Quality improvements at Johnson & Johnson was the focus of last week’s news about the company. This week, unfortunately, it’s back to recalls and warning letters. Read more »

One of PharmTech’s columnists recently wrote about individuals working in quality assurance and how, after becoming more sensitized to a problem, they significantly increased their performance. Specifically, the employees were in charge of identifying spots on finished vials—if they found a spot of a certain size, they rejected the vial. When one employee starting finding more spots than usual and bragged to his colleagues, they all started finding more spots until the team was rejecting 20% of the finished vials. Read more »

“The pharmaceutical industry is a ‘market for lemons’; a market in which the seller knows much more than the buyer about the product and can profit from selling products less effective and less safe than consumers are led to believe”. Read more »

Have you ever allowed yourself what you thought was ample time to drive somewhere, only to be delayed by a construction crew that was repairing the roads? Obviously, things don’t always work out as we plan them. Judging by its latest announcement about its facility ameliorations, Genzyme (Cambridge, MA) must have learned this lesson, too. Read more »

Last week, Sens. Sherrod Brown (D-OH), Sam Brownback (R-KS), and Al Franken (D-MN) introduced legislation, the Creating Hope Act of 2010 (S 3697), to provide incentives for drug companies to develop treatments for rare and neglected pediatric diseases. The legislation hopes to build on a private–public model to encourage targeted development for rare diseases. Read more »

The welter of recent product recalls (and phantom recalls) initially got the US Congress talking about the adequacy of Johnson and Johnson’s (J&J, New Brunswick, NJ) manufacturing and quality-control operations. But lawmakers soon began asking questions about our line of defense against potentially harmful products: the US Food and Drug Administration. Read more »

As Congress prepares to go into summer recess and begin the legislative season again after Labor Day, a subject that has been of ongoing concern for the pharmaceutical and fine-chemical industries has resurfaced: drug safety by reforming regulatory oversight for foreign drug-manufacturing facilities and related issues. The bill, the Drug Safety and Accountability Act of 2010, introduced this week by Sen. Michael Bennet (D-CO), raises again the issue on how best to oversee an increasingly global pharmaceutical supply chain. Read more »

In the current economic slump, generic versions of branded drugs have become a bigger thorn in innovators’ sides than before. To safeguard their profits for just a bit longer, many companies have paid generic-drug manufacturers to delay the introduction of their products to the market. US and European authorities have called these arrangements anticompetitive, though, and events on Capitol Hill last week indicate that they might not be tolerated much longer. Read more »

Communicating the risks of pharmaceuticals has never been easy. Say too much and no-one wants to take your drug; say too little and politicians, competitors and soon, the entire social media, will fill in the gaps for you. Read more »

The US Food and Drug Administration approved the first generic version of the anticoagulant drug enoxaprin sodium injection on last Friday, July 23. Lovenox is the drug’s brand name, and it’s manufacturer, sanofi Aventis (Paris), was not happy about FDA’s decision. Read more »