Just read Mina Kime's enlightening account of the J&J McNeil quality disaster in Fortune. Forget about the fact that the adulterated products did not and most likely would not have harmed consumers, the problems cited are very serious and go straight to the heart of GMP's. 

Conventional wisdom in the industry suggests that drug product recalls are on the rise, and in fact if you look at the chart that leads off this CNN Money report today, you'd say the 2009 escalation is quite alarming. On closer inspection, as the article points out, many of these recall events are due to the problems of a few manufacturers, such as Advantage Dose.

Some of the news reports that followed FDA's recent approval of the blood-thinner Lovenox suggested that it was the Agency's first approval of a biosimilar, or follow-on biologic. (Here's one example.) In a recent interview with Ed Silverman of Pharmalot, Jonathan Pan of Scientia Advisors disputes that Lovenox is a true biosimilar (as vague as that definition may be). Says Pan, "Lovenox is not a biologic like a protein or antibody.

Last week, FDA announced that it had joined EPA and other federal agencies in Tox21, a program to improve, and greatly accelerate, chemical screening of toxicologically active chemicals. The program had been in place for two years, but FDA’s participation signals a new scope and new possibilities.

While there is increasing acceptance of the idea of cannabis-based drugs and the use of marijuana for medicinal purposes (particularly in California), there is still political resistance across much of the U.S. Britain's GW Pharma continues to push ahead with Sativex, which was approved in Canada five years ago for neuropathic pain associated with MS. MHRA has now also approved its use related to spasticity in MS patients (see press release in italics below).

At this week’s PAT/QbD meeting, sponsored by FDA and the University of Rhode Island’s College of Pharmacy, there was no question that the speaker everyone was waiting to hear from was Ajaz Hussain, former PAT team leader, Sandoz executive and now VP at Philip Morris International.

He burst energetically up to the podium, briefly recapping the history of why PAT was advanced. At the time, he said, FDA was resisting ICH Q8, although Europe and Japan were embracing it.

Hilde Boone, Pharm, MSc, is the European Medicines Agency’s liaison official at the U.S. FDA. Boone’s post was established this past winter (FDA, reciprocating, also has a representative in London who liaises with EMA). Boone embodies a new era of collaboration between American and European regulators, and among global authorities. She spoke at BIO 2010 in Chicago about her experiences and the collaborative priorities that EMA and FDA have.

During an FDA Town Hall meeting at BIO 2010 today, FDA’s Karen Midthun (Acting Director, CBER), and Douglas Throckmorton (Deputy Director, CDER) fielded questions from the audience about current regulatory issues. What follows is a brief synopsis of this session:

Audience Question: FDA has gone through a period of significant growth . . . it was recently reported that 38% of medical reviewers have been on the job less than two years . . . how well are these staff being integrated . . . and what do you view as the opportunities and challenges of having new staff?

FDA Commissioner Margaret Hamburg spoke today at the BIO 2010 show in Chicago. Following are some of her remarks:

...FDA is an extraordinary place . . . I’ve been in my role as deputy commissioner for almost a year now. Before I took on this role, I remember hearing Senator [Ted] Kennedy say that FDA was the most important public health agency in our country . . . I was a bit surprised . . . but now that I’m in this role, I’ve come to understand how right he was.

Last week, FDA released its anticipated final guidance, “Standards for Securing the Drug Supply Chain—Standardized Numerical Identification for Prescription Drug Packages.” The aim of the guidance is to lend support to industry efforts to establish end-to-end supply chain security and realize the benefits of the myriad track and trace technologies currently available. This guidance is just a start, the Agency indicates.