Regulatory Affairs of the Heart

According to Bayer's general counsel, "Bayer has acknowledged and regrets the error it made in not sharing with the FDA information regarding [an observational study on Trasylol®] prior to the September 21st Advisory Committee Meeting on Trasylol®. Bayer immediately initiated a full investigation into the matter and based on our investigation so far, we believe this was a serious error in judgment by two individuals. These individuals have been suspended with immediate effect."

Anybody know whether these two employees were regulatory affairs professionals?

Ex-clinical study coordinator Anne Butkovitz, 48, who last year pled guilty to falsifying case report forms, has been debarred permanently by FDA. The study was a multi-site pediatric study of a rotavirus vaccine and was sponsored by an unidentified pharmaceutical company (anybody know who it might be? I know Merck was working on a rotavirus vaccine, but I'm not sure if this was their study. Regardless, the drug company apparently did nothing wrong.). According to the study protocol, the clinical study coordinator at each site was supposed to contact subjects’ parents at specified intervals to determine whether any serious adverse events had occurred. At one of the sites, however, Butkovitz failed to contact parents but stated on case report forms that she had contacted them and that no serious adverse events had occurred. The pharmaceutical company sponsor reportedly disregarded data from her site.

I'm on vacation. Be back next week...

The FDA continued its recent efforts to remove “grandfathered” drugs from the market, announcing a consent decree with Syntho/Intermax. The company will be barred from marketing:

• Coldec Tablets;
• Coldec D Tablets;
• Coldec TR Tablets;
• Dyphylline & Guaifenesin Tablets, USP;
• Guaidex PD Tablets;
• Guaidex D Tablets;
• Crantex LA Tablets;
• Migrazone Capsules;
• Usept Tablets

For years, FDA turned a blind eye to these types of products, but no longer.