Influenced by the president’s mandate to “bend the health care cost curve,” the Food and Drug Administration (FDA) is preparing to deny late-stage breast cancer patients access to the critical, but expensive, life-extending drug Avastin. The FDA wants to “de-label” the drug, a move that would force patients with insurance or Medicare coverage to pay for the drug out of their own pocket in order to survive. Now patients groups are speaking out.
Led by the Susan B. Komen Foundation for a Cure, 15 patient advocacy groups have petitioned the FDA to reverse their effort to ration the drug. In a letter to the FDA, Elizabeth Thompson, the organization’s President, expresses concern over the potential negative impact that the FDA’s decision will have on women who are benefiting from Avastin:
"We know that for some number of women, Avastin works and works well. We have heard from women who are gaining not just months, but years with a high quality of life, from this treatment.
We are concerned about the potential impact on women who are benefiting from Avastin if the FDA ultimately removes its approval for the drug for metastatic breast cancer treatment. We want to be sure that women who are using Avastin, and for whom it is working, can continue to have access to it, and that their insurers will continue to pay for it...
Today, the issue is Avastin. In the coming years, there will be other treatments that may be controversial but will help some number of women and men with breast cancer live longer, high quality lives, and perhaps to ‘beat’ breast cancer altogether…[w]e must make it possible for these treatments to be available to all who will benefit from them. The decision on Avastin is precedent setting and deserves to be considered in a public setting."
The Avastin case is the rationing camel nose under America’s health care tent. Should the FDA successfully introduce cost into the drug approval process, the long-term implications will be enormous. It will not be breast cancer patients alone who will suffer. Avastin is first step on the slippery slope toward rationing. The FDA’s action is dangerous and cannot stand.Fortunately, Judge Vinson’s ruling that ObamaCare is unconstitutional has temporarily given hope that we may reverse course before it is too late. While Vinson’s decision finds Obamacare’s individual mandate unconstitutional, it strikes down the entire law as the mandate is not severable from the full legislation.
Like the individual mandate, FDA rationing is a flawed (some might say lazy, dishonest, or inhumane) attempt to lower Obamacare’s alarming financial cost. But both come with heavy price tags, nonetheless. While the mandate will cost jobs and wages, FDA rationing will cost lives that could otherwise be extended, improved, or even saved. We simply cannot afford the real cost of ObamaCare.
Vinson’s decision makes clear ObamaCare implementation by state and federal officials should immediately cease. The Cato Institute’s Mike Cannon and Ilya Shapiro, in a
"In ruling as he did, Judge Vinson wrote that “it must be presumed that federal officers will adhere to the law as declared by the court.” Yet the Obama administration has thus far shown no inclination to do so. But neither has it sought to stay the practical effects of the ruling — perhaps because it thinks that doing so would give credence to the court’s decision."
Rather than adhering to Judge Vinson’s ruling or request a stay, the Obama Administration is instead requesting a ‘clarification’ of the decision, a thinly veiled attempt to run interference for ObamaCare’s supporters to continue moving forward with implementation of the law. Like its attempts to use the Environmental Protection Agency to bypass Congress in issuing politically unpalatable energy and environmental regulations, the Administration is showing a blatant disregard for the Constitutional separation of powers in ignoring Judge Vinson’s ruling.
Even with Vinson’s decision, the fight is not over and ObamaCare advocates may ultimately prevail, FDA health care rationing and all. The case is expected to move to the 11th Circuit Court by this summer. Efforts are even underway to expedite consideration by the Supreme Court. Until, then, however, it is clear ObamaCare implementation must be put on hold. We do still live in a nation of laws, after all.
Mr. President, Judge Vinson has made his decision, now you have to enforce it!