Please note the important advocacy news items below that are of high priority to the cutaneous lymphoma community.  We encourage you to learn more about these issues and how, together, we can affect positive change and grow support for the issues that are most important to people affected by cutaneous lymphoma.

Help FDA Help Patients Have A Bigger Voice: The New Patient Network Website

Want your voice heard concerning the FDA's regulation of medical products? Visit the FDA's new Patient Network website!

With their new website, the FDA welcomes the unique perspective of patients, family members, caregivers and patient advocates directly affected by serious disease, to the Agency’s decision-making processes. Get involved....your voice counts!

Advocacy - Why Are You Asked To Take Action So Many Times?

Ever wonder why you may be asked to frequently contact your congressional representative on the same bill? Truth is, Congress can vote on a bill five times before it becomes law. Why five times? And, why is it so important for you to act each time? Watch the American Cancer Society 90-second video to explain it all.

Rare Disease Day 2013 - February 28, 2013

The Cutaneous Lymphoma Foundation will be joining the National Organization for Rare Disorders (NORD) and others around the world in observing World Rare Disease Day on February 28, 2013.  On this day, millions of patients and their families will share their stories to focus a spotlight on rare diseases as an important global public health concern.

A rare disease is one that affects fewer than 200,000 Americans.  There are nearly 7,000 such diseases affecting nearly 30 million Americans. On Rare Disease Day, people with rare diseases around the world promote awareness of the challenges of living with a rare disease.  The global theme for 2013 is “Rare Disorders Without Borders.” 

World Rare Disease Day was launched in Europe four years ago and last year was observed in more than 60 nations.  It is always observed on the last day of February.  On that day, patients and patient organizations will post stories, videos and blogs online and host events to raise awareness of these diseases, which are often called “orphans”.

This year, the observance has special significance in the U.S. because 1983 is also the 30^th anniversary of the Orphan Drug Act, which provides incentives to encourage companies to develop treatments for rare diseases, and of NORD, which was established by patient advocates in 1983.

Rare Disease Day 2013 activities in the U.S. will include awareness events at several State Houses, a Rare Disease Research Hall of Fame, a Handprints Across America photo gallery, and an event at the National Institutes of Health (NIH) in Bethesda, MD. 

In 1983, the Orphan Drug Act was passed by Congress to create financial incentives for companies to develop treatments for rare diseases.  Since then, more than 400 orphan drugs and biologics have been approved by the Food and Drug Administration (FDA).  It is estimated that approximately 15 million Americans benefit from these products, but that still leaves millions more with diseases for which there is no approved treatment.

For more information about Rare Disease Day activities in the U.S., go to www.rarediseaseday.us.  For information about global activities, go to www.rarediseaseday.org).

Update from REAP Meeting - Politics and Policy in Health Care Reform

The semi-annual meeting of the Regulatory Education and Action for Patients consortium was held in Washington, DC on January 17, 2013.   The topics discussed focused on the current political landscape post-election and looking forward over the next two years along with the future of healthcare reform, improper payments in federal safety net programs (Medicare/Medicaid), an update on the patient focused drug development program in progress at the FDA and an update from the REAP workgroups.

Click here to read a recap of the January meeting highlights.

The REAP consortium currently has 53 member organizations across a wide variety of patient advocate groups, all coming together for a common cause - to promote the voice of patients to policy makers and regulators.  This consortium began in 2010 with a few organizations and authored one collaborative comment letter to lawmakers, was signed by 6 organizations.  By the end of 2012, the consortium had submitted 10 comment letters total, and the last comment letter was signed by 32 groups, including the CLF, who was also a member of the workgroup that developed the response.  The comment letter outlined several detailed recommendations for clarity and transparency surrounding the proposed rule published by the Department of Health and Human Services (HHS) that helps consumers shop for and compare non-grandfathered private health insurance options in the individual and small group markets by promoting consistency across plans and protecting consumers by ensuring that plans cover a core package of items and services.  Otherwise referred to as Essential Health Benefits. 

Regulatory Education and Action for Patients (REAP) - Comments on Proposed EHB Rule

The REAP collaborative work group has developed a document in response to the proposed rule entitled "Patient Protection and Affordable Care Act; Standard Related to Essential Health Benefits, Actuarial Value and Accreditation" to be distributed to state and federal stakeholders responsible for determining essential health benefit policies. The completed letter provides a collective patient voice outlining nine principles in four general areas (transparency, clarity, access and evolution) that REAP believes the Essential Health Benefits must address in order to meet patient needs. To download a copy of the letter, click here.

To read the proposed rules that the letter addresses visit the links below:

Essential Health Benefits: http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/pdf/2012-28362.pdf

Health Insurance Market: http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/pdf/2012-28428.pdf

Wellness Program: http://www.gpo.gov/fdsys/pkg/FR-2012-11-26/pdf/2012-28361.pdf

Join the Cutaneous Lymphoma Foundation in Supporting Accelerated Drug Approvals Through TREAT and FAST

Proposed legislation has been introduced recently in the Senate and House of Representatives to modernize and expand the Accelerated Approval pathway of the Food and Drug Administration (FDA). The bills are Transforming the Regulatory Environment to Accelerate Access to Treatments (TREAT) in the Senate and Faster Access to Specialized Treatments (FAST) in the House.

The Cutaneous Lymphoma Foundation believes that TREAT and FAST would speed the development of treatments for rare diseases such as cutaneous lymphoma while still maintaining standards for safety and efficacy.  

To learn more, click here to access the National Organization for Rare Disorders' policy statement on TREAT and FAST.

Click here for a pre-drafted letter to send to your Senators.

Click here for a pre-drafted letter to send to your House representatives.

Click here to access a “Find Your Legislator” resource on our website with links to the legislators’ online contact forms, providing you an easy way to copy/paste your letters into their forms and send it right away.

Act Now:  Urge Your Senators To Support Increased Funding For NIH

Your immediate help is needed to secure support for medical research funding! Sens. Bob Casey (D-PA) and Richard Burr (R-NC) are circulating a “Dear Colleague” letter seeking a sustained, strong commitment to funding the National Institutes of Health (NIH), the nation’s largest funder of cancer research, in FY 2013.

Your help is needed now! The deadline for senators to sign the letter in support of maintaining a commitment to fund the NIH is Monday, March 26, 2012 and many members will not sign these types of letters unless asked to by their constituents.

Click here for a pre-drafted letter urging your senators to sign the Casey/Burr “Dear Colleague” letter today.  

Click here to access a “Find Your Legislator” resource on our website with links to the legislators’ online contact forms, providing you an easy way to copy/paste the letter into that form and send it right away.

NIH Establishes National Center for Advancing Translational Sciences 

In a move to re-engineer the process of translating scientific discoveries into new drugs, diagnostics, and devices, the National Institutes of Health has established the National Center for Advancing Translational Sciences (NCATS). The action was made possible by Congress’ approval of a fiscal year 2012 spending bill and the president’s signing of the bill, which includes the establishment of NCATS with a budget of $575 million.

NCATS will serve as the nation’s hub for catalyzing innovations in translational science. Working closely with partners in the regulatory, academic, nonprofit, and private sectors, NCATS will strive to identify and overcome hurdles that slow the development of effective treatments and cures.

To learn more about the impetus and development of NCATS, go to:

• NCATS web page: http://www.nih.gov/about/director/ncats/index.htm

• NCATS on the Feedback NIH website: http://feedback.nih.gov/index.php/category/ncats/

Act Now:  President Obama Issues Executive Order to Address Drug Shortages

On Monday, Oct. 31, 2011, President Barack Obama issued an Executive Order addressing drug shortages, which have plagued patients for much of the last year. The Executive Order would do three things: 1) expand reporting of certain shortages, 2) speed review of applications to alter or begin production of drugs in short supply, and 3) provide more information to the Justice Department about possible price gouging.

The Executive Order on Reducing Prescription Drug Shortages is available on the White House website here: 

http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortages

Additionally, the U.S. Food and Drug Administration (FDA) has provided materials describing the FDA's actions on this issue on the agency’s website, which are available here: 

http://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm

The Cutaneous Lymphoma Foundation has been aware of the cancer drug shortages and has been encouraging action from our stakeholders to promote efforts to remedy the situation.  Legislation to help address drug shortages has been introduced in the House and Senate but has not moved to the floor for consideration since its introduction earlier this year. It is the Foundation’s hope that the Administration’s efforts will put pressure on Congress to take action on that pending legislation.

Cutaneous Lymphoma Foundation advocates can also help by contacting their members of Congress to urge their support of the Preserving Access to Life-Saving Medications Act now.  Please call the Senate switchboard at (202) 224-3121 and ask for your senator by name to urge them to support the Preserving Access to Life-Saving Medications Act or write to your Senator using a pre-drafted letter that you can download here.

Act Now - Help Preserve Access to Life-Saving Medications

Patients battling cancer like cutaneous lymphoma and other chronic diseases are increasingly facing yet another obstacle in the fight against their disease – drug shortages. A shortage of a drug used primarily to treat leukemia and lymphoma, cytarabine, has called national media attention to this problem garnering articles in the Wall Street Journal, Bloomberg News and an opinion piece in the Washington Post.

To address this issue, Sens. Amy Klobuchar (D-MN) and Robert Casey, Jr. (D-PA) have introduced the Preserving Access to Life-Saving Medications Act (S.296). The bill provides the Food and Drug Administration (FDA) with a warning system in the form of a notification of a discontinuation or prolonged interruption of a medication’s production. The advanced warning system will aid the FDA in better dealing with impending prescription drug shortages.

For patients fighting cancer and other chronic diseases, access to the proper medication is truly a life and death matter. Please call the Senate switchboard at (202) 224-3121 and ask for your senator by name to urge them to support the Preserving Access to Life-Saving Medications Act or write to your Senator using a pre-drafted letter that you can download here.

Act Now - Help Preserve Access to Save Medical Research Funding

Your help is needed to save funding for medical research. Funding for the Department of Defense’s (DoD) medical research programs is under attack as the funding is being deemed by some as “non-defense-related medical research.” Currently, a portion of that funding is used to conduct blood cancer research projects. For those members of our military who contracted a blood cancer due to their service of our country, this medical research is certainly defense-related.

For example, the Institute of Medicine and the U.S. Department of Veterans Affairs have determined that exposure to chemical and biological agents during World War II, Vietnam and the two Gulf Wars are associated with blood cancers. This makes the DoD a logical home for a blood cancer research program.

In order to protect this research funding and support our military personnel and veterans who have contracted blood cancers, we need you to contact your senators today! Please call the Senate switchboard at (202) 224-3121 and ask for your senator by name or write to your Senator using a pre-drafted letter that you can download here.