Posts Tagged ‘FDA’

Maggie
Schmerin

Spectrum Infection: Lessons Learned - H1N1 A Year Later

Tuesday, April 20th, 2010

nicGreetings from the 44th National Immunization Conference in Atlanta! With the one year anniversary of the H1N1 outbreak upon us this week, there is not a more fitting place for officials from NIH, HHS, CDC, FDA, state and local health agencies, vaccine advocacy organizations and vaccine manufacturers to gather.

Department of Health and Human Services (HHS) Secretary Kathleen Sebelius delivered the conference's keynote address, which focused on the response to the H1N1 flu pandemic, the lessons learned and efforts to strengthen America's health security in the future.

On April 21, 2009, the CDC was alerted to a new strain of influenza in California and Texas, similar to one that was presenting in Mexico. Kathleen Sebelius was still serving as governor of Kansas, but seven short days later would be sworn in as our country's 21st HHS Secretary and quickly whisked into the Situation Room at the White House where President Obama and other government leaders were beginning to mount an attack on what would become the world's first pandemic in 40 years.

Over the course of the past 12 months, the federal government worked alongside state and local health agencies to ensure that Americans were prepared for and protected against H1N1, and the H1N1 vaccine was the keystone of these efforts. As Secretary Sebelius stated, "The H1N1 vaccine was the most ambitious immunization campaign ever." (more...)

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Mary Ann
Chaffee

Food Friday: Can the FDA Light Up Our Brains?

Friday, April 9th, 2010

A few weeks ago, I was listening to a radio interview with Sheena Iyengar who was discussing the research she did for her new book The Art of Choosing.   Iyengar is a professor at Columbia University School of Business and a well-known expert on the study of choice - how we make choices and how they affect our lives.  It is a subject close to the heart of anyone working in the field of chronic disease treatment and prevention with its focus on getting people to make the choices-particularly about diet and exercise-- necessary to stay healthy.  Study after study has confirmed that educating individuals about risks and how to avoid them isn't enough to trigger behavior changes.  So what else should we be doing?

Over the past few years we've been listening to a national debate about how to address America's obesity epidemic, which is costing us $147 billion each year and is a major contributor to diabetes, heart disease and some forms of cancer.  It has also become an epidemic among our children, with one in six  classified as obese.

Last month when the First Lady launched her Let's Move campaign aimed at reducing childhood obesity, questions about choice were very much a part of the conversation.    Who and what are responsible for creating this problem?  Americans are ambivalent about the question, with many believing it is a matter of individual choice.  But public health officials see it a different way.  They believe that we need to change our "obesogenic" environment, which promotes increased food intake, unhealthful foods and physical inactivity.  Tom Frieden, who heads the Centers for Disease Control, is the lead author on a compelling article in Health Affairs about how to tackle the problem.  And there is no ambivalence in his prescription for change:

"Reversing obesity is not going to be done successfully with individual effort.  It will be done successfully as a society only with societal effort...We got to this stage of the epidemic because of a change in our environment.  And only a change in our environment again will allow us to get back to a healthier place..." (more...)

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Innovation

Technology Tuesday: How Changes to the 510(k) Process Impact Us All

Tuesday, March 23rd, 2010

If you work in health care or as a communications partner to a medical device manufacturer, chances are very high that you are familiar with the 510(k) process. Yet, the average patient who benefits from the medical technology approved through this process each year may know very little about it.    

All medical devices must go through the Food and Drug Administration (FDA) for approval. The Medical Device Amendments Act of 1976 established a regulatory framework that would classify all devices based on their complexity and the degree of risk to the public. This legislation made it easier for manufacturers to bring simpler products to market like tongue depressors, elastic bandages and gauzes. Other devices like medical imaging equipment, endoscopes and dialysis catheters, for example, are subject to the FDA's 510(k) or premarket clearance of devices that examines whether a device is "substantially equivalent" to a predicate or existing device.  The FDA also determines whether additional clinical testing is needed before the device can be sold in the U.S. While originally designed as the exception to the approval rule, the 510(k) process has now become the norm. In fact, approximately 90 percent of medical devices in the U.S. have been evaluated by the FDA through this process.

Today with the majority of devices going through this process, the 510(k) is facing scrutiny from within the FDA itself, advocate groups and lawmakers on Capitol Hill who are questioning whether this process, as it currently stands, still provides safe and effective devices to consumers. (more...)

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Kevin
Walsh

The FDA Spends $72 million to Speed Up Detection of Monitored Product Problems

Thursday, January 21st, 2010

As reported by CQ Healthbeat News, the FDA has awarded a contract to speed up  the detection of product hazards. In a nutshell, the FDA awards $72 million over five years to Harvard Pilgrim Health Care Inc to develop a scaled down version of the Sentinel System.  The system meets the requirements of a 2007 law intended to strengthen FDA drug safety oversight.

Forget for a moment the Orwellian program name "the Sentinel System", it's great to see the FDA moving up the timeline in their desire to learn sooner about Adverse Events.  However, I find it surprising that they stopped three quarters of the way and didn't go right to the source.

With all of the technology available to be on the bleeding edge of potential Adverse Events (AEs) being discussed by e-patients, the FDA has decided to spend $72 million on examining historical data. For the historians among you, my definition of historical is anything that is not a part of today's conversation.  (more...)

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Melissa
Biller

The FDA Has No Idea What To Do About Social Media – Day 2 of the FDA Public Hearing

Tuesday, November 17th, 2009

After attending last week's FDA public hearing on the internet and social media, two things stood out in my mind:

  • Pharmaceutical companies will not be taking "risks" or investing in social media until there are clear, identifiable guidelines from the FDA - as of now, pharma is living in a state of fear of social media
  • The FDA knows there is a need for implementing guidelines for pharma, but it seems they really don't know where to begin...they are looking for strategic recommendations from stakeholders - they've never been in this space before and are honestly looking for help on how to best approach it

Whereas day 1 of the hearing focused solely on Questions 1-4, the morning of the second day was dedicated to Question 5 - Internet adverse event reporting (for a quick re-cap of the first day of the hearing, check out my blog post "This is the Super Bowl of Part 15 Hearings"). If you are familiar with the pharmaceutical industry, you are well aware that adverse event reporting is a very sensitive subject, so I was particularly interested to hear the speaker presentations. I was actually excited to hear the audience reactions to the recommendations. (more...)

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Melissa
Biller

This is the Super Bowl of Part 15 Hearings

Friday, November 13th, 2009

Day 1 of the FDA public hearing on social media is over and I think it's safe to say that we'll never misunderstand again how many Internet users are looking for health information online. In case you've been slacking on your #fdasm monitoring, the Pew Internet Health Survey says it's about 80% of Internet users, or 61% of Americans.

If you tuned in for the entire day, or attended like myself, you were likely overwhelmed by the plethora of information that was being pushed out by pharmaceutical companies, agencies, and online health sites, among a host of others. (more...)

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