Drug quality is FDA's top 2013 priority: Hamburg

Share this article:
Margaret Hamburg
Margaret Hamburg

FDA commissioner Margaret Hamburg is urging the pharmaceutical industry to improve manufacturing quality, an issue she is making a top priority for FDA enforcement this year.

Delivering a keynote address at the Generic Pharmaceutical Association's annual meeting in Orlando, FL, she said FDA has seen “far too many quality lapses throughout the pharmaceutical industry over the past few years.”

While not the norm, such reports “are warning signals that we can and must do more,” Hamburg said. “Quality is the basis of the public's confidence in pharmaceuticals.”

Specifically addressing generic injectables and shortages associated with manufacturing quality, Hamburg told GPhA members about a proposal by FDA drugs center director Janet Woodcock to add transparency to quality.

To do that, Woodcock is considering some meaningful manufacturing quality metrics, “drawing from well-established measures that industry already uses to monitor quality.”

Hamburg also noted that a Woodcock proposal to create an Office of Pharmaceutical Quality is moving forward. “To address the increasing complexity of products, we will optimize the use of staff talent and review expertise to improve consistency and regulatory certainty across the wide span of drug quality review,” she said.
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.