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January 08, 2015

2015 May See Promising Legislation Come From the 21st Century Cures Initiative

21st century cures

After more than a year of bipartisan work between Congressman Fred Upton (R-MI) and Congresswoman Diana DeGette (D-CO) on the 21st Century Cures initiative, promising legislation may be introduced before Congress in 2015. Over the past year, we have provided updates on the initiative and its potential to get new treatments and cures to patients more quickly and streamline the drug and device development process.

The pair of “unlikely alliesrecently joined the Morning Joe television program on MSNBC to discuss their initiative. DeGette stressed that politics should not be a part of the initiative’s ultimate goal: to accelerate the pace of cures in America and bring our laws up to date with the advances we have made in technology, health care, and innovation.

It currently takes a decade and $1 billion in spending by researchers, pharmaceutical companies, and other parties to get a new medication approved. Both DeGette and Upton say that is unacceptable given the rapid changes in technology and health care knowledge, and Upton notes the U.S. has fallen behind Europe in coming up with cures for diseases.

“It’s about time that we change the process for approving these drugs and devices and take advantage of the technology … and really move up to the 21st Century,” commented Upton. “We’ve been working for the last year, listening to all the different stakeholders… asking them what can we do as legislators to really streamline this process.”

New Congress

So far, the 6-month effort has involved more than a dozen hearings and roundtables on Capitol Hill, plus other listening sessions outside of Washington, D.C. Lawmakers have heard from a number of witnesses, including Francis Collins, director of the National Institutes of Health (NIH), senior officials at the Food and Drug Administration (FDA), and advocacy group leaders.

Biomedical research advocates are watching the new Congress closely, anticipating proposals as a result of these discussions. “I think this effort has really gotten everybody’s attention,” says Margaret Anderson, executive director of FasterCures, a think tank in Washington, D.C. “It’s given everyone an outlet to start to funnel their thinking about what’s going on in medical research.”

I think this is the first time in quite a while where the community has been asked to try and identify specific things that they think Congress can do,” says David Moore, senior director of government relations at the Association of American Medical Colleges, also in Washington, D.C.

Legislation

ScienceInsider’s thorough reporting includes some estimates as to the specific actions Congress may take. The listening tour has helped identify some potential targets for streamlining clinical trials and the drug approval process. One area may include changes to the system of institutional review boards, commonly known as IRBs, which approve clinical trials. Critics believe the current IRB approval framework is inefficient, and there is a push to see Congress change the rules to create incentives to encourage centralized IRB approvals for multisite trials.

ScienceInsider further reports that the legislation may take aim at the way FDA evaluates biomarkers. Reliable biomarkers—the physiological measurements that indicate whether a drug is acting on its molecular target in the body—save time and money by serving as surrogates for other clinical trial endpoints that take longer to measure. FDA argues the biomarkers submitted in new drug applications may not be reliable and new legislation could possibly set standards for how the agency should evaluate new biomarkers as they are developed.

NIH and FDA also have ideas for the legislation. As reported by ScienceInsider, NIH staffers proposed ending a rule that prevents NIH’s National Center for Advancing Translational Sciences from supporting research beyond phase II of clinical testing. Some members of Congress, including recently elected Senator and former Representative Bill Cassidy (R-LA), are concerned about the way NIH allocates funding to different disease areas. For example, NIH commits a significant amount of funding to tackle AIDS, but as argued by many specialty groups, not enough is spent researching conditions such as Alzheimer’s. This is especially true given the relative impact of each disease on public health in the United States. Additionally, FDA Commissioner Margaret Hamburg suggested amending the Food, Drug, and Cosmetic Act so that clinical trials for medical devices no longer require review by a local IRB.

Regardless if a 21st Century Cures bill eventually becomes law, ScienceInsider reports that it may have only a limited impact on agency budgets because it will be an authorization bill. This means it can set policy, but only suggest funding levels and leaves final spending decisions up to the appropriations committees of Congress.

Innovative Diagnostic Tests

In December, the House Energy and Commerce Committee released a 21st Century Cures white paper regarding the regulation of in vitro diagnostic test kits and laboratory developed tests. In its report, the Committee references its numerous discussions on the topic and disagreement with FDA in some areas. There was agreement that any regulatory framework for innovative diagnostic tests—regardless of whether they are developed in a lab or distributed by a manufacturer—must prioritize patient benefit as well as encourage robust investment and allow for continued innovation.

The white paper states: “The committee understands that FDA’s approach has led to a number of important questions about administrative process and policy.  In addition to questions about the framework proposed, we are aware that the agency’s release of the guidance documents has served as a catalyst for broader conversations about the overarching need to modernize governmental oversight of these unique and increasingly important medical products. As the 21st Century Cures initiative proceeds, with preparations for a discussion draft early in the New Year, the committee appreciates all interested stakeholders input on the issues.” 

As described, and noted in the report, specific issues related to FDA oversight of LDTs that the panel sought comments on included: how to draw lines “separating the practice of medicine, the actual conduct of a diagnostic test and the development and manufacturing of diagnostic tests;”  what constitutes a “device” in the context of LDTs; how FDA will define risk; the applicability of pre-market review standards for kits to LDTs; the potential role of pre-market controls in easing premarket review; when a supplemental premarket submission is required for a modification; what constitutes labeling for an LDT; potential overlap between the Clinical Laboratory Improvements Act of 1988 (CLIA) and FDA regulation, particularly in the area of quality systems; how to address tests for rare disorders; grandfathering provisions; and incentives to encourage development of new tests.

Telemedicine

Other reports indicate that telemedicine will be a component of the 21st Century Cures package. The question is how much change lawmakers will seek. There are debates over telemedicine’s effectiveness, and limits on Medicare’s support for telemedicine (last year the program paid $12 million for telemedicine).

Proposed legislation includes the Telehealth Enhancement Act, which has backers in the House and Senate, and waives Medicare’s restrictions for home health services, critical access and sole community hospitals, and in some cases, hospice care, home dialysis patients and homebound seniors. Related proposed legislation, the Medicare Telehealth Parity Act, expands coverage of certain services to federally qualified health centers and health clinics in three phases — covering small, medium and larger metropolitan areas.

Reports are unclear if the House Energy and Commerce Committee wants to tackle the issue with 21st Century Cures legislation; cost will be a concern and the more money it will cost, the harder it will be to pass.

Another reported area of potential change includes the TELE-MED Act, backed by Reps. Devin Nunes (R-Calif.) and Frank Pallone (D-N.J.), and would allow physicians to treat Medicare patients in all 50 states with a single medical license. Additionally, hospitals have asked Congress to create new exceptions in federal anti-kickback laws to allow purchases of telemedicine equipment for doctors’ offices that would otherwise have trouble affording it.

Uncertain Future

Rep. DeGette has recently said she expects to “go big” with this issue, noting the desire of Americans to see a major bipartisan piece of legislation pass through Congress. Money for the legislation will be an issue, but insiders expect a piecemeal approach. More controversial aspects of 21st Century Cures may be delayed in order to pass less controversial legislation—at least in the beginning.

 

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