Are Differences in Disability-Free Life Expectancy by Gender, Race, and Education Widening at Older Ages?

Abstract

To examine change from 1991 to 2001 in disability-free life expectancy in the age range 60–90 by gender, race, and education in the United States. Mortality is estimated over two 10-year follow-up periods for persons in the National Health Interview Surveys of 1986/1987 and 1996/1997. Vital status is ascertained through the National Death Index. Disability prevalence is estimated from the National Health and Nutrition Examination Surveys of 1988–1994 and 1999–2002. Disability is defined as ability to perform four activities of daily living without difficulty. Disability-free life expectancy increased only among white men. Disabled life expectancy increased for all groups—black and white men and women. Racial differences in disability-free life expectancy widened among men; gender differences were reduced among whites. Expansion of socioeconomic differentials in disability-free life at older ages occurred among white men and women and black women. The 1990s was a period where the increased years of life between ages 60 and 90 were concentrated in disabled years for most population groups.

Four Food and Drug Administration draft guidance documents and the REGROW Act: A litmus test for future changes in human cell- and tissue-based products regulatory policy in the United States?

“…In particular, most of the recent debate has been centred around clarifying the FDA's definitions of “homologous use” and “minimal manipulation,” two requirements relevant to “the 361 HCT/Ps” that fall under this second tier and are exempt from FDA premarketing regulation. Between 2014 and 2015, four controversial FDA draft guidance documents were released, further narrowing the Administration's definitions of these terms: Same Surgical Procedure Exception Under § 1271.15(b): Questions and Answers Regarding the Scope of the Exception (October 2014; FDA, 2014c)Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue‐Based Products (December 2014; FDA, 2014b)Human Cells, Tissues, and Cellular and Tissue‐Based Products (HCT/Ps) from Adipose Tissue (December 2014; FDA, 2014a)Homologous Use of Human Cells, Tissues, and Cellular and Tissue‐Based Products (October 2015; FDA, 2015a) …”

“…Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue‐Based Products (December 2014; FDA, 2014b)…”

“…In this draft guidance, the FDA provide further definition of minimal manipulation expanding on the original description given in 21 CFR Part 1271 and providing numerous examples of procedures that qualify as minimal manipulation or would otherwise be considered more than minimal manipulation (FDA, 2014b). As in the original regulation, the definition for minimal manipulation is divided into two sections within this guidance depending on whether the relevant cells/tissues are classified as structural tissues or are considered cells/nonstructural tissues.…”

“…Structural tissues are defined as those that serve as a barrier or provide support within the body, such as bone, skin, blood vessels, or adipose tissue. Nonstructural tissues are defined to “serve predominantly metabolic or other biochemical roles in the body, such as hematopoietic, immune, and endocrine functions” and include tissues such as cord blood, bone marrow aspirate, lymph nodes, and pancreatic tissue (FDA, 2014b). …”

“…This guidance defines the “biological characteristics” that should be preserved in the minimal manipulation of cells and nonstructural tissue to include metabolic activity, differentiation state, and proliferation capacity (FDA, 2014b). Extraction and concentration of haematopoietic stem/progenitor cells from peripheral blood for transplantation would generally be considered minimal manipulation procedures because the concentrated stem/progenitor cells would retain their relevant ability to repopulate the bone marrow.…”