[Federal Register Volume 86, Number 83 (Monday, May 3, 2021)]
[Notices]
[Pages 23389-23391]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-09134]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-Z-0025]


Withdrawal of Notice Regarding the Food and Drug Administration 
Drug Review Timeline Transparency; Revocation of Statement of Policy

AGENCY: Food and Drug Administration (FDA), Department of Health and 
Human Services (HHS).

ACTION: Notice; withdrawal; statement of policy; revocation.

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SUMMARY: The Department of Health and Human Services (Department or 
HHS) and the Food and Drug Administration (FDA or Agency) are issuing 
this notice to withdraw the notice published in the Federal Register of 
January 15, 2021, announcing a Statement of Policy indicating that FDA 
will publish certain information regarding the timeline for its review 
of drug product applications. The Department and FDA are withdrawing 
the notice and revoking the Statement of Policy because, among other 
things, the notice did not account for all relevant considerations 
related to information that is already publicly available about FDA's 
review of drug applications.

DATES: The notice is withdrawn and the Statement of Policy is revoked 
as of May 3, 2021.

FOR FURTHER INFORMATION CONTACT: Jennifer Forde, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6228, Silver Spring, MD 20993-0002, 301-
348-3035.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 15, 2021 
(86 FR 4083), HHS published a notice entitled ``FDA Drug Review 
Timeline Transparency; Statement of Policy'' (Statement of Policy). The 
Statement of Policy described the Department's review of application 
timelines and directed FDA to publish annually on its website, for each 
approved new drug application (NDA) and abbreviated new drug 
application (ANDA) approved after the date of the Federal Register 
notice: ``(a) the date on which FDA `filed,' in the case of an NDA, or 
`received,' in the case of an ANDA, such application; (b) the date on 
which FDA approved the NDA or ANDA; (c) the total days elapsed between 
the dates in (a) and (b); and (d) the total days in excess of 180-days 
the date of (c).'' We did not find any evidence that HHS consulted 
with, otherwise involved, or even notified

[[Page 23390]]

FDA before issuing the notice. Section 1003(d) (21 U.S.C. 393(d)) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides that the 
Secretary ``shall be responsible for executing'' the FD&C Act ``through 
the [FDA] Commissioner.'' Here, the notice in directing FDA to report 
on whether the Agency's action on drug applications met statutory 
timelines is clearly an action ``executing'' the FD&C Act.
    Upon further consideration, the Department and FDA have determined 
that the Statement of Policy did not account for all relevant 
considerations related to the timing of FDA's review of drug 
applications. The Statement of Policy did not accurately account for 
the time that the review period for drug applications starts. Although 
the table of drug approvals presented in the Statement of Policy (86 FR 
4083 at 4083-4084) references the drug application submission date as 
the beginning of a 180-day review period, the review period does not 
actually start until a drug application is ``filed'' or ``received'' by 
FDA (see section 505(c)(1) and (j)(5)(A) of the FD&C Act (21 U.S.C. 
355(c)(1) and (j)(5)(A))). Under FDA's regulations, an NDA is not filed 
until FDA has made a threshold determination that the NDA is 
sufficiently complete to permit a substantive review. For NDAs, FDA 
will determine whether the application may be filed within 60 days (see 
Sec.  314.101(a)(1) (21 CFR 314.101(a)(1))). If the application is 
filed, the regulation states that the ``date of filing will be the date 
60 days after the date FDA received the NDA. The date of filing begins 
the 180-day period described in section 505(c) of the Federal Food, 
Drug, and Cosmetic Act'' (Sec.  314.101(a)(2)). An ANDA is not received 
until FDA has made a threshold determination that the ANDA is 
substantially complete (Sec.  314.101(b)(1)). If the ANDA is received, 
the date of receipt is then considered to be the date of submission 
(Sec.  314.101(b)(2)).
    Moreover, the 180-day review period can be extended by mutual 
agreement between FDA and an applicant (see section 505(c)(1) and 
(j)(5)(A) of the FD&C Act; Sec.  314.100(c)). For instance, an 
applicant that receives a complete response letter from FDA may choose 
to respond to the complete response letter (rather than requesting an 
opportunity for a hearing), thus agreeing to extend the 180-day review 
period (see 21 CFR 314.110(b)-(c) and 314.101(f)). We also note that 
since the enactment of the Prescription Drug User Fee Act of 1992 
(PDUFA), there has been a mutual understanding between industry and the 
Agency that the review cycle for an application or supplement subject 
to user fees may be adjusted (either shortened or lengthened) in 
accordance with the user fee performance goals (see ``Applications for 
Approval to Market a New Drug; Complete Response Letter; Amendments to 
Unapproved Applications,'' 73 FR 39588 at 39593 (July 10, 2008)). A 
similar understanding exists between industry and the Agency with 
respect to the review of generic drug applications under the Generic 
Drug User Fee Amendments (GDUFA).
    Further, the Department and FDA have determined that the Statement 
of Policy did not take into account all of the relevant considerations 
related to the timeframe for FDA's review of drug applications. For 
instance, the Statement of Policy did not fully consider PDUFA and 
GDUFA. The sixth reauthorization of PDUFA and the second 
reauthorization of GDUFA reference performance goals transmitted by the 
Secretary of HHS to Congress in commitment letters,\1\ which represent 
the result of FDA's discussions with the regulated industry and public 
stakeholders. The performance goals and other commitments specified in 
these letters apply to aspects of the drug review programs that are 
important for facilitating timely access to safe and effective 
medicines for patients. The commitment letters include goals for the 
timeline of the review of drug applications, and FDA regularly meets or 
exceeds these goals.
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    \1\ See sections 101(b) and 301(b) of FDA Reauthorization Act of 
2017, Public Law 115-52 (FDARA).
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    FDA's approval of drugs benefits American consumers, who have 
access to one of the safest and most advanced pharmaceutical systems in 
the world. Under PDUFA, FDA has significantly reduced the time it takes 
to evaluate new drugs and biologics without compromising its rigorous 
standards for a demonstration of safety, efficacy, and quality of new 
drugs and biologics before approval.\2\ The efficiency gains under 
PDUFA have revolutionized the drug review process in the United States 
and enabled FDA to ensure more timely access to innovative and 
important new therapies for patients.\3\ FDA also understands that high 
drug prices have a direct impact on patients. The processes under GDUFA 
continue to help reduce review times and approval times, boosting 
competition and helping to ensure that safe, effective, high-quality 
generic drug products are available to the American public.\4\
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    \2\ See FDA's Annual PDUFA Performance Reports available at: 
https://www.fda.gov/about-fda/user-fee-performance-reports/pdufa-performance-reports.
    \3\ Id.
    \4\ See FDA's Annual GDUFA Performance Reports available at: 
https://www.fda.gov/about-fda/user-fee-performance-reports/gdufa-performance-reports.
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    Transparency and accountability will not be sacrificed in the 
absence of the Statement of Policy since such information is already 
publicly available. PDUFA and GDUFA require the HHS Secretary to submit 
annual performance reports to Congress for each fiscal year during 
which fees are collected (see sections 736B(a) and 744C(a) of the FD&C 
Act (21 U.S.C. 379h-2(a) and 379j-43(a))). Annual performance reports 
document FDA performance in meeting goals in the commitment letters 
agreed to by the HHS Secretary, including goals for the timeline of the 
review of drug applications. These reports are required to be publicly 
available and posted on FDA's website (sections 736B(e) and 744C(e) of 
the FD&C Act), and they are available at https://www.fda.gov/about-fda/user-fee-performance-reports/pdufa-performance-reports (PDUFA) and 
https://www.fda.gov/about-fda/user-fee-performance-reports/gdufa-performance-reports (GDUFA). In addition, as part of FDARA and its 
GDUFA II commitments (see section 807 of FDARA and section VI(C)(1) and 
(2) of the GDUFA Reauthorization Performance Goals and Program 
Enhancements for Fiscal Years 2018-2022, available at https://www.fda.gov/media/101052/download), FDA publishes monthly metrics on 
its website that include the number of applications approved and 
tentatively approved and quarterly metrics that include the mean and 
median approval and tentative approval times, available at https://www.fda.gov/industry/generic-drug-user-fee-amendments/enhanced-accountability-reporting. Thus, the review timeline information the 
Statement of Policy sought to have FDA provide publicly would be 
redundant with information that is already publicly available.
    Therefore, the Federal Register notice announcing the Statement of 
Policy published on January 15, 2021, is withdrawn and the Statement of 
Policy is revoked.


[[Page 23391]]


    Dated: April 23, 2021.
Janet Woodcock,
Acting Commissioner of Food and Drugs.

    Dated: April 27, 2021.
Xavier Becerra,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-09134 Filed 4-30-21; 8:45 am]
BILLING CODE 4164-01-P


