85 FR 44 pgs. 12932-12933 - Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products—Submitting New Drug Applications; Withdrawal of Guidance
Type: NOTICEVolume: 85Number: 44Pages: 12932 - 12933
Pages: 12932, 12933Docket number: [Docket No. FDA-2003-D-0370]
FR document: [FR Doc. 2020-04531 Filed 3-4-20; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2003-D-0370]
Guidance for Industry: Exocrine Pancreatic Insufficiency Drug Products-Submitting New Drug Applications; Withdrawal of Guidance
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice; withdrawal.
SUMMARY:
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a guidance for industry entitled "Exocrine Pancreatic Insufficiency Drug Products-Submitting NDAs," which was issued in 2006. The guidance set forth the Agency's thinking on data and information that may support a new drug application (NDA) for a proposed pancreatic enzyme product (PEP) that contains pancreatin or pancrelipase and is intended for the treatment of exocrine pancreatic insufficiency (EPI). FDA is withdrawing the guidance because an NDA for such a product may not be submitted after March 23, 2020. Sponsors interested in submitting a biologics license application (BLA) for a proposed PEP should contact the Agency with any questions.
DATES:
The withdrawal is effective March 23, 2020.
FOR FURTHER INFORMATION CONTACT:
Kristiana Brugger, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6262, Silver Spring, MD 20993, 301-796-3600.
SUPPLEMENTARY INFORMATION:
FDA is withdrawing the guidance for industry entitled "Exocrine Pancreatic Insufficiency Drug Products-Submitting NDAs," which was issued in 2006 (see 71 FR 19524 (April 14, 2006)). The guidance described FDA's thinking regarding the data and information that may support submission of NDAs, including submission of NDAs pursuant to section 505(b)(2) of the Federal Food, Drug and Cosmetic Act (FD&C Act) (21 U.S.C. 355(b)(2)), for products that contain the ingredients pancreatin or pancrelipase and are used to treat EPI.
Pancreatic enzyme preparations of porcine or bovine origin that contain the ingredients pancreatin or pancrelipase have a long history of use for the treatment of EPI in children and adults with cystic fibrosis and chronic pancreatitis. These products have been available in the United States for decades, largely marketed as unapproved drugs. On April 28, 2004 (69 FR 23410), however, FDA announced that all orally administered PEPs are new drugs that must be approved via a marketing application for prescription use only, and explained the conditions for continued marketing of these drug products. The guidance explained FDA's thinking regarding ways in which sponsors of products containing pancreatin and pancrelipase could design drug development programs to demonstrate the safety and effectiveness of their products and satisfy the requirements for approval of an NDA, including an NDA submitted pursuant to section 505(b)(2) of the FD&C Act.
[top] Although most therapeutic biological products have been licensed under section 351 of the Public Health Service Act (PHS) (42 U.S.C. 262), some protein products historically have been
The BPCI Act requires that a marketing application for a "biological product" (that previously could have been submitted under section 505 of the FD&C Act) must be submitted under section 351 of the PHS Act; this requirement is subject to certain exceptions during a 10-year transition period ending on March 23, 2020 (see section 7002(e)(1) to (3) and (e)(5) of the BPCI Act). On March 23, 2020 ( i.e., the transition date), an approved application for a biological product under section 505 of the FD&C Act shall be deemed to be a license for the biological product under section 351 of the PHS Act (see section 7002(e)(4)(A) of the BPCI Act; see also section 7002(e)(4)(B) of the BPCI Act). After March 23, 2020, all sponsors seeking approval of a biological product (that previously could have been submitted under section 505 of the FD&C Act) will need to submit a BLA under the PHS Act (see section 7002(e) of the BPCI Act). (For additional information, see FDA's guidance for industry entitled "Interpretation of the `Deemed to be a License' Provision of the Biologics Price Competition and Innovation Act of 2009" (December 2018), available at https://www.fda.gov/media/119272/download .)
FDA is withdrawing the guidance because a marketing application for a proposed PEP that contains the ingredients pancreatin or pancrelipase may not be submitted under section 505 of the FD&C Act after March 23, 2020. The guidance included a description of data and information that may support submission of NDAs, including 505(b)(2) applications, for these products. FDA anticipates that there will be different considerations that may inform development of proposed PEPs intended for submission in BLAs under section 351 of the PHS Act. FDA intends to issue guidance regarding how the concepts described in the withdrawn guidance would apply to proposed pancreatic enzyme products submitted under the PHS Act, including the extent of integration of various types of data and information about the use of PEPs into BLAs. In the interim, the Agency encourages sponsors interested in submitting a BLA for a PEP to contact the relevant review division in the Office of New Drugs in FDA's Center for Drug Evaluation and Research with any questions.
Dated: March 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04531 Filed 3-4-20; 8:45 am]
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