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

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Features

Read the complete October 2014 Digital Edition

Read the complete October 2014 Digital Edition

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

Predicting your pink slip

Predicting your pink slip

Any time a firm needs to save money, high-salaried executives are targets

Private View: New ways to engage with customers

Private View: New ways to engage with customers

These healthcare social media campaigns successfully use emotion, altruism and the human desire to "brand" oneself to get customers engaged.