Apr 13, 2014

FDA Dysfunction

Marginal Revolution has a post on the FDA and sunscreen:
Excellent piece in the Washington Post on the FDA and sunscreen: 
…American beachgoers will have to make do with sunscreens that dermatologists and cancer-research groups say are less effective and have changed little over the past decade.  That’s because applications for the newer sunscreen ingredients have languished for years in the bureaucracy of the Food and Drug Administration, which must approve the products before they reach consumers.
…The agency has not expanded its list of approved sunscreen ingredients since 1999. Eight ingredient applications are pending, some dating to 2003. Many of the ingredients are designed to provide broader protection from certain types of UV rays and were approved years ago in Europe, Asia, South America and elsewhere.
If you want to understand how dysfunctional regulation has become ponder this sentence:
“This is a very intractable problem. I think, if possible, we are more frustrated than the manufacturers and you all are about this situation,”
Who said it? Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research! Or how about this:
Eleven months ago, in a hearing on Capitol Hill, FDA Commissioner Margaret A. Hamburg told lawmakers that sorting out the sunscreen issue was “one of the highest priorities.”
If this is high priority what happens to all the “low priority” drugs and medical devices?
The comments bring up the fact that the EU and how it is generally five years ahead of the FDA in approvals for some devices.  Transcatheter Aortic-Valve Implantation (TAVI) is a good example, where the EU has second and third generations of devices from a wide range of companies available.  The US has two first generation devices approved.  This is a good situation for the original approval to be sure, as they profit from their willingness to spend enough to perform a large clinical trial and get US approval.    However, I'm not so sure it is so good for the US consumer, even if the improvements of some of these products may be minimal or equivalent to the first device approved, it at least introduces competition and lowers the price. OTOH you could argue that it may not be so good for the EU consumer as they may have some ineffective devices on the market that people are buying.  Both systems require companies to demonstrate safety, I am assuming they both do so effectively.

12 comments:

Megan said...

To the Editor,

I represent a company whose product I believe your readers will be very interested in. Earlier this year, Human Design Medical debuted the Z1 Travel CPAP Machine (its tagline is "CPAP for interesting people"). Its integrated battery system delivers a full night (8 hours) of cord-free power, and it can be charged in an outlet or in an RV's cigarette lighter.

It's also the lightest and smallest CPAP machine ever to hit the market. It weighs 10 oz and sits comfortably in the palm of your hand.

Based on other posts you have made about technological advances in the industry, I believe your readers will be very interested in a post about the Z1. or if I can provide you with any further information, please feel free to contact me at megan.kelly@boomtownig.com.

Thank you!

Sincerely,

Megan Kelly

aarongrey112 said...

Hi, Nice site I enjoyed reading it. Thanks for sharing. Would you please consider a link to my website on your page. Please email me back. Thanks!

Aaron Grey
aarongrey112 at gmail.com

Unknown said...

Hi there ... I work for a company called Business Wire and a number of our clients have recently asked about getting their medical device news to the Medical Device Blog. I don't know if you're interested in receiving news releases but it is my job (media relations) to reach out and inquire. All of our feeds are free. I don't want to take up any more of your time so please shoot me a note if you're interested.

Thanks,
Matt
matthew.allinson@businesswire.com

Unknown said...

Awesome post!!!
Thanks for sharing extremely nice information i am also sharing more about: Pharmaceutical Formulations Company

Anonymous said...

Hi,

My name is Elsa Mora. I am an intern at TribalVision, a marketing company in Providence Rhode Island.

One of our client's will be launching a press release in the coming weeks, and I am curious if there is a contact person in your department that I can get in contact with to determine if the news of our client can be displayed on your website.

Thank you for your time.

Elsa Mora

Anonymous said...

Additionally, my contact information is
emora@tribalvision.com

Unknown said...

best blog for this type of feeds..thnx a lot for shairng and helping all with your blog!! God bless you!


Kaplan Lecture Notes Usmle Step 2 Ck 2015

Unknown said...

Nice post. I was checking constantly this blog and I am impressed! Extremely helpful information specially the last part I care for such info a lot. I was seeking this particular information for a very long time. Thank you and good luck.
Liquid Level Sensor

Unknown said...

Extremely helpful information Thanks for sharing information about FDA. To know more FDA consultants in India


Unknown said...

MrC pour application

Alarico Adalbert said...

It is no secret that I have a very deep and personal relationship with God. I have pushed and resisted that relationship this past year through all the bullshit I have had to go through living with Herpes but once again, God is bigger than my stubbornness and broke through that outbreak cold sore and all I had Genital Herpes. For me personally, hearing over and over how I am not good enough has really invaded my mind in the worst way possible. I completely shut down and I was just waking up like is this how life going to end this temporary herpes outbreak “fuck everybody with herpes if you know what I mean” but let's be honest here...
It is a cowardly to say no to herbal medicine. It is fear based. And it is dishonest to what my heart wants. Don't build a wall around yourself because you are afraid of herbals made or taking a bold step especially when it's come to health issues and getting cure. So many young men/ women tell me over and over that Dr Itua is going to scam me but I give him a try to today I feel like no one will ever convince me about herbal medicine I accept Dr Itua herbal medicine because it's cure my herpes just two weeks of drinking it and i have been living for a year and months now I experience outbreak no more, You can contact him if you need his herbal medicine for any such diseases like, Herpes, Schizophrenia,Cancer,Scoliosis,Fibromyalgia,Fluoroquinolone Toxicity Syndrome Fibrodysplasia Ossificans Progressiva.Fatal Familial Insomnia Factor V Leiden Mutation ,Epilepsy Dupuytren's disease,Desmoplastic,Diabetes ,Coeliac disease,Creutzfeldt–Jakob,,Lyme Disease,Epilepsy, ,ALS,Hepatitis,Copd,Parkinson disease.Genetic disease,Fibrodysplasia disease,Fibrodysplasia Ossificans Men/Woman infertility, bowel disease ,Huntington's disease ,Diabetes,Fibroid. disease,Lupus,Lipoid Storage diseases( Gauchers disease),Polycystic Disease.,Cerebral Amyloid Angiopathy, Ataxia,Cirrhosis of Liver,Arthritis,Amyotrophic Lateral Sclerosis,Alzheimer's disease,Adrenocortical carcinoma.Asthma,Allergic,HIV, Epilepsy, Infertility, Love Spell,. Email..drituaherbalcenter@gmail.com then what's app.+2348149277967.... My advice to any sick men/women out there is simple... Be Always an open book. Be gut wrenching honest about yourself, your situation, and what you are all about. Don't hold anything back. Holding back will get you nowhere...maybe a one way ticket to lonelyville and that is NOT somewhere you want to be. So my final truth...and I'm just starting to grasp this one..    

Digital X-Ray said...

Nice blog.. Thanks for sharing such a really great information with us.
digital radiography system
c-arm machine