Did lawyers help write labeling rules?

Share this article:
Margaret Hamburg
Margaret Hamburg

Nineteen Republicans on the House Energy and Commerce Committee want FDA commissioner Margaret Hamburg to explain the role the American Association for Justice (trial lawyers) played in drafting proposed changes to generic drug labeling. In a letter they said they have questions about FDA's motivation for the changes and the agency's legal basis for proceeding with it. The letter referenced testimony from FDA drugs director Janet Woodcock that the agency did not meet with drugmakers, doctors, or pharmacists, but met with trial lawyers.

They ask Hamburg for all documents and communications referring or relating to a 2013 meeting with representatives of the American Association for Justice. They also reiterate a request for the names of executive branch employees outside FDA who were involved in the decision to proceed with the proposed rule or who participated in drafting or reviewing it.

Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

More in Features

Read the complete September 2014 Digital Edition

Read the complete September 2014 Digital Edition

Click the above link to access the complete Digital Edition of the August 2014 issue of MM&M, with all text, charts and pictures.

Medical marketing needs mainstream Mad Men

Medical marketing needs mainstream Mad Men

Agencies must generate emotional resonance with the target audience, not unlike Apple, Pepsi or Nike

Are discounts cutting out co-pays?

GSK's decision to cut Advair's price spurred some PBMs to put it back on formulary. Will drugmaker discounts diminish the need for loyalty programs? How can these programs stay relevant beyond giving co-pay assistance?