The US Food and Drug Administration has taken a lot of heat in recent years. Events such as the heparin scandal and the recall of Actavis’s (Morristown, NJ) Digitek product have led critics to call the agency a lax and ineffectual protector of the public health. These comments, which I think are partly justified, finally seem to have spurred FDA into action. Several initiatives seem to show an agency that wants to regain its credibility and shield us from dangerous medications. Read more »

An initiative to develop consensus-based industry standards to identify and define green chemicals and process technologies is underway. The move is a helpful step toward more sustainable practices for the chemical and pharmaceutical industries, but it raises larger questions. Can the pharmaceutical industry be more proactive in becoming green? And can regulatory authorities do more to encourage process improvement for green pharmaceutical manufacturing? Read more »

At a joint session of the PharmTech Conference and the 4^th Annual Manufacturing Execution System in Life-Sciences Congress earlier this month, during my opening remarks, I discussed FDA’s proposed budget increase of $166 million and 346 FTEs toward Medical Product Supply Chain Safety and Security Oversight. The globalization of manufacturing and supply of medical products has created unique and demanding challenges for industry and FDA alike. Yet, according to a recent Axendia study on QMS trends in Life-Sciences, only 34% of respondents reported view global quality data in real time. Read more »

FDA issued two new proposed rules this week that would require all manufacturers to report adverse events electronically. The idea seems perfectly reasonable—every company uses computers and the Internet these days. But what struck me as odd is that the agency is still entering adverse event reports manually and that paper filings are still being used at all. As an editor, I spend a good portion of my day typing, but I haven’t had to retype or transcribe from a hard copy in years. It’s no wonder FDA has such a backlog of paperwork and lengthy review times. The growing global industry demands fast, electronic communication, and the agency must keep up with the culture. Before they know it, pharma companies will be sending adverse event reports or supply-chain breaches via Twitter—surely 140 characters is enough to note that a patient experienced a negative effect after taking a certain drug product. Read more »

Yesterday, I stumbled upon a list of someone’s opinion of the “top 10 accidental discoveries.” On the list were at least two drug products (take a guess before you research). Although I’m certain there are bound to be more accidental discoveries, I’m even more certain that most future discoveries will be deliberate, based on detailed knowledge of the systems under study.

For example, recent advances in therapeutic biologics have raised the need for a greater understanding of how the body fights infectious diseases at the most fundamental level. One of the most elusive parts of this understanding is the inner workings of ribosomes, those parts of the cell responsible for producing proteins. Read more »

Two announcements made on two consecutive days last week vividly showed that whether a thing is helpful or harmful often depends on how we use it. The announcements’ subject? Tobacco. Read more »

The high-profile case of contaminated heparin last year was reason not only to consider issues relating to supply-chain integrity, but it also reminded us how critical a production process is to the quality of a drug substance. Pharmaceutical-grade heparin, a sulfated glycosaminoglycan, is derived from the mucosal tissues of slaughtered meat animals such as pig intestines, and a synthetic route has been elusive. Researchers at the Rensselaer Polytechnic Institute (RPI) report on a potentially interesting solution that may not only be valuable for producing heparin, but may also be a relevant approach for developing other biopharmaceuticals. Read more »

Like the recent report on Microsoft Bing’s sponsored ads for online pharmacies, a new report released this week by Internet-pharmacy verification organization LegitScript and antispam firm KnujOn focuses on the legitimacy of online pharmacies advertising in sponsored links on Yahoo.com. Read more »

In a recent New England Journal of Medicine article, researchers from Stanford University and the Veterans Affairs Palo Alto Health Care System propose that FDA require drug labels to state whether a product is superior to other products in its therapeutic field. I think this idea is going way too far when it comes to comparative-effectiveness information.

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Pharmaceutical scientists are still just beginning to understand the working mechanisms of nano-sized particles in drug delivery. For formulators, one of the key challenges has been to design particles that increase bioavailability of the drug to specific targets but still have minimal side effects to the patient. For manufacturers, processing nanomedicines requires having to rethink traditional production operations. How do the unique properties of nano-sized particles affect the means in which they are handled, blended, mixed, coated, lyophilized? Read more »