Agency begins 'swift' enforcement actions

Share this article:

Less than three weeks after FDA commissioner Margaret Hamburg pledged better enforcement against firms violating agency laws and regulations, swifter and more aggressive actions by the agency are already being felt as the agency dismantles a controversial Bush administration directive that required all FDA Warning Letters to be screened by the Office of Chief Counsel (OCC).

FDA presenters at a University of Rhode Island College of Pharmacy “GMP by the Sea” conference appeared to be energized by the new enforcement posture. One industry questioner welcomed the end of OCC Warning Letter reviews, but he was also concerned that as a result “we may have a lack of consistency and uniformity in what Warning Letters are issued for by districts around the country.

FDA's Division of Field Investigations director Mike Rogers noted that all domestic Warning Letters will continue to have product center review and concurrence for consistency purposes.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Features

Email Newsletters

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

Headliner: Ipsen head leads continental charge

Headliner: Ipsen head leads continental charge

"When I look at the business, I actually see patients in my mind. I don't see numbers."

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