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Post Info TOPIC: FDA approval process for a medical seastead


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FDA approval process for a medical seastead
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FDA, medical seastead, Randy Hencken, intent, get approval, Kafka, comments, strategies, communication, buerocracy, visionary, frontier development, interference, progress speed up, project development strategy, oceanic freedom, mobilis in mobili, seasteads, ethics matters, not antiquated rulesets,

 

This thread contains comments and tougths about the process to get answers and clearance from FDA if a medical seastead could be performed...see the 5 thread posts from the seasteading.org blog below.

 

- they are a interference agency they will interfer.

- project setup strategies.

- only a "true believer" in the "value of the sistem" would even try to work within...

...if you come in with “something interruptive” never ask the “interrupted party” if they are OK with you interrupting...

- play it fast and mobile

- give them a reason to declare themselves "out of jurisdiction" they will take it gratefully. Instead of fighting the case to supreme court. - it is in their buerocratic nature.

- as a model what road "trying to get clarification" will take you down - and how you will "end dying before clarification comes" - read Kafka's "The Castle"

Kafka-The Castle:

http://en.wikipedia.org/wiki/The_Castle_%28novel%29

 

Project setup questions:

- If seasteading is about escape the soffocating grip of land based monopols (http://www.seasteading.org/2014/10/power-market-report-interviews-randolph-hencken/) - why would you try to get approval by a soffocating monopol organisation in first place?

- If using the mobilis in mobili (http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/ ) card to break free from jurisdiction is the key value of seasteading why would you build the project "around and inside US jurisdiction" instead of breaking free of it.

- why would you give your fiercest interferer a year of headstart by informing him directly over your intentions and loose one of your strongest cards "the surprise factor"  moving faster than they can.

- why would you allow them and even assist in deploying their strongest weapon (eternal delay of formal processes) against your project before even starting it, instead of putting their "fussy rulings and slow movements" against THEM - (try to catch me if you can - i am moving fast and worldwide - you can't )

 

Since you did contact them - technically you are now in a “open permit process” and if you build a seastead now, a FDA lawyer will turn that against you for not waiting until the “due process is done”. If you had built without asking, you would have in favor that there is no law “against” building medical seasteads outside of US jurisdiction and obviously can't be. What your intervention now allows them is to "put a passus on a existing law" saying something like "FDA competence expands to US citicens wherever in the world might be" - expanding their jurisdiction.

as you masterly describe in your blog - there is no incentive for an FDA burocrate to move things forward - this works both ways - there is also no incentive for them to get involved in a lawsuit on a fussy legal base to punish a venture that is "obviously out of their jurisdiction" .... because it did not ask them for a permit. Even more so if this venture is stuffed with good lawyers and arguments to defend its point. - And has public support because it is doing ethical good medicine helping patients.

On the other hand in "asking for permit" you already recognized that you aknowledge them in actually "being a entity you should ask" - so you handed your strongest card over without a fight. That is a "business implementation strategy you might want to rethink...

On the other hand you learned a lot about your oponent and how he works, you now have a much better picture how to handle him, how to beat him, how to defend yourself in case action comes in...

- read more here:

http://concretesubmarine.activeboard.com/t56351996/business-and-third-party-interference-freedom/

http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/

 

According to Paul Watzlawick (Austrian-American family therapist, psychologist, communications theorist, and philosopher. A theoretician in communication theory and radical constructivism...)

 

You can not "not communicate".

 

If you do not communicate you communicate a lot - for example:

 

- your communication is so irrelvant that i do not find it worth an anwer.

- your question is so difficult that i HAVE no answer. (and as i have no answer and no legal base i will not present a fight if you do it)

- i have an answer but i will not communicate it, because you will not like what you hear...

- and especially in this case - if i say nothing you are blocked anyhow - your investors will go away frustrated -  the project will be buried and i like that.

 

So i would rather try to find out what of the 4 reasons is the most likley for this non-comunication - plan my project according to the findings...and move it forward before the investors get bored and step out. Finally the interesting and investment worthy part of the project was "to break free" - so if you get it "entangled anyhow" the project is dead by nature of logics.

 

Project deveopment base questions:

Ask yourself the following questions:

- What is the probability that the FDA officials i was talking with (sleeping on their desks trying to avoid work not even capable to produce an answer ) will develop a "fierce military enforcement branch that comes after me when i operate patients in my seastead near Jamaica in territorial waters of Colombia? - boarding my platform, interrupting surgery in progress getting VERY bad press.

- What is the probability that Coast Guard / Navy will enforce something that is already declared out of jurisdiction by Customes and Border protection. Does FDA even have contacts or agreements with the Navy ?

- In the light of learning that FDA officials are "press sensitive" do i really believe that they want to produce pictures of a worldwide recognized indian surgeon arrested in a war operation to protect US special business interests...?

- What is the capacity to fund, persue, proyect out to sea, of FDA in general - do i not fear a sleepy paper mouse to act like a furious elephant here ?

- What are the legal and management resources i need to defend my case successfully - or put it on the long waiting list for supreme court - in case the mouse acts like an Elefant because special business interestes inflate their budget and capacity.

(If you put a med-stead on a ship the ship is structurally gone after 15 years of operation - so a shipstead has a service span that allows you to operate for 15 years at most - so if you have a pendent process on its way to supreme court - it does basicly not matter what the court rules in the end. You can make a lot of money in 15 years of operation.)

All this you need to collect data for, discuss it in your board, with your investors, and then get an ACTION plan.

 

on the topic oceanic med research platform i wrote:

.... i am quite familiar with this topic from my years as product group manager in the pharmaceutical industry, in fact i was in a case where a non FDA approved experimental substance from the research pipeline was handed out to European top medics (university clinics) for special cancer treatment of terminal ill patients. We got a special permit to “circumvent the approval sistem” because all involved top experts considerd it “obsolete and non applieable for terminal illness” even then – that was back in 1994 in Vienna Austria… Interference freedom in pharma research and fast track for new treatments has just increased its urgency since then. A big problem is also this nasty habit of american patients to sue their doctors … for all kind of real or imagined failure… medic science is not always exact science where you can do double blind experiments on geneticly identcial patients to measure “successfull” or “correct” treatment. Even many established treatments are just a “educated guess” this opens the door for endless multi million law suits that are fought on base of “diverging expert opinions” in courts where the judge has no idea of the subject…so moving out of jurisdiction is definitly a way to fast track things in advanced treatments with a high uncertainty component. At the moment the sistem puts a “slow buerocratic apparatus” in charge of the decision what dose of uncertainty is the correct one. In a future this decision might rest in the patients hands supported by a “ethics commission” of medic experts. You might want to choose a different dose of treatment risk for “flu treatment of healthy babies” than for “last chance treatment of terminal ill cancer patients”. The current sistem is not flexible enough. A “blockchain voting sistem” might help to find “politicly correct” decisions without going over the sclerotic FDA approval sistem.

 

You probably need to fear patient law suits fought in US courts against you much more than FDA approval questions....

hospital ship

 

I think we can take for given that no US warship will "open fire" "arrest personal" or "tow to a police pier" or "interrupt by any means"- someting like this - no matter what happens on the legal and ruling front - just to avoid the "political fire" this unevitably would bring up.  - This is a "project base condition" you can count on - the applyable ruleset does not matter. Doing something like that would just not "feel right" for 99,9% of the planetary population - and this is something that matters. Admirality law and war style blockades are authority processes that are trending to the trash basket of history for the reasons described here - http://concretesubmarine.activeboard.com/t58993851/humanity-growing-out-of-its-childhood-pants/ - these things are born in a different century made for a different society - things are changing... http://concretesubmarine.activeboard.com/t57838040/blockchain-technology/

Instead of adapting your project 100% to the ruleset of the century gone - you need to make sure that it has the "ethical approval" of "most of mankind" - this - and the protection of the sea - will be sufficient.

 If you are a visionary and move a visionary project forward, you need to act, talk, defend yourself like a visionary, you need visionary investors to support your cause. Uncertainty is part of the deal. Asking FDA for a permit and clarification is acting like a bureaucrat....asking for "relevant legal frames" is acting like a bureaucrat...the eternal surreal pain of K in Kafkas novel comes from the fact that he is trying to break out of the sistem while stuck inside the sistem and acting inside the sistem.

So stop acting like K and start acting like a visionary or K's "eternal pain" will all be yours.... FDA is really good in BEING the Castle - as close as it gets in a real world application...

the antithesis to the castle is : http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/

 We really need to stop asking and investigating what FDA would say - because the core of IMPLEMENTING our FREEDOM is, that it does not MATTER what they say.

If you have Lawyer capacity in your project, focus those Lawyers to predict correctly what a legal attack on your project will contain in its core, and how you can defend your project. Instead of focus them on matters like "investigate what is the ruling of FDA"

Have in mind that defense is easy if you do something "etical appoved by mankind in general and by global press in special" on your seastead    -   if you are involved in "trafficking orgrans" from poor indians to rich americans on the transplant list - this "ethical approval of mankind" will not be on your side and ways to shut you down will be found by somebody under some ruling code.

As long as you do good ethical strong medicine nobody under no ruling code will be able to shut you down, defense will always be easy for your lawyers.

As american citicen you commit 3 felonies per day anyhow - no matter what you do - http://www.threefeloniesaday.com/Youtoo/tabid/86/Default.aspx

And somebody will come after your project to try to pray on it involving it in lawsuits anyhow - http://www.economist.com/news/leaders/21614138-companies-must-be-punished-when-they-do-wrong-legal-system-has-become-extortion

This is part of the game we need to escape from - this is what seasteading is about....

http://concretesubmarine.activeboard.com/t56351996/business-and-third-party-interference-freedom/

 



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Welcome to the first part of a five-part series that recounts my efforts over the past year to initiate a medical tourism business functioning outside of the jurisdiction of US government agencies, while operating from US ports.

Rather than overwhelm our readers with one long long email, we divided this story into shorted sections and have released one section a day. My hope is that this story will encourage others to continue my efforts – particularly legal scholars who can find and draft answers that I was unable to uncover. I’ll let Seavangelist and seasteading author Joe Quirk take it from here.
For seasteading,

Randolph Hencken

Executive Director, The Seasteading Institute

Part 1: Waiting for FDA to Answer Our Question

by Joe Quirk, Seavangelist

At the Institute we’re celebrating waiting one-year for the FDA to our question.

Actually, a year and three months.

But I write not to criticize a state agency but to praise one.

One.

Brace yourselves while I inform you of an obscure fact: People appear to be dissatisfied with their health care. Patients Beyond Borders, which counsels patients seeking medical travel, estimates that well over a half million people will have travelled abroad for treatment in 2014, and the numbers will grow 15 to 20 percent each year as baby-boomers overwhelm the system.

Frustrated patients are seeking new, nearby alternatives. Frustrated medical professionals want to serve them. The current regulatory structure represents a great dam holding that market back.

Could medical care at sea serve a portion of that market?

While stuck in a roadblock on the Bay Bridge, The Seasteading Institute Executive Director Randy Hencken watched dozens of international vessels crisscross the Bay: foreign-flagged cargo ships staffed with laborers exempt from US labor laws; cruise ships staffed with foreign physicians not licensed in the US who practice medicine on US citizens in US waters, cruise ships outfitted with casinos that begin operating when they are outside of California’s waters — outside the jurisdiction of California. If the transport, cruise ship, and gambling industries can avoid US regulations by operating at sea, why can’t we do the same for a medical tourism ship?

Once back at the office, Randy grabbed his copy of Benedict on Admiralty, Volume 10, Cruise Ships, turned to Chapter IX, “Shipboard Medical Care,” and was soon copiously underlining where the scholarly tome became a gripping page-turner for a seasteader with a vision. Randy contacted the legal scholar who authored the chapter to confirm he was reading the law right.

When I arrived at the office the next morning, Randy announced that he believed he had found the legal escape valve for medical innovation and superior service at sea.

I’ll spare you the legalese and just say that Randy’s hypothesis is that a foreign-flagged vessel could legally operate a medical business out of a U.S. port that is not subject to FDA approval, as long as it sailed beyond territorial waters (or the contiguous zone) to perform treatments, and returned back to the same port. Such “voyages to nowhere,” are used by gambling ships to skirt gambling laws.

Why not use the same principle for medical treatments? Under current admiralty law, physicians not licensed in the U.S. are allowed to practice medicine on foreign vessels in U.S. waters. For example, cruise ships travel through U.S. waters with foreign doctors providing care to cruise ship passengers.

Randy asked our team of volunteer legal advisors. They each got back to Randy within a day or two to confirm that nothing in the law appeared to disallow his idea, but they counseled Randy through the subtleties. The troubling reality is that medical regulations are so vague, numerous, obsolete, and contradictory, even legal experts can’t predict what the FDA will do, because any rule can be interpreted in many ways. Medical innovators operate in an industry where nobody really knows exactly how old rules apply to new ideas. If Randy wanted answers, he needed to ask the lawyers at the U.S. Customs and Border Protection and the Food and Drug Administration.

Gulp.

Tomorrow I’ll tell you about Randy’s epic quest.



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ellmer - yook3.com 10:28 am

FDA is a “interference agency” so it is easy to predict what they will do – INTERFERE !
concretesubmarine.activeboard.com/t56351996/business-and-third-party-interference-freedom/
Profile photo of ellmer - yook3.com
ellmer - yook3.com 10:51 am

if you come in with “something interruptive” never ask the “interrupted party” if they are OK with you interrupting. If you come with Napster don’t ask the record labels, if you come with paypal do not ask the proponents of the traditional banking sistem, if you come with a medical seastead do not ask FDA. Play fast play hard, see their move comming, be a step ahead.
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OCEANOPOLIS 11:22 am

LOL, what “interference”? They didn’t even bother to answer TSI in 1 YEAR AND 3 MONTH!! There is no “play fast, play hard” in the good old US bureaucratic system…You play by their rules or you don’t play at all.
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ellmer - yook3.com 11:35 am

technically you are now in a “open permit process” and if you build a seastead now, a FDA lawyer will turn that against you for not waiting until the “due process is done”. If you had built without asking, you would have in favor that there is no law “against” building medical seasteads. They already fired their best weapon “time delay” against you…

www.seasteading.org/2014/12/celebrating-one-year-waiting-fda-answer-question-part-1/

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Part 2: Waiting for FDA to Answer Our Question.

December 16, 2014 by randolph

This is the second part in our five part series. Yesterday Joe shared how I came up with a hypothesis that a foreign-flagged vessel could legally operate a non-FDA approved medical business out of a U.S. port, as long as it sailed beyond territorial waters (or the contiguous zone) to provide medical care. Today’s installment refers to communications with the U.S. Customs and Border Patrol and the Food and Drug Administration. We’ve refrained from identifying the people we engaged with at each agency.

For seasteading,
Randolph Hencken, Executive Director

Part 2: Waiting for FDA to Answer Our Question
by Joe Quirk, Seavangelist

The Day I Learned to Stop Worrying and Love the Man

With a hopeful vision that faster, cheaper, superior health care could be legally offered on ships that depart from and return to the same US port, Randy penned an official inquiry for the U.S. Customs and Border Protection, asking if a “voyage to nowhere” that sold medical treatments fell beyond their jurisdiction. They immediately let him know that they would offer an official answer within 90 days.

The Customs and Border Patrol actually answered within 60 days with an information letter:

“You request a ruling regarding the contemplated use of foreign flagged vessels on ‘voyages to nowhere,’ either with U.S. territorial waters or beyond the 3 nautical mile U.S. territorial waters, whereby said vessels return to the same United States port from which they embarked. In particular, you contemplate offering medical procedures not available in the U.S., or medical procedures provided by foreign physicians, from a foreign vessel flying another country’s flag…

At the outset, please note that U.S. Customs and Border Protection takes no position regarding the legality of any medical procedure of any sort whether aboard a vessel or otherwise. Such determination is beyond the scope of this agency’s mandate.”

OK, that makes sense to us. We knew from the beginning this matter would involve multiple agencies. The letter goes on to acknowledge USCSB’s role in regulating coast-to-coast trade.

“In its administration of [coastwise trade] U.S. Custome and Border Protection has consistently ruled that the carriage of passengers entirely within territorial waters, even though the passengers disembark at their point of embarkation and the vessel touches no other coastwise point, is considered coastwise trade subject to the coastwise laws. However, the transportation of passengers to the high seas (i.e. beyond U.S. territorial waters) and back to the point of embarkation, assuming the passengers do not go ashore,even temporarily, at another United States point, often called a “voyage-to-nowhere,” is not considered coastwise trade.”

Score one for seasteading! Randy spent the next day sharing the letter with his seasteading colleagues. Who says state agencies can’t be prompt and serviceable? Now all he had to do was ask the Food & Drug Administration what their position was. How hard could it be?

Brace yourselves for another earth-shattering discovery.

The Labyrinth

First it took Randy six weeks just to find an office that said it could answer his inquiry. Randy began contacting the FDA on August 6, 2013 with an email to the general office. Nothing. Then he called and left messages at many different offices, directly emailing the individuals listed on their web site. Nothing. As the days passed, Randy wondered if the department was defunct. Eventually he discovered a lone functionary willing to return his call. She informed Randy that most of the agents and attorneys listed on her department’s website no longer worked there.

Our former Operations Manager Eric Jacobus, working in the same office with Randy listening to his repeat inquiries, was compelled to submit a Facebook post:

Screen Shot 2014-12-15 at 1.00.51 PM

“Listening to phone call with the FDA is hilarious. I wish I was recording just our half, because it’s hilarious. Best line, ‘So none of the people on your website are in your department any more? … Just you, you’re the only one left? … So there are no lawyers anywhere that I can talk to?’ This is the real face of US Government.”

Over the next month Randy scurried like a mouse through a maze. The Office of Partnerships referred him to the office of Health and Constituent Affairs. The Office of Health and Constituent Affairs directed him to Office of Regulatory Affairs. The Office of Enforcement suggested he speak to the Center for Drugs. The Center for Drugs suggested he speak to Office of Compliance. Also he should check in with the Center for Regulation and Policy. Engaging each of these departments involved working up chains of receptionists to directors, who referred Randy to new sub-departments. How could there be so many departments and none able to address our question?

Eventually, on September 11, 2013, an officer from Regulations and Policy Staff engaged Randy and informed him that she would handle the communications. We celebrated this modest breakthrough. She in turn forwarded his inquiry to the the Office of Communication, Outreach and Development and emailed Randy to let him know someone was working on a response to his question.

Randy followed up with the officer from Regulations and Policy Staff every two weeks for the next two months. Finally on November 5, 2013 a communications officer from the FDA Center for Biologics Evaluation and Research called – called! – to say she was collaborating with her counterparts in the Center for Drug Evaluation and Research, as well as the Center for Medical Devices. She said she would try to have a response within in two weeks, and to contact her then.

Now all we had to do was wait.

This was early November 2013.

Tune in tomorrow to vicariously experience Randy’s dark night of the soul.
3 comments

spark 5:59 am

Job well done.
Thank you.
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ellmer - yook3.com 7:54 am

I recommend lecture of Kafka’s “THE CASTLE” on that topic…en.wikipedia.org/wiki/The_Castle_%28novel%29
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ellmer - yook3.com 8:52 am

U.S. Customs and Border Protection’s answer – gives you a lead on a project development strategy – whenever a buerocratic entity is “pushed out of comfortzone” it is declined to declare itself “out of jurisdiction” – you can take that – and make it work in FAVOR of your project…


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Part 3: Waiting for FDA to Answer Our Question

December 17, 2014 by randolph

Here is the third installment in our five part series about my efforts to investigate my hypothesis that a foreign-flagged vessel could legally operate a non-FDA approved medical business out of a U.S. port, as long as it sailed beyond territorial waters (or the contiguous zone) to perform the treatments, taking advantage of a loophole in US coastwise trade laws that allows for “voyages to nowhere.”

On Monday we shared how I derived this hypothesis. Yesterday we shared that U.S. Customs and Border Patrol essentially confirmed our hypothesis from an admiralty law perspective, but that we needed to find out if medical agencies would regulate our proposed use of medicine. We then recounted the months-long challenges of finding someone at the Food and Drug Administration (FDA) to answer our inquiry. As a reminder, we quote all our correspondents at FDA anonymously. My seasteading colleague Joe Quirk picks it from here.

For seasteading,
Randolph Hencken, Executive Director

Part 3: Waiting for FDA to Answer Our Question
by Joe Quirk, Seavangelist

The Great Scroll

Imagine multiple lanes through a traffic jam, each peppered with hundreds of signs that contradict each other and refer to other signs. You ask a police officer if you can take the faster lane that other vehicles similar to yours are taking. The police officer says he can’t answer your question. Try it and see if one of my colleagues pulls you over, he says. You protest that the toll for the lane costs thousands of dollars, and you’d really like to know before you pay it. The police officer gives you the phone number to another police officer, who refers you to another police officer, who won’t call you back.

Should you pay and get in the fast lane? Or should you keep waiting? What if no one will tell you how long you will have to wait?

Gambling ships take “voyages to nowhere” to skirt US gambling laws. Can medical ships do the same?

Once Randy secured a promise to receive an official answer to his question, reading through Randy’s long scroll of communiques logged after that promise may give you a chance to laugh at his expense:

11-22-2013: I sent follow up email to Communications Officer at the FDA.

11-26-2013: I left a voice message for Communications Officer at the FDA.

12-3-2103. I left a voice message for Communications Officer at the FDA with a receptionist.

12-6-2013: I sent follow up email to Communications Officer at the FDA.

12-9-2013: I left a voice message for Communications Officer at the FDA.

12-11-2013: I left a voice message for Communications Officer at the FDA. Shortly thereafter I got an email from Communications Officer at the FDA stating that the departments were still working on an answer.

On Dec 11, 2013, after Randy’s sixth request for an update, he received this perky response:

“I inquired about it earlier today to get an update myself. I’ll gladly touch base when I know more. In the meantime, please don’t hesitate to call or email to check in whenever you’d like.”

Hope at last! Randy let another month go by.

1-6-2014: I sent follow up email to Communications Officer at the FDA.

Worried that he was being strung along, Randy called a colleagues for advice. Randy was encouraged to appeal to the ombudsman, defined as “a public advocate appointed to investigate individual’s complaints against maladministration, especially that of public authorities.”

1-9-2014: I sent follow up email to Communications Officer at the FDA, mentioning that I had been advised by a colleague of mine that if I didn’t get an answer in a timely fashion to contact the FDA’s Ombudsman.

1-16-2014: I left a voice message for Communications Officer at the FDA. Shortly thereafter she responded that the departments and lawyers were still working on a response, and that she understood if I felt the need to contact the ombudsman.

Randy seemed to resemble the protagonist in the the Franz Kafka novel The Castle, where a land surveyor struggles to gain access to mysterious governors who live in an impenetrable castle. Wikipedia describes the novel as “focused on alienation, bureaucracy, the seemingly endless frustrations of man’s attempts to stand against the system, and the futile and hopeless pursuit of an unobtainable goal.” Kafka planned to have his protagonist die before he got an answer, but Kafka died before he finished it.

On January 13 2014, two weeks after Randy mentioned that he would contact the Ombudsman, Randy made good on his claim. The following day the Ombudsman responded offering no hope to expedite the process:

“FDA, as a rule, does not move quickly and the wait that you have experienced is not surprising to me. Further, I would advise you against repeatedly contacting FDA personnel seeking updates because that will not result in a quicker response. No FDA office can respond to every single inquiry made to them. Correspondence involving an issue that involves multiple product types regulated by FDA will take time.

If you have not heard back after a few weeks, you can contact me again and I will further inquire about it for you.”

Disturbed but not deterred, Randy stepped back from the process for four months. On May 15, 2014 he followed up with the Ombudsman. The following day, he wrote back to say that he had spoken to the Communications Officer who had reported:

“…both FDA’s Center for Biologics Evaluation and Research (CBER), the part of FDA that regulates biologics, and FDA’s Center for Drug Evaluation and Research (CDER), the part of FDA that regulates drugs, are actively working on this. You should receive FDA’s response soon, though I can’t be more specific than that.”

Two more months went by. Randy’s last attempt was on July 23, 2014. He emailed both the Communications Officer and the Ombudsman and asked if he could expect an answer at all. That email was never answered.

Tomorrow we will explain why, though we are frustrated by the bureaucracy at the FDA, we appreciate the bureaucrats. No, really. We truly do. Then we will introduce you to the physician and bioethicist to plan to offer a way for the innovators and the protectors to work toward the same goal.

The only catch is, it has to float.
6 comments

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ellmer - yook3.com 12:23 am

Randy you have my respect for really trying….. only a “firm believer in the sistem” who has completly ruled out the idea that the sistem could be “basicly flawed in its core” would do that…
Naufrage 1:14 am

Thats all very nice but do you really think the right strategy is to, basically, ask your masters if they can let you free? Because they won’t. As soon as they will realize what is going on, they will fight back.

Of course in the beginning it is a good idea to play along an appears like a loyal citizen. But in the meantime, please prepare for the inevitable…
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ellmer - yook3.com 1:29 am

Randy, why not operating from non-US ports and take the med-stead “out of jurisdiction” for good…
Mirco 2:38 am

IANAL but I do not understand why do not simply have a non-US ship, with a non-US flag, operating from a non-US port, in the international waters.
Just use a third party service to ferry the patients from and to the US ports to the Health Ship
Mirco 2:39 am

I forgot to add, the personnel of the Health Ship must not be US citizens or residents or US licensed.
spark 6:00 am

This is good work. It is a pioneering work. There are some actual answers, but no answer is an answer too. That is a default.
I have a few professional certification on the medical field, and these certifications come with a few letters after my name (I am not a doctor). When I deal with governmental agencies regualting my profession, I use these letters behind my name. This seems to speed up the process for me. The system seems to work faster within. Seasteading, and medseasteading seems to be the cutting edge of political regulations. Agencies might be reluctant to make statements because it could be used in litigations, when litigations come up.

In the medical field there are often dead human bodies.
Returning to any port with a dead human body will require some explanation.
Good luck to you, and good luck to me.
And by the way, good work.


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December 18, 2014 by randolph

Please enjoy this fourth installment in our five-part series about my efforts to investigate my hypothesis that a foreign-flagged vessel could legally operate a non-FDA approved medical business out of a U.S. port, as long as it sailed beyond territorial waters (or the contiguous zone) to perform the treatments, taking advantage of a loophole in US coastwise trade laws that allows for “voyages to nowhere.”

To recap, on Monday we wrote about how I derived this hypothesis. Tuesday we shared that U.S. Customs and Border Patrol, for all intents and purposes confirmed our hypothesis from their maritime law perspective, but that they took no position regarding the medicine aspect of the business idea. Then we recounted my months long challenges of finding someone at the Food and Drug Administration (FDA) to answer my inquiry. Yesterday we shared the byzantine process of getting no one at the FDA to answer our inquiry, even the couple people who said they would get us an answer in a couple weeks. Author, Seavangelist, and my left-hand man Joe Quirk continues our comic tragedy below.

For seasteading,
Randolph Hencken, Executive Director

Part 4: Waiting for FDA to Answer Our Question
by Joe Quirk, Seavangelist

We learned first-hand why successful and determined entrepreneurs we know personally have given up or discovered there’s no point in trying their ingenious medically-oriented business plan. Compared to the prompt responses and superlative work by our seasteading volunteers, working with the FDA felt like wading through quicksand.

Most striking was the politeness and humanity of the agents who made efforts to guide Randy through the process, explain why they couldn’t answer his question, and forward him to other departments they couldn’t guarantee would help. They appeared to be experts at maintaining dignity in a pervasive institutional malaise, where nobody experiences any incentive to update their web site, answer simple inquiries, or follow-through on promises, while simultaneously in the grip of a seemingly powerful incentive to pass the buck, avoid risk, promise progress, then simply stop communicating without explanation. Randy searched for the person authorized to simply tell him what the law was, and found that no one really knows the law, not even the agents in charge of enforcing the law.

Why should an employee at the FDA take on the risk that any permission they put in writing could come back and get them in trouble in the future? If they agree with our hypothesis they are acknowleding that we have found a loophole in their colleagues’ latitude to enforce the law. FDA functionaries are blamed for disasters yet receive no credit when medical innovations save lives. They can’t possibly evaluate all the innovations that come across their desks, so they turn for help to the industries they regulate.

It’s not the people. It’s the monopoly that prevents alternatives. Rules and regulations proliferate, producing endless variation, and few are ever eliminated, allowing no selection. How do we get that? Provide market selection among competing rule-providers.

But Who Will Build the Road Blocks?

Why do we need seasteads permanently stationed at sea? Ask Allison and Chris Heddon, co-founders of Resonance Medical Technologies, who recently presented their medical innovation, a therapy for the hearing impaired which involves a novel brain-machine interface and drug delivery technology, at the Exponential Medicine Conference in November 2014. They stopped off to visit the Seasteading Institute.

We’ll tell you about our conversation with them tomorrow.

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www.seasteading.org/2014/12/celebrating-one-year-waiting-fda-answer-question-part-1/
www.seasteading.org/2014/12/part-2-waiting-fda-answer-question/
www.seasteading.org/2014/12/part-3-waiting-fda-answer-question/
www.seasteading.org/2014/12/part-4-waiting-fda-answer-question/

www.seasteading.org/2014/12/part-5-waiting-fda-answer-question/

 



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Part 5: Waiting for FDA to Answer Our Question

December 19, 2014 by randolph

Today we present the final installment in our five-part-series chronicling my efforts to get the FDA to confirm or deny a hypothesis I came came up with over a year ago. Rather than recap each part of the series, you can find the Parts 1, 2, 3, & 4 on our website.

Today, Joe Quirk concludes our story by offering us some fresh perspective on why the FDA hasn’t bothered to follow through on their claim that they would answer my inquiry, and why seasteading may be our best hope to bring about a renaissance in medicine.

For seasteads,
Randolph Hencken, Executive Director

P.S. The end of the year is just around the corner. We’d be grateful if you would support our work with an end-of-year donation. Thanks.

Part 5: Waiting for FDA to Answer Our Question
by Joe Quirk, Seavangelist

Dr. Chris Heddon is an anesthesiologist, inventor, and disaster relief volunteer. His wife Allison Heddon is a bioethicist published in The Journal of Medical Ethics and consultant at Sg2, a healthcare analytics firm.  They co-founded Resonance Medical Technologies to provide their patented therapy for the hearing impaired.  Before presenting their innovation at the Exponential Medicine Conference in November 2014, they visited the Seasteading Institute.

“It might be easy to place blame upon the staff at the FDA for the immense hurdles that their department creates,” says Allison “but, ultimately, they are a group of people doing the best they can with very limited resources.”

“Some medical professionals think they dislike the FDA, but they don’t realize what their purpose is and the constraints that they’re under,” says Chris.  “It’s a machine. It’s not terrible people.  It’s the regulatory machine that we’ve built up. How do you break those barriers down? Silicon Valley managed to do it. Why can’t we apply the same principals?”

They explained why the intractable situation is not the fault of individuals who work at the FDA, who for the most part want the same results that medical entrepreneurs want.  Chris and Allison have a plan to skirt the system that pits the innovators against the gatekeepers and get them working toward the same goal.

“Our proposed use of seasteading for medical research,” says Allison, “will be designed to supplement the FDA and shift some of the regulatory burden away from their overworked team and to a more agile regulatory option.  If properly organized and with careful design, seasteading has the potential to alleviate some of the stress on regulatory agencies by taking on medical research …  Simply stated, I think we can mirror the beneficial aspects of existing review structures and combine them with a lean, agile seastead venture.”

“We have a moral obligation to be better,” says Chris. “Medicine is in shambles right now. It makes me sad.  The fact that I became involved in the development of truly novel technology outside of my specialty played a big part in the speed at which I left medicine.”

“At the heart of my goal to see medical research succeed on a seastead,” says Allison, “is my belief that we have an ethical responsibility to make effective treatments available to all patients in an expedited manner … I believe that seasteading is the first step in a new regulatory paradigm that ensures patients have access to life-saving treatments without having to wait years for the drug or medical device to travel through the US regulatory pathway.”

“If you’re in an industry like medicine,” Chris continues, “where I spent most of my professional life, you see that we have a bag of bricks attached to our legs. And that’s all regulation. I think it’s become obvious that one segment of business, namely Silicon Valley, is taking off, because they’re so much more efficient, and we’re left behind.  There’s a disparity between the speed at which information technology is improving, and speed at which medical technology is improving, and it’s holding humanity back.  Seasteading is a way to illuminate that disparity, to become the lighthouse on the hill that everybody looks to for innovative medicine and other highly regulated industries.  It’s very important.  I think it’s a moral imperative.”

The FDA, founded in 1906, has held a monopoly over the production of regulations in the US medical field for more than a century, and the citizens they are charged with serving need them to be challenged by offshore competitors to reinvigorate its mission.

“I do believe seasteading is one of the most important things that I could ever do in my life,” says Dr. Chris Heddon. “This is world-changing. It may change the course of history if we can successfully do this, if we’re the first people to do it.  Seasteading has to be the beacon on the hill.  It changes the course of human history, because when people start experimenting with new societies, and they figure out what the best way is, and maybe you don’t like the way this one is, so you go to another one. It’s just like Patri said. It’s a marketplace of societies.”

With continued appreciation for the extraordinary work of our volunteers and donors, I ask again for your help in fostering the next great stride to the seas.

Tomorrow we’ll hear a final word from Randy whose persistence in the trenches is fueled by his vision of the big picture.  He’ll let you know how you can help him navigate the regulatory thicket.

Epilogue: Waiting for FDA to Answer Our Question

December 20, 2014 by randolph

I hope this week-long series (parts 1, 2, 3, 4, & 5) has been enjoyable to read, even if the content frustrated you like it has me. I felt compelled to share this story with you for a multitude of reasons:

1. I don’t want the FDA’s avoidance of my inquiry to be the end of the line for my hypothesis. Ideally a team of legal scholars will investigate this matter, and presuming my hypothesis is correct, draft a legal opinion that would encourage a medical ship business to get started here in the US taking advantage of cruises to nowhere.

If you are a legal scholar reading this, particularly if you have knowledge of FDA regulatory matters, and wish to investigate this hypothesis, I encourage you to contact me at info@seasteading.org. The Institute would like to foster a team of researchers willing to volunteer their skills as part of working group to uncover an answer to our investigation.

2. Perhaps by sharing our story publicly the FDA will be encouraged to respond to us.

3. I want the efforts that I’ve put into this matter known. This is one of the many ways we seek opportunities on behalf of the seasteading community with the funds that have been graciously donated to us, and our supporters deserve to know how we spend our time.

 

For seasteading,
Randolph Hencken, Executive Director

randy

 

Coment on

Epilogue

 Randy, is not Seasteading all about “achieving freedom” – so basicly if you have success in achieving a status of freedom, the question what FDA says is just irrelevant to investigate because it DOES NOT MATTER anymore.
If it did – you would not have implemented your freedom successfully. So maybe we should focus on getting rid of FDA regulation instead of asking and “scholasticly investigate” what they will say…giving them additional relevance. http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/




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In this context also read about oceanic medical research platforms...

http://concretesubmarine.activeboard.com/t58782592/medical-research-oceanic-platform/



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comments on part 5:

A valid analysis and a constructive proposal. I suggest that we understand that FDA and its way of doing things is just a pixel in a bigger picture which is :


- the general role of interference (http://concretesubmarine.activeboard.com/t56351996/business-and-third-party-interference-freedom/ ) on a 7 billion inhabitant planet.
- The urgent need of breaking free of soffocating interference to unleash the power of fast R&D ( http://concretesubmarine.activeboard.com/t58921987/sustainability-population-growth-consumption-growth-ocean-co/ )
- The application of a break free strategy following existing successful models (http://concretesubmarine.activeboard.com/t58935854/subdue-to-nobody/ )
- The understanding that this is a cultural movement as old as the enlightenment questions ( http://concretesubmarine.activeboard.com/t57057056/ocean-colonization-enlightenment-industrial-revolution-front/ )
- The understanding that all above is necessary for humanity to grow out of its childhood pants (http://concretesubmarine.activeboard.com/t58993851/humanity-growing-out-of-its-childhood-pants/ )

- The quest to get rid of politics in all its forms (http://concretesubmarine.activeboard.com/t57838040/blockchain-technology/ )


 



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medical seasteads interference free space to develop and research, stem cell research, affordable treatment, / i am sure investors will see that pretty quick...

future among us

 



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The big five business fields of ocean colonization: | oceanic transport | oceanic energy | oceanic real estate | deep sea mining | oceanic aquaculture |



The four fundamental quests of ocean colonization : | The quest for interference freedom | The quest for mobility | The quest for oceanic resources | The quest for space on the planet |



Meta Topics:


 



Axes of ocean colonization: | Main Axes | Plate Seastead | Floating Real Estate | Catamaran concept | Captain Nemo Concept | Floating Breakwater Concept | Submerged Living Space Bubble Concept |


Concepts: / Lens shell pictures overview / / Ramform floating home pictures / / c-shell floating home pictures / / Floating concrete building methods / / shell cluster pictures / / investor proposal list /



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nautilusmaker.com/t/what-you-should-know-about-me/1584/1

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