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ACS CAN statement on appointment of Ned Sharpless, MD, as acting FDA commissioner

Sharpless will be replaced in his current role as NCI director by Doug Lowy, MD

The White House has announced its intention to appoint Ned Sharpless, MD (pictured here), current director of the National Cancer Institute (NCI), as acting commissioner of the Food and Drug Administration (FDA). Doug Lowy, MD, current deputy director at NCI, will take over as acting director.

Following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN):  

“Dr. Sharpless has demonstrated extraordinary leadership at NCI and has been a strong ally in the fight against cancer. While his vision and direct engagement with the cancer community will be sorely missed at NCI, Dr. Sharpless is well-positioned to lead the FDA forward along with Secretary Azar.

“With his exceptional perspective and experience in cancer research, Dr. Sharpless will be able to continue FDA’s work prioritizing the review and approval of innovative therapies that have the potential to cure diseases like cancer. It will also be vital that Dr. Sharpless advance and implement policies previously endorsed by outgoing-Commissioner Gottlieb aimed at curtailing the soaring rates of youth tobacco use, especially e-cigarettes.

“We are also pleased to hear about the appointment of Dr. Doug Lowy as acting director of NCI. Dr. Lowy has been a longtime champion of cancer issues as he returns to head the institute once again.

 “ACS CAN looks forward to working with both Dr. Sharpless and Dr. Lowy in their new roles.”


  • ACS CAN: FDA needs to take stronger steps to address youth e-cigarette epidemic

    The U.S. Food and Drug Administration (FDA) issued draft guidance this morning outlining steps it will take to address the public health crisis that has resulted from surging rates of youth use of tobacco products, a trend being largely driven by access to and use of flavored e-cigarettes. 

    While the draft guidance does include some restrictions on the sale of flavored e-cigarettes, a major contributing factor to the popularity of the products among youth, it falls far short of the agency's statutory obligations under the Family Smoking Prevention and Tobacco Control Act of 2009.

    The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN):

    "While we appreciate Commissioner Gottlieb and the administration's recent efforts to shine a light on the public health epidemic that is resulting from youth use of tobacco products, the guidance released by FDA today falls far short of adequately addressing this crisis. Only a full prohibition on all flavored tobacco products will help prevent new, young consumers from initiating use.

    "It is disappointing that FDA continues to stop short of fulfilling its full statutory obligations, instead relying on industry self-improvement to address the very problem the industry has created. In short, the plan unveiled today will not do nearly enough to improve the health of our nation by keeping kids off tobacco products.

    "No tobacco product defined as "new" by the Tobacco Control Act should be on the market without a premarket review order from the FDA. Yet, the vast majority of e-cigarettes that are driving the explosion of tobacco use among youth have not undergone a premarket review. It's for this reason ACS CAN and our public health partners have filed suit in federal court to compel FDA to exercise its statutory mandate and regulatory authority over all tobacco products.

    "We once again are calling on FDA to implement proposals that will reverse the alarming trend of youth use of e-cigarettes and other tobacco products by prohibiting all flavors and exercising its full authority over all tobacco products. FDA must also stop relying on the tobacco industry to self-improve when their very products and actions are designed to addict a new generation of consumers to their deadly and addictive products."

  • ACS CAN: Administration budget risks reversing progress against cancer

    Medicare prescription drug proposals and e-cigarette user fee welcome changes

    The administration released its FY20 budget today including a $4.7 billion cut for medical research at the National Institutes of Health (NIH), including a nearly $900 million cut for the National Cancer Institute (NCI). The budget also reduces funding by $34.5 million for important cancer screening and prevention programs at the Centers for Disease Control and Prevention (CDC), and transforms Medicaid funding into a block grant structure.

    Also included is a $50 million increase to childhood cancer research funding, a cap on out-of-pocket prescription drug costs in Medicare Part D, elimination of cost-sharing for generic drugs for some low-income Medicare beneficiaries, and a user fee to help fund the Food and Drug Administration's (FDA) regulatory work around electronic cigarettes.

    A statement from Lisa Lacasse (pictured here), president of the American Cancer Society Cancer Action Network (ACS CAN, follows:

    Research

    "If passed, the proposed cut to NIH and NCI funding would squander years of renewed momentum and progress in advancing discovery in cancer and other chronic diseases.

    "These investments have long enjoyed strong bipartisan support and have led to incredible understanding in how to detect, diagnose, and treat cancer that still claims the lives of more than 600,000 Americans each year.

    "The additional $50 million dedicated to childhood cancer research, while welcome, will not be as effective as possible if overall research funding is significantly reduced. Childhood cancer research is intertwined with all of cancer research and cuts to NIH and NCI funding will consequently have deleterious effects on such research regardless of age.

    Prevention

    "We are deeply troubled by the proposed cuts and elimination of proven cancer prevention, screening, and early detection programs at the Centers for Disease Control and Prevention (CDC). The proposed block granting of all chronic disease funding could essentially eliminate federal tobacco prevention and control programs. Tobacco use remains the number one cause of preventable premature death in the U.S.

    "The inclusion of a new e-cigarette manufacturer user fee to help fund FDA regulation of the electronic cigarette industry is a welcome acknowledgement of the epidemic in youth e-cigarette use. However, FDA's urgent regulatory work to address this crisis should not be dependent on the assessment of this fee.

    Access to Care

    "Capping out-of-pocket prescription costs for seniors on Medicare Part D and allowing some low-income enrollees to be spared cost-sharing on generic drugs would be welcome changes and could help enrollees better afford their care.

    "However, transforming Medicaid funding into a block grant would likely leave millions of Americans unable to access critical health services. Medicaid serves as an essential safety-net for more than 2.3 million Americans with a history of cancer, including one-third of all pediatric cancer patients at the point of diagnosis.

    "Budget realities require setting priorities. Federal funding for medical research and access to preventive and curative medical care is essential to ensuring our country can lead, innovate, and save the most lives from cancer as possible. On behalf of the more than 1.7 million Americans expected to be diagnosed with cancer this year, we urge Congress to reject these cuts, raise the impending budget caps, and ensure cancer research and access to health care remains among our nation's the top priorities." 

  • New legislation would halt surprise bills for people with Medicare coverage

    Bipartisan legislation introduced today (March 6) in the U.S. Senate and House of Representatives would ensure that surprise out-of-pocket expenses are not a barrier to lifesaving colorectal cancer screenings for seniors on Medicare. 

    March is Colorectal Cancer Awareness Month and American Cancer Society Cancer Action Network (ACS CAN) volunteers are urging lawmakers to support and pass the Removing Barriers to Colorectal Cancer Screening Act, authored by Representatives Donald Payne (D-NJ.), Rodney Davis (R-Ill.), Donald McEachin (D-Va.), and David McKinley (R-W.Va.); and Senators Sherrod Brown (D-Ohio), Roger Wicker (R-Miss.), Ben Cardin (D-Md.), and Susan Collins (R-Maine).

    The bill calls for eliminating cost sharing for seniors on Medicare who are hit with a surprise bill during a routine screening colonoscopy, when a polyp is discovered and removed during the procedure. Currently, Medicare covers the full cost of routine screening colonoscopies. However, if a polyp is found and removed during a screening colonoscopy, patients wake up to a pricey cost-sharing payment of up to $350. Learning about the possibility of an unexpected expense can deter people from getting screened for this type of cancer, which is highly preventable.

    The following is a statement from Lisa Lacasse, president of ACS CAN:

    “Colorectal cancer can be prevented with regularly-scheduled screenings. Unfortunately, too many seniors on Medicare are forced to forego this simple procedure because of cost. Congress has the opportunity to help reduce the burden and suffering of colorectal cancer on senior citizens by removing financial barriers to screenings.

    “The Removing Barriers to Colorectal Cancer Screening Act would help ensure that everyone has access to lifesaving cancer screenings, regardless of their ability to pay. ACS CAN is calling on Congress to advance this legislation with broad bipartisan support as we work to close this Medicare coverage loophole and increase screening rates, a proven way to reduce colorectal cancer.”




  • ACS CAN reacts to resignation of FDA Commissioner Scott Gottlieb

    The former venture capitalist and Hodgkin's lymphoma survivor says he is leaving his post after less than two years to spend more time with his wife and three daughters in CT

    The following is a statement from Lisa Lacasse, president of the American Cancer Society Cancer Action Network (ACS CAN), responding to the news that Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, 46, will be stepping down from his position in one month:

    “As head of the FDA, Commissioner Gottlieb successfully elevated the burden of tobacco use, particularly among youth, as an urgent issue of national importance with deadly consequences. On behalf of those impacted by cancer, we appreciate Commissioner Gottlieb’s intent to lower nicotine levels and prohibit menthol flavoring in cigarettes, along with a commitment to restrict the sale of other flavored tobacco products, including cigars and e-cigarettes. If fully implemented, those key measures would significantly improve the health of our nation and reduce cancer death. These proposals must move forward despite the commissioner’s departure.

    “At a time when youth use of tobacco products has been labeled as an epidemic by leaders in the public health community, Commissioner Gottlieb’s successor must rise above any political pressures and do what is best for the health our nation and our children as we continue to work to end the scourge of tobacco use in this country."

    Read The Washington Post story about Commissioner Gottlieb's resignation.




  • ACS CAN: Proposed health plan rule changes could increase patient costs

    On Feb. 19,  the American Cancer Society Cancer Action Network (ACS CAN) submitted comments to the Department of Health and Human Services (HHS) on the Notice of Benefit and Payment Parameters, which would set the rules for health care plans in 2020.

    The proposed rule includes several changes which would leave patients paying more for health coverage, including a formula change that would reduce the amount of subsidies available to those who purchase plans on the exchange – and therefore would increase monthly premiums for many – and increase the annual maximum out of pocket costs for people enrolled in exchange and employer-sponsored plans.

    The rule would also make numerous changes to requirements for prescription drug coverage, some of which could make it easier for plans to discriminate against people with serious health conditions like cancer or make it prohibitively expensive for such patients to enroll in coverage.

    A statement from ACS CAN President Lisa Lacasse, follows:

    "We have serious concerns that these changes, if they are implemented, would result in fewer people being able to afford comprehensive health care coverage and more people becoming uninsured.

    "Cancer patients and survivors depend on access to quality health care that covers the things they need at a cost they can afford. The changes being proposed in this rule threaten to make that care more expensive and potentially more difficult to obtain.

    "We urge the administration to reject these changes and work with stakeholders to make comprehensive health coverage more affordable and available without shifting more costs onto patients."

    Read the full comments on the 2020 Notice of Benefit and Payment Parameters.

  • President calls for a $500 million investment in childhood cancer research

    10-year-old brain cancer survivor from New Jersey gets standing ovation at State of the Union

    In his State of the Union Tuesday night, President Trump vowed to act to bring drug prices down, protect people with pre-existing conditions, make insurance and hospital costs more transparent, eliminate HIV in the U.S. within the next 10 years, and invest $500 million in childhood cancer research over the next decade.

    "Together we will defeat AIDS in America and beyond. Tonight I am also asking you to join me in another fight that all Americans can get behind, the fight against childhood cancer," he said.

    "Joining Melania in the gallery this evening is a very brave 10-year-old girl, Grace Eline [applause erupted]. . . Every birthday since she was four, Grace asked her friends to donate to St. Jude's Children's Hospital. She did not know that one day she might be a patient herself. That's what happened. Last year, Grace was diagnosed with brain cancer. Immediately she began radiation treatment. At the same time, she rallied her community and raised more than $40,000 for the fight against cancer.  [more applause] When Grace completed treatment last fall, her doctors and nurses cheered, they loved her, they still love her,  with tears in their eyes, as she hung up a poster that read, "Last day of chemo." [more applause]

    "Many childhood cancers have not seen new therapies in decades. My budget will call for a $500 million in the next 10 years to support this lifesaving research," the President said.

    In regards to pre-existing conditions and drug prices, the President said a "major priority for me and for all of us should be to lower the cost of health care and prescription drugs and to protect patients with pre-existing conditions.  .  . It's unacceptable that Americans pay vastly more than people in other countries for the exact same drugs, often made in the exact same place. This is wrong, this is unfair, and together we will stop it, and we'll stop it fast."

    Here is a response from ACS CAN President Lisa Lacasse:

    "ACS CAN commends the administration for continuing to elevate the important issue of childhood cancer research. Cancer remains the leading disease-related cause of death among U.S. children.

    "Federally-funded cancer research is the engine that drives ongoing progress in the fight against pediatric cancers. Passage of the STAR Act this past June with overwhelming bipartisan support reflects the priority lawmakers place on addressing a disease that affects some of the most vulnerable in our nation. ACS CAN calls on Congress and the administration to fully fund the STAR Act in the FY20 budget and ensure childhood cancer research remains a national priority."


  • ACS CAN: Strengthening nation's health care system should be a priority in State of the Union address

    ACS CAN Maryland volunteer an invited guest; illustrates need to maintain and strengthen ACA patient protections

    Cancer patients, survivors, and caregivers will tune into the president's State of the Union address, watching to see if the president will commit to strengthening the nation's health care system by preserving access to comprehensive and affordable health care coverage, support life-saving medical research through increased federal research funding, and improve patient quality of life with increased access to palliative care.

    ACS CAN Maryland State Lead Ambassador Jacqueline Beale (pictured above), a 17-year breast cancer survivor, has been invited to attend the State of the Union by House Majority Leader Steny Hoyer to highlight the importance of patient protections in the health care law for those with a history of cancer.

    Jacqueline has been fortunate that her employer-sponsored health insurance has covered her treatment and necessary follow-up. But like millions of cancer patients and survivors, she is extremely concerned that elimination of those protections could reintroduce discrimination that would make health care unaffordable or completely out of reach. 

    A statement from American Cancer Society Cancer Action Network (ACS CAN) President Lisa Lacasse follows:

    "Tonight the president has an opportunity to commit to improving the lives of the 16 million American cancer survivors and the nearly 1.8 million Americans who will be diagnosed with the disease this year.

    "Patients like Jacqueline Beale rely on access to affordable, comprehensive health care coverage in order to diagnose, treat and survive their disease. Preserving patient protections under current law and stabilizing the health insurance markets should be a top priority. This can and should include measures that reduce patients' out-of-pocket drug costs without jeopardizing their access to innovative new therapies.

    "Developing those new therapies requires ongoing, robust federal funding for life-saving medical research through the National Institutes of Health (NIH) and National Cancer Institute (NCI). Consistent year-over-year funding increases are essential to continuing our nation's progress reducing cancer incidence and deaths through improved diagnostic tests, treatments and therapies. 

    "Finally, it is important to take into account the entire patient experience from diagnosis through survivorship. This should include expanded access to palliative care. Palliative care is a holistic approach that can greatly improve a patient's quality of life and can be offered alongside curative treatment. The Palliative Care and Hospice Education and Training Act (PCHETA) currently before Congress would help train more professionals and educate the public about the need for and benefits of this coordinated care for the millions of Americans with serious illness.

    "Health care is among the most pressing issue facing our nation and on behalf of cancer patients, survivors and their loved ones we urge the president to make fighting this disease a top national priority. ACS CAN stands ready to work with the president and members of Congress on both sides of the aisle to make cancer-fighting policy and legislation at the top of their agenda." 




  • ACS CAN expert testifies about need to preserve pre-existing condition protections in health care law

    Preserving critical protections for cancer patients, survivors, and all those with pre-existing medical conditions will be the focus of a House Ways and Means Committee hearing today, Jan. 29. Committee members will hear testimony from Keysha Brooks-Coley, vice president for federal advocacy at the American Cancer Society Cancer Action Network (ACS CAN), along with that of other health policy experts and patients.

    Keysha will share with the committee how the patient protections included in the Affordable Care Act (ACA) have improved cancer patients and survivors' ability to access comprehensive health care and how recent regulatory changes, including the expansion of short-term plans, threaten to erode those protections.

    "Expansion of these short-term plans does not help consumers, it puts them at increased risk," she says. "Unfortunately, there is a real possibility that many people – attracted by lower premiums – could find themselves with seriously inadequate coverage and greater out of pocket costs under these short-term plans. And with younger, healthier consumers being siphoned off, the insurance market will be destabilized leaving those who need comprehensive coverage with plans that are expensive or out of reach. We urge Congress to enact legislation to limit or prohibit the availability of these products."

    Read Brooks-Coley's full testimony to the committee.

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