I’m
pleased to share the news that on Thursday,
December 1, the U.S. Food and Drug Administration (FDA) issued artificial
pancreas (AP) draft guidance. While the draft guidance is still under review,
our initial analysis suggests that it affirmatively addresses many of JDRF’s
key issues, and, in so doing, it appears to lay a foundation for accelerating
the development and availability of AP technologies that will improve the lives
of millions of Americans living with type 1 diabetes (T1D).

But
there is more to the story. The fact is that this encouraging outcome probably
would not have happened without the contributions of JDRF, our community, and
our allies. In fact, it is fair to say that without JDRF, there might not have
been any guidance at all, or at least not in 2011. And that is a good place to
start the story.

By
2010, it was clear that JDRF-funded research in academic, hospital settings
showed that prototype AP systems could greatly improve glucose control, and
with encouragement from JDRF, companies had committed to developing commercial
products for people with T1D. But there was no defined regulatory pathway for
AP outpatient studies or product review, nor were there any immediate plans for
the FDA to develop these clinical guidelines, which threatened to greatly slow
the research and development process. So JDRF decided to play a leadership role
to short-circuit potential bureaucratic delays, and to ensure that the FDA had
the most current, state-of-the-art scientific thinking on the AP. 

In
July 2010, JDRF convened a panel of leading clinicians and researchers to make
recommendations to the FDA about the key clinical questions for AP studies,
which were presented at a public meeting that
November.
In early 2011, JDRF incorporated those recommendations into a guidance document
that we proposed to the FDA. At the same time, we intensified our efforts by
making issuance of AP guidelines a key “ask” of the advocates at our annual
Government Day in March. Their efforts, and the efforts of countless JDRF
volunteers across the country, resulted in more than 250
House members and more than 60
U.S. senators sending letters to the FDA calling on the agency to produce
timely AP guidance that takes into account the recommendations of leading
experts. In these highly partisan times, securing such broad bipartisan support
for this goal was truly remarkable. 

We
continued our efforts at Children’s Congress in June, where, at a Senate hearing on
June 22, the FDA committed to releasing AP draft guidance by December 1. It
soon became apparent that simply seeing the FDA issue guidance would not be
enough. Indeed, when the FDA released unreasonable, highly problematic
low-glucose suspend (LGS) system guidance—guidance covering a system that was
already available and in use in more than 40 countries around the world—JDRF’s team
recognized the very real risk that the AP guidance might be similarly flawed,
setting back the development of AP systems by years. 

Once
again, we mobilized and increased our efforts. JDRF chancellor Pam Sagan testified
at a House hearing on medical device regulation on July 20, when she
highlighted the need for timely access to innovative, life-saving technologies
to help better manage diabetes, citing LGS systems as a key example. In August,
we launched our Promise to Remember Me Campaign, in which our volunteers held
250 meetings with members of Congress in communities across the country by the
end of November to enlist them to encourage FDA action. 

After
Labor Day, we began a more intense campaign to encourage the FDA to not only
issue AP guidelines by December 1, but to issue guidelines that, unlike the LGS
ones, would not throw up unnecessary obstacles to the development of these
systems. Of course, the centerpiece of these efforts was substantive,
solutions-oriented engagement with the FDA’s scientific and device center
teams. To their credit, members of the FDA staff not only were open to dialogue
with JDRF’s AP team and the clinical community, they genuinely listened to our
concerns. 

Beyond
this interaction with the FDA, some of our activities were
visible, such as the letter from leading diabetes clinical organizations (AACE,
ADA, AADE, Endocrine Society), the powerful full-page newspaper ads in The
New York Times and The Washington Post, and the Capitol Hill press conference; and others were
less visible, such as our ongoing outreach to key Congressional supporters, who
directly communicated to the FDA how important it was to get the AP guidance
right. Then there was our online petition, which so many of you signed, a
petition that was eventually delivered to the FDA with more than 100,000
signatures gathered in five weeks’ time.

Which
brings us back to Thursday’s announcement by 
the FDA. 

The
AP draft guidance clearly indicates that the FDA has worked hard to produce
reasonable guidelines for artificial pancreas systems. The guidance appears to
provide a rapid timetable to move from inpatient trials to outpatient trials,
and its flexible requirements allow for clinical development in a manner that
will advance AP trials while ensuring their safety and effectiveness. For this,
the FDA deserves great credit. Furthermore, this draft guidance suggests that
Commissioner Margaret Hamburg and the FDA are committed to fostering innovation
and being a global leader in bringing life-saving technologies for people with
T1D to the U.S. market.

We
are still studying the details of this highly technical, 60+-page draft
guidance. We know there will be issues and further considerations that we will
want to address; we know there will be more dialogue with the FDA before final
guidance is completed. But we also know that without the involvement of
the clinical community; without the contributions of so many of our volunteers
who testified, wrote op-eds and letters to the editor, signed petitions, and
more; without the commitment of our Hill allies such as Diabetes Caucus
co-chairs Susan Collins, Jeanne Shaheen, Diana DeGette, and Ed Whitfield;
without the outpouring of signers to the petition; without our successful
efforts to raise the profile of this issue in the FDA, the Congress, the White
House, and the T1D community; without a regulatory agency with committed
professionals pushing forward an innovative agenda; and without the
extraordinary commitment and cooperation of so many JDRF staffers and
departments, we would not be as close as we are to seeing this revolutionary
technology reach the hands of people with T1D.

Thank
you for your continued dedication.