26 August, 2011
The Honorable Kay Bailey Hutchison
U.S. Senate
284 Russell SOB
Washington, DC 20510
Dear Senator Hutchison:
As a patient advocate and former lymphoma survivor of 22 years, I am writing to seek your support for legislation regarding drug shortages of life saving medicines. This current issue of drug shortages is at a crisis point, putting both our patients and family pets in this country at risk and opening up an unconscionable “grey market” with no clear solutions in sight.
The number of drug shortages in the United States has reached unprecedented levels having tripled since 2005 to roughly 300 now, most of which are sterile injectables manufactured by generic companies. The shortage is hitting treatments for rare cancers particularly hard. So far this year, at least 180 drugs that are crucial for treating childhood leukemia, breast and colon cancer, infections and other diseases have been in short supply — a record number. Life-saving medicines for our pets are also in short supply such as drugs to treat heart worm disease. Top government officials have held a bolus of meetings in recent weeks to tackle the shortage issue, and more are expected over the next month — including a public advisory meeting at the F.D.A. Sept. 26th and hearings in Congress.
Texas is not immune to this issue and it is getting worse. I personally have spoken to several friends denied some of their cancer treatments or who have had to wait sometime to be treated. Moreover, some of my pharmacy hospital friends are just trying to get a hold of any medications they can so that lives are not lost. According to the hospital association, "labor costs associated with managing shortages translates to an estimated annual cost of $216 million nationally.
An American Hospital Association survey of 820 hospitals nationwide, including some in Texas, revealed that nearly all had reported at least one shortage in the last six months and nearly half had 21 or more shortages. During that time, 82 percent had delayed treatment and more than half were not consistently able to provide recommended treatments, according to the study, which was released in July. Nearly half reported experiencing shortages daily and 35 percent reported that patients were experiencing "adverse outcomes." Sixty-nine percent reported being forced to give patients a less-effective drug, which in the case of cancer, can result in early deaths or in some cases, the inability to be cured. One of the cancer drugs that has been discontinued completely, Bleomycin, cured my cancer and I am here 22 years later seeking your support to help others live productive lives again as I have been so fortunate to do. I am certain you can identify with my sentiments having had your own cancer journey.
There are many reasons for the shortages, including manufacturing problems, distribution disruptions, difficulties obtaining raw materials, regulation issues and even natural disasters. But those tend to be temporary. Longer-lasting shortages are related to drug manufacturer’s business decisions to discontinue or cut back production, consolidation of manufacturers, particularly generic manufacturers, and current Medicare regulation and reimbursement (Part D)-see the NYT article in the link at the bottom of the letter.
The generic drug manufacturer is a low margin business and with many of the highly marketable compounds having come off patent over the past several years, their focus has turned to quickly doing bioequivalence studies (e.g. clinical trial studies) so as to manufacture more high demand drugs. Moreover, with some of the top-selling block buster drugs coming off patent (e.g. Lipitor, Xalatan, Protonix), this situation will only get worse as generic makers will continue to scramble to produce these high sellers so as to increase their revenues and margins, thus pushing more life-saving drugs out of their production plans. It begs the question of making the generic cancer drugs and some other life-saving drugs more profitable for generic manufacturers.
As you probably well know, Sen. Amy Klobuchar (D-Minn.) has proposed legislation intended as a first step in remedying this situation. Rep. Diana DeGette (D-Colo.) has been a congressional leader on the issue, introducing a bill in June that would require drug companies to notify the FDA of impending shortages. The bill, introduced with Rep. Tom Rooney (R-Fla.), is a companion to a Senate proposal from Sen. Amy Klobuchar (D-Minn.). Both of these proposals are to be commended as great first steps. However, we need more to stop this tragedy from unfolding and making our wonderful nation look like a third world country.
For these reasons, I am respectfully requesting your support in crafting some additional legislation to combat this issue. The solutions need to be a balanced approach: protecting patients and allowing companies to achieve profitability, especially generic manufacturers of medically necessary and life-saving medications. Perhaps some of the following solutions could be taken under consideration: 1) creating a financial incentive such as a tax credit to manufacturers that produce life-saving drugs, 2) building statewide stockpiles of necessary and life-saving drugs 3) expediting the approval for raw material suppliers that can step in when needed, 4) removing regulatory barriers and expediting approval of changes to manufacturing lines and 5) tax incentives and breaks for the construction of new facilities and generic manufacturers. 6) incentives to manufacturers for training and educating the workforce that is needed for the industry’s future. 7) minimally increasing some of the prices for generic life-saving drugs.
I have listed the enclosure link of the New York Times article for your perusal below. Thank you in advance for consideration of this request.
