Have You Heard of Environmental Assessments for New Drugs and Biologics?

 

The latest Climate Change Calamities that has ravaged the State of California starting 3 weeks ago reminded me of an article I wrote about Environmental Assessments. Today may be the end of this atmospheric river this year, but I am sure this will happen again in the future.  Here's the article for your information.

I believe most of my readers in this blog have not heard of environmental assessments requirement for new drugs and biologics applications submitted to the FDA. At that time, part of my job as a Review Chemist is to evaluate the adequacy of the Environmental Assessment (EA) report submitted by an applicant for new drug application. An EA is a concise public document that evaluates the potential risk for the drug or feed additive to cause significant environmental impacts. Using fate, exposure, and effects data, the EA focuses on relevant environmental issues relating to the use and disposal of drugs or feed additives (21 CFR 25.40).

Here's a summary of the guidance published for the information of the public and the pharmaceutical industry, published July, 1998. I hope you are curious enough that you will read it.  

GUIDANCE FOR INDUSTRY Environmental Assessment of Human Drug and Biologics Applications

The National Environmental Policy Act of 1969 (NEPA) requires all Federal agencies to assess the environmental impacts of their actions and to ensure that the interested and affected public is informed of environmental analyses. 

The Food and Drug Administration (FDA) is required under NEPA to consider the environmental impacts of approving drug and biologics applications as an integral part of its regulatory process. 

FDA's regulations in 21 CFR part 25 specify that environmental assessments (EAs) must be submitted as part of certain new drug applications (NDAs), abbreviated applications, applications for marketing approval of a biologic product, supplements to such applications, investigational new drug applications (INDs) and for various other actions (see 21 CFR 25.20), unless the action qualifies for categorical exclusion.

Under the President's reinventing government (REGO) initiatives, announced in April 1995, FDA reevaluated and revised its environmental regulations to reduce the number of EAs required to be submitted by industry and, consequently, the number of findings of no significant impact(FONSIs) prepared by the Agency under NEPA. FDA issued for public comment a notice of proposed rule making on April 3, 1996 (61 FR 14922) (republished May 1, 1996 (61 FR 19476)),that proposed additional categorical exclusions for those actions that have been identified as normally not having a significant effect, individually or cumulatively, on the quality of the human environment.  

The final rule was published on July 29, 1997 (62 FR 40569), and became effective August 28, 1997. All applications or petitions requesting Agency action (e.g., NDAs, abbreviated new drug applications (ANDAs),INDs, biologics license applications (BLAs), supplements to such applications) must be accompanied by either an EA or a claim of categorical exclusion.Failure to provide (1) a claim of categorical exclusion or (2) an adequate EA, is sufficient grounds for refusing to file or approve the application (21 CFR 314.101(d)(4), 601.2(a) and (c), and 25.15(a)). An EA that is adequate for filing is one that addresses the relevant environmental issues. 

An EA adequate for approval is one that contains sufficient information to enable the Agency to determine whether the proposed action may affect significantly the quality of the human environment. This guidance provides information on when an EA should be submitted; it also makes recommendations on how to prepare EAs for submission of drug or biologics applications to the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).

This guidance has been prepared under the direction of the Chemistry Manufacturing Controls Coordinating  Committee, Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. This guidance represents the Agency's current thinking on environmental assessments. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.

For Details read:

  https://www.fda.gov/media/70809/download

Meanwhile enjoy this photo from my collection: