"Right to Try" becomes law

President Trump signed into law legislation dubbed "Right to Try" on May 30  allowing terminally ill patients access to experimental medical treatments not yet approved by the Food and Drug Administration (FDA). 

Here is a link to an article in The Hill and it is included here (Author: BY JESSIE HELLMANN, The Hill).

Dubbed "right to try," the law's passage was a major priority of Trump and Vice President Pence, as well as congressional Republicans.

"Thousands of terminally ill Americans will finally have hope, and the fighting chance, and I think it's going to better than a chance, that they will be cured, they will be helped, and be able to be with their families for a long time, or maybe just for a longer time," Trump said at a bill signing ceremony at the White House, surrounded by terminally ill patients and their families. 

Trump thanked lawmakers sitting in the audience who sponsored the bill, including Sen. Joe Donnelly, a vulnerable Democrat up for reelection in Indiana.

Despite calling Donnelly a "really incredible swamp person" earlier this month, Trump thanked the senator for his work on the bill. 

Sen. Joe Manchin (W.Va.), another vulnerable Democrat up for reelection, was the only other Democratic co-sponsor on the bill, but did not attend the ceremony because he is in West Virginia this week, his office said. 

Congress is on recess this week for Memorial Day. 

Most Democrats and public health groups oppose the bill, arguing that it could put patients in danger. 

“FDA oversight of access to experimental treatments exists for a reason — it protects patients from potential snake oil salesmen or from experimental treatments that might do more harm than good,” said Rep. Frank Pallone Jr. (D-N.J.), ranking member of the House Energy and Commerce Committee.  

Opponents also argue it gives “false hope” to patients, since drugmakers aren’t required to give unapproved medicines to patients who ask for them. 

Supporters say, however, it will provide new treatment opportunities for terminally ill patients who have exhausted existing options. 

"While a long time coming, today is a monumental win for patients desperately seeking the ‘right to try’ investigational treatments and therapies," said Energy and Commerce Committee Chariman Greg Walden (R-Ore.) and health subcommittee chairman Michael Burgess(R-Texas). 

“With ‘right to try’ being the law of the land, we are confident that the Trump Administration, and FDA Commissioner [Scott] Gottlieb, will take both congressional intent and the safety of patients into consideration when implementing this important law.” 

One Voice Against Cancer (OVAC) Impact

OVAC Lobby Day on Tuesday, May 15th  had 100 cancer patients, survivors, caregivers, physicians and researchers representing 31 states on Capitol Hill pushing federal legislators to support a robust and sustained federal investment in cancer research and prevention programs.

OVAC released a poll showing that nearly 92 percent of voters say federal medical research funding, including for cancer, is “extremely” or “very” important. Seventy-three percent say they support Congress’ decision to increase NIH funding by $3 billion in the FY 2018 omnibus bill and nearly 70 percent say they favor continued significant budget increases for NIH. Additionally, 68 percent of all voters—including 47 percent of Republican voters—oppose significant NIH budget cuts proposed by the president and 60 percent of respondents say Congress should continue to increase investments in medical research even in light of increasing national debt.

And, 87 percent of voters say federal funding for state and local cancer prevention programs through the Centers for Disease Control and Prevention (CDC) is “extremely” or “very” important and 60 percent think CDC funding should be increased. 

Appropriations Process/FDA’s Oncology Center of Excellence

This week both the House and Senate Appropriations Committees approved their FY2019 - 302 (b) allocations for each of their 12 Appropriations Subcommittees.  This is the total amount of discretionary dollars given to each committee for their individual spending bills.  The Senate Appropriations Committee provides the Labor-HHS subcommittee with $2 billion above the FY2018 allocation while the House Appropriations Committee provides Labor-HHS with level funds for FY2019 when compared with the FY2018 level.  These spending levels mean that we will need to continue to make our case that funding for cancer research & prevention programs need to remain a top Congressional priority going forward.  


Although we are still waiting for movement in the House and/or Senate to move on the Labor HHS Appropriations bill, both sides have been very busy working on their Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations bill.  Both the House bill completed in Committee last week and the Senate bill completed in full Committee today include a $5 million increase for the OCE (Oncology Center of Excellence) for a total of $20 million.  (Source: OVAC, May 2018)

Advocating for Increases in NIH/Natl Cancer Institute (NCI) Funding

Here are a few shots from visits to the NIH and Capitol Hill to request an increase in research funding for the National Cancer Institute at the National Institutes of Health. 

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Here is an excerpt from the AUA Advocacy Snapshot - Week of April 30, 2018

AUA Advocacy Snapshot: Week of April 30, 2018

By Policy and Advocacy Brief posted yesterday

This week’s update includes information on the AUA’s advocacy for graduate medical education funding as well as funding for cancer research and prevention. 

AUA Summit: Follow-up Hill Meetings

As part of the AUA’s continued efforts to remain engaged with the offices that AUA members met with during the Annual Urology Advocacy Summit, the AUA had multiple follow-up meetings to provide more specific details and answer staff questions on the issues discussed during the AUA Summit Hill meetings. On April 25-27, the AUA met with staff in the offices of Senators Rob Portman (R-OH), Bill Cassidy, MD (R-LA), Richard Burr (R-NC), Michael Bennet (D-CO), Johnny Isakson (R-GA), Orrin Hatch (R-UT), John Cornyn (R-TX), Pat Roberts (R-KS) and Debbie Stabenow (D-MI), as well as Representatives Brian Higgins (D-NY-26), David Schweikert (R-AZ-6), and Sandy Levin (D-MI-9). We will continue bridging congressional offices with Advocacy Summit attendees and look for opportunities to collaborate during the remainder of the year.

Patient and Research Advocacy: Cancer Research Funding Meetings on Capitol Hill

On April 25, in collaboration with the One Voice Against Cancer (OVAC) coalition, the AUA participated in meetings with staff from the House and Senate Labor, Health and Human Services (HHS), and Education Appropriations Subcommittee, as well as with staff in the offices of Senators Shelley Moore Capito (R-WV) and Brian Schatz (D-HI). The meetings focused on urging Congress to make funding for cancer research and prevention a top priority in fiscal year (FY) 2019. OVAC also shared a letter with Congressional staff to emphasize the need for increased, predictable and sustained federal investment and outlines OVAC’s cancer research appropriations for FY 2019. OVAC recommends a $39.3 billion budget for the National Institutes of Health, including funding provided through the 21st Century Cures Act, $6.375 billion for the National Cancer Institute, and $514 million for Centers for Disease Control and Prevention that includes $35 million for a prostate cancer awareness campaign. Further meetings with offices on the Appropriations Committee are scheduled for May 14-15 during OVAC’s Legislative Day of Action.

Additionally, the AUA supported the Friends of National Institute of Diabetes and Digestive and Kidney Diseases (FoNIDDK) initiative to support the NIDDK in receiving $2.165 billion in FY 2019. This funding will ensure that the vital benign urologic research activities taking place at the NIDDK sustained.

Finally, in collaboration with our patient advocacy partner, Kidney Cancer Action Network, on April 25, the AUA met with the office of Representative Nita Lowey (D-NY-18), Ranking Member of the full House Appropriations Committee. The meeting focused on thanking the Congresswoman for her efforts in securing a $15 million line item for the Kidney Cancer Research Program as part of the Department of Defense’s Congressionally Directed Medical Research Programs for fiscal year 2018. This $5 million increase from the previous year was the largest increase ever in the federal budget for kidney cancer research, and urged Rep. Lowey’s ongoing support for this critical program in FY 2019 and beyond.

Politico on the mysterious 302(b)'s

HAC (House Appropriations Committee) and SAC (Senate Appropriations Committee) coordinate FY 19 302(b)s

Politico reported that the HAC and SAC Chairmen are working to coordinate their FY 19 302(b)s.   
We have also heard that SAC Chairman Richard Shelby is working with Vice Chairman Patrick Leahy.

Politico story

Senate Appropriations Chairman Richard Shelby said today that GOP spending leaders are planning to closely coordinate their subcommittee allocations in an attempt to fast-track bills to the floor this summer. Shelby and House Appropriations Chairman Rodney Frelinghuysen discussed the funding levels for individual bills, known as 302(b)s, in a closed-door meeting today. Shelby told POLITICO after the meeting that he and Frelinghuysen plan to match 302(b)s "as much as we can.""We're going to work together to try to come to regular order, and we know that's a challenge," Shelby told POLITICO. "We're hoping it's workable, we want to make it efficient and we want to do our jobs."When asked if the House would match the Senate's 302(b)s this year, Frelinghuysen told POLITICO after the meeting: "We're going to be working very closely together."

The New Jersey Republican added that he and Shelby, an Alabama Republican, are "on the same page."

Closely coordinating 302(b)s would be a shift from last year, when the House and Senate panels started with vastly different spending levels for their individual fiscal 2018 bills. House appropriators were told to write their bills assuming that sequestration would actually go into effect, while Senate appropriators wrote their bills using the previous year's funding levels.

The 302(b) allocations - which determine how much of Congress' overall spending pot for fiscal 2019 goes to each of the 12 subcommittees - are expected to be released any day now. Both Appropriations panels are planning to release their first bills within weeks.

(Source: https://www.politico.com/story/2018/04/23/government-spending-appropriations-bill-congress-545744

$20 Million for KCRP - Senate letter

Sen. Kirsten Gillibrand, (D-NY) and several of her Senate colleagues including Sen. Mazie Hirono, (D-HI) signed onto a Dear Colleague letter (circulation within the Senate Chamber and addressed to the Senate Defense Appropriators) requesting $20 million for the FY'19 funding level for the Kidney Cancer Research Program (KCRP) pursuant to the Congressionally Directed Medical Research Program. 

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FDA Approves New Kidney Cancer Treatment

In a breakthrough for the treatment of those with advanced kidney cancer, the FDA approved two immunotherapy drugs, nivolumab and ipilimumab, to be provided in combination as a first line treatment option.  You can read more here.  The FDA granted these applications priority review and breakthrough therapy designation. This is an exciting development for the community as there were a significant number of patients in the trials who experienced very favorable responses in terms of tumor shrinkage.

The FDA official announcement is here. 


$5 Million Increase for Kidney Cancer Research

With the passage of the 2018 Omnibus spending bill (H.R. 1625 Consolidated Appropriations Act, 2018) by both chambers of Congress and signed into law by the President this past Friday, March 23rd, the KCRP (Kidney Cancer Research Program http://cdmrp.army.mil/kcrp/) pursuant to the CDMRP (http://cdmrp.army.mil/) Congressionally Directed Medical Research Program will receive a $5 million dollar increase in available research funds starting immediately. Because we are 6 months into the current fiscal year ('FY18), this funding will be made available for grant awards in the next round of the funding application process. Please stay tuned for additional updates on the FY18 application process.

Research Funding Increase - Congressional Letter

The following is the text of the letter submitted to Congress on March 6th for an increase in funding for the Kidney Cancer Research Program pursuant to the CDMRP.


February 23, 2018

The Honorable Rodney Frelinghuysen                The Honorable Nita Lowey

Chairman                                                                  Ranking Member

House Committee on Appropriations                   House Committee on Appropriations

H-305 The Capitol                                                   H-305 The Capitol              

Washington, DC 20515                                           Washington, DC 20515

Dear Chairman Frelinghuysen and Ranking Member Lowey:

We are grateful for the Committee's past support for the Congressionally Directed Medical Research Programs (CDMRP) conducted by the U.S. Department of Defense (DoD). As you know, the CDMRP’s highly innovative research drives scientific discovery in high-impact research areas not sponsored by the National Institutes of Health (NIH) and other federal agencies.

As you work to develop your respective versions of the fiscal year 2019 Appropriations Act, we encourage you to consider including additional funding for the Kidney Cancer Research Program (KCRP) at the Congressionally Directed Medical Research Program (CDMRP) managed by the U.S. Department of Defense (DoD).

We respectfully request that the committee provide $20 million within the CDMRP for the Kidney Cancer Research Program for fiscal year 2019.

During the ten years prior to KCRP approval, kidney cancer was a topic area under the Peer Reviewed Cancer/Medical Research Programs and had a limited number of successful grant applications. With the advent of the KCRP, the total number of kidney cancer grant applications skyrocketed six-fold in one year over previous submissions, confirming the major need and outpouring of interest in kidney cancer research and underscoring the research community’s commitment to finding a cure for this disease.

Unfortunately, there have been far more meritorious applications for the KCRP than there is funding available. We very much appreciate the Committee's past support and believe an increased investment through CDMRP would make a tremendous difference to many Americans, including our military, military families, retirees and veterans.

The National Cancer Institute estimates that $4.2 billion is spent in the United States each year on treatment of kidney cancer. Unlike the majority of cancers, the rate of people developing kidney cancer has been climbing for the last 65 years, and it is the deadliest urologic malignancy with 30 to 40 percent of patients dying of their cancer. Kidney cancer is the ninth leading cancer overall but ranks fourth in incidence among both African American and Hispanic males. In the United States, the incidence of RCC has increased since the 1970’s by an average of 3 percent per year for Caucasians and 4 percent for African Americans. In 2018, it is estimated that 65,340 new cases of kidney cancer will be diagnosed, and 14,970 people will die from this disease.

When found early, kidney cancer may be treated successfully with surgery, however nearly 35 percent of patients are diagnosed with advanced disease, where survival rates are very low. Additionally, as many as 40 percent of patients diagnosed with local disease will face recurrence later in life. No standard screening or other early detection protocol to diagnose kidney cancer at an early stage exists. Therefore, much work still needs to be done.

We encourage you to support an increase in the dedicated funding for the KCRP.


Kidney Cancer Action Network (KCAN)

American Urological Association (AUA)

Society for Urologic Oncology (SUO)

American Association of Clinical Urologists (AACU)

The Judy Nicholson Kidney Cancer Foundation


Action to Cure Kidney Cancer

Kidney Cancer Coalition

Powerful Patients

Joey’s Wings