BIO Submits Comments on FDA proposed rule: Good Laboratory Practice for Nonclinical Laboratory Studies
January 20, 2017
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD, 20852
RE: Docket No. FDA-2010-N-0548: Good Laboratory Practice for Nonclinical Laboratory Studies; Proposed Rule
The Biotechnology Innovation Organization (BIO) appreciates the opportunity to offer comments to Food and Drug Administration (FDA)’s “Good Laboratory Practice for Nonclinical Laboratory Studies.” In our comments to FDA’s 2011 advanced notice of proposed rulemaking (ANPRM), we applauded FDA’s initiative to revise the Good Laboratory Practice (GLP) regulations to more completely address how nonclinical studies are currently conducted. These efforts are particularly critical in light of the fact that the regulations have not been substantially revised since the late 1970s. BIO continues to support a quality systems approach to GLP to ensure continual improvement and high quality lab studies, which is embodied in the current GLP regulation.
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products.
Retention of single point of control
In previous comments, BIO indicated that additional specific responsibilities of Sponsors of nonclinical laboratory studies will not improve the quality and integrity of nonclinical laboratory study conduct. The current GLP regulations require the Sponsor to approve nonclinical laboratory protocols prior to study initiation (section 58.120(a)). Once the study is initiated, the Study Director is the single point of control.
In the proposed rule, we note that single points of control and oversight appear to be spread across several management individuals, the sponsor, contributing scientists, principle investigators, and quality assurance units simultaneously. These proposed changes introduce overlapping, duplicative, and conflicting responsibilities. We are very concerned that the proposed rule will likely cause confusion in the determination of the person who is ultimately accountable in any given situation...