Senate Labor-HHS funding Bill has several FDA references; bipartisan House Members urges USDA and FDA to cooperate on animal genetics

Top-Line:

• Senate releases Labor-HHS funding Bill with several FDA references

• Bipartisan group of House Members urges USDA and FDA to cooperate on animal genetics

• Upcoming Alliance Webinars: Oncology Center of Excellence Deputy Director Paul Kluetz November 15, 3:30-4:30 PM ET; Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD December 6 at 10 a.m.; Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne December 14 at 2 p.m.

• Fortenberry Temporarily Steps Aside from Committee Assignments

• Analysis and Commentary - Alliance for a Stronger FDA Webinar with National Center for Toxicological Research Director Dr. William Slikker, Jr

Senate Releases Labor-HHS Funding Bill; Several FDA References. FDA is not a focus of the Labor-HHS funding bill. However, we found four notable references to FDA in the Explanatory Statement accompanying the Senate bill that was released this week:

• Improving Accuracy of Diagnosis of Rare Diseases.—…The Committee encourages the National Center for Health Statistics at CDC to work with Federal agency partners, including the FDA and the NIH, to establish a pathway for pursuing a specific diagnostic code for rare diseases that currently lack one.

• Nonrecurring Expenses Fund.—The Committee directs HHS to continue implementing previously notified projects and prioritize obligations for the following projects: …FDA laboratory renovations…

• Adult Cellular Therapies.—…encourages the NIH-in coordination with FDA and HRSA-to continue their efforts to enhance transparency regarding outcomes from adult cellular therapies…by ensuring that results are submitted to appropriate databases such as the Stem Cell Therapeutic Outcomes Database and ClinicalTrials.gov.

• Advancing Cell-Based Therapies.—The Committee encourages…continued NIH collaboration with FDA and HRSA to enhance transparency regarding outcomes from cellular therapies from adult (somatic) cells…by ensuring that results are submitted to appropriate databases such as the Stem Cell Therapeutic Outcomes Database and ClinicalTrials.gov

Bipartisan Group of House Members Urges USDA and FDA to Cooperate on Animal Genetics. Considering multiple challenges to the health of food-producing animals, a group of House Members has asked USDA and FDA to work together to modernize the regulatory pathway for animals developed or improved through biotechnology. The letter can be found here.

House Agriculture/FDA Appropriations Subcommittee Ranking Member Jeff Rotenberry Temporarily Steps Aside
Congressman Jeff Fortenberry (R-NE) has temporarily stepped aside from the House Appropriations Committee and his position as ranking member of the Agriculture/FDA Subcommittee. Rule 25 of the House Republican Conference Rules requires "A member of a standing, select, joint or ad hoc committee, or any subcommittee thereof, who is indicted for a felony for which a sentence of two or more years imprisonment may be imposed, shall submit his or her resignation from any such committees to the House promptly." Congressman Fortenberry has been indicted on a charge of concealing information and lying to the FBI regrading an investigation into illegal campaign contributions. Who will serve as the subcommittee ranking member in his absence has not yet been announced.

Analysis and Commentary. This week’s column (below) summarizes the Alliance’s webinar with Dr. William Slikker, Director of FDA’s National Center for Toxicological Research (NCTR). The Center is involved in a range of projects, particularly for the other Centers, which go beyond what its name suggests.

Upcoming Alliance Webinars. We continue to invite FDA leadership to address the Alliance membership and media.

• Oncology Center of Excellence Deputy Director Paul Kluetz is scheduled for November 15, 3:30-4:30 PM ET. The FDA Oncology Center of Excellence leverages the combined skills of regulatory scientists and reviewers with expertise in drugs, biologics, devices, and diagnostics. The Center helps expedite development of medical products for oncologic and hematologic malignancies and supports an integrated approach to their clinical evaluation. Alliance members and media can register here

• Director of the Office of Tissues and Advanced Therapies at CBER Wilson Bryan, MD is scheduled for December 6 at 10 a.m. His office is the front-line in the development of gene therapies. Sign up here.

• Director of the Center for Food Safety and Advanced Nutrition, Susan Mayne is scheduled for December 14 at 2 p.m. She will be discussing FDA’s nutrition programs and major initiatives in that area. Sign up here.

Non-members interested in participating in any of these events should contact Alliance Executive Director Steven Grossman at: sgrossman@strengthenfda.org.