Republicans Get Ready to Vote on “Right-to-Try” Bill Again

Published March 19, 2018 by The American Journal of Managed Care

The right-to-try bill, which suffered a surprise 259-140 defeat in the House of Representatives last week, is scheduled for another vote this week, perhaps as early as Wednesday.

On Monday, the House Committee on Rules was scheduled to meet late in the day to change the procedure so that it could be passed with just a simple majority, rather than a two-thirds majority, and this time approval seems likely.

Last week, AJMC spoke with Marjorie A. Speers, PhD, executive director of the WCG Foundation, a public charity that works to ensure experimental medicines to very ill patients under the FDA’s current expanded acccess and compassionate use programs. Speers has previously participated on a panel on this subject at AJMC‘s Patient-Centered Oncology Care meeting in Philadelphia, Pennsylvania. Speers told AJMC she did not think the bill added much beyond the FDA’s current expanded access program

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Weighing the Merits of Right-to-Try Laws and FDA’s Expanded Access Program

Published February 27, 2018 by The American Journal of Managed Care

Just a month before attendees gathered in Philadelphia, Pennsylvania, for the annual meeting of Patient-Centered Oncology Care®, legislators in the state’s capital of Harrisburg made it the 38th to pass a right-to-try law. That was 6 states in 2017 alone.1 Championed by conservative groups like the Goldwater Institute as well as Vice President Mike Pence,2 the laws sound good on their face: they can connect terminally ill patients with experimental treatments; even opponents say the idea of giving dying patients “one last chance” is hard to oppose.

But as panelists discussed during the session presented by The American Journal of Managed Care®, these state laws are not necessarily good for patients or long-term drug development, and there is a better alternative: the FDA’s newly streamlined Expanded Access program, which allows patients to gain access to investigational therapies in a more regulated way, with greater accountability. Thus, there is great concern about a proposed federal right-to-try legislation, including a version that has passed the United States Senate.

The panel featured W. Kevin Kelly, DO, director of the Division of Solid Tumor Oncology at the Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia; Marjorie A. Speers, PhD, executive director for the WCG Foundation; and Diana Zuckerman, PhD, president of the National Center for Health Research, board member of the Reagan-Udall Foundation.

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Free WCG Foundation webinars offer insights on speeding access to experimental drugs for intermediate-size patient populations

Presenters include Richard Klein, formerly of FDA, and Marjorie Speers of WCGF

ATLANTA, Ga., Jan. 9, 2018—WCG Foundation will host free webinars Jan. 25 and Feb. 5 on how to streamline the application process for experimental medications for intermediate-size populations of desperately ill patients.

The webinars—“Intermediate-Size Patient Populations INDs: What Are They, When Should They Be Used, and Who May Apply for Them?”—feature Richard Klein, former director of the Food and Drug Administration Patient Liaison Program Office, and Marjorie A. Speers, Ph.D., executive director, WCGF.

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Right to Try Bills Push the Needle on Risk’ –  panel of experts, including WCGF Executive Director Marjorie A. Speers, discuss risks associated with Right-to-Try legislation

Published December 24, 2017 by OncLive

“Congressional “right-to-try” legislation could make investigational drugs available to desperately ill patients sooner in the trials process, but there are substantial risks, said a panel of experts at the Patient-Centered Oncology Conference, held November 16-17 in Philadelphia, Pennsylvania.

Earlier in the clinical trials process, less is known about the drugs, which may be highly toxic and may have no efficacy. Furthermore, the House of Representatives’ version of the bill would allow companies to charge any amount for access to their investigational drugs. That is a scary proposition due to the potential for cost exploitation, members of the panel said.”

You can read the full article from OncLive HERE

Panel of experts, including WCGF Executive Director Marjorie A. Speers, discuss Right to Try bill at Patient Centered Oncology Care 2017 meeting

Published November 17, 2017 by HCA News

“Marjorie A. Speers, Executive Director of the WCG Foundation, also had problems with Right to Try laws. Under the existing system, the process encourages deliberate decisions: first, the patient and their physician decide they want to pursue a drug undergoing clinical trial; then, they request that access from the drug’s maker and the company can decide if they believe the drug will be useful; finally, the FDA reviews and approves the request.

Right to Try, Speers argued, bypasses all of that, which could be detrimental. “These uses can only occur for desperately ill people, there’s no other treatment option for them,” she said. “It’s not necessarily the best time to be making a decision.”’

You can read the full article from Healthcare Analytics News HERE

One patient’s story: How WCGF helped speed approval for experimental treatment

It took more than two years for Tyson Fowler to receive an accurate diagnosis of the cause of his motor neuron symptoms. By then, chronic Lyme disease had taken its toll. The once healthy, athletic 30-something was confined to a wheelchair, unable to move on his own. His condition was worsening rapidly, and the prognosis was grim.

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WCGF Director David Farber, JD provides expertise in NPR’s 1A Discussion of Expanded Access and Senate Right-To-Try Legislation

David Farber, Partner in the FDA and Life Sciences practice of the law firm King and Spalding, and a Director of WCGF lent his expertise to a nuanced discussion of the questions surrounding expanded access to experimental drugs for patients seeking drugs outside of clinical trials.  The program, which provided multiple views on state Right-To-Try legislation as well as the Senate’s recent passing of federal Right to Try legislation, aired on NPR’s 1A program on August 7, 2017.

You can listen to the complete program at:

http://the1a.org/audio/#/shows/2017-08-07/experimenting-with-drugs-while-terminally-ill/111721/@00:00

Pfizer Grant Helps WCG Foundation Identify Obstacles to Expanded Access

WCG Foundation Progress Report, January 25, 2017

WCG Foundation (WCGF) has received a $5,000 grant from Pfizer to identify obstacles that could discourage physicians from helping desperately ill patients who want to access investigational drugs.

The grant is the latest to support WCGF’s Expanded Access Project, which helps those who have exhausted all treatment and clinical trial options and want the chance to try experimental medicines. Learn more.

GlaxoSmithKline Grant Supports WCGF Expanded Access Project

WCG Foundation Progress Report, January 24, 2017

WCG Foundation (WCGF) has received $15,000 from GlaxoSmithKline (GSK) for the Foundation’s Expanded Access Project. The project helps desperately ill patients who have exhausted all treatment and clinical trial options and want to try experimental medicines.

WCGF will use the GSK grant to help institutional review boards (IRB) streamline the process that patients must navigate to gain access to investigational drugs and devices. Learn more.

$100,000 Grant from Robert Wood Johnson Foundation Supports WCGF Expanded Access Program

WCG Foundation Progress Report, October 31, 2016

WCG Foundation (WCGF) has received $100,000 from the Robert Wood Johnson Foundation (RWJF) to support WCGF’s new Expanded Access Project. The grant targets physicians and institutional review boards (IRBs), who play key roles in helping desperately ill patients gain access to experimental medicines.

Launched in July, the Expanded Access Project seeks to streamline the process for those seeking Food and Drug Administration (FDA) approval to try investigational drugs and devices. The goal is to make the process less burdensome and more equitable and transparent. Learn more.

First WCGF Grant Funds Innovative Research Ethics Curriculum at NYU

WCG Foundation Progress Report, August 17, 2016

WCG Foundation’s (WCGF’s) first grant—a two-year $200,000 award to New York University (NYU)—has already enabled NYU Langone Medical Center (NYULMC) to strengthen research ethics education within and beyond the medical center. During the first year, NYU funded curriculum development and supported faculty participation in lectures, webinars, panel discussions, and other outreach efforts.

As a result, 20 students at NYULMC completed a new course in research ethics and integrity, and 12 research professionals from resource-poor countries attended a two-week intensive ethics training program. In addition, thousands of students and faculty from the nation’s top academic institutions and high schools gained a better understanding of today’s research ethics issues through webinars, lectures, and publications. Learn more.

Foundation Seeks IRBs to Review Single-Patient Expanded Access Applications

WCG Foundation RFP, July 28, 2016

WCG Foundation (WCGF) has issued a request for proposals (RFP) to pilot an expanded access program. The Foundation wishes to engage several organizations with institutional review boards (IRBs) to conduct full board reviews of single-patient expanded access (compassionate use) applications. Details are available in the RFP.

Deadline to respond is 5 p.m. EDT August 29.