Celebrating One Year Waiting for FDA to Answer Our Question (part 1)

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.

Read Part 2