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Regulatory News | 23 March 2015 | By Alexander Gaffney, RAC
While the US Food and Drug Administration (FDA) may be primarily concerned with what medicinal products do to the human body, a lesser-known secondary concern of regulators is what a product will do to the environment.
Under 21 CFR 25.40 of the Code of Federal Regulations, most pharmaceutical and biotechnology companies are required to submit an Environmental Assessment (EA) when submitting a new drug for approval.
The assessments are meant to show how a drug might affect the environment. Many drugs enter the environment as sewage after being excreted by patients.
FDA has explained in the past that it's particularly concerned with how drug substances behave once they enter "into the aquatic environment" (i.e. the water supply), whether they can be filtered out by water treatment facilities, and how those drug substances might cause harm to the environment or any wildlife.
The need for environmental assessments is taken seriously by FDA. A company's failure to submit an EA can result in a submission being rejected by FDA.
For more information read FDA's 1998 guidance, Environmental Assessment of Human Drug and Biologics Applications.
But FDA's 1998 guidance was written at a time when the term "drug" was largely synonymous with "chemical"—not "biotechnology." Nearly 20 years later, FDA has asked itself whether its environmental guidelines ought to apply to biotechnology products like gene therapies, vectored vaccines and related recombinant viral or microbial products (GTVVs) as well.
In June 2014, FDA released a draft guidance document, Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products.
The guidance document explained that since most GTVV's are not naturally found in the environment—FDA's standard for exclusion—they will generally be subject to FDA's environmental testing regulations.
Even biotechnology products which are highly similar to naturally occurring species will need to undergo an environmental assessment, FDA said in the guidance. "Applications requesting agency action for GTVVs that are engineered to express one or more proteins from a different genus should include an EA because FDA would not consider the criteria for a claim of categorical exclusion to be met," the regulator explained.
One concern highlighted by FDA is the potential for variants of the approved product to make their way into the environment. For example, while some biotechnology products are engineered to make them unable to replicate, defects in the manufacturing process may allow some products to do so.
Read our coverage of the draft guidance document here.
The guidance also contained extensive details regarding what information should be included in a company's EA submission to FDA, including a lengthy list of questions sponsors are supposed to answer:
On 23 March 2015, FDA announced the release of the final iteration of its GTVV environmental assessment guidance.
In an accompanying Federal Register notice, FDA said that while there were "a few comments on the draft guidance," the final guidance contains "no changes … except for one correction to a technical error regarding influenza taxonomy."
The guidance is immediately in effect.
Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products (FR)
Tags: Guidance, Final Guidance, GTVV, gene therapies, vectored vaccines, related recombinant viral products, related recombinant microbial products