FDA Public Workshop - Medical Device Patient Labeling - I may mention VW.

I am speaking as a "stakeholder" at FDA's Public Workshop - Medical Device Patient Labeling, September 29-30, 2015. I'm scheduled to go at 10:35, kicking of stakeholders on the 29 and a round table conversation on identifying label needs on the 30th.

Word is that it will be webcast. The site says registration is required and "All webcast registration requests should contact Susan Monahan at susan.monahan@fda.hhs.gov*"

Update: These appear to be the links and they look like they allow a Guest Login
Webcast Links for the September 29-30, 2015 Public Workshop: Below are the webcast links for the Public Workshop from an FDA email:

Medical Device Patient Labeling 

• September 29, 2015: https://collaboration.fda.gov/plpw092915/  
• September 30, 2015: https://collaboration.fda.gov/plpw093015/

Directions for mobile access to the meeting

1. Download the Adobe Connect Mobile App
2. Enter Meeting
3. Log-in as a Guest: Enter Name
4. Accept disclaimer

A key part of what I have to say will be your views shared with YDMV .

While not exactly on the topic, I will add my 2¢ that meters are like cars. YDMV is a direct copy of the Your Milage May Vary disclaimer of window sticker milage claims. Your meter may vary and just like VWs the test done for the feds may not be close to real world performance.

It is not the driving public job to know the real emissions of cars, nor the PWD's job to know if meters preform to FDA standards. Our jobs are to drive safe and in the case of diabetes is to do the self management to be safe. We need to know the devices we use are safe and that the emissions and device safety police have our backs.

I'm open to the betting odds of my be being allowed back day 2 if I say that day 1. LOL

*http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm



Here are some of the slides I will be using:

Please Register for #DOCasksFDA. NOW!

FDA and diaTribe invite you, her, him and all the rest of the DOC to join an unprecedented patient dialogue on November 3 from 1-4pm EST - you can register for the online webcast at:  

www.cvent.com/d/z4qgt1/1Q. 

Even if you are only available for part of the conversation, I strongly encourage you to sign up and join the virtual discussion based on our recent collective feedback.

As a community, it is essential that we show the FDA how committed we are to more open communication. Please register and join as a signal to the Agency that you are interested in dialogue, have valuable input to share, and want to advocate for better treatment options for diabetes.

Thanks so much to everyone at FDA and diaTribe for making this possible!

Hey Adam needs a hand, Little help?

This is from my good friend and inspiration to bicycle, Adam Brown at diaTribe. Help him out OK? Just to be clear, diaTribe is asking to help better focus on what matters to PWD when we do the next round of #DOCasksFDA, not FDA asking. Go us!

Hello DOC friends! 

On November 3, the FDA will host an unprecedented discussion between the diabetes community and senior agency leadership (both drugs and devices). The event will be live webcast from 1 - 4 pm. We want this to be nothing short of a home run. The event will include a panel of patients (T1 and T2), as well as representatives from ADA, JDRF, and diaTribe. As a community, our job is to present the numerous challenges we as patients face each day, and we need as many opinions as possible to be a part of this discussion! With FDA, ADA, JDRF, and dQ&A input, we have created a survey posted at www.diaTribe.org/survey. We are asking the entire diabetes community (T1 and T2!) to please fill out this short survey and share thoughts on what's important when it comes to living with diabetes. This feedback will go DIRECTLY to FDA and help influence the conversation on November 3. 

FDA is currently working on the registration to sign up for this webcast event; as we understand it, this should be posted within the week. We will be in touch with that information and a finalized agenda as soon as we have it. For now, it is mission critical to have a massive response to the survey. We need to show the FDA that patients care about these issues, that patients have valuable input to share, and that the treatment options we have are still not good enough.

Thank you on behalf of our entire team for your help in spreading the word on the survey and about the event. We’re truly excited about the potential to open the lines of communication with the FDA, which for too long has been a black box. We need more patient input into the drug and device approval process, and we see November 3 as a very key avenue to making that happen. Let’s show the FDA how committed our community is.

very best wishes,

Adam

Mark Your Calendar - Nov 3 diaTribe Town Hall Meeting with FDA

Let’s Put on a Show! (aka FDA has open dockets)

FDA has a docket open seeking public comment on Medical Device Data Systems (MDDS.)

What is that you ask? Good question.

A MDDS is a systems that, in the FDA words, facilitates, “the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.” In other words provide second screens for information. FDA is proposing lessening the regulatory process for MDDS as they introduce little additional risk. I agree.

For people with diabetes this may mean seeing our information on additional screen such as our phones. Go FDA!

The guidance speaks directly to mobile.

It is unclear how CGM data is viewed for this data. FDA specifically draws a line at active patient monitoring in the guidance. They don’t exactly say what that is. In my view is that is meant to be in clinic critical care monitoring, not patient self monitoring such as CGM.

I hope to help FDA make that distinction by sharing my views. I would love some company helping FDA see how PWD feel about information.

So far there are two (2) comments on the FDA docket. That seems hardly enough.

One of the keys to successful advocacy is getting attention. I have talked a lot about how much I love the paper Back to Basic as a model for diabetes advocacy. Now the book is a block buster summer movie. (OK part of the paper is in this Youtube video from MasterLab.)

In my view one way the diabetes community can get attention is to speak up in droves when FDA is listening. MDDS isn’t the sexiest subject in the world, neither are food labels (http://diabetesadvocates.org/tell-fda-your-thoughts-on-the-proposed-nutrition-fact-label-by-aug-1/) but if we don’t show up when the policy makers are listening how can we claim we need to be heard?


Please comment on food labels. The docket is open to August 1.

Comment on MDDS, it is open August 25.

Let’s get policy makers attention. Let’s put a show making of comments into the dockets.

Yes, Who is accountable? FDA Notice on Generic Strips

StripSafely asked Who is Accountable for generic test strips.  Apparently it is not a academic question. FDA today release a warning titled, "FDA Safety Communication: Shasta Technologies GenStrip Blood Glucose Test Strips May Report False Results"

From that release:

Recommendations:
Identify whether you are using GenStrips glucose test strips. The strips may be packaged in green and white packaging with the GenStrip name on top, similar to those shown below.


For People with Diabetes:

• Discontinue use of GenStrip Blood Glucose Test Strips.
• Obtain alternative glucose test strips that are designed for use with the LifeScan OneTouch family of glucose meters.
• Ask your pharmacist or contact your diabetes care provider if you need help determining which test strips to use with your glucose meter.
• As always, be aware of symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia). If you experience symptoms of either high or low blood sugar, contact your diabetes care provider for advice on treatment.

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm395180.htm

4/30 Update: Please see this MarketWatch report on the issue. GenStrip's Acquiring company states they will replace strips.  http://www.marketwatch.com/story/decision-diagnostics-responds-to-shasta-technologies-fda-safety-warning-letter-2014-04-30

Help FDA understand how generic strips can be part of their new guidance structure. Comment to the dockets and ask for clear rules to protect PWD. Copy and paste the draft comments from StripSafely below to the FDA docket HERE.

Progress

I find many encouraging ideas in the FDA’s draft guidance. Its tighter accuracy standards (particularly in the hypo range) are a big step forward. The new emphasis on test strip lot release criteria will lead to better quality control, and the requirement for front-of-package accuracy information will make clear that the quality of blood glucose meters varies – and allow users to make informed choices.

Suggestions:

Third Party Strips – Who is Accountable?

In the introduction to its proposed guidance on blood glucose meters, FDA speaks of self-monitoring blood glucose test SYSTEMS (SMBGs – caps mine.) This terminology is important because of its clearly implied meaning:  a meter and its strips are a complete system, designed to be used together.

Why is this important?

There are several reasons:

One is liability. When a third-party manufacturer makes test strips for a meter it is unclear who should be responsible for maintaining the system’s integrity and who would be held accountable in the case that something goes wrong:  the meter company, the strip company, caregiver or the patient.

Generic strips are approved for use with meters sold before specific dates. The data a meter is sold is not always clear. Patients need clarity.

FDA draft guidance speaks of third-party strips starting at line 990 of the over the counter draft guidance (1050 of POC) saying. “We strongly recommend that agreements between the third-party strip manufacturer and the meter manufacturer are in place to ensure that the third-party strip manufacturer is made aware of any design changes to the meter. In cases where this is not possible, the third-party strip manufacturers should sufficiently address, in their submission, how they will mitigate the risk of incorrect results due to meter design changes.”

That is not an academic issue. Insulin is a very dangerous drug that puts over 97,000 American in the emergency room each year.  A recommendation is not enough.  The FDA’s final guidance on blood glucose meters and strips should require formal agreements (and plans) between meter manufacturers and third-party strip manufacturers as part of the criteria used for clearance. Until these standards are in place, third-party strips should not be considered part of a system. Without bing part of a system the should not be cleared for sale. Patient lives are at stake.

Additional third party strip considerations

RESPONSIBILITY – I hope FDA clearly defines who is responsible/liable when an adverse event occurs as a result of the use of a third-party strip.

ACCURACY – Third-party strips should be be held to the same standards of accuracy as all blood glucose test strips. Accuracy should advance. Strips that fail to meet new accuracy standards set by this guidance should be rapidly phased out of the market.

POSST MARKET SURVEILLANCE  - There should be a program in place to ensure the quality and accuracy of all meters and strips, including third-party, after the meters and strips have been cleared for sale

RECALL – Recalls of all strips and meters are an important post market protection. Options to recall must stay open and include third-party strips. In the case of a recall communication to users of a SYSTEM are important. Clear guidance should be in place to ensure that the safety of patients using systems that include third-party strips is not compromised.

MDR – The FDA should require all strip and meter manufacturers to establish clear procedures for Medical Device Reporting in the event of adverse events related to these meters or strips. Third-party strips will add complexity to the submission process; before they are allowed to enter the market, third-party strip manufacturers must establish a clear, robust and simple process for tracking and submitting MDR.

DME – The FDA should make clear in its guidance documents that systems of meters and strips (including third-party) that do not meet the FDA’s stated accuracy requirements cannot be considered durable medical equipment (DME) and thus should not be eligible for reimbursement by CMS or other payers.

THERAPY ADJUSTMENTS Therapy Adjustments: the FDA should also make clear that if a meter and strips cannot be used to “make therapy adjustments” — meaning to dose insulin or calibrate a CGM — then they are, by definition, not a blood glucose meter  (or strip) and cannot be considered DME (and thus cannot be reimbursed as such).

LABELING: Who is going to be responsible for keeping an accurate and up-to-date list of which third-party strips work with which meters? Until this issue is clarified, third-party strips should not be cleared for sale.

Until all of these issues are addressed, third-party strips cannot be considered parts of a self-monitoring blood glucose test system, and should not be cleared for sale.

Yay Team!

At the risk of sounding like one of the Borg collective from Star Trek Star Trek: The Next Generation, I was 6 of 17. One of a diverse group of people who spoke at the Afrezza ADCOM meeting.

It was an interesting day. It overstate things, possibly wildly, but I’ll describe the day as MannKind spoke about the wonders of their insulin and FDA showered upon it a lack of love. Pubic speakers talked of a need for options. The panel considered risk, patient needs and in what the called a difficult choice voted almost unanimously for the drug. 

I don’t know what FDA will do, approve it or not. They have to July 15.  

I do know that those who spoke with me were a fascinating group that spanned the cross section of the diabetes community.  There were a number of physicians who treat PWDs, CDEs who teach PWDs, ADA and JDRF that represent PWDs, and a mix of type 1, type 2 and type 3 (caregivers) people who live with diabetes.

I have not seen as wide a mix at any previous FDA meeting. Nor I had not seen anything like Manny Hernandez’s video presentation, bringing views into the room from a champion who could not be there physically. He spoke of reactions to the drug at tuDiabetes and estudiabetes. He spoke in Spanish, with subtitles when representing Spanish speaking American. That was an appropriate first in my experience. 

Through the diversity of speaker, the message could not have been clearer if we had sat down and scripted it out. In fact one public speaker commented about that, noting that we had not. 

There is not one best way to manage diabetes. People with diabetes need more options to consider with their health care professionals. 

Doctors and patients should consider care plans that reflect individual lifestyles, fears and aspirations. There is an emotional component to care, some folks are afraid or needles. Some shy away from the stigma of injecting in a restaurant, plane or other public place. Some fear hypoglycemia. Others reached unprecedented control with an ultra fast acting insulin.  

Following the public comments, it seemed that in addition to the critical safety issues, the panel also considered the psycho - social aspect of diabetes self care.  All too often, it seems to me, these are overlooked with words like adherence and compliant.

I hope the panel would have had those discussions without the hour of public comments. In the hand full of these meeting I have attend, that as not been the case, certainly to the extent we saw on April 1. 

I hope this was not some twist of April Fool’s Day fate. I hope that the broad community of physicians, CDEs, Big Advocacy and individual PWDs will continue speak in one voice because more options means better care. 

No doubt, the idea of options will need to be better appreciated by third party payers. We can help. Advocacy, just like good diabetes care, work best with a team, doctors, educators and advocates all working with and for patients. 

FDA has Trending List. DOC is On It

Howdy DOC.

We're trending.

No not anyplace super cool. At regulations.gov. Yeah, they have that and here we are:

The SMBG docket is open to May 7. Let's keep it up. Draft comments here: http://www.stripsafely.com/sample-page/guidance/

Y'know, maybe this super cool.



Update 4.11.14.
Like any trend, we fell off. That isn't to say we can't get back.
StripSafely has new comments you can send about third party strips
and who is responsible for what.  Sent them, even if you have sent
other comments already It is our health, we have a say.

I was 6 of 17 at FDA's ADCOM on Afrezza

I was one of a large group of public voice who spoke the the Afrezza ADCOM hearing April 1. It was an privilege to be part of the amazing range of patients, doctors, science officers, CDEs, seventeen of us in all speaking up for people with diabetes. I felt it was an unusually powerful set of presentations. My personal favorite was Adam Brown. His comment about the short comings of A1C were fantastic. Adam's point was very much inline with Aaron Kowalski's, he said that being in range is often a passing state between highs and lows. Many of us spoke about hypos while other spoke to the need to lower the anxiety level associated with needles. 

Maybe all were my favorites. The power came from the diversity of presenters and uniformity of message - People with diabetes need more and better insulin options. I wish I could reproduce them all. I can't.

Here are my notes. 

Hello I am Bennet Dunlap. I have no relationship with the sponsor. I am the father of two type 1 children and I work to be successful in managing my type 2 diabetes. As an advocate I created the StripSafely campaign for accuracy in diabetes testing tools, work with other programs and recently was a PCORI infrastructure reviewer.

As a parent caregiver and person with diabetes. I appreciate the panel's individual commitments to work with FDA to help layperson like myself understand the nuanced risks medications. When considering those nuances I urge you to remember that there is significant risk in the diabetes status quo. Insulin is a very dangerous drug. It is not a cure. It is a treatment, self administered by millions of laypersons in the wild.

Just a few weeks ago JAMA published estimates of emergancy room visits and hospitalizations caused hypoglycemia. The estimate is over NINTY SEVEN THOUSAND American a year go to the Emergence Room because of insulin and 29% are admitted. The American Journal of Managed Care, a publication that is going to be super geeky about costs, estimate the “costs for hypoglycemia visits.”

The cocktail napkin arithmetic of EVENTS times COSTS works out to $645 Million for insulin overdose every year. Seniors over 80 are twice as likely to visit the ER and five times more likely to be admitted.














The JAMA article points to two real world reasons for ER visits. Less food consumption and taking the wrong insulin. An insulin, such as todays candidate, that is sufficiently fast acting that it can be taken with or after a meal, can be balanced to the food actually eaten. vs insulin taken in anticipation of what may be eaten. Bolus insulin taken in a uniquely different way from basal insulin can help address confusing types.









Insulin options can help individuals and their care teams create personalize treatments plans. As you look at risk do please not overlook the real world reasons for ER TRIPS in the wild.

Let me put that risk into a March Madness perspective. NIH estimates that stimulants including methamphetamine, are involved in 93k ED visits annually. Insulin is responsible for 97k. I don’t know who picked Duke to loose in the first round but that isn't the only bracket madness this year. : 









That insulin beats breaking bad in ER visits is a real world signal that innovative insulins are desperately needed.






Citations Citations  are appropriate so there they are.
Thank you for your diligence in bringing innovative insulins SAFELY to market.

National Estimates of Insulin-Related Hypoglycemia and Errors Leading to Emergency Department Visits and Hospitalizations
Andrew I. Geller, MD; Nadine Shehab, PharmD, MPH; Maribeth C. Lovegrove, MPH; Scott R. Kegler, PhD; Kelly N. Weidenbach, DrPH; Gina J. Ryan, PharmD, CDE; Daniel S. Budnitz, MD, MPH
AMA Intern Med. March 10, 2014. doi:10.1001/jamainternmed.2014.136

The Incidence and Costs of Hypoglycemia in Type 2 Diabetes
Brian J. Quilliam, PhD; Jason C. Simeone, PhD; A. Burak Ozbay, PhD; and Stephen J. Kogut, PhD
AJMC.com. October 10, 2011 http://www.ajmc.com/publications/issue/2011/2011-10-vol17-n10/AJMC_11oct_Quilliam_673to680#sthash.iHj0bkb9.dpuf

DrugFacts: Drug-Related Hospital Emergency Room Visits 

NIH, National Institute on Drug Abuse

Published online May 2011. http://www.drugabuse.gov/publications/drugfacts/drug-related-hospital-emergency-room-visits

National Diabetes Statistics
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), 2011

http://diabetes.niddk.nih.gov/dm/pubs/statistics/

Yo! DOC - FDA is Listening, Let's Speak Up

Public Policy on Diabetes Needs Our Help, Our Voices.

FDA is listening for our comments about glucose meters 'till April 7. They have two dockets open.

Please comment on FDA’s meter guidance proposals. Open dockets are a very important and rare time that the FDA is explicitly and officially focused on listening. Let’s be heard. Just as important as what we say, is that our community's message is repeated to be clear over voices that may seek to maintain the unacceptable status quo for their proprietary gain.

Through the dockets we can:

• Support FDA’s efforts for higher accuracy.
• Call for the same accuracy in both patient and clinical use.
• Ask that only the new level of accuracy be labeled to dose insulin.
• Suggest that only devices meeting new accuracy levels be considered DME by Medicare.
• Repeat the call for robust post market enforcement.

Learn more about the guidance.

http://www.stripsafely.com/sample-page/guidance/about-guidance/

See how to steps to posting on a FDA docket. (It is easy.)

http://www.stripsafely.com/sample-page/comment2fda/

Here's links to the open dockets and one set of sample comments to post to both.

http://www.stripsafely.com/sample-page/guidance/

The current set rules for glucose meters is from 2003. It may be another decade before we get another chance. These dockets are open to April 7. Now is the time to join the community and speak up.

Please help build momentum for the effort by sharing that you posted to the docket through your favorite social media channels with the hashtag #StripSafely.

New Proposed FDA Meter Regulations

From StripSafely.com

Proposed new guidance is out today from FDA on blood glucose meter systems (BGMS).  There are two documents. One for patent users and one for use in clinical settings such as hospitals. I am still reading them but I thought other may wish to do so too..

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380327.pdf

Starting at line 420, page 11,

... you should demonstrate that 95% of all SMBG results in this study are within +/- 15% of the reference measurement across the entire claimed measuring range of the  device ...

There are actually two pieces of proposed guidance, over the counter (linked above) and point of care. The later is at:

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM380325.pdf

That document for BGMS use by HCPs in clinical stetting states (starting at line 277, p9):

Although many manufacturers design their BGMS validation studies based on the International Standards Organizations document 15197, FDA believes that the criteria set forth in the ISO 15197 standard do not adequately protect patients using BGMS devices in professional settings, and does not recommend using these criteria for BGMS devices.

FDA EMDAC Public Comments

I had the privilege of offering public comments at the December 12 FDA Advisory Committee meeting for BMS/AZ's dapagliflozin (aka DAPA). My comments were roughly what follows. I say roughly because I know I get lost and stray from the notes. I have tried to bring what portions of my ad-libbing I remember into what follows.

My sincerest thanks to Kelly Close and the team at diaTribe for sharing detailed background material that made it possible to offer informed comments. DAPA has had a complex and carefully scrutinized regulatory path. There were concerning possible signals of risk. Without being able to read though its history it would have been impossible to appreciate the Sponsor's (FDA hearing speak for the pharma companies behind the drug application), FDA's and committee's conversation on those risks. 

My Comments:

Good afternoon. My name is Bennet Dunlap. I have no relationship with the sponsor. My travel here today is at my own expense, including the cost to a good nights sleep of getting up at 4:am to drive down from Philly for this meeting. 

I am a diabetes advocate, a blogger, been a PCORI reviewer and I recently created the StripSafely.com campaign for meter accuracy. I am a member of Diabetes Advocates, an association of diabetes patients and writers. Last time I was here I absolutely slaughtered the name of the drug in question, so this time I’m not even going to try.

Like 26 million other Americans, I live with diabetes. This morning somebody spoke of unintended wisdom. Those of us with diabetes will take wisdom any which way we can.

I often feel that, the conventional wisdom in medical literature projects that diabetes care is easy. Many of us have felt it is not.  We have found  it doesn’t help when – despite our best efforts – we are labeled non-compliant.  Maybe the problem has to do with unrealistic expectations, or maybe the problem has to do with imperfect treatments.

What I am certain about is while all of us with diabetes can benefit from similar diet and exercise, there is no one size fits all approach to good diabetes medications. We need choices to talk about with people like Bob Ratner, (Gesture to Bob who just spoke) our doctors…  and we need innovation.

Which brings me to the purpose of today’s meeting.

Has the sponsor met the safety and efficacy requirements to market their candidate drug and does it present potential heal value to some of us living with diabetes?             

Broadly speaking, the class of SGLT medication is an exciting new opportunity for glucose regulation. The class encompasses four benefits we haven’t seen together before in one diabetes therapy:

- improved glucose, 

- weight loss, 

- less hypoglycemia, 

- and ease of use that comes with a pill. 

Expanding the class with this DAPA increases choice: although there is already one approved for SGLT-2 therapy, a second one would provide obvious benefits from competition, broader education and outreach. 

We all know third party payers love to bid the pharma. companies against each other and a second SGLT-2 would give them a chance to do so in this exciting new class.

As you consider benefits of diabetes medication outcomes, I encourage you to look to endpoints that can create success in patients’ daily lives. In addition to endpoints of lowering A1C, and avoiding cancer and CV risk profiles -  look to endpoints that we can see and feel in our daily efforts to be “compliant.” Medicines that show less weight gain or even loss and less hypoglycemia can help with the phyco-social struggle to stay compliment. 

The safety issues raised at the DAPA first hearing we're quite concerning. Nobody wants to trade blood sugar control for cancer. I appreciate the scrutiny the the agency and sponsor have given to the issues. I was particularly interested in this mornings presentation on the bladder cancer risk and look forward to detailed professional exploration of it this afternoon. 

As Dr Wilding pointed out this morning, we need better treatments. As a patient I worry that regulation creep may inhibit those innovation. That the endpoints move after trials have begun. What constitutes an effective study need to be resolved before the trials start, not after the fact in discussion at an advisory meeting. 

In closing, please remember diabetes care… is self-care. As patients, we see our doctors just a few times a year, maybe for a combined total of an hour, or two if we are really lucky. That leaves us on our own, responsible for self-care the other eight thousand, seven hundred, fifty eight hours a year. 

We could use a hand seeing success in that.  

Thank you very much.

Medtronic LGS Approved!

Just saw a press release that Medtronic has FDA clearance for the 530G Low Glucose Suspend (LGS) system. This is good news. It is the first step on the path to AP.

LGS uses a sensor to stop delivering insulin when the system detects a low. That seem only logical.

Regular YDM readers may have seen these posts on LGS

Approval is good news. It shows FDA has figured out how to allow an innovative step to better diabetes management. Before people start quibbling about sensors sensitivity and perfection, let's remember that diabetes perfection is not possible. Better is.

This is a significant step to better.

Your Diabetes May Vary

I Love it When a Plan Comes Together (or at least starts to)

My first reply to a StripSafely letter from Congress was a long piece that included the history of the FDA and nothing about the subject to which the good Senator was replying, meter accuracy. I shared it with some friends who were a little disappointed. 

Not to worry, regardless of sequesters and partisanship, Congress sorts and counts. If we get enough letters to them, they will start sorting and counting diabetes accuracy messages. They don’t need to know or understand anything about diabetes care, at first, they need to start counting. Maybe they have. 

Yesterday I received a letter from my Congresswoman. (Yes, woman. Cool right?)  She (or her staffer more accurately) wrote specifically about FDA  post market oversight. Citing exactly the three points FDA wants me to hear; inspections, MDRs and recalls. That is glorious. That can only mean the Congresswoman’s office reached out to FDA. The FDA had some explaining to do to the Hill. 

Each episodes of the “A-Team” ended with Hannibal saying, “I love it when a plan comes together.” The joke being that things may not go as planned but the A – Team gets results, typically with a lot of action.

I know the FDA has action hero-ish special abilities. On September 5th the Agency published a story of how twenty one individual, potentially contaminated, candy bars from New Zealand were tracked down by FDA to keep American consumers safe.  FDA should just as actively use its powers for good to Americans safe from test strips that fail to deliver the accuracy on our fingers that those test systems had to demonstrate to be approved for sale.

If anything is clear from the Diabetes Technology Society meetings on May 21 and September 9, it is that we know there is a problem. We know firms fail to comply with MDRs and other parts of FDAs existing regulatory controls. Committees, commissions and post market studies to know more, without enforcing more, is unacceptable.

We need acton for plan to come together.

People with Diabetes are starting to get the FDA’s attention. StripSafely is still in the opening of the third act. Regular viewers know what is needed, action, lots of it.

If you get a reply from you Congresswoman (or man) that mentions three parts of a  post market program, write back. Tell congress we need more action, independent inspection. We have a letter for that. Face and BA are in shed beating the Strip Safely Twitter page into shape too.

The third act is always the most fun.

(My lodging to attend the September 9 meeting was paid for by the Diabetes Hands Foundation.)

If it happens to Walmart, Does it Happen to FDA?

This piece in the New Your Times paints a troubling picture of gaming the system of Walmart overseas factory inspections. I would love to know who makes more of an effort to inspect overseas factories Walmart or FDA. 

Fast and Flawed Inspections of Factories Abroad

http://www.nytimes.com/2013/09/02/business/global/superficial-visits-and-trickery-undermine-foreign-factory-inspections.html

No question the processes of FDA and Walmart are different. Still this articles does raise questions about a culture of gaming the inspection system.

I am not saying this is what is happening with test strips. I am saying this is what PWD do not want for an inspection process.

One of Three

To Perpetuity.

Diabetes doesn't end. This fantastic piece from the Diabetes Art Day collection, by the Gulo family, makes that clear. 

Diabetes is a disease not a character flaw. A disease that 25 million american live with, significantly more than that if the undiagnosed are includes. Some estimates put that 'significantly more' as ONE in THREE Americans.

FDA is is holding patient meetings to provide "a more systematic approach to obtaining the patient perspective on certain disease areas." Diabetes isn't on of them. Let's Change that

1 in 3

diatribe.org/petition

 One in three of us have it and the other two loves someone who does. I have asked FDA for a patient meeting on diabetes. Join me, sign the petition, get two loved ones to sign too.

Be one of three

FDA / Sponsor a Patient Meeting on Diabetes

The Food and Drug Administration has begun to hold a series of patient meetings to gain a better understanding of specific diseases. Over the next five years, the agency plans to conduct at least 20 such meetings on conditions ranging from Chronic Fatigue Syndrome to Narcolepsy to Irritable Bowel Syndrome.

But not diabetes.

That is unacceptable.

Four “slots” remain open (view the current list), and we want the FDA to add diabetes to its meeting docket for 2013.

According to the American Diabetes Association, nearly 26 million Americans have either type 1 or type 2 diabetes, and an additional 79 million have prediabetes. Those numbers are also increasing each year – the CDC estimates that if current trends continue, one in three US adults will have diabetes by 2050.

No one disputes that diabetes is one of America’s – and the world’s – most serious health epidemics. In 2012, more than one in five total US healthcare dollars was spent on diabetes, totaling $245 billion, and the government covered 62% of those costs, meaning everyone is paying for this epidemic. Despite growing needs, research dollars have also leveled off.

New therapies need to be investigated, tested, and brought to market, and as part of that process, the FDA must understand the daily challenges that patients face.

We need to tell our story to the FDA: about the need for accurate strips, more physiologic insulin, a broader range of drugs, and the Artificial Pancreas.

Our voices need to be heard.

Please sign this petition to urge the FDA to sponsor a patient meeting focused on diabetes – and the sooner, the better.

Thank you very much.

You can sign the petition here:

Diatribe.org/petition

YDMV on PDUFA

FDA Blog on Gluten Free Labeling

From the FDA:

Gluten-Free Labeling Consumers Can Count On

Posted on August 2, 2013 by FDA VoiceBy: Virginia A. Cox
Celiac disease is a serious health issue that can lead to critical complications if not treated.  

While there is no cure for celiac disease (CD), there is one way to manage it – following a gluten-free diet. The only choice for the up to three million Americans living with CD is to adhere strictly to a gluten-free diet, avoiding proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains. To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer. 

Without a standard definition of “gluten-free,” people with gluten-related health problems can never be certain if a food is likely to be tolerated by them. So as a person living with CD for over a decade, I’m delighted to say that today, FDA is mandating a new rule on food labeling that will help people with CD – people just like me –be able to trust what the words “gluten-free” mean on their food purchases. Not only will this help those with CD manage their disease more carefully, but it will also improve life for many others who are gluten intolerant or gluten sensitive. 

More at: http://blogs.fda.gov/fdavoice/index.php/2013/08/gluten-free-labeling-consumers-can-count-on/?source=govdelivery