” policy, anyone can post comments for all to see on pharmaceutical company pages devoted to certain medical conditions and patient communities.  Some pharmaceutical companies, including AstraZeneca and Johnson & Johnson, have responded by removing such pages. [Read more →]

Aug. 4, 2011 -     We are rarely surprised to hear about shocking decisions or large verdicts coming from our neighbors in West Virginia.  We therefore were pleasantly surprised to learn that a West Virginia jury recently returned a defense verdict in Hines v. Wyeth, 04cv00690 (S.D. W. Va.) finding that Wyeth’s (now Pfizer’s) hormone replacement drug Prempro did not cause a plaintiff’s breast cancer.  As the linked article indicates, Pfizer is now 8 for 16 in Prempro jury trial verdicts. [Read more →]

July 29, 2011 -  Big Pharma is yet again under fire in a new article published in the Archives of Internal Medicine.  Samuel D. Krumholz, David S. Egilman, & Joseph S. Ross, Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial:  A Narrative Account of a Gabapentin Seeding Trial, Arch Intern Med., vol. 171, no. 12, 1100-1107 (2011).  This time, the topic of “seeding trials” is at issue.  [Read more →]