Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 4083 

1E.g., 85 FR 75893 (Nov. 27, 2020). 

2 Drug Amendments of 1962, Pub. L. 87–781, 76 

Stat. 780 (Oct. 10, 1962). 

3 1962 U.S.C.C.A.N. 2884, 2891. 

4Proceedings, FDA Conference on the KefauverHarris Drug Amendments and Proposed 

Regulations, at 7 (Feb. 15, 1963). 

5 Id. at 6. 

6 Drug Price Competition and Patent Term 

Restoration Act of 1984, Public Law 98–417, 98 

Stat. 1585, 1588 (Sept. 24, 1984). 

7 GAO, FDA Drug Approval, Application Review 

Times Largely Reflect Agency Goals (Mar. 2020), 

https://www.gao.gov/assets/710/705193.pdf. 

8FDA, New Drug Therapy Approvals 2019, 

https://www.fda.gov/drugs/new-drugs-fda-cdersnew-molecular-entities-and-new-therapeuticbiological-products/new-drug-therapy-approvals2019. 

9 In its review, the Department obtained the 

‘‘submission date’’ (or, if available, ‘‘filing date’’) of 

the 48 drugs by searching documents available to 

the public on FDA’s Drugs@FDA website. 

Dated: January 11, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–00833 Filed 1–14–21; 8:45 am] 

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DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

FDA Drug Review Timeline 

Transparency; Statement of Policy 

The Department and its component 

agencies exist to serve the American 

people. Consistent with and in follow 

up to the Department’s previous 

transparency efforts,1 and given the 

significant impact FDA’s approval of 

drugs has on Americans, the Secretary 

believes the public would benefit from 

information regarding the timeline for 

FDA’s review of drug product 

applications as provided in this 

document. 

In 1962, Congress amended the Food, 

Drug, and Cosmetic Act (FD&C Act) to 

authorize the Food and Drug 

Administration (FDA) to review and 

approve ‘‘new drugs’’ for safety and 

efficacy.2 When Congress made this 

historic change to our nation’s drug 

laws, it provided a timeframe for FDA’s 

review. In section 104 of the Drug 

Amendments of 1962, codified at 

section 505(c) of the FD&C Act, 21 

U.S.C. 355(c), Congress required that, 

for New Drug Applications (NDAs), 

‘‘[w]ithin one hundred eighty days after 

the filing of an application . . . , the 

Secretary shall either approve the 

application . . . or give the applicant 

notice of an opportunity for a hearing 

before the Secretary.’’ As the Senate 

Judiciary Committee explained at the 

time, ‘‘this provision strikes a balance 

between the need for governmental 

control to assure that new drugs are not 

placed on the market until they have 

passed the relevant tests and the need 

to insure that governmental control does 

not become so rigid that the flow of new 

drugs to the market, and the incentive 

to undergo the expense involved in 

preparing them for the market, become 

stifled.’’ 3

At the time, the 180-day timeframe for 

review of ‘‘new drugs’’ was 

uncontroversial. At a 1963 public 

hearing, the Acting Director for FDA’s 

Division of New Drugs stated that 

‘‘[a]pplications for drugs of questionable 

safety or effectiveness will continue to 

take more of every body’s time.’’ 4

However, the Director ‘‘pledge[d] action 

greatly short of the 180-day limit on all 

applications and supplements that 

present good scientific evidence of the 

safety and effectiveness of the drugs and 

that are properly informative to the 

physician or patient.’’ 5

When Congress made additional 

amendments to the FD&C Act in 1984, 

it borrowed from and applied the 

existing 180-day review framework to 

the review of Abbreviated New Drug 

Applications (ANDAs), the approval 

mechanism for generic drugs.6 Under 

section 505(j)(5)(A) of the FD&C Act, 21 

U.S.C. 355(j)(5)(A), the Secretary ‘‘shall 

approve or disapprove the [ANDA] 

application’’ ‘‘[w]ithin one hundred and 

eighty days of the initial receipt of an 

application.’’ FDA promulgated 

regulations implementing the 180-day 

statutory provisions for review of NDAs 

and ANDAs. See 21 CFR 314.100, 

314.101. While the Prescription Drug 

User Fee Act (PDUFA) and Generic Drug 

User Fee Act (GDUFA) in their iterative 

forms have provided FDA with 

additional resources to carry out its 

statutory mission, Congress did not do 

away with the 180-day provisions in 

section 505 of the FD&C Act, 21 U.S.C. 

355, in those laws. 

Though the agency has made strides 

over the years to expedite review in the 

face of limited resources, the total time 

elapsed between FDA’s filing of an NDA 

or receipt of an ANDA to ultimate 

approval or disapproval of the 

application often exceeds 180 days. 

Even so, reporting on drug approvals, 

such as GAO’s March 2020 report,7

focused primarily on agency compliance 

with PDUFA dates. The GAO report did 

not mention the 180-day benchmark or 

discuss the agency’s approval timeframe 

in view of that requirement. 

Given this gap in reporting, the 

Department reviewed FDA’s New Drug 

Therapy Approvals from 2019 8 in view 

of the 180-day timeframe. The 

Department’s review considered 48 

products listed by the agency as 

approved in 2019.9 The table below 

presents, among other things, the date of 

submission, date of approval, total days 

from submission to approval, and total 

days in excess of 180 days of 

submission for these drugs. 

Drug brand name Summary of FDA-approved use on approval 

date 

Submission 

date Approval date 

Days 

submission 

to approval 

Days in 

excess of 

180 days 

Accrufer ......................... Iron deficiency anemia ......................................... 9/27/2018 7/25/2019 301 121 

Adakveo ........................ Reduce vasoocclusive crises in sickle cell disease.5/16/2019 11/15/2019 183 3 

Aklief .............................. Acne vulgaris ....................................................... 10/4/2018 10/4/2019 365 185 

Balversa ........................ Locally advanced or metastatic bladder cancer .. 9/18/2018 4/12/2019 206 26 

Beovu ............................ Wet age-related macular degeneration ............... 2/7/2019 10/7/2019 242 62 

Brukinsa ........................ Mantle cell lymphoma .......................................... 6/27/2019 11/14/2019 140 N/A 

Cablivi ............................ Acquired thrombotic thrombocytopenic purpura .. 6/6/2018 2/6/2019 245 65 

Caplyta .......................... Schizophrenia ...................................................... 9/27/2018 12/20/2019 449 269 

Dayvigo ......................... Insomnia ............................................................... 12/27/2018 12/20/2019 358 178 

Egaten ........................... Fascioliasis ........................................................... 6/14/2018 2/13/2019 244 64 

Enhertu .......................... Metastatic breast cancer ...................................... 8/29/2019 12/20/2019 113 N/A 

Evenity ........................... Osteoporosis ........................................................ 7/9/2018 4/9/2019 274 94 

ExEm Foam .................. Diagnostic agent for fallopian tube assessment .. 10/9/2018 11/7/2019 394 214 

Fetroja ........................... Complicated urinary tract infection ...................... 12/14/2018 11/14/2019 335 155 

fluorodopa F 18 ............. Diagnostic agent for Parkinsonian syndromes .... 4/10/2019 10/10/2019 183 3 

4084 Federal Register / Vol. 86, No. 10 / Friday, January 15, 2021 / Notices 

Drug brand name Summary of FDA-approved use on approval 

date 

Submission 

date Approval date 

Days 

submission 

to approval 

Days in 

excess of 

180 days 

Ga 68 DOTATOC .......... Diagnostic agent for neuroendocrine tumors ...... 5/23/2018 8/21/2019 455 275 

Givlaari .......................... Acute hepatic porphyria ....................................... 6/4/2019 11/20/2019 169 N/A 

Ibsrela ............................ Irritable bowel syndrome with constipation .......... 9/12/2018 9/12/2019 365 185 

Inrebic ............................ Certain types of myelofibrosis ............................. 1/4/2019 8/16/2019 224 44 

Jeuveau ......................... Improve appearance of glabellar lines (lines between eyebrows).5/15/2017 2/1/2019 627 447 

Mayzent ......................... Relapsing forms of multiple sclerosis .................. 6/28/2018 3/26/2019 271 91 

Nourianz ........................ Parkinson’s disease ‘‘off’’ episodes ..................... 7/27/2019 8/27/2019 31 N/A 

Nubeqa .......................... Non-metastatic prostate cancer ........................... 2/26/2019 7/30/2019 154 N/A 

Oxbryta .......................... Sickle cell disease ............................................... 6/26/2019 11/25/2019 152 N/A

Padcev .......................... Refractory bladder cancer ................................... 7/15/2019 12/18/2019 146 N/A 

Piqray ............................ Advanced or metastatic breast cancer ................ 12/18/2018 5/24/2019 157 N/A 

Polivy ............................. Relapsed or refractory diffuse large B-cell 

lymphoma.

12/19/2018 6/10/2019 173 N/A 

pretomanid .................... Treatment-resistant forms of tuberculosis ........... 12/14/2018 8/14/2019 243 63 

Reblozyl ......................... Anemia associated with beta thalassemia .......... 4/4/2019 11/8/2019 218 38 

Recarbrio ....................... Complicated urinary tract infections and complicated intra-abdominal infections 11/16/2018 7/16/2019 242 62 

Reyvow .......................... Migraine with or without aura .............................. 10/11/2018 10/11/2019 365 185 

Rinvoq ........................... Moderately to severely active rheumatoid arthritis.12/18/2018 8/16/2019 241 61 

Rozlytrek ....................... Metastatic non-small cell lung cancer and locally 

advanced or metastatic solid tumors with a 

specific genetic defect.

12/18/2018 8/15/2019 240 60 

Scenesse ....................... Increase pain-free light exposure in patients with 

erythropoietic protoporphyria.

11/8/2018 10/8/2019 334 154 

Skyrizi ............................ Moderate-to-severe plaque psoriasis .................. 4/3/2018 4/23/2019 385 205 

Sunosi ........................... Excessive daytime sleepiness in patients with 

narcolepsy or obstructive sleep apnea.

12/20/2017 3/20/2019 455 275 

TissueBlue ..................... Dye used in eye surgery ...................................... 4/29/2019 12/20/2019 235 55 

Trikafta .......................... Cystic Fibrosis ...................................................... 7/19/2019 10/21/2019 94 N/A 

Turalio ........................... Symptomatic tenosynovial giant cell tumor ......... 12/3/2018 8/2/2019 242 62 

Ubrelvy .......................... Migraine ............................................................... 12/26/2018 12/23/2019 362 182 

Vyleesi ........................... Hypoactive sexual desire disorder in premenopausal women.3/23/2018 6/21/2019 455 275 

Vyndaqel ....................... Cardiomyopathy caused by transthyretin-mediated amyloidosis.11/2/2018 5/3/2019 182 2 

Vyondys 53 ................... Duchenne muscular dystrophy ............................ 12/19/2018 12/12/2019 358 178 

Wakix ............................. Excessive daytime sleepiness in patients with 

narcolepsy.

12/14/2018 8/14/2019 243 63 

Xcopri ............................ Partial-onset seizures .......................................... 11/21/2018 11/21/2019 365 185

Xenleta .......................... Community-acquired bacterial pneumonia .......... 12/19/2018 8/19/2019 243 63 

Xpovio ........................... Relapsed or refractory multiple myeloma ............ 8/6/2018 7/3/2019 331 151 

Zulresso ......................... Postpartum depression ........................................ 4/9/2018 3/19/2019 344 164 

The Department found that 38 of the 

48 drugs (79.1%) were approved more 

than 180 days after submission of an 

application. The average time from 

submission to approval for the 48 drugs 

in the table above was 273.8 days. It 

should be noted that in many instances 

the failure to meet the 180-day statutory 

benchmark may have been justified and 

in such cases, was frequently the result 

of questions by the agency and 

responses by the applicant. 

Because FDA’s approval of drugs 

affects the health and financial wellbeing of all Americans, the Department 

believes the public is entitled to 

information like the data provided in 

the table above regarding the amount of 

the time required for FDA review and 

approval of new and generic drugs. To 

that end, effective upon publication of 

this Notice, for all NDA and ANDA 

approvals, FDA must take the following 

action. 

FDA shall publish annually on its 

website, for each approved NDA and 

ANDA approved after the date of this 

publication, (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). For 

example, if an NDA was ‘‘filed’’ on 

January 25, 2021 and approved on 

December 27, 2021, then the total days 

elapsed for review would be 336 days, 

and the days in excess of 180 days 

would be 156 days. 

Members of the public can use this 

information to further study the health 

and economic impacts of FDA review 

timelines. This reporting is also 

consistent with FDA’s mission to 

‘‘promote the public health by promptly 

and efficiently reviewing clinical 

research and taking appropriate action 

on the marketing of regulated products 

in a timely manner.’’ 21 U.S.C. 

393(b)(1). In addition to educating the 

public, the Department believes this 

information will inform Congress as to 

whether to provide FDA with additional 

resources to carry out the agency’s 

review obligations within the timeframe 

prescribed by Congress. 

Dated: January 8, 2021. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–00786 Filed 1–14–21; 8:45 am] 

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