In the interests of cancer patients and oncologists nationwide, the Lorenzen Cancer Foundation (LCF), a non-profit dedicated to fighting pancreatic cancer, has joined the public interest law firm Washington Legal Foundation (WLF) and others today in presenting a written comments statement to the U.S. Centers for Medicare and Medicaid Services (CMS) voicing support for the Section 641 demonstration project and expressing concerns regarding CMS's proposed restrictions limiting coverage of the drug benefit to exclude off-label uses of FDA-approved drug or biological therapies.

Monterey, CA July 7, 2004 -- In the interests of cancer patients and oncologists nationwide, the Lorenzen Cancer Foundation (LCF), a non-profit dedicated to fighting pancreatic cancer, has joined the public interest law firm Washington Legal Foundation (WLF) and others today in presenting a written comments statement to the U.S. Centers for Medicare and Medicaid Services (CMS) voicing support for the Section 641 demonstration project and expressing concerns regarding CMS's proposed restrictions limiting coverage of the drug benefit to exclude off-label uses of FDA-approved drug or biological therapies.

Once the Food and Drug Administration approves a drug for marketing, physicians may prescribe the drug for purposes other than those that the FDA has given specific indication. Off-label prescribing is common in cancer treatment as drugs often work well for many types of cancer. A General Accounting Office analysis in 1991 demonstrated that over half of cancer patients received at least one off-label medicine in the course of their care.

In enacting Section 641 of the Medicare Prescription Drug and Modernization Act of 2003, Congress did not exclude off-label uses from the demonstration project related to Section 641. To the contrary, Section 641(a) directs that the project be conducted following the standards of the part D benefit program which does not exclude off-label use.

Recently announced proposed eligibility criteria by the CMS effectively exclude the coverage of off-label use of FDA-approved agents for cancer therapy and in other serious diseases.

Today's statement urges CMS officials to reverse this position and to make clear to the public and to medical providers that Medicare will reimburse for off-label use for medications and biological therapies in the demonstration project related to Section 641. And further, to make clear that any proposed or actual restriction on off-label use in the demonstration project is not a precedent for full enactment of the part D prescription drug benefit program.

Pancreatic Cancer Facts:

? Pancreatic cancer is the most virulent of the major cancers

? Pancreatic cancer research is the least funded of the major cancers

? Pancreatic cancer causes more than 1% of all death in the U.S.

? Pancreatic cancer is the fourth most common cause of cancer mortality

The Lorenzen Cancer Foundation is a 501(c) (3) non-profit organization dedicated to the fight against pancreatic cancer. LCF is oriented to increasing awareness and education about pancreatic cancer, helping physicians and patients create optimal treatment strategies, and fostering the development of a molecular or genetic marker to aid in diagnosis.