Communicating early and proactively with FDA appears to improve the likelihood of an earlier approval for a new drug or biologic. Last Friday, FDA released a report commissioned by Booz, Allen Hamilton which shows that:

• 52% of companies that met with FDA at the end of Phase 2 trials received approval during the first review cycle vs. 29% for companies that did not meet with FDA during this period.

• Of 58 new drug products for which manufacturers met with FDA before even submitting the application, nearly half received approval during the first cycle.

These early meetings did not always eliminate the need for multiple review cycles. In fact, in 71% of the applications where FDA identified problems during presubmission meetings, manufacturers failed to address the issues by the time of first action.

Nevertheless, it appears that early and proactive communication works well. The Agency has seen a 60% increase in requests for consultations, which exceeded 2,400 last year. For more information on the study and to order a copy, click here.

-AMS

A thought-provoking article by John Calfee of the American Enterprise Institute summarizes the crisis that drug manufacturers and the FDA currently face, the obstacles preventing them from improving, and some potential solutions. To access the article, click here.

-AMS

This report by profesors at Dublin City University, on behalf of the Irish Patients Association, provides a nice summary of the state of drug counterfeiting around the world, and proposes some solutions that any country and its citizens (individuals and corporations) should take.

On Pharma is a web log that looks at the drug industry with a special focus on its invisible and long-neglected stepchild, manufacturing, which is now coming into its own as a strategically important area.  It's administered by Pharmaceutical Manufacturing's editor, Agnes Shanley, a late 20th century editor who is still adjusting to digital 21st century media, but who finds the industry's evolution to be as interesting a story as she's ever had to cover.  

This blog is affiliated with Pharmaceutical Manufacturing magazine, although views expressed here do not necessarily reflect those of the magazine's  publisher, Putman Media LLC. Its aim is to direct the reader to fresh coverage of news and issues in that magazine and its affiliated web sites, www.pharmamanufacturing.com and www.knowpharma.com, but also, those of its competitors, and other sources. 

 It is still a work in progress, but aims to find useful, entertaining, and unusual information in as many different formats, and from as many sources, as possible, and to get more people involved in drug manufacturing and other areas within the industry to discuss the issues, both technical and non-technical, that affect them day to day.

This blog will soon migrate to the magazine's web site, and will feature contributions from the entire editorial team, including Heidi Parsons, Bill Swichtenberg and Michele Vaccarello and guest columnists.

Recruitment and turnover are becoming a problem, he says.

PharmaManufacturing.com's contributor Ed Silverman, lead healthcare reporter for the Newark Star Ledger just did a very interesting interview with one of pharma's most enigmatic and interesting figures: Dr. Peter Rost. 

In it, he reveals some of the questions that had puzzled me for so long—why he remained at Pfizer for so long and why he sued them for wrongful termination, why he decided to speak out in favor of drug reimportation while his qui tam suit was pending, why his blogging had strayed so far from the issues he'd espoused.  He also talks about his new career as a writer and a new thriller novel, "The Wolf Pack" that he is working on. 

At times the Peter Rost appearing in the press can appear arrogant and paranoid, and almost like the "Madonna" of pharma (or at least the Madonna of the 1990s before she learned how tedious it all can be), eager to be in the public eye.  His candor in this interview, instead, speaks of resilience and courage. 

Now if we could only get the video up on our site.  Attached, a low resolution video (still 20 mg) and a written transcript.

Pittcon has been interesting (individual booth visits more so than the press conferences)