Department of Health and Human Services August 15, 2024 – Federal Register Recent Federal Regulation Documents

Findings of research misconduct have been made against Richard L. Eckert, Ph.D. (Respondent), who was a Professor, Chair of the Department of Biochemistry and Molecular Biology, and Deputy Director of the University of Maryland and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore (UMB). Respondent engaged in research misconduct in research supported by U.S. Public Health Service (PHS) funds, specifically National Cancer Institute (NCI), National Institutes of Health (NIH), grants R01 CA211909, R01 CA184027, R01 CA131074, R01 CA131064, R01 CA092201, R01 CA109196, P30 CA134274, and P30 CA043703, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, grants R21 AR065266, R01 AR046494, R01 AR053851, R01 AR060388, P30 AR039750, R01 AR041456, R01 AR049713, and R01 AR045357, National Eye Institute (NEI), NIH, grants P30 EY011373 and T32 EY007157, and National Institute of General Medical Sciences (NIGMS), NIH, grant R01 GM043751. The questioned research was included in two (2) grant applications submitted for PHS funds, specifically R01 CA233450-01 and R01 CA233450-01A1 submitted to NCI, NIH. The administrative actions, including debarment for a period of eight (8) years, were implemented beginning on August 1, 2024, and are detailed below.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for ENTEREG (alvimopan) Capsules, 12 milligrams (mg), held by Cubist Pharmaceuticals LLC, 126 East Lincoln Ave., Rahway, NJ 07065 (Cubist). Cubist notified the Agency in writing that the drug product was no longer marketed and requested that the approval of the application be withdrawn.

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring Ryan Stabile for a period of 15 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Stabile was convicted of three felony counts under Federal law: one count of conspiracy and two counts of introduction of misbranded drugs with intent to defraud/mislead. The factual basis supporting Mr. Stabile's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Stabile was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of June 7, 2024 (30 days after receipt of the notice), Mr. Stabile had not responded. Mr. Stabile's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

The Food and Drug Administration (FDA or Agency) announces a forthcoming public advisory committee meeting of the Science Board to the Food and Drug Administration. The Science Board provides advice to the Commissioner of Food and Drugs and other appropriate officials on specific, complex scientific and technical issues important to FDA and its mission, including emerging issues within the scientific community. Additionally, the Science Board provides advice to the Agency on keeping pace with technical and scientific developments, including in regulatory science, input into the Agency's research agenda, and on upgrading its scientific and research facilities and training opportunities. It will also provide, where requested, expert review of Agency-sponsored intramural and extramural scientific research programs. The meeting will be open to the public.