ASCO in ActionASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.

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August 8, 2017

On Aug. 3, the United States Senate approved a "right-to-try" bill by unanimous consent. The bill would authorize the use of unapproved drug therapies by terminally ill patients, who have exhausted other treatment options and are unable to participate in ongoing clinical trials, as long as the drugs have been tested in Phase I clinical trials and are continuing in further Food and Drug Administration (FDA) research. A physician must certify that the patient is not eligible for a clinical trial with the drug, but there no requirements for physician participation.  

August 4, 2017

The Senate passed the FDA Reauthorization Act (FDARA), which governs FDA’s authority to collect user fees from the industry it regulates in order to fund core FDA programs.

August 3, 2017

On July 28, the Food and Drug Administration (FDA) announced a new strategy to address tobacco-related disease and death.  The agency seeks to develop a plan to reduce the nicotine levels in combustible cigarettes to non-addictive levels.  However, as part of the strategy, the FDA also announced it will delay the regulation of e-cigarettes for several years. This regulation was part of the implementation of the Deeming Rule 2021/2022, which was issued last year.

July 31, 2017

The U.S. Food and Drug Administration (FDA) has released a guidance, effective immediately, allowing for an Institutional Review Board (IRB) to waive informed consent requirements for clinical investigations that include adequate protections for human subjects and present a minimal risk.

July 25, 2017

The nonprofit Reagan-Udall Foundation for the Food and Drug Administration has released a new, online resource called the Expanded Access Navigator. The website, which focuses on oncology with plans to expand to other disease areas, features the first pharmaceutical company directory of expanded access policies and criteria, as well as educational resources, guides and downloadable forms. ASCO was one of several organizations to help develop the Navigator.

July 13, 2017

The U.S. House of Representatives voted to pass the Food and Drug Administration (FDA) Reauthorization Act, which governs FDA’s authority to collect user fees from the industry it regulates in order to fund core FDA programs. 

July 11, 2017

The FDA recently announced it will undertake a new Medical Innovation Development Plan to facilitate the development of innovative drugs and lower health care costs.

July 11, 2017

ASCO submitted a comment letter to FDA about proposed modifications to the “FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioids,” which outlines optional training for health care providers who prescribe Extended Release (ER) and Long-Acting (LA) opioids.

July 11, 2017

ASCO and Friends of Cancer Research (Friends) held a meeting on June 30 with key stakeholders across the cancer research community to identify concrete approaches to broaden eligibility criteria for cancer clinical trials.

June 21, 2017

ASCO joined more than 35 other organizations, including professional societies, patient advocacy groups, and research institutions, to encourage the U.S. Food and Drug Administration (FDA) to develop a guidance on plain language summaries for clinical trials results.

June 9, 2017

On June 6, 2017, the U.S. Food and Drug Administration approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan, NX Development Corp.) as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery.

May 23, 2017

On May 19, ASCO submitted comments to Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, on the FDA’s proposed guidance for industry on demonstrating interchangeability of biosimilars with a reference product. In ASCO’s comments to the FDA, the society took the opportunity to reiterate its strongly held position that physicians and patients should have the ability to select evidence-based treatment options – including the specific biologic product – most appropriate for the patients’ circumstance.

May 10, 2017

ASCO submitted comments to congressional committees regarding the Food and Drug Administration (FDA) Reauthorization Act, which Congress expects to take up before the current authorization expires on September 30, 2017.

May 10, 2017

ASCO submitted comments to congressional committees regarding the Food and Drug Administration (FDA) Reauthorization Act, which Congress expects to take up before the current authorization expires on September 30, 2017.

May 10, 2017

On May 10, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA® , Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC).

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