FDA recalls Medtronic 600-series MiniMed insulin pumps
Alert says Medtronic's MiniMed device could malfunction on airplanes
From the Star Tribune: Entire article can be found here
“The problem has long been known. Medtronic first notified patients about the problem in 2017.”
The U.S. Food and Drug Administration is reminding patients who use the popular 600-series MiniMed insulin pumps made by Medtronic that the devices contain an issue that could cause their buttons to get stuck while flying or other situations when air pressure changes quickly.
The FDA on Wednesday issued alerts for more than 189,000 MiniMed insulin pumps worldwide. Such pumps are used by diabetic patients who need a steady infusion of the drug insulin to break down the glucose in their blood, in addition to periodic doses (or "boluses") of insulin related to meals, exercise and other factors.
The alerts issued Wednesday are classified by the FDA as a class 2 recall, which is a medium-severity action used when a problem caused by a medical product would be temporary, or when the probability of serious adverse consequences related to the problem is considered remote.
Medtronic has issued an urgent safety notification to patients, which the FDA calls a "recall." However, FDA and Medtronic are not requesting any devices be returned to the manufacturer. The FDA uses the term "recall" to include situations where no product need be returned.
The recalls apply to MiniMed 670G, 640G, 630G, and 620G models, which have physical keypad buttons that can temporarily become "unresponsive" when atmospheric pressure goes up or down quickly around the pump, typically during takeoff and landing.
Read the entire article here
Podder Talk
Thank you to Omnipod for highlighting the Juicebox Podcast in their Father's Day blog post!
Two Podding parents chat about being bold with insulin, not being a diabetes defense attorney, and creating great content that helps people manage their type 1 diabetes.
Check out Amy’s post and the podcast conversation that we had.
Sanofi Insulin Pricing Program
from press release - 4/10/19
Starting in June, Sanofi will further expand its innovative Insulins Valyou Savings Program so people living with diabetes in the United States can pay $99 to access their Sanofi insulins* with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month. The expansion of this program helps to address the challenge too many patients face regarding unpredictable and unaffordable pricing for their insulin.
“People living with diabetes in the United States can pay $99 to access their Sanofi insulins* with a valid prescription, for up to 10 boxes of pens and/or 10 mL vials per month.”
People exposed to high out-of-pocket prices at the pharmacy counter can participate in the Insulins Valyou Savings Program regardless of income level. This includes those who are paying high retail prices for their insulin and those who don't qualify for other patient assistance programs.
Under current government regulations, pharmaceutical companies cannot offer this type of program to patients insured under Medicare, Medicaid, or similar federal or state programs, though Sanofi supports changing rules to expand this access program to all those who might benefit.
For more information or to learn how to access this program, visit www.InsulinsValYOU.com.
Additional patient resources available for accessing Sanofi medicines
Sanofi continues to offer other resources to make insulins more accessible including co-pay cards which may limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of income level. In addition, Sanofi offers assistance programs that provide medications, including insulin, at no charge for qualified low-income, uninsured patients through the patient assistance component of the Sanofi Patient Connection program. Together, these programs demonstrate the company's dedication to finding support to help people living with diabetes gain access to the insulins they need.
Sanofi also encourages anyone who is prescribed a Sanofi medicine who may be having financial challenges or trouble navigating their insurance, to call Sanofi Patient Connection at (888) 847-4877 where eligible patients can be connected to the medicines and resources they need at no cost.
* The Insulins Valyou Savings Program does not include Sanofi's combination insulin product.
The entire press release is available here
Second Hearing: Rising Cost of Insulin
Date: Wednesday, April 10, 2019 - 10:30am
Location: 2322 Rayburn House Office Building
Subcommittees: Oversight and Investigations (116th Congress)
The Oversight and Investigations Subcommittee will hold a hearing on Wednesday, April 10, at 10:30 am in 2322 of the Rayburn House Office Building. The hearing is entitled, “Priced Out of a Lifesaving Drug: Getting Answers on the Rising Cost of Insulin.” This will be the second hearing on the rising cost of insulin.
First Hearing: Insulin Costs
Date: Tuesday, April 2, 2019 - 10:30am
Location: 2322 Rayburn House Office Building
Subcommittees: Oversight and Investigations (116th Congress)
The Subcommittee on Oversight and Investigations of the Committee on Energy and Commerce will hold a hearing on Tuesday, April 2, 2019, at 10:30 a.m. in room 2322 of the Rayburn House Office Building. The hearing is entitled, “Priced Out of a Lifesaving Drug: The Human Impact of Rising Insulin Costs.”