Monthly Archives: July 2009

Should FTC Oversee Online Communications?

As is well known, FDA's DDMAC has stubbornly refused to deliver any guidance for industry and for advertisers on what is and is not acceptable in communications on the Internet.  Instead, the agency has repeatedly stated that it is not … Continue reading

Posted in DTC Advertising | Comments Off

Change Coming to Pharmacovigilance

Just about every conversation about the use of digital and social media with pharmaceutical companies starts at the same point – NO.  Even if there is a willingness, Med-Reg intimidates and shuts down the effort in most cases, causing the … Continue reading

Posted in Drug Safety | 2 Comments

A Warning Letter Story

Normally here at Eye on FDA, warning and untitled letters are reviewed quarterly.  Sometimes, however, one stands out as somewhat extraordinary.  So it happens with a warning letter DDMAC issued last week regarding a DVD. The DVD features an interview with … Continue reading

Posted in FDA Policy | 2 Comments

Why Healthcare Reform is Struggling – A Failure to Communicate

Back in the 1990s when I was working as Policy Director at AIDS Project Los Angeles, I was having trouble getting an appointment with a particular Congressman to discuss proposed cuts to the Housing Opportunities for People with AIDS (HOPWA) … Continue reading

Posted in Legislation | Comments Off

Breakthrough in Pain Relief – Kind of….

No, it isn't a scientific breakthrough – it is a regulatory breakthrough.  Yesterday the FDA approved a new opioid based pain relief medication indicated for use with patients in with cancer who experience breakthrough pain who have developed a level … Continue reading

Posted in Risk Management | Comments Off