It is like a scene from a bad cowboy movie. Or, a Chuck Norris episode, with GMC trucks and everything. Scott Brown was probably "coached" by his friends at some of the Biotech companies which have impressed on how they have to "train" FDA officials who are regulating them.
Equipped with this, he went and stood in front of a whole bunch of his Biotech friends in some dog and pony show in Massachusetts in his probably inimitable style, that gives no credence to facts or reality.
Here is a dose of what he is purported to have set. "Whether it’s the FDA, EPA or the “ABCDEFG, you name it — there’s so much overregulation right now,” he said. “When you go overseas, the processes are down, they’re set.”".
Too bad, entry into the U.S. Senate is not even under-regulated you say?
Well, according to Scott Brown's constituents, you have to drive certain vehicles, and take money from donors and recite what they ask you to say. See, the process are down, they're set!
Fighting with facts!
You may not like how the FDA regulates things. And if you choose to do so, you can fight in a way that doesn't make you look like a special-plastic smelling aficionado! Just don't do what Scotty here has done - ranting so poorly that one of the FDA spokespeople who he might deem "lacking in mental capability" was able to come out and say that Scott Brown is mostly, if not completely wrong - without having to try hard! As to mental capabilities, what do they say about it taking one to knowing...
Given that more devices and drugs have been approved over the past decade than ever before, and given that the US is still one of the safest bets as far as medical standards go, Scott Brown's statements make him look very eligible to hire himself out to children's parties for some quality entertainment, which some cynical people might deem all politicians to be eligible for...
Cacophony
Armed with the unfortunate ability that renders any ill-minded person to register "non-profits" in the US, a couple of them have engaged in all kinds of cacophony about "over regulation", "loss of competitiveness" and other terms that they can express without developing even a superfluous understanding for.
While the people of a state should observe and regulate their regulatory agencies, it has to be done without rants and forged reports. Bring up the facts, and urge patient-oriented action, not profit or donor oriented action.
Consulting "Experts" - the wrong way
On the other hand, Senator Franken got too excited and has asked the FDA to consult "experts" in the device industry before making changes to device approval processes. Er., should the cop stop you on the freeway and consult you on whether you were speeding or how much the ticket should cost you?
The right way
Health advocacy agencies that don't take money from biotech and device firms; consumer non-profits and other members of the public who have an understanding that goes beyond the sound-bites handed to US senators should be the ones most actively engaged in discussing any industry's state of regulations.
Senators, biotech companies and others have a right to fight regulations too, if they plan to do it with facts, sanity and coherence. That day, pigs plan to fly...
References:
- Where is medical device approval headed? The horse's mouth speaks... [Last Updated On: August 17th, 2024] [Originally Added On: May 3rd, 2010]
- Starting a medical device company? You are better off without some of these "VC"s! [Last Updated On: August 17th, 2024] [Originally Added On: May 4th, 2010]
- Silicon Valley Business of Engineering - A great event and resource for local medical device folks and others... [Last Updated On: August 17th, 2024] [Originally Added On: May 5th, 2010]
- MedTech: A great bioscience resource for folks in New York [Last Updated On: August 17th, 2024] [Originally Added On: May 7th, 2010]
- Blog brief: Inventables - a nice resource for your medical device projects [Last Updated On: August 17th, 2024] [Originally Added On: May 17th, 2010]
- Want to help out a biotech hackerspace AND learn about medical device regulations? Come to my class... [Last Updated On: August 17th, 2024] [Originally Added On: June 8th, 2010]
- A prototyping tip & a quick update [Last Updated On: August 17th, 2024] [Originally Added On: August 2nd, 2010]
- The Healthcare bill of rights is here... [Last Updated On: August 17th, 2024] [Originally Added On: October 11th, 2010]
- Come join me for a workshop on "The Rules of Brainstorming" [Last Updated On: August 17th, 2024] [Originally Added On: October 11th, 2010]
- DIYBio gets a little more local...Bangalore just got one - is there one in your area? [Last Updated On: August 17th, 2024] [Originally Added On: November 7th, 2010]
- Are you an entrepreneur? A job seeker? Where are your major hurdles coming from? [Last Updated On: August 17th, 2024] [Originally Added On: November 28th, 2010]
- The World Diabetes Day is here [Last Updated On: August 17th, 2024] [Originally Added On: November 28th, 2010]
- Healthgamescamp, San Francisco is tomorrow, barcamps and more... [Last Updated On: August 17th, 2024] [Originally Added On: December 13th, 2010]
- Healthgamescamp - liveblog: "It's crazy and wild and fun" [Last Updated On: August 17th, 2024] [Originally Added On: December 13th, 2010]
- Healthgamescamp - liveblog; part 2 - break time! [Last Updated On: August 17th, 2024] [Originally Added On: December 13th, 2010]
- Quick Post: Are others (guests) allowed to post on this blog? [Last Updated On: August 17th, 2024] [Originally Added On: December 19th, 2010]
- Entrepreneurship Opportunities: The Health 2.0 challenge for 2011 is announced [Last Updated On: August 17th, 2024] [Originally Added On: December 19th, 2010]
- A heartwarming story, a foundation and a few medical device challenges for the future [Last Updated On: August 17th, 2024] [Originally Added On: December 27th, 2010]
- What will your 2011 medical device design resolutions be? [Last Updated On: August 17th, 2024] [Originally Added On: January 2nd, 2011]
- Elan was recently asked: Your workers or your private jet..guess what they chose? [Last Updated On: August 17th, 2024] [Originally Added On: February 6th, 2011]
- Blog Briefs: A great resource: The National Academies Press makes all pdf books free! [Last Updated On: August 17th, 2024] [Originally Added On: June 12th, 2011]
- There's trouble ahead for Pharma... [Last Updated On: August 17th, 2024] [Originally Added On: July 3rd, 2011]
- The Acne Apps Scandal - how a select few make everyone suffer... [Last Updated On: August 17th, 2024] [Originally Added On: September 18th, 2011]
- Faculty Interview | MIT Introduction to Bioengineering, Spri [Last Updated On: August 17th, 2024] [Originally Added On: October 10th, 2011]
- Destroying Humanity with Social [Last Updated On: August 17th, 2024] [Originally Added On: October 10th, 2011]
- Bioengineering- Clemson Graduate School [Last Updated On: August 17th, 2024] [Originally Added On: October 10th, 2011]
- Faculty Interview | MIT Introduction to Bioengineering, Spri - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 13th, 2011]
- Grant to benefit Bioengineering research - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 14th, 2011]
- BioEngineering Associates, Inc. - Mad River Bluffs Stabilization Project - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 14th, 2011]
- BIO ENGINEERING - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 15th, 2011]
- Cross-Species Hybridization and Bioengineering: We're Not in Kansas Anymore! - Alex Jones Tv 2/2 - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 16th, 2011]
- Paul Root Wolpe: It's time to question bio-engineering - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 19th, 2011]
- BioEngineering Insights 2009 - BioMaterials Part 2 - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 22nd, 2011]
- Blog Action Day - Blogging for Food... [Last Updated On: August 17th, 2024] [Originally Added On: October 23rd, 2011]
- [KAIST-Bioengineering]Biomimetics - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 24th, 2011]
- [KAIST Bioengineering] Bioengineering through movies - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 26th, 2011]
- PhD Research in Belgium (Bioengineering at the University of Leuven) - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 29th, 2011]
- Penn Bioengineering: Modeling Contractile Forces - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 29th, 2011]
- Global 3000 | How One Bio-engineering Seed Producer is Dominating Markets - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 31st, 2011]
- White House Awards UC San Diego Bioengineering Professor Shu Chien National Medal of Science - Video [Last Updated On: August 17th, 2024] [Originally Added On: October 31st, 2011]
- [KAIST BioEngineering] Olleh! BioEng! - Video [Last Updated On: August 17th, 2024] [Originally Added On: November 9th, 2011]
- Calling BS on the link between tax increases and medical device innovation... [Last Updated On: August 17th, 2024] [Originally Added On: January 1st, 2012]
- Stanford's Stephen Quake, Bioengineer - Video [Last Updated On: August 17th, 2024] [Originally Added On: January 1st, 2012]
- Plandai Biotechnology, Inc. Announces Appointment of World-Renowned Physicist to Chair Plandai Scientific Board [Last Updated On: August 17th, 2024] [Originally Added On: January 30th, 2012]
- Need muscle for a tough spot? Turn to fat stem cells [Last Updated On: August 17th, 2024] [Originally Added On: January 31st, 2012]
- India gets her own stem cell hosptial [Last Updated On: August 17th, 2024] [Originally Added On: February 5th, 2012]
- A marketable major [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- US Navy here to talk biofuels [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- Carlsberg-invested Chongqing Brewery to hire independent auditors [Last Updated On: August 17th, 2024] [Originally Added On: February 7th, 2012]
- Industry linkage beefs up livestock nutrition [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- The Hertz Foundation Selects 50 Finalists for 2012-2013 Hertz Fellowship Supporting Gifted Young Leaders in Applied ... [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- US Navy eyes Aussie biofuel research [Last Updated On: August 17th, 2024] [Originally Added On: February 13th, 2012]
- Researchers make breakthrough in stem cell research [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2012]
- UQ researchers make breakthrough in stem cell research [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2012]
- Brand Marvel Worldwide Consumer Products Corporation Update [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2012]
- U.S. and Canadian Scientists Form a Global Alliance for Nano-Bio-Electronics in Order to Rapidly Find Solutions for ... [Last Updated On: August 17th, 2024] [Originally Added On: February 14th, 2012]
- Speaker to discuss Honor Code at UPUA meeting [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- Understand the Lessons Learned from the FDA QbD Pilot Programme - Case Study Merck Serono [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- Lewis: Fully caffeinated professor dreams up business [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- Titan Spine Acquires Additional Patent Protection for its Spinal Implant Surface Technologies [Last Updated On: August 17th, 2024] [Originally Added On: February 15th, 2012]
- Histogenics to Present at 7th Annual New York Stem Cell Summit [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]
- Microchip successfully delivers bone-loss drug: study [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]
- Microchip delivers drug; can it replace shots? [Last Updated On: August 17th, 2024] [Originally Added On: February 16th, 2012]
- Bioengineering company bringing ideas to Huntington [Last Updated On: August 17th, 2024] [Originally Added On: February 18th, 2012]
- UCLA Discovery that Migrating Cells "Turn Right' has Implications for Engineering Tissues, Organs [Last Updated On: August 17th, 2024] [Originally Added On: February 18th, 2012]
- After scrapping bigger plans, HP says webOS still has an open-source future [Last Updated On: August 17th, 2024] [Originally Added On: February 19th, 2012]
- Discovery that migrating cells 'turn right' has implications for engineering tissues, organs [Last Updated On: August 17th, 2024] [Originally Added On: February 19th, 2012]
- Biotechnology and Bioengineering: Cell stamping from PEG-oleyl surfaces - Video [Last Updated On: August 17th, 2024] [Originally Added On: February 21st, 2012]
- American Oriental Bioengineering Inc. Announces Plans for Reverse Stock Split of its Common Stock [Last Updated On: August 17th, 2024] [Originally Added On: February 22nd, 2012]
- Injectable gel could repair tissue damaged by heart attack [Last Updated On: August 17th, 2024] [Originally Added On: February 22nd, 2012]
- World’s First Lab-Engineered Burger Just Months Away [Last Updated On: August 17th, 2024] [Originally Added On: February 22nd, 2012]
- For UC Berkeley’s New Helios Energy Research Facility: Firespray’s Ductwork Solves Lab Construction Challenge [Last Updated On: August 17th, 2024] [Originally Added On: February 22nd, 2012]
- IBM and IBN Treating MRSA With Nanotechnology and Nanomedicine in February's Edition of Healthcare Global [Last Updated On: August 17th, 2024] [Originally Added On: February 22nd, 2012]
- Injectable gel could repair damaged cardiac tissue [Last Updated On: August 17th, 2024] [Originally Added On: February 22nd, 2012]
- DNA2.0 Partners with Cosmo Bio to Deliver Bioengineering Solutions to Japanese Researchers [Last Updated On: August 17th, 2024] [Originally Added On: February 23rd, 2012]
- Three UI professors win Sloan fellowships [Last Updated On: August 17th, 2024] [Originally Added On: February 23rd, 2012]
- IBM and IBN Treating MRSA with Nanotechnology and Nanomedicine in February’s Edition of Healthcare Global [Last Updated On: August 17th, 2024] [Originally Added On: February 23rd, 2012]
- Now, injectable gel that could repair tissue damaged by heart attack [Last Updated On: August 17th, 2024] [Originally Added On: February 23rd, 2012]
- India's drug discovery innovation prognosis is "poor". Is anyone surprised? [Last Updated On: August 17th, 2024] [Originally Added On: February 26th, 2012]
- NASA Scientist Wins Free Space Trip on Rocket Plane [Last Updated On: August 17th, 2024] [Originally Added On: February 28th, 2012]