A review of this year’s biggest stories for cancer research and their implications for 2012
Partisan stalemate overshadowed efforts in Congress this past year, and the conflict over federal spending will likely escalate leading up to the November 2012 elections.
Like other federal agencies and programs, the National Cancer Institute (NCI) and its parent agency, the National Institutes of Health (NIH), spent much of the year operating under budgetary uncertainty as the two political parties clashed over fiscal priorities.
Ultimately, in fiscal year 2011, cancer research funding took a cut, though it dodged the drastic cuts that many had feared, and then was given a small boost in funding for the remainder of FY2012. President Obama will release his administration’s FY2013 budget request on Feb. 7, which will signal the official start of the next spending debate, and cuts to NIH will undoubtedly be on the table.
Exacerbating budgetary woes is the recent failure of the congressional “supercommittee” that was charged with recommending more than $1 trillion in federal savings before its Nov. 23 deadline. The collapse of the panel’s nearly three-month effort to find a compromise on taxes and entitlement programs leaves a wide range of federal programs, like the NIH, facing automatic spending cuts beginning in January 2013 unless Congress takes action to circumvent the cuts that were mandated by the Budget Control Act.
A MILESTONE IN THE NATION’S COMMITMENT TO CONQUER CANCER
This year marked the 40th anniversary of the signing of the National Cancer Act of 1971, which was a turning point in our nation’s efforts to cure cancer.
The cancer community commemorated this historic event through various publications and events throughout the year, reflecting on the last four decades of progress and transformative advancements in cancer prevention, detection and treatment that have resulted from the federal commitment to cancer research.
Notably, on Sept. 20, the AACR released a special report that detailed both the top achievements of the last 40 years, as well as the promising directions for the future. The days following were devoted to carrying the message of progress to Capitol Hill through two congressional briefings and a reception honoring members of Congress who have demonstrated a commitment to the advancement of cancer research.
And most recently, the Senate approved a congressional resolution introduced by Senators Sherrod Brown (D-Ohio), Jerry Moran (R-Kan.) and John Kerry (D-Mass.) that recognizes the 40th anniversary and reaffirms the national commitment to understanding and controlling cancer.
TRANSLATIONAL RESEARCH CENTER TO MOVE FORWARD
Last December, the NIH first proposed the establishment of the new National Center for Advancing Translational Science (NCATS) as an entity to help bridge research and industry and speed promising discoveries through the drug development pipeline.
This signature project of NIH Director Francis Collins raised controversy over the last year, but it looks to be moving forward, as the initiative just received approval from Congress in the fiscal year 2012 spending bill.
OPPORTUNITIES FOR COMPARATIVE EFFECTIVENESS RESEARCH EXPAND
One of the major research-related provisions of the health care reform enacted in 2010 was the expansion of federally-funded comparative effectiveness research (CER), which aims to better understand and compare the clinical merits of different treatments, devices and procedures. The 2010 law set up a new, non-governmental organization called the Patient-Centered Outcomes Research Institute (PCORI), which has a charter through 2019 to fund CER. While the organization has taken time to get off the ground, new opportunities are emerging for researchers, as well as patients, to shape the future of this important field of research. Proposals for methodological development are currently being reviewed and solicitations for clinical research proposals are anticipated early in 2012.
While PCORI is moving forward with implementation, the overall health care reform law remains a target for Republicans, and 2012 will likely bring continued efforts to turn back the clock on provisions that have so far been enacted.
STEM CELL RESEARCH UNCERTAINTY PERSISTS
A lawsuit threatening to bar all federal funding for research using human embryonic stem cells (hESCs) continues to move forward in federal appeals court, with a final ruling expected by the fall of 2012.
Sherley v. Sebelius was filed in 2009 by two scientists claiming that the National Institutes of Health (NIH) guidelines easing restrictions on hESC research are illegal. In 2010, a district court judge agreed and blocked NIH funding for hESC research, a decision that was soon overturned and then dismissed earlier this summer.
For the time being, federally-funded embryonic stem cell research activities have resumed, but the plaintiffs are now appealing. Briefs are due between January and mid-March and oral argument has been set for April 23, 2012. A ruling is expected by fall 2012.
TOBACCO PRODUCTS FACE TIGHTENING REGULATION
Over the last year, the federal government continued efforts to intensify the regulation of tobacco products as it entered the second year of the implementation of the Family Smoking Prevention and Tobacco Control Act of 2009. The tobacco industry, meanwhile, is fighting the new policies at every step.
One disappointing setback came in November, when a federal judge granted a preliminary injunction blocking the government from requiring new warnings labels, which were unveiled in June 2011 and were due to appear by September 2012. The new labels use large color photos or drawings to depict the negative health consequences of smoking and include concise statements, such as “Cigarettes cause cancer.”
More industry pushback can be expected in 2012 if the FDA decides to place special regulations on menthol, the sole flavoring excluded from the initial ban on the distribution, manufacture and importation of candy-, fruit- or spice-flavored cigarettes that took effect in September 2009. The agency is expected to soon publish results of a scientific study on the effects of menthol, but there is no deadline for reaching a decision.
The FDA has further indicated that it intends to exert regulatory control over other tobacco-related products such as cigars and e-cigarettes.
The AACR, for its part, worked to raise awareness about the dangers of tobacco throughout the year, holding congressional briefings in March and April, as well as a policy session at the AACR Annual Meeting.
CONCERN GROWS OVER DRUG SHORTAGES
While shortages of certain pharmaceuticals have concerned clinicians and researchers for years, the worsening problem caught the attention of Congress in 2011, leading key House and Senate panels to hold hearings investigating the problem.
At this stage, most federal action is directed at understanding the problem and improving the notification manufacturers provide to the FDA when there is a discontinuation, interruption or adjustment to the production of a specific drug. The AACR has endorsed two similar bills, one in the House (H.R. 2245) and one in the Senate (S. 296). Both proposals would require mandatory notification of pending shortages by manufacturers, a process that is currently voluntary. There is consensus that while these proposals may improve notification, they do not address the underlying causes of the shortages, which are still poorly understood. A number of additional bills are expected that approach the issue from a variety of angles, including addressing the secondary or “grey” market where drugs in shortage have been amassed by third-party wholesalers and resold at markups of several hundred percent, to efforts to change Medicare drug reimbursement policy.
A number of additional bills are expected that approach the issue from a variety of angles, including addressing the secondary or “grey” market where drugs in shortage have been amassed by third-party wholesalers and resold at markups of several hundred percent, as well as efforts to change Medicare drug reimbursement policy.
The Department of Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation issued a report in October that reviewed the underlying causes of the issue as well as the FDA’s efforts in combating shortages. The Government Accountability Office also issued a report in November that has encouraged greater authority for the FDA in order to fight shortages.
REAUTHORIZATION OF FDA USER FEES
In preparation for the reauthorization of the user fee programs, the U.S. Food and Drug Administration (FDA) has been engaged in discussions over the last year with industry and patient groups to assess the overall performance of the various program and to determine what aspects should continue or be changed to further strengthen and improve the program.
The Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee Act authorize the FDA to collect fees from manufacturers to help offset the cost of reviewing new applications to medical devices, including drugs, biologics and devices. User fees, supplemented by dollars appropriated by Congress, support specified activities that are critical for conducting thorough and timely review of applications.
The administration's proposals will be submitted to Congress in January of 2012 so that lawmakers can begin to craft a bill that can be passed before PDUFA and MDUFA expire in September. In addition to user fee reauthorizations, it is likely that Congress will consider additional legislative changes to FDA. Several FDA-related bills have been introduced this Congress and will likely resurface in the next.
The AACR Regulatory Science and Policy Task Force, a working body of the AACR Science Policy and Legislative Affairs Committee, is monitoring the FDA-related legislation and stands ready to provide input to the FDA and Congress.
Read more from the December Edition of the AACR Cancer Policy Monitor: