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RECOMBINANT DNA-PRODUCED PRODUCTS IDENTICAL TO EXISTING DRUGS WILL STILL NEED PRE-MARKETING APPROVAL FROM FDA, AGENCY SAYS IN FINAL BIOTECH POLICY STATEMENT

Executive Summary

The use of recombinant technology to produce drugs previously available either from conventional technology or as natural proteins will require either a full NDA or supplemental NDA due to concerns about structural differences in the biotechnology-derived product, according to FDA's final policy statement for regulating biotechnology. "The agency has re-examined this issue and continues to believe, that as a general principle, new marketing applications will be required for most products manufactured using new biotechnology," the guidelines state. "Because of potential differences in the products resulting from use of recombinant DNA technology, the resulting products may be 'new' products requiring separate approval under the applicable statutory provisions." As an example, the policy statement points out that use of recombinant DNA technology to produce an already approved drug or biological could lead to "new structural features in the product, result in product micro-heterogeneity, or introduce new contaminants (e.g., associated with new cell substrates), each of which may affect the safety, efficacy and stability of the product." The FDA biotech policy statement notes that each case will be examined separately and that "in some instances complete new applications may not be required." FDA's statement on the regulatory requirements for biotechnology-produced compounds identical to other drugs was in response to "many comments" on the draft guidelines that questioned "the need for new or supplemental marketing applications" for such products. Overall, FDA proposed "no new procedures or requirements for regulated industry or individuals" in the policy statement. Instead, FDA stated, "the administrative review of products using biotechnology is based on the intended use of each product on a case-by-case basis." The FDA biotechnology policy statement is part of the Administration's guideline package to regulate biotechnology, signed by the President on June 18. This "Coordinated Framework for the Regulation of Biotechnology" is expected to appear in the Federal Register on June 26. At a June 20 press conference, White House Biological Sciences Coordinating Committe Chairman David Kingsbury said that individual agencies are expected "to have technical briefings for people who would like to have the opportunity to get . . . detailed information." Kingsbury said that agency public affairs offices will arrange dates for the briefings "Maybe the week after next."
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