Posts Tagged ‘FDA’

Where is the Device Industry’s Seat at the “Network of Experts” Table?

December 8th, 2011
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Recent draft polices from the FDA’s Center for Devices and Radiological Health (CDRH) have created concern by industry members that they have been left out of the “network of experts,” a program to supplement the FDA’s existing expertise and to expedite the review process. Despite the fact that the FDA has more than 800 scientists, engineers and clinicians, the agency believes that it is impractical to expect CDRH staff to keep current with so many new and complex technologies surfacing.
The network of experts is designed to be a resource for CDRH, particularly to address questions on emerging and unfamiliar technologies. The outside organizations that are being considered by CDRH for inclusion in the network “…will include professional scientific and medical organizations and academic institutions.”  Even though we have not yet heard what organizations the FDA will use in a pilot program to assess their new process, a number of organizations are interested in participating in the program. Industry also would like a seat at the table.

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Applauding Cautious Optimism from a Big Pharma CEO

December 1st, 2011
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Recently journalists at WSJ and Xconomy interviewed John Lechleiter, Chairman, President & CEO, of Eli Lilly and Company. When I sat down to read Mr. Lechleiter’s interviews, I was prepared to get up from my desk several times to find something more interesting to do thinking the articles were to be somewhat mind-numbing. My expectations were not based on any preconceived notions about Mr. Lechleiter, but rather that I assumed the focus of the interviews would be lamenting the pharmaceutical industry’s problems. Instead I was encouraged by Lechleiter’s dedication and optimism.
It is increasingly easy to criticize big pharma: Fewer truly “new” drugs are developed. It is difficult to understand the economics behind the high costs of certain drugs. After being approved, some drugs go on to be proven ineffective or, sometimes, potentially dangerous.
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Notes From Afield—#TEDMED, Day One

October 27th, 2011
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TEDMED, that health-focused meeting of the minds, is underway in San Diego, and I wanted to share some impressions of the ideas proposed at the conference. This week, there are a lot of very interesting exhibits, thoughtful presentations, and a bright, energetic audience here. And if there was a central theme to this year’s TEDMED, I’d say it was “redefinition;” rephrasing our questions to reflect what we’ve learned about how the natural, social, and physical worlds actually work.  I’d like you to chime in; share your thoughts with me on these ideas, or any others!
Here are some of my initial takeaways:


  1. Dr. David Agus of USC observed that the power of sophisticated diagnostics is needed to produce truly targeted personalized medicine, but wonders if we need to not only redefine diseases such as cancer, but also to find different, more useful definitions of health. In other words, should we focus on defining health, or instead focus on what is meant by disease?
  2. Ger Brophy of General Electric Healthcare focused on the theme of cancer on a personal basis, rather than on the geography of where the cancer is. As we’ve discussed via this blog, cancer’s traditional definitions based on anatomical location are not keeping up with what we know about the disease – and its many forms – today. Read the rest of this entry »

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Can We Take the Excitement out of the FDA? Agency Could be Turning a Corner

October 10th, 2011
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The U.S. Food & Drug Administration (FDA) likes to trot out the statistic that claims it regulates about $100 billion in biomedical R&D each year: investments made by industry (and government) to create new innovations to treat today’s health challenges. But the agency has been hesitant to address another facet of investments: that they should be predictable. As the late, great economist Paul Samuelson said, “Investments should be like watching paint dry. If you want excitement, take $800 and go to Las Vegas.”
Anybody who’s watched the stock market the last few years knows we would rather live without this kind of excitement. However, the latest documents issued by the FDA – from Research Use Only/Investigational Use Only (RUO/IUO) guidance to LDT to the latest strategy document on boosting innovation (read coverage from Xconomy) – are inconsistent enough to make drug development resemble a Roulette wheel, rather than a science-based, multi-year, multibillion-dollar strategy to develop therapeutics and diagnostics. Even venture capitalists, not known for their risk-averseness, have gone to Congress to demand more predictable responses from the FDA.
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Investors May Back a Revolution, but It Takes the People to Start One

May 19th, 2011
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A recent article posted by Luke Timmerman of paints a bleak picture for the state of biotech investment. He explains that the general public no longer views biotech as worthy of the almighty buzz factor, i.e., the magazine cover stories and TV morning shows so important to the elusive independent investor. He suggests that the biotechnology industry may never capture the public’s imagination again, a strong assertion considering the amazing things happening in genomic research, companion diagnostics, medical technology, telemedicine and other parts of the sector. But is the buzz factor the only thing that matters in an age of consumer empowerment? What about the equally powerful phenomenon of simply going viral?
In some ways Mr. Timmerman’s article, in which he speaks of investor excitement for TECHnology versus BIOTECHnology, may not present a fair comparison. Facebook and LinkedIn do not have an entity like the Food & Drug Administration (FDA) that sends years of data to the trashcan more frequently than it approves a product for use. Nor do many technologies reckon with the complex reimbursement issues faced by products utilized within the healthcare system.
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Putting the Cart Before the Horse when Leading a Test to Market

April 28th, 2011
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Berkeley HeartLab’s experience with its KIF6 StatinCheckTM highlights the discrepancies between how well a test is marketed versus its clinical utility.
In 2008, the assay KIF6 StatinCheck genotype test was introduced as a laboratory developed test.  More than 250,000 tests, with a price tag of about $100 each, have now been performed. In December of 2010, Celera (Berkeley HeartLab’s parent company) submitted a pre-market approval application to the U.S. Food & Drug Administration (FDA) based on several studies. These studies suggested a relationship between carriers of the KIF6 gene and an increased risk of coronary heart disease (CHD) and statin response.
TheBerkeleyHeartLab states the test’s clinical value on its website as follows:
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Point/Counterpoint: On FDA Regulation of DTC Genetic Tests

March 10th, 2011
Posted by reporter Emma Hitt wrote yesterday, “A U.S. Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the U.S. Food and Drug Administration (FDA).”
The recommendation came after the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met for two days in Washington, DC. The Panel discussed several issues – from potential risks of incorrect results for DTC testing performed without medical counseling to claims associated with various DTC genetic tests.
We’ve long been interested in this subject area and we followed some of the live coverage of the panel via Twitter posts from the likes of @RDGene @aliciaault @likesky3 @genomicslawyer and @dgmacarthur using the hashtag #FDADTC. Subsequently, we read perspectives surrounding the Panel’s deliberations via blog posts by @dnalawyer and @dgmacarthur, which you may want to check out.
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“Supplementing” Conversation About Nutraceuticals/Cosmeceuticals

March 8th, 2011
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“Relieves, helps, aids, protects, reduces, may help to slow…”
Fill in the blank for many products (particularly those labeled nutraceuticals or cosmeceuticals) whose marketers some times “claim” that they can do all or some of the above.
These claims can be dangerous, as shown by a recent report in FDA’s Medwatch. The report provided public notification of an “undeclared drug ingredient” in Fruta Planta, a dietary supplement imported from outside the United States.  The FDA had received multiple reports of adverse events associated with the use of the product, which included cardiac events and, in one case, death.
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Upcoming 510(k) Improvements: FDA’s Tall Order

February 9th, 2011
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On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
For context, here’s a current definition of the 510(k) program from the FDA website:
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.” Read the rest of this entry »

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This Is Not Your Grandfather’s Big Diagnostics

February 7th, 2011
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Danaher Corporation (NYSE:DHR) announced today (see San Francisco Chronicle story here) that it has entered into an agreement with Beckman Coulter, Inc. (NYSE: BEC) to acquire Beckman for approximately $6.8 billion. When the acquisition is complete, Beckman will become part of Danaher’s Life Sciences and Diagnostics business segment.
This is yet another example of the diagnostics landscape’s rapid upheaval in which different players will clearly be dominating and leading the industry.
The diagnostics industry shake up is in full swing: As we wrote recently, sequencing technology (one critical part of the Dx space) is changing at an earth-shattering speed and today’s announcement is evidence of what is happening on the market level. Need more evidence? Check out this post by Xconomy’s Luke Timmerman on “diagnostics warming up.”
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