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.

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. 

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Defense Foundation (“T1DF”) welcomes the opportunity to submit comments on the Food and Drug Administration’s (“FDA’s”) Draft Guidance entitled “ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin” issued on October 4, 2017 (“Draft Guidance”).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. 

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.