Regulatory Focus™ > News Articles > Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

Posted 26 January 2017 | By Zachary Brennan 

Pharma Companies Take Issue With FDA Proposal to Overhaul Nonclinical Study Regulations

A group of the world’s largest biopharmaceutical companies, including Pfizer, Novartis, Celgene, Bristol-Myers Squibb and more than 170 others have offered their critiques and are seeking further clarifications on the US Food and Drug Administration’s (FDA) proposed rule to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies.

The proposed rule, unveiled in August, would require a complete quality system approach for these safety and toxicity studies. The proposal is also part of FDA’s attempt to further efforts to encourage the implementation of the “3Rs”: to reduce, refine and replace animal use in testing.

“We agree with the numerous comments to the December 2010 ANPRM that support a clear delineation of study responsibilities and effective communication among all parties involved in multisite studies,” FDA said, noting that some stakeholders suggest that certain provisions in the current regulations are outdated and hamper efficient use of present technology (ie., requiring hard copies of records and documentation instead of allowing computerized options).


The 175 comments released earlier this week offer a look into ways the biopharmaceutical industry is interested in reforming this proposed rule, as well as some complaints of issues and requests for clarification.

Pfizer, for instance, said it welcomes a number of “positive changes,” including the quality system approach presented by FDA and efforts to harmonize the regulations with the Organisation for Economic Co-operation and Development (OECD), but the drugmaker also took issue with the scope of the regulations, the section on animal welfare, some of the sections on quality assurance unit roles and the incomplete alignment with OECD.

On the animal welfare front, Pfizer notes that the proposal includes the phrase “accredited persons” but that there’s only one accrediting organization for this purpose (AAALAC International) and it’s “unclear why accreditation by this organization would be required by the regulations.”

In addition, Novartis is seeking some clarifications on what studies need to be GLP compliant.

“The language currently reads as if there would be no more non-GLP studies for drug safety or efficacy, that once a drug candidate moves past the early discovery phase and into testing paradigms that would be included in any regulatory package, it becomes subject to GLP requirements,” Novartis said. “In addition, it is unclear if Dose Range Findings Investigative & Mechanistic studies all now need to be GLP compliant.”

Novartis also said it does “not agree with the new requirement that QA [quality assurance] review all SOPs [standard operating procedures] applicable to a given nonclinical laboratory study and documenting this review. This is not necessary because QA does not inspect/audit all phases of a non-clinical laboratory study, only specific designated phases.”

Celgene, meanwhile, says it “disagrees with the inclusion of the ‘Animal Rule’ requirements to the proposed rule amending GLP regulations” as “this may potentially create confusion with standard GLP requirements for nonclinical studies.”

The New Jersey-based company also said it “disagrees with broadening the Scope of the GLP regulations in the proposed rule to include studies not traditionally covered under current regulations (i.e. efficacy studies, in vitro screens, dose range finding studies)” as this “does not add value and could slow the regulatory approval process by adding unnecessary procedural burden and increase documentation requirements.”

Similarly, Bristol-Myers Squibb said that its assessment of the proposed rule found it to be “administratively and operationally burdensome.”

Other companies offering comments include Alexion Pharmaceuticals, Regeneron Pharmaceuticals, Gilead, Sanofi, Teva Pharmaceuticals, AbbVie, AstraZeneca Pharmaceuticals, Merck, GlaxoSmithKline, Takeda, several contract research organizations and industry groups such as PhRMA, BIO and AdvaMed.

Docket folder: Good Laboratory Practice for Nonclinical Laboratory Studies


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