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Brian Haug, President of Pharmacy and Managed Markets, Pharmacy Times (PTNN) This weekly video program highlights the latest in pharmacy news, product news, and more. (video)

…nonpartisan watchdog group called Project on Government Oversight published a report…that highlights flaws in the FDA’s 2010 approval of Pradaxa…group says this case study is a "cautionary tale" for U.S. legislators considering the 21st Century Cures Act which aims to expedite the drug approval process…Food and Drug Administration was "lax" and "permissive" in its approval…analysis suggests the FDA rubber-stamped the drug on the basis of a single poorly designed clinical trial that overlooked safety concerns…damning report comes at a time when Congress is considering the 21st Century Cures Act…

...soon, Apple Inc. iPhones and watches may be able to recognize when someone’s having an epileptic seizure, and call for help…Researchers at Johns Hopkins University have developed an app that can track and measure seizure symptoms, and is the first research app to combine sensors on both Apple’s watch and phone. Eventually, it may run in the background and alert caregivers that a patient is having an event….the app measures heart rate, movement and other data as the seizure progresses. The watch will also display queries designed to test whether the wearer is alert…

…health authorities warned consumers recently about dangers of so-called herbal Viagra, non-prescription products sold to enhance sexual performance, reportedly used by former professional basketball player Lamar Odom, who is in critical condition in a Las Vegas hospital...unregulated sex performance supplement could cause a severe reaction…You can get into trouble because some of these remedies for sexual prowess are stimulants…taken in sufficient quantity, can cause problems with your cardiovascular system…Food and Drug Administration has found that some supplements sold as herbal alternatives to Viagra or Cialis contain the active ingredients of those drugs…falsely marketed as "dietary supplements" that promise to enhance sexual performance are "a risky proposition."..We've seen pills, coffees, chewing gum and dissolvable oral strips that contain hidden drug ingredients or untested chemicals…

Three in four NHS hospitals are unsafe, official watchdogs warned last night…In an alarming report, they said casualty cases had been left in makeshift huts outside A&E. Other patients were given the wrong drugs or illegally sedated…Care Quality Commission also warned of a culture of bullying and blame, with staff scared to raise concerns or admit blunders…The report came on the day that an NHS whistleblower was named by his shameless bosses. The professor had revealed that dozens of patients were needlessly put through the agony of chemotherapy…The most comprehensive NHS assessment ever, the CQC’s 120-page report covers 150 hospitals. A shocking 74 per cent were graded either ‘inadequate’ or requiring ‘improvement’ in terms of patient safety.

Pfizer CEO Ian Read says he's met the drug-cost enemy, and it isn't pharma. The firestorm over U.S. drug pricing isn't a problem for drugmakers to solve…The public debate about rising drug prices--be they increases for existing meds or 6-figure cancer-treatment costs--overlooks the financial benefits of drug treatment...Read cites cost-benefit analyses showing that Lipitor and other statin meds cost $305 billion between 1987 and 2008, but they generated $1.3 trillion in economic benefits, by preventing heart attacks and strokes, and their costs to the healthcare system.

Combination products – medical products that do not fit into the traditional categories of drugs, devices, or biological products – are a growing and important category of therapeutic and diagnostic products under FDA’s regulatory authority…These products, that combine drugs, devices, and/or biological product ("constituent parts") with one another… Products in this category range from familiar products such as prefilled syringes and surgical kits to novel and innovative products, which target and enhance therapies. Examples of groundbreaking combination products include antibodies combined with drugs for targeted cancer therapy and products that mimic or replace organs, such as an artificial pancreas….we’re taking a number of steps to clarify regulatory requirements and improve our internal processes and IT systems.

• Issuing more guidance for review of combination products (e.g., our pending draft guidance document on human factors);
• Enhancing and simplifying data access and sharing for internal staff;
• Making it easier for staff to request and monitor inter-center consults;
• Updating and maintaining our internal contact directory for experts to review a combination product; and
• Improving our internal standard operating procedures for premarket reviews and compliance activities.

Kenya has become the first country to take up the Novartis Access programme, under which the Swiss drug giant is providing a batch of essential medicines at a cost of $1 per treatment per month…15 therapies on offer all target chronic diseases such as diabetes, respiratory illnesses, and breast cancer, the idea being to increase access to potentially life-saving medicines and thereby help reign in their growing spread in areas with limited access to healthcare…In Kenya, noncommunicable diseases...account for 27% of deaths, or almost 100,000 people per year...by 2030, it is estimated that they will be responsible for more than 60% of deaths, highlighting the urgent need for intervention.

Dynamic podcast interview with Alex Barker PharmD, founder of Pharmacy School HQ Alex is a self proclaimed ‘neopharmaphobic’ clinical pharmacist in Michigan.

Nick Gentile, Director of State Grassroots Advocacy and Political Action for ASHP, provider status update

Dietary supplements - those "all natural" products people consume for weight loss, extra energy or to self-treat various conditions - send 23,000 people…to the emergency room…each year, according to a new estimate…9 percent require hospitalization…new study "illustrates the idea that something that's 'natural' is not necessarily safe, and these products do not come without risk,"…a trade association that represents supplement manufacturers…reacted…arguing that the results…reinforce that dietary supplements are safe products…Congress has thwarted attempts to strictly regulate the $14.8 billion industry, where products are often marketed as if they were drugs but safety testing and FDA approval are not required. Only if a product is later found to be unsafe can the agency ban it…The number of emergency department visits attributed to supplement-related adverse events…is probably an underestimation, since supplement use is underreported by patients, and physicians may not identify adverse events associated with supplements as often as they do those associated with pharmaceuticals…