Who is advancing a smarter approach to pharma, in all its facets, and who isn’t? Every week we’ll run through top news, and divide the proactive and those who have (knowingly or unwittingly) spurred positive change from the reactive, inactive, or soon-to-be-extinct.
Sometimes, good news gets buried in general media coverage. Please right this wrong by sending us updates on positive efforts and results you are seeing within your company and elsewhere. But don’t be afraid to call out the dodos and dinosaurs among you.
The US Department of Justice Drug misbranding cases have dominated the DOJ’s pharmaceutical industry activities, but, according to the Regulatory Affairs Professionals Society’s Journal, Regulatory Focus, DOJ plans to make current good manufacturing practices (cGMPs) one of its top areas for scrutiny this year. Will this new focus take manufacturing out of its stepchild role, and drive the use of more modern technology and quality management methods?
China’s State Food and Drug Administration SFDA is already overhauling its cGMP regulations. But now it is working over its supply chain, too. Cynics might recall that this was the nation that brought melamine and oversulfated chondroitin sulfate into daily breakfast table conversation, and the government body that executed its former commissioner back in 2007, but SFDA appears to be serious in its efforts to modernize quality control and supply chain management. As FiercePharmaManufacturing reports, SFDA’s new good supply distribution practices are mandating use of track and trace technologies that have been widely discussed for the past 10 years, and remain “under discussion” in the US without clear mandates set by the FDA.
Shanta Russell After reportedly taking contraceptives as directed on the package label for 12 years, the UK Daily Mail and several other newspapers recently reported, this single mother from Kansas City has sued Qualitest Pharmaceuticals and parent company Endo for birth-control labeling errors that led to the drug’s recall, and also, presumably, to her pregnant condition. Labeling errors can lead to adverse patient reactions, but they also compromise and silently invalidate clinical trials. Could this suit and others like it involving contraceptives (reportedly planned in California, Texas, and other states) and other suppliers, eventually drive the use of PAT and smarter methods in clinical and full-scale manufacturing? Stay tuned to more on this topic from blogger and NIR expert Emil Ciurczak.
John LaMattina Pfizer’s former head of R&D said recently in an interview in the Connecticut-based publication, The Day, that he had an epiphany when a guest on Dr. Mehmet Oz’s TV show two years ago. As he relates, shouting audience members showed him vividly how poor the public’s opinion of the industry is. He is now bringing that sensibility, and some balance, to showing the more positive face of pharma and muses on the topic in his new book, Devalued and Distracted.
Ranbaxy's US legal team When you have released, and recalled, pharmaceuticals that may contain small pieces of glass, wouldn’t it be best to take an apologetic stance to any consumers who might have purchased these products? Blaming the victims (alleged or not) of cGMP violations seems the wrong tactic. Yet that is what Ranbaxy’s U.S. legal defense team is doing now, Pharmalot and FiercePharma reported recently. Given the cGMP violations already on record, and hundreds of millions of dollars in costs stemming from those violations, mightn’t another approach have been better? Just ask John LaMattina.
Teva The booming generic drug market is based on the idea that the drugs can be marketed only after the name-brand patents have expired. But some generic drug manufacturers have gambled on being able to jump the gun. This strategy may cost Teva $2 billion, according to PharmaTimes.
Pfizer Is it good practice to capitalize on a brand’s reputation for “right first time” quality, yet outsource manufacturing of offshoot generic product lines to suppliers with inconsistent quality and compliance records? Pharmalot reports that Pfizer has allied with Indian active pharmaceutical ingredient (API) suppliers such as Aurobindo and Claris Lifesciences to manufacture generics. However, both Aurobindo and Claris have recently been cited for cGMP problems. Even though Pfizer’s drugs were not affected in either case, could there be a need for greater scrutiny of supply chain partners? One might expect a company like Pfizer to know better.
It all leads back to rules and enforcement Regardless of geography, this sector is still quite regulatory- and enforcement-driven. I unerstand there are good reasons for that; still, it makes me nostalgic for a good old fashioned conversation about innovation and competition. I guess molecular equations of how diffferent chemicals get integrated may not burn up the boards either.
Case files redux Good article! All of the examples show an industry that still remains in a bottom-up process orientation. Many of these problems could have been averted with forward thinking. I suspect that the spate of problems is far from over.
Re: PharmaEvolution Case Files 1 Great article. The mislabelling cases are particularly worrisome to me, because it undermines the entire industry. For example, many parents are concerned and hesitant to vaccinate their young children as a result of real and rumored problems in the recent past. The cornerstone of this industry must be trust.
PharmaEvolution Case Files 1 Pfizer had issues with Claris in summer of 2010. There were glass found in some injectables. Companies outsourcing APIs and formulated products have to police their product coming in.