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Oct 16, 2009


Dr. Smith

FDA plans to revise its GLP regulations soon. Period comment starts in June 2010 and ends sometime in September 2010. http://www.reginfo.gov/public/do/eAgendaViewRule?pubId=201004&RIN=0910-AG47

HHS/FDA RIN: 0910-AG47 Publication ID: Spring 2010
Title: ¤Good Laboratory Practice for Nonclinical Laboratory Studies
Abstract: The Food and Drug Administration (FDA) is seeking comment on whether to amend the regulation governing good laboratory practices (GLPs) (21 CFR part 58--Good Laboratory Practice for Nonclinical Laboratory Studies). The GLP regulation was finalized in December 1978 and prescribes GLPs for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for FDA-regulated products. Since this regulation was published, clinical studies have changed markedly. To help ensure the integrity of data in nonclinical studies submitted to FDA, the agency is proposing that nonclinical facilities/laboratories follow a risk-based GLP quality system. While many of the requirements of the existing regulation are consistent with a GLP quality system, FDA is proposing modifications to incorporate all basic elements needed for a GLP quality system consistent with internationally recognized quality systems. FDA believes that implementation of a GLP quality system would institute a risk-based approach, reduce regulatory burden, and encourage science-based technology.
Agency: Department of Health and Human Services(HHS) Priority: Other Significant
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Prerule Stage
Major: No Unfunded Mandates: No
CFR Citation: 21 CFR 58 (revision) (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: 21 USC 342 ; 21 USC 346 and 346a; 21 USC 348; 21 USC 351 to 353; 21 USC 355; ...
Legal Deadline: None

Timetable: Action Date FR Cite
ANPRM 06/00/2010
ANPRM Comment Period End 09/00/2010

Regulatory Flexibility Analysis Required: No Government Levels Affected: Undetermined
Small Entities Affected: Businesses Federalism: No
Included in the Regulatory Plan: No
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No
Agency Contact:
C.T. Viswanathan
Associate Director, Division of Scientific Investigations, Office of Compliance
Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research, WO 51, Room 5346, 10903 New Hampshire Ave.,
Silver Spring, MD 20993
Phone:301 796-3394
Fax:301 847-8748
Email: ct.viswanathan@fda.hhs.gov

Bryan Rahija

Dr. Paller and Dr. Smith,

Thank you for the comments. You raise some good points — we are working on whistleblower and transparency issues at FDA but right now we do not have any additional news. Please stay tuned.

Bryan Rahija

Dr. Smith

FDA must be transparent, equitable, accountable, trustworthy, and respectful in its decisions with employees and the American public. The American public has a right to know the devices approved by CDRH for marketing and research (clinical trials) based on false and misleading information. GLP issues remain. GAO and OIG audits are needed.

Bryan, has anyone in POGO addressed this matter recently with the FDA Commissioner or with Congress? Has anyone contacted FDA Transparency Task Force?

Dr. Paller

By the way, do you know if anything has been done to restore the reputation of whistleblowers?

Dr. Paller

On February 18, POGO released a report, "The FDA's Deadly Gamble on the Safety of Medical Devices." An Appendix to the report contains excerpts from chilling statements made to POGO, anonymously, by scientists in the FDA. They describe a climate of fear. Fear, harrassment, and retiliation still exists. Unsafe and ineffective products are approved.

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