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Category: Diabetes and the Government

FDA generic drugs

FDA Blocking Sneaky Moves from Brand Names to Block Generics

Chris Stocker 1 Comment

As part of my “educate myself more” attempts, I wanted to dig into an article about the FDA a little deeper. The most confusing part of my coverage of diabetes in the decade that I’ve been doing this has easily been anything to do with the FDA.

It has always been confusing to me.

But, this article is pretty straight forward, the practice being talked about is a bit, well, shady.

Blocking Generics

So, when a company submits a generic drug to the FDA, the brand name pharmaceutical company will help organize citizen petitions to the FDA which will bog down the process of getting said generic approved by the FDA.

generic manufacturingI get it, it makes sense, but it seems like a pretty sketchy move in my book.

The FDA announced last week that it is going to crack down on these practices.

FDA Commission Scott Gottlieb is quoted in the article saying,

while the record shows that citizen petitions have rarely delayed specific generic drug approvals, there’s no doubt that the process requirements associated with … petitions can add to resource burdens on the generic drug review process.”

Another tactic that brand name companies use is to withhold samples from the generic company. According to the Washington Examiner article,

“a generic company needs up to 5,000 samples of a brand name drug to complete approval testing.”

These both seem like old school pharmaceutical tricks that have probably been used for a long time, but I don’t like them and I like the crack down.

Building the Biggest Building

I’ve used this example in the past, but there are two ways to have the biggest building in town.

1. Knock down the current biggest
2. Build the biggest building in town

What does that mean?

You can either become the best by trying to knock down the others and cheat and get ahead by putting them down.

Or

You can become the biggest building by putting in the work, making a better product and just dominating your competitor.

I get it, once a generic comes out, you’re not going to make as much money as you will if there’s not a generic, but you know this going into launching a new medication.

What are your thoughts on this? Are there any other sneaky little tricks played on the FDA that are worth discussing?

Share this article on Facebook or Twitter now and keep the conversation going.

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This is Not an April Fool’s Joke – I Am Back

Chris Stocker

This is not an April Fool’s Joke. I am actually posting something today. Let’s first talk about why I haven’t been posting lately on my site. There are several reasons, so here we go.

Facebook Attention Spans

Facebook (as well as Snapchat and Instagram) has created digital attention spans that last for about 8-30 seconds. After that, it’s just scroll on to the next thing. And in most cases, the 8-30 seconds is being very generous. It’s more like 2-3 seconds.

Because of this, I started to feel like people just weren’t reading blog posts like they once were. People were more interested in video, especially native Facebook video. So, I decided that I was going to do more video. Well, I’ve made a few, but nowhere near the amount that I planned on. That’s changing this month to as I am participating in a Vlog Every Day in April challenge #SSSVEDA

You can check those out at my Chris Stocker You Tube Channel

Politics, Politics, Politics

I am not one to typically let political talk affect me. In fact, it barely does. But these past couple of months have been draining. It’s not so much the stuff happening in DC (which a lot of irritates me), it’s just been the massive amount of content created around it. I’m not saying this is a bad thing, because we have to use our platforms to speak our voice. It’s just that, it’s all I was consuming. Every day it seemed to just be the same stuff, different angle. Which in the times we are living in now, there is absolutely nothing wrong with that.

However, I am a firm believer that I am the one who is in charge of creating the life I want. This is why I don’t spend too much time on political issues or talking about them. I will if it’s something that I am extremely passionate about, like Pre-Existing Condition coverage. I am a proud supporter of DPAC and everything that they are doing and I will continue to promote and share their content until the cows come home. But, I don’t write about those issues because I can only write what I know about and what is top of mind for myself. Like I said, I will promote it though.

Because of all of this, I stopped writing. I felt like maybe this is all people want to read about now. They just want to find out about the next march or protest or other way to contact their local reps.

If so, then I don’t feel like I would have enough to contribute.

Business Development

As you may now, being the CEO of a CSI Marketing Solutions, a boutique digital marketing agency, is what I do for a living. This takes up majority of time. More than my wife would like for sure. This blog is more of a “side hustle” thing. Over the past few months, my business has been growing. Adding a few assistants, some larger clients, additional services and it has required more of my attention to be hands on during this process.

We all have 24 hours in a day. So the 1-2 hours that I had once put towards this blog during the day was now being used elsewhere. Which meant that this blog was put to the side.

But then over the past couple of weeks I’ve received an insanely high amount of emails coming from the site.

“Where have you been?”

“Is everything ok?”

“My son is in college and I always share your articles with him.”

And many more of the same type of emails.

And then I thought to myself. A long time ago, you set out to do this and you didn’t know what you were getting yourself into. But then you started to hear from people how a post changed their life or mentality or living with diabetes and you just knew you had to keep going to help inspire people. And you let them down.

I don’t mind failing. I do it all the time. But one thing I don’t like to do, is let people down. Especially people who rely on me.

So that’s why, starting today, I am back. I have audited my day and my time and I’m back. And I’m putting this out on the internet to hold myself accountable. I will be here 7 days a week. If I’m not, call me out.

Every day missed is a missed opportunity to inspire or help someone living with diabetes.

Learn How to Advocate on a State Level

Chris Stocker

As many of you know, I am pretty big fan of advocating for changes at the policy level. I strongly believe that majority of what we all advocate for, comes down to policy change. For example, better access to diabetes technologies will require state and federal policy changes to truly create the access that we need.

Next Thursday, the Diabetes Patient Advocacy Coalition (DPAC) will be holding its monthly Ask an Expert webinar series. This month’s expert is Tom Karlya. Most of you may already know who Tom is and what Tom has done for people with diabetes. You may also know Tom as the Diabetes Dad.

Tom will be speaking about Reegan’s Rule in North Carolina and how we can all use the success of Reegan’s Rule as a model of how to engage in state level diabetes advocacy.

I highly, highly recommend that you all join this webinar and learn from Tom on what we can do as advocates. If we truly want change, then we have to attack it from all angles, not just from a Federal perspective, but also from a state and local level as well.

I don’t ask for much, but when I do ask, it is because it is something that is extremely important.

So, please sign up for the webinar next Thursday, April 28 @ 12PM EST. If you are unable to attend live, there will be a replay link. Please comment below or ping me if you would like for me to send you the replay link once it is available.

DPAC_ASKanEXPERT_TomK-Reg-768x768

Suspend Medicare’s Bidding Program

Chris Stocker

Yesterday, the Diabetes Patient Advocacy Coalition (DPAC), launched the Suspend Bidding Action Center. Even if you are not using Medicare now, you may be one day, and people are using it today. People should not have to have their health suffer because they are on Medicare. That is exactly what the Competitive Bidding program is doing.

Please check out the Suspend Bidding Action Center as well as the infographic below for more information and to take action:

DPAC Suspend Bidding
DPAC Suspend Bidding

Thanks a lot Local and State Government….NOT!

Chris Stocker 1 Comment

After writing a few blog posts about my thankfulness and appreciation of the DOC, I now want to write a post about the local and state government. This, unfortunately, is not a thankful post. After losing my COBRA insurance almost two weeks ago now, I reached out and sent e-mails to every single local and state elected officials, every advisory board, panel, and organization I could think of. With it being re-election time, I knew that their plates would all be filled and they would not have much time for a voter because they are focused on the masses at this time looking for a re-election.

On the other hand, I thought that I would at least get some sort of responses that explained that, because I could understand that and be fine with that response. However, the responses (the few that I did receive) were not that great.

When it came to the different agencies or groups that I contacted, none of them seem to be the right place to contact. About 5-6 different e-mail responses said, “that’s not something we handle, contact this department.” So, I would contact “that” department, and they would say the same thing. Eventually, I was sent to 5 different groups until it came full cycle and I began getting referred to groups that I already contacted. Either, there is no sort of group out there that can help somebody who just lost COBRA, or nobody wanted to get their hands dirty. I’m going to go out on a limb here and say, everybody likes clean hands during re-election season.

So, it’s back to working with Big Red and Big Blue (ADA and JDRF) about resources or advocacy plans on making sure there is some sort of group or organization that can help fight this.

The adventure continues….

No COBRA Follow Up – Supply Inventory

Chris Stocker 5 Comments

It has been a very long week for me. There has been a lot of adjustments, a lot of planning and figuring out what I am going to do for all of my supplies and insulin, etc. Like I said in yesterday’s post, I just wanted to say thank you again. Honestly, I have never been in this position before and it means so much that you all would be so kind and considerate to reach out and help in times of need. It still feels weird asking for supplies when over my almost 10 years with diabetes, I have been the one who has sent supplies out to others. What comes around, goes around right?

I spent a lot of time last week figuring out what my inventory of supplies currently is and how long that current supply will last me before I have to start purchasing items out of pocket. It breaks down like this:

– OneTouch Strips – 400 strips
– MMT397 Infusion Sets – 9
– Reservoirs – a lot (stocked up on these throughout my insurance life)
– Dexcom sensors – 2 (found one in my home office where it wasn’t supposed to be)
– Things to put over my Dexcom sensor in bath or pool (I use a bunch of different items) – 2
– Insulin – I had only 1-2 weeks left, but the insulin fairy hit me and I now have a 3-4 month supply of inuslin. Greatest act of kindness I have ever seen!

So, my two biggest areas of concerns in my eyes are the test strips and the infusion sets. I think that I will be fine with the infusion set side of things because there are some very cool and awesome people out there who are willing to help out.

That leaves me with the test strips side of things. I have a decision to make, do I go with a cheaper strip, like a Walmart brand or such and deal with inaccuracies, or do I continue with one of the most expensive brands of strips and just suck it up and pay out of pocket for them? I am unfortunate to still have a job while living without insurance. I still am making a living, in fact, since I own my own business, I can have more control over how much income I do make and if I have to take on a few more lower paying tasks throughout the month to cover these additional costs, then so be it.

I’m sure that I could easily get more and more strips from my endo’s office, but I don’t want to do that. I’ve seen the community that my endo services and there are people out there far worse off than me financially and could use the strips a lot more than I can.

But, this is where I am looking to hear back from y’all. If you were in my situation, would you go with the higher cost, more accurate, or move on to the cheaper choice and deal with the inaccuracies from the cheaper meter and strips?

Your opinions and suggestions are welcomed.

Thank you once again.

If You Want It, Go and Get It

Chris Stocker

The other day I saw a tweet from Rob Dyrdek, from MTV’s Rob & Big and Fantasy Factory.  I don’t remember the exact tweet, but I remember that I re-phrased it on Facebook and it has had me thinking about the tweet ever since then.  Basically, this is what I said, “There’s two types of people you can be.  Those that bitch about the shit you don’t have, or those that work hard to get the things you want.  I know which I am, which will you be?”

Ever since then, I have really been thinking about it.  Not just in my personal life, but in the business side of things as well. I then started relating it to my diabetes as well.  I always talk about how I want certain things related to diabetes, and I want to do certain things.  Well, it’s time to stop talking about them and doing them.  So, here are the top five things that I want and will work my ass off until I get to it.

  1. Omnipod – I’ve been saying for a long time that I want an Omnipod.  I have ripped out so many infusion sets from my wire being caught on the arm of my office chair.  Or a hassle to connect and disconnect when I’m at the beach and I want to go into the water.  The one and only reason that I am not using an Omnipod right now has nothing to do with insurance or coverage.  It is because I use too much insulin.  I would be changing sets every single day.  In order to cut down on my insulin usage, I need to lose weight.  When I was 60 pounds lighter when I was first diagnosed, I was using only about half of the insulin that I am using now.  I WILL work my ass off to lose that weight, so I can start using an OmniPod
  2. A1C below 6.5% – I am definitely not a fan of the A1C, nor do I get too upset when I see a high number.  I know the number is important and it gauges how the last 90 days went, but I know that I can always improve it.  Well, I want it to be below 6.5%.  This is something that is in my control and bitching and complaining about it is not going to accomplish anything.  Losing weight, eating better ,exercising, wearing my Dexcom constantly, are all actions that I can take to accomplish this.  I WILL work my ass off to lower my A1C to below 6.5%
  3. New Jeans – I don’t just want any kind of new jeans, but I want new jeans at the old size I used to wear.  I am not setting any unrealistic goal here.  I want to fit into the size jeans I was wearing about a year or maybe two years ago.  There is nothing better than losing weight back into an old wardrobe.  I have done it before, but I just went back and ate myself right back into the heavy wardrobe again.  I WILL work my ass off to be able to buy new, smaller jeans.
  4. Attend More Events – This year, I really want to attend more diabetes events.  The main reason that I haven’t been able to go to as many as I want to is because of financial reasons.  That will be the same issue this year, but I am working on ways for that not to be as much of an issue.  The few events that I do get to travel to every year are amazing.  I love spending time with everybody that I talk to online and meeting new people at these events.  I WILL work my ass off to be able to attend more events this year.
  5. Make a Difference in my Community – I have plans on being more active with my local government and local leaders on becoming more active with them and getting diabetes in front of their faces a bit more.  I was able to start on this last year, but did not have a lot of success, so I WILL work my ass off this year in order to make a difference in my community.
That’s it.  That’s a lot of things that I want to do that I kept talking about, and I have put some plans together to be able to get this stuff accomplished.
I’ll do a follow up shortly to see how I have done.

Meetings Scheduled with Local Government Reps

Chris Stocker 2 Comments

Following up with what I posted last night about the e-mail response from US Senator Bill Nelson, I wanted to get feedback from the DOC about your success and failures of reaching out to your local reps.  I have some meetings coming up with local reps, and I don’t know exactly what I am going to do.  I told them before setting meetings, that I don’t have all the answers or all of the best ideas for, but just getting an opportunity to bring diabetes to somebody with some power is what is most important.

On a local level there is not much that can be done.  I am meeting with the local city reps, so I can’t ask for their help in getting funding for the FDA to proceed with research on the artificial pancreas.  But I will be asking them to be more involved in local JDRF and ADA events.  If need be, I will speak to large groups of locals about diabetes and get some truth to these people instead of the false “facts” that they are hearing on Oprah and Dr. Phil and Dr. Oz.

I am asking for your help DOC…what items have you had success with on a local level.

I look forward to hearing your comments and suggestions.

E-mail Response from US Senator Nelson (D-FL)

Chris Stocker

A few weeks ago I was inspired by a social media victory when a fellow DOC member had written a letter to their representative and eventually they were granted a meeting with him.  After that, I decided to send an e-mail to every single one of my reps.  Whether it was on a national level (to discuss FDA and the artificial pancreas) State reps, and even the most local reps.  I received quick responses from most of the local reps within 48-72 hours.  I did not hear anything back from the two Senators….until today.  And let’s just say, I wasn’t very happy with the response.

First, I could tell that it was an automated response, and most likely not even from him.  The first two sentences mentioned my concerns about the FDA and the artificial pancreas and funding for diabetes research.  After those two sentences, it went straight into campaign rhetoric.  It was mentioned that he will take this into consideration, but his main focus is working on a budget that will help reduce the national debt and work on funding for public education.  So, basically you’re saying that theres no room or no time left of yours to deal with the diabetes issue?

That is why you, as a Senator, have a lot of aides.  Because you may not have the time personally to deal with this issue directly, but one of your aides can speak with people about diabetes, and some of the major issues that are out there and then during one of your meetings, it can be discussed.

I was not a fan of Senator Nelson to begin with, but as the one with power, I had to reach out to him.  I always said that, it doesn’t matter on a Federal level, your voice is never heard.  Unfortunately, this is another example of that happening.  When you are ready to discuss the importance of diabetes Mr. Senator, I will be hear with an open mind wanting to discuss what you can do to better the lives of the millions of diabetics out there.

Thanks.