83 FR 36604 - Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 146 (July 30, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 146 (July 30, 2018)
| Page Range | 36604-36604 | |
| FR Document | 2018-16148 |
[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)] [Notices] [Page 36604] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16148] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2008-N-0549] Prescription Polyethylene Glycol 3350; Denial of a Hearing and Order Withdrawing Approval of Abbreviated New Drug Applications; Temporary Stay of Effective Date AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is providing notice that the effective date of an April 2, 2018, order denying requests for a hearing and withdrawing approval of abbreviated new drug applications (ANDAs) for certain prescription laxatives with the active ingredient polyethylene glycol 3350 (PEG 3350) is stayed until November 2, 2018. DATES: FDA is staying the effective date of the April 2, 2018, order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient PEG 3350 until November 2, 2018. ADDRESSES: For access to the docket, go to https://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ``Search'' box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Publicly available submissions may be seen in the docket. FOR FURTHER INFORMATION CONTACT: Julie Finegan, Office of Scientific Integrity, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, MD 20993- 0002, 301-796-8618. SUPPLEMENTARY INFORMATION: In the Federal Register of April 2, 2018 (83 FR 13994), FDA denied requests for hearing and issued an order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient PEG 3350. The effective date of the order was May 2, 2018. Between April 6, 2018, and April 13, 2018, FDA received petitions for stay under Sec. 10.35 (21 CFR 10.35) on behalf of four ANDA holders: Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. (hereafter Breckenridge/Nexgen) who submitted a joint petition; Lannett Company, Inc.; and Paddock Laboratories, Inc. (collectively the ANDA holders). Breckenridge/Nexgen, Lannett, and Paddock petitioned FDA to stay its order withdrawing the approval of their ANDAs for prescription PEG 3350 and argued that all four criteria for a mandatory stay under Sec. 10.35(e) were met. Bayer Healthcare, LLC, (Bayer) which holds an approved New Drug Application for MiraLAX, an over-the-counter laxative containing PEG 3350, responded. Bayer argued that the petitioners failed to meet any of the factors in Sec. 10.35(e).\1\ --------------------------------------------------------------------------- \1\ On April 30, 2018, Bayer filed a submission titled ``Request for Clarification of FDA Granting of a Petition for Stay of Action.'' Bayer requested that FDA clarify that the stay allowed new manufacturing only until May 2, 2018, with shipment of product permitted until November 2, 2018. Breckenridge/Nexgen responded to Bayer's request for clarification and argued that Bayer's submission should have been a petition for reconsideration and that it failed to meet the standards required for reconsideration. Regardless of whether Bayer's submission should have been a petition for reconsideration, FDA's letter granting the stay provides that the order is stayed until November 2, 2018, without the limitations Bayer now requests. --------------------------------------------------------------------------- By a letter dated April 16, 2018, the Acting Chief Scientist, pursuant to authority delegated by the Commissioner, concluded that the ANDA holders had not met the criteria for a mandatory stay under Sec. 10.35(e). The Acting Chief Scientist granted a temporary, discretionary stay of the effective date of the order until November 2, 2018. As described in the April 16, 2018, letter, based upon information submitted by the ANDA holders and not disputed by Bayer, it would likely be difficult for manufacturers of OTC PEG 3350 products to compensate for the removal of prescription PEG 3350 products within 30 days. The letter explained that public health interests would not be served should the 30-day effective date negatively impact the availability of PEG 3350, particularly given that the basis of the withdrawal of the ANDA products is not an issue of safety or efficacy. The April 16, 2018, letter additionally noted that FDA has provided lengthier time frames to phase out manufacturing and distribution of affected products in other cases. While the Acting Chief Scientist rejected the petitioners' arguments that financial hardship and harm to reputation resulting from the withdrawal order rise to the level of irreparable injury necessary for a mandatory stay under Sec. 10.35(e), she agreed that there may some validity to the petitioner's concerns of harm to their business interests as a result of the 30-day effective date. The Acting Chief Scientist concluded that it is in the public interest and in the interest of justice to stay the effective date of the April 2, 2018, order until November 2, 2018. The parties' submissions and the Agency's orders are available at https://www.regulations.gov and with the Dockets Management Staff (see ADDRESSES). FDA is providing notice of the decision to grant a temporary stay in accordance with Sec. 10.35(f). Dated: July 24, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-16148 Filed 7-27-18; 8:45 am] BILLING CODE 4164-01-P
![36604 Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices
click on the Device Registration and polyethylene glycol 3350 (PEG 3350) is By a letter dated April 16, 2018, the
Listing Module (DRLM) of FURLS stayed until November 2, 2018. Acting Chief Scientist, pursuant to
button. New establishments will need to DATES: FDA is staying the effective date authority delegated by the
register and existing establishments will of the April 2, 2018, order withdrawing Commissioner, concluded that the
update their annual registration using approval of ANDAs for certain ANDA holders had not met the criteria
choices on the DRLM menu. When you prescription laxatives with the active for a mandatory stay under § 10.35(e).
choose to register or update your annual ingredient PEG 3350 until November 2, The Acting Chief Scientist granted a
registration, the system will prompt you 2018. temporary, discretionary stay of the
through the entry of information about ADDRESSES: For access to the docket, go effective date of the order until
your establishment and your devices. If to https://www.regulations.gov and November 2, 2018. As described in the
you have any problems with this insert the docket number, found in April 16, 2018, letter, based upon
process, email: reglist@cdrh.fda.gov or brackets in the heading of this information submitted by the ANDA
call 301–796–7400 for assistance. (Note: document, into the ‘‘Search’’ box and holders and not disputed by Bayer, it
This email address and this telephone follow the prompts and/or go to the would likely be difficult for
number are for assistance with Dockets Management Staff, 5630 Fishers
establishment registration only; they are manufacturers of OTC PEG 3350
Lane, Rm. 1061, Rockville, MD 20852, products to compensate for the removal
not to be used for questions related to between 9 a.m. and 4 p.m., Monday
other aspects of medical device user of prescription PEG 3350 products
through Friday. Publicly available within 30 days. The letter explained
fees.) Problems with the BER system submissions may be seen in the docket.
should be directed to https:// that public health interests would not be
FOR FURTHER INFORMATION CONTACT: Julie served should the 30-day effective date
www.accessdata.fda.gov/scripts/email/
Finegan, Office of Scientific Integrity, negatively impact the availability of
cber/bldregcontact.cfm or call 240–402–
Office of the Chief Scientist, Food and PEG 3350, particularly given that the
8360.
Drug Administration, 10903 New basis of the withdrawal of the ANDA
D. Enter Your DFUF Order PIN and PCN Hampshire Ave., Bldg. 1, Rm. 4218, products is not an issue of safety or
After completing your annual or Silver Spring, MD 20993–0002, 301– efficacy. The April 16, 2018, letter
initial registration and device listing, 796–8618.
additionally noted that FDA has
you will be prompted to enter your SUPPLEMENTARY INFORMATION: In the provided lengthier time frames to phase
DFUF order PIN and PCN, when Federal Register of April 2, 2018 (83 FR out manufacturing and distribution of
applicable. This process does not apply 13994), FDA denied requests for hearing affected products in other cases. While
to establishments engaged only in the and issued an order withdrawing
the Acting Chief Scientist rejected the
manufacture, preparation, propagation, approval of ANDAs for certain
petitioners’ arguments that financial
compounding, or processing of licensed prescription laxatives with the active
ingredient PEG 3350. The effective date hardship and harm to reputation
biologic devices. CBER will send resulting from the withdrawal order rise
invoices for payment of the of the order was May 2, 2018. Between
April 6, 2018, and April 13, 2018, FDA to the level of irreparable injury
establishment registration fee to such
received petitions for stay under § 10.35 necessary for a mandatory stay under
establishments.
(21 CFR 10.35) on behalf of four ANDA § 10.35(e), she agreed that there may
Dated: July 24, 2018. some validity to the petitioner’s
holders: Breckenridge Pharmaceutical,
Leslie Kux, Inc. and Nexgen Pharma, Inc. (hereafter concerns of harm to their business
Associate Commissioner for Policy. Breckenridge/Nexgen) who submitted a interests as a result of the 30-day
[FR Doc. 2018–16178 Filed 7–27–18; 8:45 am] joint petition; Lannett Company, Inc.; effective date. The Acting Chief
BILLING CODE 4164–01–P and Paddock Laboratories, Inc. Scientist concluded that it is in the
(collectively the ANDA holders). public interest and in the interest of
Breckenridge/Nexgen, Lannett, and justice to stay the effective date of the
DEPARTMENT OF HEALTH AND Paddock petitioned FDA to stay its April 2, 2018, order until November 2,
HUMAN SERVICES order withdrawing the approval of their 2018.
ANDAs for prescription PEG 3350 and The parties’ submissions and the
Food and Drug Administration
argued that all four criteria for a Agency’s orders are available at https://
[Docket No. FDA–2008–N–0549] mandatory stay under § 10.35(e) were
www.regulations.gov and with the
met. Bayer Healthcare, LLC, (Bayer)
Dockets Management Staff (see
Prescription Polyethylene Glycol 3350; which holds an approved New Drug
ADDRESSES).
Denial of a Hearing and Order Application for MiraLAX, an over-the-
Withdrawing Approval of Abbreviated counter laxative containing PEG 3350, FDA is providing notice of the
New Drug Applications; Temporary responded. Bayer argued that the decision to grant a temporary stay in
Stay of Effective Date petitioners failed to meet any of the accordance with § 10.35(f).
factors in § 10.35(e).1 Dated: July 24, 2018.
AGENCY: Food and Drug Administration,
HHS. 1 On April 30, 2018, Bayer filed a submission Leslie Kux,
ACTION: Notice. titled ‘‘Request for Clarification of FDA Granting of Associate Commissioner for Policy.
a Petition for Stay of Action.’’ Bayer requested that [FR Doc. 2018–16148 Filed 7–27–18; 8:45 am]
SUMMARY: The Food and Drug FDA clarify that the stay allowed new
daltland on DSKBBV9HB2PROD with NOTICES
manufacturing only until May 2, 2018, with BILLING CODE 4164–01–P
Administration (FDA) is providing shipment of product permitted until November 2,
notice that the effective date of an April 2018. Breckenridge/Nexgen responded to Bayer’s
2, 2018, order denying requests for a request for clarification and argued that Bayer’s
hearing and withdrawing approval of submission should have been a petition for
reconsideration and that it failed to meet the
abbreviated new drug applications standards required for reconsideration. Regardless the stay provides that the order is stayed until
(ANDAs) for certain prescription of whether Bayer’s submission should have been a November 2, 2018, without the limitations Bayer
laxatives with the active ingredient petition for reconsideration, FDA’s letter granting now requests.
VerDate Sep<11>2014 20:33 Jul 27, 2018 Jkt 244001 PO 00000 Frm 00092 Fmt 4703 Sfmt 9990 E:\FR\FM\30JYN1.SGM 30JYN1](https://thefederalregister.org/doc/83_FR_36750/page/1.svg)
Document Created: 2018-07-28 01:44:24
Document Modified: 2018-07-28 01:44:24
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | FDA is staying the effective date of the April 2, 2018, order withdrawing approval of ANDAs for certain prescription laxatives with the active ingredient PEG 3350 until November 2, 2018. | |
| Contact | Julie Finegan, Office of Scientific Integrity, Office of the Chief Scientist, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4218, Silver Spring, MD 20993- 0002, 301-796-8618. | |
| FR Citation | 83 FR 36604 |
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