Mistakes happen. In the pharma industry, these mistakes can lead to product recalls. Perhaps the medication is not the correct strength or maybe it became contaminated with metal fragments…

…and sometimes, entirely the wrong drug is found in the packet. In a case that has had UK media reports aflame, a prescription only antipsychotic drug was found in certain packets of a common pain medication that was manufactured by a completely different company. Is it a repackaging mistake? Or are more sinister intentions at work? Either way, it’s clear there are could be a few security holes in pharma’s distribution chains. Read more »

FDA may soon revise the labeling of over-the-counter pediatric medications to place a stronger emphasis on weight rather than age for dosing instructions. In mid-May, two advisory committees to the agency, the Nonprescription Drugs Advisory Committee and the Pediatric Advisory Committee, recommended a change for children’s OTC medicines that contain acetaminophen, such as Tylenol. The labeling issue has been a concern for many years now, and has gained attention since January 2008, when postmarket adverse events were reported for McNeil Consumer Healthcare’s pediatric formulations of Tylenol, Motrin, Zyrtec, and Benadryl. Read more »

The subject of over-the-counter drugs is quite popular lately (see related blog post, “Using Drugs Right”), probably because of the many OTC drug recalls that have occurred in the past 18 months, and also because OTCs are part of most Americans’ daily lives (especially now, when the allergy season is running rampant across the US). FDA released this week a new final guidance, on OTC drug products, this one focusing on liquid medications that have dispensing devices.

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I just finished writing an article on over-the-counter (OTC) drugs and how their safety and market approvals are managed (look for it in the May issue of PharmTech). As a consumer, something stood out in my research. Read more »

This blog post was written  by Christina I. Ortiz

You might want to rethink buying that bulk-sized hand sanitizer if you’re trying to protect you and your family from Methicillin Resistant Staphylococcus Aureus bacteria (MRSA) and other diseases. FDA is cracking down on over-the-counter (OTC) drug companies that are claiming their products prevent infection from MRSA.  The agency has sent letters to firms Tec Laboratories, JD Nelson and Associates, Dr. G.H. Tichenor Antiseptic Co., and Oh So Clean, Inc. (who also does business as “CleanWell Company”), among others. Read more »

The European Medicines Agency (EMA) has released recommendations concerning pack design and labelling for non-prescription medicines for a 3-month public consultation period, which will run until 30 June 2011. Such features are important for the safe use of all medicines, but are arguably more crucial for non-prescription medicines — especially when no intervention from a pharmacist is required. For this blog, I thought I’d take a an in-depth look at the recommendations and what pharma manufacturers will be required to provide, if the recommendations are enforced.

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Barely a month after its ruling in Bruesewitz v. Wyeth, the US Supreme Court has begun to hear arguments in another case with big ramifications for drugmakers. The current case raises questions about generic-drug companies’ responsibilities and whether federal law pre-empts state regulations, among other issues. Read more »

Have you ever been confused by instructions on a medicine bottle or packet of pills? When it says “avoid alcoholic drinks”, does it mean avoid completely or just cut down? And how exactly should the word “drowsiness” be interpreted? Sleepy? A bit tired? Read more »

At a press conference in the waning days of 2010, Senator Amy Klobuchar (D-MN) raised an alarm about what she called an “unprecedented” drug shortage. Citing a scarcity of treatments for chemotherapy, she called for greater collaboration between industry and FDA to ensure that Americans have access to the medicines they need. But shortages also can affect drugs that are used for purposes other than healing. Read more »

Big Pharma companies with weak pipelines likely envy the makers of generic drugs, whose profits stand to increase as innovators’ drugs lose patent protection. But business for generic-drug manufacturers is not necessarily simple. In fact, a lawsuit to be heard by the US Supreme Court shows that these companies may face significant risks, even if they play by the rules. Read more »