How patients with insulin-dependent diabetes forced by commercial insurers, with CMS complicity, to overpay for ‘deep-discount’ rebated insulin are subsidizing premiums and bailing out America’s public-private health insurance partnership.Read More
Six million Americans have type 1 and other insulin dependent diabetes.
That’s over six million people to stand together against inflated drug prices, discrimination in access to health care and insurance (including inflated cost sharing), discrimination in school or employment. T1DF was created to safeguard and, if necessary, fight for your rights. But we can't do it without your help.
Our civil rights and consumer protection programs depend on people like you who are willing to take action.Read More
The Type 1 Diabetes Defense Foundation (“T1DF”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) Draft Guidance entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin” issued on October 4, 2017 (“Draft Guidance”). Effective implementation of the Biologics Price Competition and Innovation Act (“BPCI Act”) is of importance to the individuals T1DF represents, and we greatly appreciate the FDA’s efforts to provide clarity on the interplay between the new drug approval pathways under the BPCI Act and the existing approval pathways under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”).
As detailed below, we do have concerns about (1) the agency’s arbitrary reduction of the scope of “biological products,” as defined in the Public Health Service Act (“PHS Act”) and as amended by the BPCI Act, to a class solely based on the number of amino acids; (2) the resulting misclassification of glucagon as a molecule governed by the FD&C Act instead of the PHS Act; and (3) the bifurcation of approval pathways for analogous biological products, e.g. analog glucagon and analog insulin.Read More
Dear H.E.L.P. Committee Chairman, Ranking Member, and Committee Members:
As you and your staff are preparing follow-up questions to submit to Mr. Azar by Friday, we hope you will take into consideration the clarifications we offer below and the potential follow-up questions we list at the end of this letter.
I’d like to begin by thanking members of the H.E.L.P. committee for their bipartisan attention during yesterday’s hearing to the crisis now facing Americans with type 1 diabetes, for whom access to insulin and glucagon emergency kits isn’t an issue of choice or convenience, but a matter of life and death. As accurately described by Mr. Azar during a November 2016 talk at the Manhattan Institute, current drug-channel actors have collectively created a pricing crisis for the uninsured, and a “cost-sharing” crisis for those insured under high deductible and high cost-sharing benefit designs.Read More
Senator Hassan (D-N.H.): Where is your indictment of insurers’ exploitation of Americans with chronic medical conditions such as diabetes? Missing from your comments on Wednesday was an acknowledgment of the harmful effect of the current overcharging on the financial but also medical welfare of your constituents with chronic medical conditions. Insurers have been misleadingly messaging to the public that premium increases are caused by the skyrocketing list prices of diabetes drugs—while in fact these commercial insurers pay only a fraction of the list price, sometimes as low as 25% in the case of analog insulin. That this overcharging may, as T1DF’s lawsuits allege, be fraudulent, makes the oversight even more troubling. There is no evidence that rebates received by manufacturers, and accounted as general revenues, are actually used by insurers to lower premiums instead of increasing profits. In fact, enforcing cost transparency, and thus accountability—across the entire channel, from manufacturers to insurers—would likely reduce costs across all plans. Your unqualified statement that reduced cost- sharing would drive up premiums condones payers’ current discriminatory practices. These payers turn your constituents with diabetes into scapegoats.Read More
The Type 1 Diabetes Defense Foundation has reached out to Senator Lamar Alexander (R-TN), Chairman of the U.S. Senate H.E.L.P. Committee, and Senator Patty Murray (D-WA), Ranking Democratic Member, and other members of the HELP Committee, in anticipation of the full committee hearing scheduled for November 29 on the nomination of Alex Azar to serve as Secretary of Health and Human Services.
T1DF has asked committee members, on behalf of their constituents with type 1 and other insulin dependent diabetes, to consider with all serious deliberation whether Alex Azar is the right choice to solve America’s current drug-pricing crisis.
The Type 1 Diabetes Defense Foundation is deeply concerned by the nomination of Alex Azar to lead the Department of Health and Human Services. Over the years Mr. Azar has cultivated a public persona as an advocate of efficient market solutions and consumer empowerment. Yet as president of Lilly USA, he also demonstrated a willingness to sacrifice patient welfare in order to claim and retain for Lilly market domination in diabetes drugs. We are skeptical that an Azar-led HHS would deliver the most meaningful solution: downward pressure on list prices via regulatory enforcement of point-of-sale consumer protections, including transparency on net drug cost to insurance plans.Read More
"It’s a complicated and opaque system. All consumers deserve to know the cost and quality of what they are purchasing . . . They have tremendous amounts of price and quality data on all sorts of things—except for health care. Our vision for health care is to fix that and give Americans the tools they need to become educated consumers."
— Alex Azar, Deputy Secretary of Health and Human Services (2007)Read More
The Type 1 Diabetes Defense Foundation is deeply concerned by the nomination of Alex Azar to lead the Department of Health and Human Services. Azar once advocated for healthcare consumer empowerment and price transparency. But during his 2012–17 tenure as president of Lilly USA, LLC, he evolved into an aggressive enabler of the opaque drug pricing system that as former Deputy Secretary of HHS he had once pledged to reform.Read More
On May 24, 2017, the Type 1 Diabetes Defense Foundation filed two new lawsuits in federal court with class-action law firm Keller Rohrback, L.L.P., seeking disclosure of manufacturers’ net realized prices on blood glucose test strips and emergency glucagon kits, both used in diabetes treatment. Following on T1DF’s insulin pricing lawsuit filed March 17, 2017 (Boss, et al. v. CVS, et al.), T1DF now joins with individual plaintiffs in test strip claim Prescott, et al. v. CVS, et al. and glucagon claim Bewley, et al. v. CVS, et al., expanding its consumer rights campaign against the unconscionable pricing of essential pharmaceuticals.Read More
The Type 1 Diabetes Defense Foundation has filed a lawsuit in federal court seeking disclosure of manufacturers’ net realized prices on insulin and now calls for support to expand its campaign to make insulin affordable again. The lawsuit alleges that for years insulin manufacturers and PBMs have conspired to hide the actual U.S. price of insulin—the heavily rebated prices that PBMs and insurers actually pay, instead of the artificially inflated list prices used by PBMs to calculate consumer pre-deductible and coinsurance payments.Read More