Tag Archives: FDA

Pradaxa: Case study on DTC marketing moratorium ?

Posted on January 16, 2012 | 1 Comment

In the first quarter of 2011, the FDA received 40,151 domestic reports of serious, disabling or fatal injury associated with drug therapy. The total represented a 3% increase over the previous calendar quarter, and a 19.5% increase over the first quarter of 2010. Continue reading →

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Posted in FDA, Focus on patients

Tagged FDA, Pradaxa

Drug companies cannot hope for blockbuster drugs anymore.

Posted on December 22, 2011 | 4 Comments

Blockbuster drugs. They are, to this day, an addiction for big pharma. A blockbuster can produce a huge ROI and fund the development of new drugs and new marketing programs but today the deck is stacked against blockbuster drugs.

The healthcare environment today is one in which cost containment is a key element. A lot of blockbuster drugs are going to come off patent including,Zyprexa, Cymbalta and Viagra. Insurers, before adding new and improved brands, are asking for clinical proof that new products outperform generics. In addition the FDA is taking a harder look at all NDA’s and in most cases is asking for more clinical studies before approval cutting down on the time the drug is on the market and this the ROI for these products. Continue reading →

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Posted in Business of the drug industry

Tagged Atorvastatin, Blockbusters, FDA, Food and Drug Administration, Long Tail, Marketing, Pharmaceutical drug, Pharmaceutical industry, Zyprexa

Summary of healthcare news

Posted on November 11, 2011 | 2 Comments

Despite the challenges for pharma in social media, the industry accounted for 4 percent of the $25.8 billion spent on overall US online advertising last year, according to new estimates from eMarketer. eMarketer also predicts that healthcare and pharma advertisers will see double digit growth over the next few years, rising from U.S. $1.03 billion in 2010 to $1.86 billion in 2015. Continue reading →

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Posted in Weekly news mash-up

Tagged Abbott Laboratories, FDA, Food and Drug Administration, Health care, Merck, Merck & Co, Phil Baumann, United States

The future of healthcare is visible but requires new ways of thinking

Posted on November 10, 2011 | 5 Comments

An editorial in today’s Times asks “WHY can’t Americans tap into the ingenuity that put men on the moon, created the Internet and sequenced the human genome to revitalize our economy and consumer health?” The editorial says that “we are in the early phases of the next big technology-driven revolution, which I call “consumer health.” When fully unleashed, it could radically cut health care costs and become a huge global growth market.” The answers are both complicated and simple but at their core they require a new way of thinking about marketing and health. Continue reading →

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Posted in Contrarians POV

Tagged Bill Gates, Consumer, Facebook, FDA, Food and Drug Administration, iPad, Pharmaceutical industry, United States

More bad news on medical devices

Posted on October 26, 2011 | 1 Comment

U.S. reviewers said a Medtronic Inc device was effective for treating a common heart rhythm disorder, but they raised concerns about its safety. Medtronic’s Cardiac Ablation System is designed to treat persistent atrial fibrillation, a major cause of strokes. But, in documents released on Tuesday, Food and Drug Administration staff expressed concerns about the high rate of stroke found in patients treated with the device. Yet medical device makers continue to fight any more regulatory oversight rules by the FDA. Clearly patient safety is not as important as sales. Continue reading →

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Posted in Medical Devices

Tagged Atrial fibrillation, Clinical trial, FDA, Food & Drug Administration, Medical Devices, Medtronic, New York Times, Patient

Why medical devices need more scrutiny

Posted on October 1, 2011 | 4 Comments

An article this morning in the Times on faulty metal hip implants is enough to get readers depressed and angry. Imagine if you had gone through the pain and inconvenience of getting a metal hip implant only to learn later that the device has been recalled and that it could lead to more complications ? Sure some people are going to be angry and sue but what about the others who are going to have the quality of their lives upended ? What about the people who may get permanently depressed because of damage to their bodies ? Isn’t the FDA supposed to protect consumers ? Continue reading →

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Posted in Medical Devices

Tagged DePuy, England, FDA, Food & Drug Administration, Hip replacement, Insulin pump, Medical device, Medtronic

Medtronic: Investors first, patients second

Posted on August 24, 2011 | 1 Comment

The new chief executive of Medtronic, who took over the company in June, said Medtronic remained committed to returning cash to shareholders and to exploring smaller acquisitions. In his strategy vision, however, there was no mention of focusing on patients or providing evidence based medical devices for better patient outcomes. Is it any wonder then that Medtronic doesn’t want the FDA to add new regulations for testing and approving medical devices ? Continue reading →

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Posted in Medical Device business

Tagged Business, FDA, Food & Drug Administration, Healthcare, Medical device, Medtronic, Patient, United States

Providing a better online product health website

Posted on August 9, 2011 | 3 Comments

While the FDA continues to delay on implementing social media guidelines DTC marketers can do more, a hell of lot more, with their interactive strategies to make them more relevant to consumers. It starts with the realization that consumers are probably going to come your product website and that there is a hell of an opportunity to answer their questions and provide them with information THEY want in language they understand. But it doesn’t stop there. Continue reading →

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Posted in Health information online

Tagged Consumer, Facebook, FDA, Food and Drug Administration, Harvard Medical School, Health informatics, Mayo Clinic, Social media

Shortage of cancer drugs

Posted on August 8, 2011 | 2 Comments

Ezekiel J. Emanuel wrote an opt ed piece in this weekends Times about the shortage of cancer drugs.He says “Of the 34 generic cancer drugs on the market, as of this month, 14 were in short supply. Only the older but curative cancer drugs — drugs that can cost as little as $3 per dose — have become unavailable. Most of these drugs have no substitutes, but, crazy as it seems, in some cases these shortages are forcing doctors to use brand-name drugs at more than 100 times the cost.” The story is full of generalizations and does not address the real problem underlying problems of generic cancer drugs. Continue reading →

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Posted in FDA

Tagged Chemotherapy, Economic shortage, Ezekiel Emanuel, Ezekiel J. Emanuel, FDA, Food and Drug Administration, Health, Manufacturing

It’s not about online health information, it’s what consumers do with that information

Posted on July 26, 2011 | 5 Comments

There is a lot, and I mean a lot, of health information on the Internet. Unfortunately there is also a lot of bad health information on the Internet and consumers have to pretty much figure out for themselves which sites offer credible and good health information, that they can understand, and which ones are full of garbage. What we should be worried about however is not all the health information that’s out there but what decisions consumers are making with information in hand. Continue reading →

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Posted in in the news

Tagged FDA, Food and Drug Administration, Google, Health, Health care provider, Health informatics, Patient, Physician