Category Archives: drug manufacturers
US Pharma Spending Declines for First Time in 60 years
Despite the fact that overall healthcare spending (direct and indirect costs, revenues), are at all time highs, U.S. spending on pharmaceuticals is reaching an all time low –if you are willing to count the last 60 years an adequate measuring stick. It’s simple: the market’s acceptance of widely used, inexpensive, generic substitutes has succeeded in driving the decline. And the generic manufacturing industries’ adept maneuvering –when a big drug hits its patent cliff— is darn near optimized. Not only do employers and insurers “get it,” but according to lots of related survey data, consumers understand the drill too. “The largest [...]
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Just in Time for Mother’s Day: New FDA Warnings for Moms-to-be
The FDA is now warning doctors and putting out the message to women of child-bearing age that half-a-dozen medications commonly prescribed to treat migraine headaches have been found to decrease a child’s intelligence, if taken while their mothers are pregnant. In fact, just yesterday, the FDA said that the drugs, including Depakote and Depacon, should never be taken by pregnant women for the prevention of migraine headaches. These drugs all contain the ingredient valproate sodium which already carries a boxed warning about the risk of birth defects. But the FDA said that it is now adding this new warning based [...]
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Big Pharma Preparing for a Pipeline Shopping Spree, Says GlobalData
Despite a recent fall in deal volume and overall value, some of the pharmaceutical industry’s major players are about to splash out in an effort to restock depleted drug pipelines, says an analyst with research and consulting firm GlobalData. In a new report, Adam Dion, analyst with GlobalData, states that industry leaders such as Pfizer, Merck, GSK and AstraZeneca are paying the price for failing to adequately prepare for the effects of the patent cliff. This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry [...]
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Adverse Effects of Hormonal Contraceptives Now On the Docket
I received a note over the weekend from Eric Burns, the immediate past president of Media Matters for America. Along with Karl Frisch, a former communications director, they launched a new company called Bullfight Strategies –and their business is good. The company was founded with a goal to empower clients “to win in the media arena.” It does so by focusing on the right kinds of rapid response narrative, fully conditioned to take advantage of what has become known as “the 15 minute news cycle.” Eric wanted to make sure that Healthcare Matters’ readers were aware of the latest developments [...]
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ViiV Healthcare, Medicines Patent Pool — Big Pharma Can’t Buy Better Public Relations
GlaxoSmithKline’s HIV/AIDS drugs business is demonstrating some nice character. Their words and actions support a design to share intellectual property rights on children’s medicine in a patent pool designed to make treatments more widely available in poor countries. ViiV Healthcare, majority-owned by GSK, is the second research-based pharmaceutical business to sign up to the new Medicines Patent Pool, following a lead set in 2011 by Gilead Sciences. The Medicines Patent Pool (MPP), launched in 2010 by the UNITAID health financing system that is funded by a levy on airline tickets, aims to address the remaining gap by getting patent holders [...]
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FDA Approves Revolutionary Breast Cancer Drug
The drug is called Kadcyla, but it will be better known as TDM-1. The FDA last Friday announced that it has approved TDM-1, as clinical trials have shown it is effective and has lower toxicity (less complications) for women with human epidermal growth factor receptor 2 (HER2) positive forms of the disease. It’s revolutionary in that it contains the original drug Herceptin, a drug more commonly used to treat aggressive estrogen positive breast cancer, but there’s another drug in the same compound and a unique approach to killing the bad cells (from the inside out) is supported. Richard Pazdur, M.D., [...]
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NECC’s Demise: A Tragedy of “Failed Organizational Ethics”
It’s been three months since the deadly outbreak of fungal meningitis began. And yesterday, the New England Compounding Center (NECC), the compounding pharmacy that produced the contaminated medicines, filed for Chapter 11 bankruptcy. It’s highly doubtful that NECC has enough assets to adequately compensate its victims, including the thousands of people who were exposed, the 620 who fell ill, and the 39 who died, but one thing is for sure, the lawyers will be turning over a lot of rocks in their quest for settlement money. For example and according to Alyson Oliver, a Michigan attorney representing victims, the fatal [...]
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Amgen Undercover Whistleblower Speaks Out
As you read through this post, please keep in mind that the off-label dosing regimen that Amgen was promoting (that we reported on this week) was unapproved and illegal because it was considered risky and likely to cost lives. An old Tower of Power lyric comes to mind: “It’s not the crime; it’s not the thought; it’s not the deed; it’s if you get caught.” ———- I have a special place in my heart for the “whistleblowers” of the world —those who stand up and defy corrupt power structures. Consider this: when the DOJ only pursues about 20% of the [...]
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Amgen Agrees to Pay $762 Million to Settle Aranesp False Claims Case
Amgen pled guilty yesterday to marketing its blockbuster anemia drug darbepoetin alfa (Aranesp) for off-label dosing regimens, agreeing to pay more than $760 million in fines. The drug, administered once weekly, was initially approved in September 2001 to treat anemia caused by chronic renal failure. Simply put, here’s what Amgen did: Because Amgen knew it would have a difficult time competing with JNJ’s Procrit –which had a FDA approved dosing schedule of every other week– Amgen intentionally misused a statement in the Aranesp label that said it had a longer serum half-life –a statement it used to justify a less-frequent [...]
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GPOs –like Premier– Driving Solutions to Eliminate Drug Shortages
Several months ago, President Obama signed an executive order that required the FDA to take more action to help alleviate drug shortages by more comprehensive reporting, expediting regulatory reviews, and monitoring the behavior of manufacturers and distributors to prevent stockpiling or price gouging of scarce medications. In a separate letter to drug manufacturers, President Obama reminded them of their legal responsibilities and prodded them to work more effectively to share information in advance of a shortage. Not too long afterwards, the Generic Pharmaceutical Association (GPhA) proposed a new, unprecedented multi-stakeholder initiative designed to accelerate the recovery of critical drugs in [...]
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Standards for Drug Quality Assurance & Regulatory Enforcement Should Be Consolidated
You shouldn’t be surprised to learn that the New England Compounding Center (NECC), the compounding pharmacy responsible for 32 deaths so far, has been reprimanded by the FDA several times prior to this latest, highly publicized disaster. Going all the way back to 2004, the FDA conducted inspections of NECC’s facilities which resulted in the issuance of a Warning Letter citing at least three infractions. From compounding a commercially available product, to manufacturing a blend of several compounds and marketing the new product as its own, to the reckless repackaging of easily contaminated drugs into syringes (sound familiar?), the company [...]
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SAP & Molecular Health to Shape Personalized Medicine (PMx) Market
The concept of personalized medicine (PMx) is less than 20 years old, and it does not have a perfect track record. But where it has been proven successful, it has been a game-changer –for providers, payors and especially patients, who can finally participate, meaningfully, in their own care. When physicians and patients can efficiently integrate genetic and biological data into the diagnostic process, personalized therapy will become the norm –there will be no turning back. Yesterday, SAP AG (NYSE: SAP) and MolecularHealth, a leader in clinico-molecular informatics™, announced that they have joined forces to create a clinical decision-making system designed [...]
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The WHO Drug Certification Scheme: Pharmaceutical Quality Assurance
While it may now be safe to assume that the lack of FDA regulatory control over compounding pharmacies is a problem that will soon be corrected –especially given recent events– keep in mind it will be over the stripped carcass of NECC. If you tend to agree with me, then it is likely you will also agree that one of the downstream problems (i.e. qualifying good pharmaceutical suppliers/procurement) is also bound to get more than its usual dose of attention. Qualifying suppliers is a quality assurance process. Here are three required components of a system for selecting reliable suppliers of [...]
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Omnicell “Wins” Renewal with Partners Health
Omnicell is a well-recognized provider of sophisticated automation technologies supporting medication management. Pyxis remains the market leader in this expanding niche, but with more than 2500 hospital-customers now, Omnicell is coming on strong. Omnicell’s automated hardware/software systems for medication dispensing include solutions that span the continuum –from the point of hospital entry through the central pharmacy, nursing unit, operating room, and patient bedside –-as well as in long-term care sites. Partners HealthCare just announced its decision to continue its relationship with Omnicell. It’s not only welcomed news at Omnicell, but according to spokespeople at Partners, “it is the most recent example [...]
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Regulating Compounding Pharmacies: Sometimes it Takes a Disaster
Can you envision the supply chain? Grinding medicine into specialized doses for individual, special-needs patients; it conjures up an image of a bygone era. But it’s actually not a “thing” of the past. In fact, there is a growing need in the marketplace for “personalized medicines,” so making them is still big business. But for some strange reason it remains unregulated –and scaling what is supposed to be a per-order-based custom manufacturing process turns out to be a very dangerous enterprise. Just ask New England Compounding Center (NECC). By now you’ve probably heard that NECC is at the center of [...]
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FDA Doesn’t Regulate Compounding Pharmacies?
The meningitis outbreak that has so far killed 15 people and sickened more than 200 others is “nowhere near the end,” a top medical expert said Tuesday, a day after federal authorities warned more tainted drugs may be linked to the health crisis. Dr. William Schaffner, an infectious diseases expert said that he expects a “steady increase” in the number of fungal meningitis infections over the coming weeks. “I think we’re still in the middle,” Schaffner said, when asked about the outbreak’s scope. “We’re nowhere near the end of this problem. And we will see more patients reporting in ill [...]
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