 | Register Now! | | |
|
Want to post to the discussions? Comment on a Blog? Register Now.
|
|
|
| NPI Community Blogs | | |
|
|
|
|
|
|
Location: Blogs Marc Ullman FYI Blog |
|
| Posted by: marc |
5/9/2008 2:03 PM |
On May 2nd, a United States District Court judge certified a class action against Glaxo Smith Klein (“GSK”). That case has something in common with GSK’s recent Citizen’s Petition aimed at forcing weight loss dietary supplements of the market.
On May 2, 2008 Judge Bruce W. Kauffman of the United States District Court for the Eastern District of Pennsylvania certified a class action seeking damages against GSK for allegedly making sham filings with the Untied States Patent Office as part of a plan to prevent generic competition for its antidepressant drug Wellbutrin. According to the allegations against GSK, the company’s actions forced class members to pay unnecessarily high prices for its drug because no generic competition was available for nearly two years after its patent had expired as a result of delays caused by the baseless patent suits.
On April 22, 2008, GSK along with the American Dieticians Association and two other so-called public interest groups filed a Citizen’s Petition calling on FDA to classify all weight loss claims for dietary supplements as implied obesity claims. Such a move would essentially convert all weight loss supplements into unapproved new drugs, forcing them off the market. In case there is any doubt as to GSK’s motivation for this filing, keep in mind that the company markets Alli, the only FDA approved over-the-counter weight loss drug that is not a stimulant. While Alli apparently has had fairly strong sales, it certainly has also had to deal with issues related to its expected side effects including “gas with oily spotting” and “more frequent stools that are hard to control”. (You can translate these into layman’s terms yourself). Also, you have to wonder if directions that include a suggestion that users bring extra pairs of dark-colored pants to work might dampen sales a bit. If FDA acts on this petition, all of Alli’s non-stimulant nonprescription competition disappears.
Does anyone see a pattern here?
|
|
| Permalink |
Trackback |
|
|
|