1_CRD INTRODUCTION_NN1 
When_CJS the_AT0 COVID-19_AJ0 pandemic_AJ0 emerged_VVN in_PRP late_AJ0 2019_CRD ,_PUN researchers_NN2 across_PRP disciplines_NN2 employed_VVN various_AJ0 techniques_NN2 to_TO0 estimate_VVI its_DPS impact_NN1 ._SENT For_PRP example_NN1 ,_PUN some_DT0 research_NN1 estimates_VVZ the_AT0 expected_AJ0 number_NN1 of_PRF infections_NN2 (_PUL Jung_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD )_PUR ,_PUN hospitalizations_NN2 (_PUL Sussman_NP0 ,_PUN 2020_CRD )_PUR ,_PUN mortality_NN1 (_PUL Jung_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Sussman_NP0 ,_PUN 2020_CRD )_PUR ,_PUN and_CJC broader_AJC economic_AJ0 consequences_NN2 (_PUL Borgonovi_NP0 and_CJC Andrieu_NP0 ,_PUN 2020_CRD ;_PUN Coibion_NP0 et_NP0 al._NP0 ,_PUN 2020a_NP0 ;_PUN 2020b_NP0 ;_PUN Cachanosky_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Nicola_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD )_PUR ._SENT Hoping_VVG to_TO0 implement_VVI effective_AJ0 policy_NN1 responses_NN2 to_PRP COVID-19_AJ0 ,_PUN other_AJ0 literature_NN1 examines_VVZ the_AT0 effectiveness_NN1 of_PRF various_AJ0 voluntary_AJ0 and_CJC involuntary_AJ0 measures_NN2 to_TO0 prevent_VVI healthcare_NN1 systems_NN2 from_PRP becoming_VVG overwhelmed_VVN (_PUL Chudik_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Gupta_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Hornstein_NP0 ,_PUN 2020_CRD ;_PUN Mongey_NN1 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Piguillem_NP0 and_CJC Shi_NP0 ,_PUN 2020_CRD )_PUR .1_CRD 
As_CJS the_AT0 COVID-19_AJ0 pandemic_AJ0 continued_VVD into_PRP 2020_CRD ,_PUN health_NN1 policy_NN1 and_CJC medical_AJ0 literature_NN1 began_VVD examining_VVG how_AVQ the_AT0 US_NP0 healthcare_NN1 sector_NN1 might_VM0 adjust_VVI to_TO0 provide_VVI treatment_NN1 for_PRP COVID-19_AJ0 patients_NN2 and_CJC treat_VVB patients_NN2 with_PRP other_AJ0 conditions_NN2 ._SENT This_DT0 literature_NN1 includes_VVZ policy_NN1 recommendations_NN2 for_PRP technology_NN1 adoption_NN1 and_CJC expanded_AJ0 access_NN1 to_PRP telemedicine_NN1 (_PUL Hollander_NP0 and_CJC Carr_NP0 ,_PUN 2020_CRD ;_PUN Kandel_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Keesara_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Portnoy_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD )_PUR ._SENT However_AV0 ,_PUN many_DT0 of_PRF the_AT0 recommended_AJ0 policy_NN1 changes_NN2 face_VVB regulatory_AJ0 obstacles_NN2 issued_VVN by_PRP the_AT0 Food_NN1 and_CJC Drug_NN1 Administration_NN1 (_PUL FDA_NP0 )_PUR ._SENT Consequently_AV0 ,_PUN much_DT0 of_PRF the_AT0 literature_NN1 examining_VVG how_AVQ to_TO0 expand_VVI healthcare_NN1 capacity_NN1 during_PRP the_AT0 pandemic_AJ0 notes_NN2 how_AVQ existing_AJ0 FDA_NN1 regulations_NN2 prevent_VVB or_CJC delay_VVB recommended_AJ0 policy_NN1 changes_NN2 (_PUL Atluri_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD ;_PUN Chen_NP0 and_CJC Mao_NP0 ,_PUN 2020_CRD ;_PUN March_NP0 ,_PUN 2020_CRD ;_PUN Ravi_NP0 et_NP0 al._NP0 ,_PUN 2020_CRD )_PUR ._SENT 
Much_DT0 of_PRF the_AT0 analysis_NN1 examining_VVG the_AT0 FDA_NN1 's_POS impact_NN1 during_PRP the_AT0 COVID-19_AJ0 pandemic_AJ0 is_VBZ found_VVN in_PRP medical_AJ0 and_CJC public_AJ0 health_NN1 journals_NN2 ._SENT However_AV0 ,_PUN a_AT0 considerable_AJ0 body_NN1 of_PRF economics_NN1 research_NN1 finds_VVZ that_CJT FDA_NN1 regulations_NN2 have_VHB hindered_VVN the_AT0 U.S._NP0 healthcare_NN1 sector_NN1 's_POS ability_NN1 to_TO0 treat_VVI patients_NN2 long_AJ0 before_PRP COVID-19_NN1 (_PUL Higgs_NP0 ,_PUN 1995_CRD ;_PUN Philipson_NP0 and_CJC Sun_NP0 ,_PUN 2008_CRD )_PUR ._SENT Previous_AJ0 literature_NN1 specifically_AV0 finds_VVZ FDA_NN1 regulations_NN2 of_PRF approving_VVG pharmaceuticals_NN2 ,_PUN medical_AJ0 devices_NN2 ,_PUN and_CJC other_AJ0 forms_NN2 of_PRF treatment_NN1 prolong_VVI or_CJC prevent_VVI their_DPS adoption_NN1 within_PRP the_AT0 US_NP0 to_PRP the_AT0 detriment_NN1 of_PRF patients_NN2 and_CJC healthcare_NN1 providers_NN2 (_PUL Evans_NP0 and_CJC Watson_NP0 ,_PUN 2015_CRD ;_PUN Higgs_NP0 ,_PUN 1995_CRD ;_PUN Peltzman_NP0 ,_PUN 1973_CRD ;_PUN Ward_NP0 ,_PUN 1992_CRD )_PUR ._SENT 
Curiously_AV0 ,_PUN previous_AJ0 economic_AJ0 literature_NN1 examining_VVG the_AT0 FDA_NN1 has_VHZ not_XX0 examined_VVN the_AT0 agency_NN1 's_POS impact_NN1 during_PRP public_AJ0 health_NN1 crises_NN2 ,_PUN including_PRP pandemics_NN2 ._SENT Given_VVN the_AT0 impact_NN1 of_PRF COVID-19_NN1 on_PRP the_AT0 U.S._NP0 economy_NN1 and_CJC healthcare_NN1 sector_NN1 ,_PUN a_AT0 more_AV0 robust_AJ0 understanding_NN1 of_PRF how_AVQ FDA_NN1 regulation_NN1 impacted_VVD the_AT0 United_NP0 States_NP0 '_POS response_NN1 to_PRP the_AT0 COVID-19_AJ0 pandemic_AJ0 is_VBZ vital_AJ0 to_PRP developing_VVG effective_AJ0 policy_NN1 responses_NN2 to_TO0 better_AV0 help_VVI the_AT0 healthcare_NN1 sector_NN1 serve_VVB patients_NN2 ._SENT 
This_DT0 article_NN1 examines_VVZ this_DT0 question_NN1 by_PRP employing_VVG a_AT0 political_AJ0 economy_NN1 framework_NN1 to_TO0 examine_VVI how_AVQ FDA_NN1 regulations_NN2 have_VHB impacted_VVN COVID-19_AJ0 testing_NN1 ,_PUN the_AT0 utilization_NN1 of_PRF remdesivir_NN1 ,_PUN and_CJC COVID-19_AJ0 vaccines_NN2 ._SENT I_PNP specifically_AV0 examine_VVB these_DT0 components_NN2 of_PRF addressing_VVG the_AT0 pandemic_AJ0 because_CJS they_PNP were_VBD issued_VVN Emergency_NN1 Use_NN1 Authorization_NN1 (_PUL EUA_NP0 )_PUR by_PRP the_AT0 FDA_NN1 ,_PUN allowing_VVG them_PNP to_TO0 reach_VVI clinicians_NN2 and_CJC patients_NN2 without_PRP undergoing_VVG the_AT0 agency_NN1 's_POS regulatory_AJ0 approval_NN1 process_NN1 ._SENT Comparing_VVG the_AT0 healthcare_NN1 sector_NN1 's_POS adoption_NN1 of_PRF COVID_AJ0 testing_NN1 and_CJC treatment_NN1 before_PRP and_CJC after_PRP the_AT0 EUAs_NP0 provides_VVZ insight_NN1 into_PRP the_AT0 impact_NN1 of_PRF the_AT0 FDA_NN1 's_POS regulations_NN2 restricting_VVG access_NN1 to_PRP testing_NN1 and_CJC treatment_NN1 ._SENT My_DPS analysis_NN1 finds_VVZ that_CJT the_AT0 FDA_NN1 's_POS regulations_NN2 enacted_VVN before_PRP the_AT0 COVID-19_AJ0 pandemic_AJ0 began_VVD strongly_AV0 restricted_AJ0 clinician_NN1 and_CJC patient_NN1 access_NN1 to_PRP COVID-19_AJ0 testing_NN1 ,_PUN remdesivir_NN1 ,_PUN and_CJC vaccines_NN2 ._SENT After_PRP the_AT0 FDA_NN1 issued_VVD EUAs_NP0 ,_PUN the_AT0 healthcare_NN1 sector_NN1 quickly_AV0 adopted_VVN COVID-19_AJ0 testing_NN1 and_CJC remdesivir_NN1 with_PRP little_AJ0 evidence_NN1 of_PRF negative_AJ0 consequences_NN2 ._SENT These_DT0 findings_NN2 contribute_VVB to_PRP the_AT0 economics_NN1 literature_NN1 examining_VVG the_AT0 FDA_NN1 and_CJC contemporary_AJ0 COVID-19_AJ0 policy_NN1 research_NN1 ._SENT 
This_DT0 article_NN1 proceeds_VVZ as_CJS follows_VVZ ._SENT Section_NN1 2_CRD reviews_VVZ the_AT0 economic_AJ0 literature_NN1 assessing_VVG the_AT0 FDA_NN1 's_POS regulatory_AJ0 impact_NN1 on_PRP the_AT0 healthcare_NN1 sector_NN1 ._SENT Section_NN1 3_CRD develops_VVZ a_AT0 political_AJ0 economy_NN1 framework_NN1 to_TO0 examine_VVI the_AT0 FDA_NN1 's_POS incentives_NN2 when_CJS determining_VVG whether_CJS to_TO0 approve_VVI goods_NN2 ._SENT Section_NN1 4_CRD applies_VVZ this_DT0 framework_NN1 to_TO0 examine_VVI the_AT0 development_NN1 of_PRF COVID-19_AJ0 testing_NN1 ,_PUN remdesivir_NN1 treatment_NN1 ,_PUN and_CJC vaccination_NN1 before_PRP and_CJC after_PRP the_AT0 FDA_NN1 issued_VVD EUAs_NP0 ._SENT Section_NN1 5_CRD concludes_VVZ and_CJC provides_VVZ implications_NN2 for_PRP future_AJ0 research_NN1 ._SENT 
2_CRD LITERATURE_NN1 REVIEW_NN1 
Most_DT0 economic_AJ0 analysis_NN1 of_PRF the_AT0 FDA_NN1 occurs_VVZ after_PRP the_AT0 Kefauver-Harris_NP0 Amendments_NN2 of_PRF 1962.2_CRD These_DT0 legislative_AJ0 acts_NN2 granted_VVD the_AT0 FDA_NN1 the_AT0 authority_NN1 to_TO0 determine_VVI both_DT0 efficacy_NN1 and_CJC safety_NN1 standards_NN2 for_PRP drugs_NN2 before_PRP entering_VVG the_AT0 market_NN1 ._SENT The_AT0 amendments_NN2 also_AV0 allowed_VVN the_AT0 agency_NN1 to_TO0 set_VVI clinical_AJ0 trial_NN1 standards_NN2 and_CJC designs_NN2 (_PUL Hanson_NP0 ,_PUN 1995_CRD )_PUR ._SENT In_PRP the_AT0 first_ORD economic_AJ0 analysis_NN1 of_PRF the_AT0 FDA_NN1 and_CJC the_AT0 1962_CRD Amendments_NN2 ,_PUN Peltzman_NP0 (_PUL 1973_CRD )_PUR finds_VVZ that_CJT the_AT0 increased_AJ0 regulatory_AJ0 stringency_NN1 resulted_VVN in_PRP an_AT0 estimated_AJ0 5_CRD –_PUN 10_CRD %_NN0 tax_NN1 on_PRP drug_NN1 purchases_NN2 ._SENT The_AT0 author_NN1 also_AV0 noted_VVD the_AT0 high_AJ0 cost_NN1 of_PRF compliance_NN1 "_PUQ engendered_VVN a_AT0 marked_AJ0 reduction_NN1 in_PRP drug_NN1 innovation_NN1 "_PUQ (_PUL p._NN0 1049_CRD )_PUR ._SENT 
Much_DT0 of_PRF the_AT0 literature_NN1 following_PRP Petlzman_NP0 's_POS analysis_NN1 concludes_VVZ increased_AJ0 regulatory_AJ0 stringency_NN1 into_PRP the_AT0 drug_NN1 market_NN1 resulted_VVN in_PRP considerable_AJ0 increases_NN2 in_PRP drug_NN1 prices_NN2 ._SENT Examining_VVG a_AT0 sample_NN1 of_PRF 93_CRD randomly_AV0 selected_VVN new_AJ0 chemical_AJ0 entities_NN2 ,_PUN DiMasi_NP0 et_NP0 al._NP0 (_PUL 1991_CRD )_PUR estimate_VVB the_AT0 cost_NN1 of_PRF developing_VVG a_AT0 new_AJ0 drug_NN1 in_PRP 1991_CRD was_VBD approximately_AV0 $_NN0 114_CRD million_CRD (_PUL $_NN0 260_CRD million_CRD in_PRP 2020_CRD dollars_NN2 )_PUR ._SENT Nearly_AV0 a_AT0 decade_NN1 after_PRP ,_PUN DiMasi_NP0 et_NP0 al._NP0 (_PUL 2003_CRD )_PUR estimate_VVB the_AT0 cost_NN1 of_PRF new_AJ0 drug_NN1 approval_NN1 to_TO0 be_VBI approximately_AV0 $_NN0 804_CRD million_CRD in_PRP 2003_CRD (_PUL $_NN0 1.2_CRD billion_CRD in_PRP 2020_CRD dollars_NN2 )_PUR ._SENT Adams_NP0 and_CJC Branter_NP0 (_PUL 2006_CRD )_PUR similarly_AV0 estimated_VVN the_AT0 cost_NN1 to_TO0 be_VBI between_PRP $_NN0 500_CRD and_CJC $_NN0 2_CRD billion_CRD in_PRP 2000_CRD dollars_NN2 (_PUL between_PRP $_NN0 752_CRD million_CRD and_CJC $_NN0 3_CRD billion_CRD in_PRP 2020_CRD dollars_NN2 )_PUR ._SENT 
FDA_NN1 authority_NN1 to_TO0 set_VVI drug_NN1 approval_NN1 standards_NN2 also_AV0 lengthened_VVD the_AT0 time_NN1 required_VVN for_PRP drugs_NN2 to_TO0 reach_VVI patients_NN2 ._SENT Grabowski_NP0 et_NP0 al._NP0 (_PUL 1978_CRD )_PUR find_VVB the_AT0 average_AJ0 time_NN1 required_VVN to_TO0 approve_VVI new_AJ0 drugs_NN2 from_PRP 1962_CRD to_PRP 1967_CRD increased_VVN from_PRP an_AT0 average_NN1 of_PRF approximately_AV0 7_CRD –_PUN 30_CRD months_NN2 ._SENT Pharmaceuticals_NN2 '_POS time_NN1 to_TO0 complete_VVI FDA_NN1 approval_NN1 continued_VVD to_TO0 increase_VVI throughout_PRP the_AT0 1980s_CRD and_CJC mid-1990s_CRD ._SENT From_PRP 1980_CRD to_PRP 1989_CRD ,_PUN the_AT0 average_AJ0 time_NN1 from_PRP the_AT0 synthesis_NN1 of_PRF a_AT0 new_AJ0 drug_NN1 to_PRP marketing_NN1 approval_NN1 averaged_VVD 14.1_CRD years_NN2 ,_PUN rising_VVG to_PRP 15.2_CRD years_NN2 from_PRP 1990_CRD to_PRP 1996_CRD (_PUL Miller_NP0 ,_PUN 1988_CRD )_PUR ._SENT These_DT0 long_AJ0 approval_NN1 times_NN2 exceeded_VVD those_DT0 found_VVN in_PRP other_AJ0 developed_AJ0 nations_NN2 ._SENT Over_PRP mostly_AV0 the_AT0 same_DT0 period_NN1 ,_PUN Wardell_NP0 (_PUL 1973_CRD )_PUR notes_VVZ the_AT0 time_NN1 required_VVN to_TO0 have_VHI new_AJ0 drugs_NN2 approved_VVN in_PRP the_AT0 United_NP0 States_NP0 exceeded_VVD those_DT0 in_PRP the_AT0 United_NP0 Kingdom_NP0 by_PRP an_AT0 average_NN1 of_PRF 2_CRD years_NN2 ._SENT Kaitin_NP0 et_NP0 al._NP0 (_PUL 1989_CRD )_PUR find_VVB a_AT0 similar_AJ0 two-year_AJ0 difference_NN1 between_PRP drug_NN1 approval_NN1 times_NN2 between_PRP the_AT0 United_NP0 States_NP0 and_CJC the_AT0 United_NP0 Kingdom_NP0 from_PRP 1977_CRD to_PRP 1987._CRD From_PRP 1970_CRD to_PRP 1993_CRD ,_PUN approval_NN1 times_NN2 for_PRP drugs_NN2 and_CJC medical_AJ0 devices_NN2 in_PRP the_AT0 United_NP0 States_NP0 trailed_VVD those_DT0 in_PRP the_AT0 United_NP0 Kingdom_NP0 ,_PUN Germany_NP0 ,_PUN France_NP0 ,_PUN and_CJC Spain_NP0 (_PUL Kaitin_NP0 and_CJC Brown_NP0 ,_PUN 1995_CRD )_PUR ._SENT Longer_AJC approval_NN1 times_NN2 for_PRP many_DT0 drugs_NN2 can_VM0 be_VBI lethal_AJ0 ._SENT Gieringer_NP0 (_PUL 1985_CRD )_PUR estimates_VVZ that_CJT a_AT0 one-year_AJ0 delay_NN1 in_PRP drug_NN1 benefits_NN2 can_VM0 result_VVI in_PRP approximately_AV0 37_CRD ,_PUN 000_CRD –_PUN 76_CRD ,_PUN 000_CRD patient_NN1 deaths_NN2 ._SENT 
Economic_AJ0 analysis_NN1 of_PRF the_AT0 FDA_NN1 's_POS drug_NN1 approval_NN1 process_NN1 frequently_AV0 finds_VVZ increased_AJ0 costs_NN2 to_TO0 develop_VVI new_AJ0 drugs_NN2 and_CJC longer_AJC times_NN2 required_VVN to_TO0 reach_VVI the_AT0 market_NN1 deters_VVZ producers_NN2 from_PRP introducing_VVG new_AJ0 drugs_NN2 and_CJC engaging_VVG in_PRP pharmacological_AJ0 innovation_NN1 ._SENT Faust_NP0 (_PUL 1985_CRD )_PUR writes_VVZ ,_PUN "_PUQ since_CJS the_AT0 passage_NN1 of_PRF the_AT0 New_AJ0 Drug_NN1 Amendments_NN2 of_PRF 1962_CRD ,_PUN the_AT0 influence_NN1 of_PRF regulation_NN1 on_PRP the_AT0 drug_NN1 development_NN1 process_NN1 and_CJC biomedical_AJ0 research_NN1 ,_PUN in_PRP general_AJ0 ,_PUN has_VHZ resulted_VVN in_PRP considerable_AJ0 negative_AJ0 fall-out_NN1 highlighted_VVN by_PRP a_AT0 decline_NN1 in_PRP drug_NN1 innovation_NN1 "_PUQ (_PUL p._NN0 201_CRD )_PUR ._SENT The_AT0 author_NN1 also_AV0 finds_VVZ that_CJT other_AJ0 advanced_AJ0 nations_NN2 "_PUQ where_CJS regulatory_AJ0 stringencies_NN2 have_VHB not_XX0 been_VBN as_AV0 significant_AJ0 a_AT0 deterrent_NN1 to_PRP research_NN1 productivity_NN1 "_PUQ did_VDD not_XX0 experience_VVI a_AT0 similar_AJ0 decrease_NN1 in_PRP new_AJ0 drug_NN1 introductions_NN2 (_PUL p._NN0 201_CRD )_PUR ._SENT Case_NN1 studies_NN2 and_CJC empirical_AJ0 analyses_NN2 support_VVB these_DT0 claims_NN2 ._SENT Grabowski_NP0 et_NP0 al._NP0 (_PUL 2002_CRD )_PUR note_VVB that_CJT R_ZZ0 &_NN1 D_ZZ0 for_PRP beta-blockers_NN2 ,_PUN anxiolytics_NN2 ,_PUN anti-depressants_NN2 ,_PUN and_CJC the_AT0 first_ORD birth_NN1 control_NN1 drugs_NN2 constituted_VVD a_AT0 large_AJ0 component_NN1 of_PRF drug_NN1 producers_NN2 '_POS R_ZZ0 &_NN1 D_ZZ0 before_PRP the_AT0 1962_CRD amendments_NN2 ._SENT Wiggins_NP0 (_PUL 1981_CRD )_PUR estimates_VVZ the_AT0 1962_CRD amendments_NN2 reduced_VVD the_AT0 introduction_NN1 of_PRF new_AJ0 medicines_NN2 by_PRP approximately_AV0 60_CRD %_NN0 ._SENT More_AV0 recently_AV0 ,_PUN Evans_NP0 and_CJC Watson_NP0 (_PUL 2015_CRD )_PUR and_CJC Tabarrok_NP0 (_PUL 2017_CRD )_PUR find_VVB that_CJT the_AT0 FDA_NN1 's_POS approval_NN1 process_NN1 has_VHZ delayed_VVN genomic_AJ0 medicine_NN1 advancement_NN1 within_PRP the_AT0 United_AJ0 States.3_AJ0 Economic_AJ0 literature_NN1 examining_VVG the_AT0 FDA_NN1 's_POS medical_AJ0 device_NN1 regulation_NN1 through_PRP legislative_AJ0 acts_NN2 in_PRP 1976_CRD ,_PUN 1988_CRD ,_PUN and_CJC 1990_CRD (_PUL Munsey_NP0 ,_PUN 1995_CRD )_PUR reaches_VVZ similar_AJ0 conclusions_NN2 ._SENT From_PRP 1983_CRD to_PRP 1990_CRD ,_PUN the_AT0 FDA_NN1 received_VVN about_PRP 80_CRD premarket_AJ0 approvals_NN2 a_AT0 year_NN1 but_CJC only_AV0 approved_VVN approximately_AV0 45_CRD (_PUL Higgs_NP0 ,_PUN 1995_CRD )_PUR .4_CRD By_PRP 1992_CRD ,_PUN the_AT0 FDA_NN1 had_VHD only_AV0 approved_VVN 12_CRD (_PUL Higgs_NP0 ,_PUN 1995_CRD )_PUR ._SENT Miller_NP0 (_PUL 1988_CRD )_PUR similarly_AV0 finds_VVZ that_CJT the_AT0 FDA_NN1 's_POS oversight_NN1 of_PRF medical_AJ0 devices_NN2 restricts_VVZ new_AJ0 product_NN1 development_NN1 and_CJC innovation_NN1 ._SENT 
Consistent_AJ0 findings_NN2 that_CJT the_AT0 FDA_NP0 regulatory_AJ0 barriers_NN2 delay_NN1 drug_NN1 development_NN1 ,_PUN increase_VVB the_AT0 cost_NN1 of_PRF development_NN1 ,_PUN and_CJC prolong_VVB approval_NN1 times_NN2 have_VHB resulted_VVN in_PRP economists_NN2 '_POS widespread_AJ0 agreement_NN1 that_CJT they_PNP are_VBB on_PRP net_NN1 harmful_AJ0 to_PRP patients_NN2 (_PUL Klein_NP0 ,_PUN 2000_CRD )_PUR ._SENT With_PRP few_DT0 exceptions_NN2 ,_PUN the_AT0 FDA_NN1 's_POS regulatory_AJ0 scope_NN1 continued_VVD to_TO0 expand_VVI into_PRP the_AT0 early_AJ0 2000s_CRD (_PUL FDA_NP0 ,_PUN 2018a_NP0 )_PUR ._SENT Philipson_NP0 et_NP0 al._NP0 (_PUL 2008_CRD )_PUR estimate_VVB the_AT0 FDA_NN1 's_POS regulatory_AJ0 scope_NN1 encompasses_VVZ approximately_AV0 20_CRD %_NN0 of_PRF all_DT0 consumer_NN1 spending_VVG in_PRP the_AT0 United_NP0 States_NP0 ._SENT However_AV0 ,_PUN considerably_AV0 less_AV0 economic_AJ0 research_NN1 has_VHZ examined_VVN the_AT0 FDA_NN1 's_POS impact_NN1 on_AVP and_CJC its_DPS regulatory_AJ0 impact_NN1 on_PRP the_AT0 U.S._NP0 healthcare_NN1 industry_NN1 since_PRP the_AT0 early_AJ0 2000s_CRD (_PUL Philipson_NP0 and_CJC Sun_NP0 ,_PUN 2008_CRD )_PUR ._SENT What_DTQ research_NN1 has_VHZ been_VBN produced_VVN continues_VVZ to_TO0 find_VVI that_CJT the_AT0 agency_NN1 's_POS regulation_NN1 continues_VVZ to_TO0 stifle_VVI innovation_NN1 ._SENT Chorniy_NP0 et_NP0 al._NP0 (_PUL 2021_CRD )_PUR find_VVB that_CJT three_CRD additional_AJ0 months_NN2 of_PRF delayed_AJ0 approval_NN1 time_NN1 result_NN1 in_PRP one_CRD less_DT0 drug_NN1 developed_VVN by_PRP drug_NN1 producers_NN2 ._SENT 
Although_CJS a_AT0 considerable_AJ0 body_NN1 of_PRF research_NN1 finds_VVZ that_CJT FDA_NN1 regulations_NN2 are_VBB harmful_AJ0 ,_PUN the_AT0 agency_NN1 does_VDZ provide_VVI avenues_NN2 for_PRP patients_NN2 to_PRP experimental_AJ0 treatments_NN2 under_PRP certain_AJ0 circumstances_NN2 ._SENT For_PRP example_NN1 ,_PUN the_AT0 FDA_NN1 's_POS expanded_AJ0 access_NN1 allows_VVZ patients_NN2 with_PRP terminal_AJ0 illnesses_NN2 to_TO0 access_VVI experimental_AJ0 treatments_NN2 with_PRP the_AT0 agency_NN1 's_POS approval_NN1 (_PUL FDA_NP0 ,_PUN 2020a_NP0 )_PUR ._SENT Dranvoe_NP0 and_CJC Meltzer_NP0 (_PUL 1994_CRD )_PUR find_VVB that_CJT the_AT0 FDA_NN1 approves_VVZ "_PUQ more_DT0 important_AJ0 drugs_NN2 "_PUQ comparatively_AV0 more_AV0 quickly.5_CRD However_AV0 ,_PUN the_AT0 author_NN1 's_POS estimates_NN2 for_PRP drug_NN1 importance_NN1 do_VDB not_XX0 account_VVI for_PRP medicinal_AJ0 urgency_NN1 and_CJC broader_AJC public_AJ0 health_NN1 considerations_NN2 ._SENT Because_CJS addressing_VVG the_AT0 impact_NN1 of_PRF COVID-19_NN1 requires_VVZ assessing_VVG tradeoffs_NN2 of_PRF evaluating_VVG the_AT0 safety_NN1 and_CJC effectiveness_NN1 of_PRF goods_NN2 used_VVN to_TO0 treat_VVI a_AT0 novel_AJ0 virus_NN1 with_PRP a_AT0 need_NN1 to_TO0 quickly_AV0 disseminate_VVI treatments_NN2 due_AJ0 to_PRP medical_AJ0 urgency_NN1 ,_PUN further_AJC research_NN1 into_PRP contemporary_AJ0 FDA_NN1 regulatory_AJ0 actions_NN2 are_VBB necessary_AJ0 to_TO0 bolster_VVI our_DPS understanding_NN1 of_PRF the_AT0 agency_NN1 's_POS impact_NN1 on_PRP the_AT0 healthcare_NN1 sector_NN1 's_POS ability_NN1 to_TO0 treat_VVI patients_NN2 during_PRP pandemics_NN2 ._SENT 
3_CRD THE_AT0 FDA_NN1 ,_PUN POLITICAL_AJ0 ECONOMY_NN1 ,_PUN AND_CJC PANDEMICS_NN2 
Although_CJS the_AT0 FDA_NN1 's_POS regulatory_AJ0 scope_NN1 includes_VVZ a_AT0 variety_NN1 of_PRF products_NN2 ,_PUN Higgs_NP0 (_PUL 2004_CRD )_PUR notes_VVZ the_AT0 agency_NN1 's_POS primary_AJ0 authority_NN1 is_VBZ "_PUQ banning_VVG existing_AJ0 products_NN2 from_PRP the_AT0 market_NN1 until_PRP their_DPS manufacturers_NN2 adduce_VVB satisfactory_AJ0 evidence_NN1 of_PRF efficacy_NN1 and_CJC safety_NN1 "_PUQ (_PUL p._NN0 60_CRD )_PUR ._SENT Because_CJS the_AT0 FDA_NN1 is_VBZ a_AT0 federal_AJ0 agency_NN1 ,_PUN it_PNP follows_VVZ the_AT0 incentive_NN1 structure_NN1 of_PRF a_AT0 bureaucracy_NN1 ,_PUN mainly_AV0 that_DT0 of_PRF maximizing_VVG its_DPS revenue_NN1 (_PUL Tullock_NP0 ,_PUN 1965_CRD ;_PUN Mises_NN2 ,_PUN 1944_CRD )_PUR ._SENT The_AT0 FDA_NN1 ,_PUN as_CJS well_AV0 as_CJS other_AJ0 regulatory_AJ0 bodies_NN2 ,_PUN typically_AV0 obtains_VVZ more_DT0 revenue_NN1 through_PRP expanding_VVG its_DPS number_NN1 of_PRF operations_NN2 ,_PUN increasing_VVG the_AT0 regulatory_AJ0 stringency_NN1 over_PRP the_AT0 products_NN2 it_PNP oversees_VVZ ,_PUN and_CJC expanding_VVG its_DPS regulatory_AJ0 scope_NN1 (_PUL Tullock_NP0 ,_PUN 1965_CRD )_PUR ._SENT 
The_AT0 incentive_NN1 to_TO0 obtain_VVI more_DT0 personnel_NN2 ,_PUN federal_AJ0 funding_NN1 ,_PUN and_CJC other_AJ0 resources_NN2 while_CJS expanding_VVG its_DPS regulatory_AJ0 stringency_NN1 and_CJC scope_NN1 works_VVZ to_TO0 elongate_VVI and_CJC complicate_VVI the_AT0 FDA_NN1 's_POS approval_NN1 process_NN1 for_PRP the_AT0 goods_NN2 it_PNP oversees_VVZ (_PUL Higgs_NP0 ,_PUN 2004_CRD )_PUR ._SENT The_AT0 agency_NN1 's_POS incentives_NN2 also_AV0 influence_VVB its_DPS willingness_NN1 to_TO0 approve_VVI potentially_AV0 harmful_AJ0 treatments_NN2 and_CJC other_AJ0 goods.6_NN1 Because_CJS the_AT0 FDA_NN1 faces_VVZ the_AT0 threat_NN1 of_PRF public_AJ0 backlash_NN1 or_CJC political_AJ0 disapproval_NN1 by_PRP approving_VVG a_AT0 product_NN1 which_DTQ could_VM0 potentially_AV0 harm_VVI a_AT0 patient_NN1 ,_PUN it_PNP has_VHZ little_DT0 incentive_NN1 to_TO0 approve_VVI the_AT0 product_NN1 despite_PRP its_DPS potential_AJ0 benefits_NN2 ._SENT Instead_AV0 ,_PUN the_AT0 agency_NN1 either_AV0 fails_VVZ to_TO0 approve_VVI the_AT0 product_NN1 or_CJC requires_VVZ the_AT0 producer_NN1 to_TO0 conduct_VVI more_DT0 clinical_AJ0 research_NN1 to_TO0 further_AV0 demonstrate_VVI it_PNP is_VBZ safe_AJ0 (_PUL Higgs_NP0 ,_PUN 1995_CRD )_PUR ._SENT The_AT0 agency_NN1 also_AV0 faces_VVZ little_AJ0 threat_NN1 of_PRF repercussions_NN2 from_PRP failing_VVG to_TO0 approve_VVI a_AT0 safe_AJ0 and_CJC effective_AJ0 product_NN1 because_CJS the_AT0 harms_NN2 of_PRF denying_VVG patients_NN2 a_AT0 safe_AJ0 treatment_NN1 option_NN1 are_VBB rarely_AV0 observable_AJ0 (_PUL Tabarrok_NP0 ,_PUN 2000_CRD )_PUR ._SENT 
Both_DT0 considerations_NN2 create_VVB a_AT0 disincentive_NN1 for_PRP the_AT0 FDA_NN1 to_TO0 weigh_VVI the_AT0 risks_NN2 of_PRF harm_NN1 against_PRP the_AT0 benefits_NN2 ,_PUN providing_VVG overly_AV0 stringent_AJ0 regulation_NN1 (_PUL March_NP0 ,_PUN 2016_CRD ;_PUN Tabarrok_NP0 ,_PUN 2000_CRD ,_PUN 2017_CRD )_PUR ._SENT A_AT0 pandemic_AJ0 caused_VVN by_PRP a_AT0 novel_AJ0 disease_NN1 creates_VVZ a_AT0 demand_NN1 to_TO0 provide_VVI novel_AJ0 products_NN2 to_TO0 treat_VVI ,_PUN detect_VVI ,_PUN or_CJC deter_VVB a_AT0 disease_NN1 ._SENT Novelty_NN1 combined_VVN with_PRP the_AT0 FDA_NN1 's_POS motivation_NN1 to_TO0 approve_VVI products_NN2 conservatively_AV0 could_VM0 motivate_VVI the_AT0 agency_NN1 to_TO0 exercise_VVI harmfully_AV0 stringent_AJ0 standards_NN2 for_PRP goods_NN2 created_VVN to_TO0 address_VVI a_AT0 pandemic_AJ0 ._SENT Recent_AJ0 analysis_NN1 finds_VVZ evidence_NN1 for_PRP this_DT0 ._SENT Using_VVG a_AT0 Bayesian_AJ0 decision_NN1 analysis_NN1 ,_PUN Isakov_NP0 et_NP0 al._NP0 (_PUL 2019_CRD )_PUR find_VVB the_AT0 FDA_NN1 is_VBZ overly_AV0 conservative_AJ0 in_PRP designing_VVG clinical_AJ0 studies_NN2 for_PRP drugs_NN2 designed_VVN to_TO0 treat_VVI terminal_AJ0 illnesses_NN2 with_PRP no_AT0 existing_AJ0 therapies_NN2 ._SENT 
Philipson_NP0 and_CJC Sun_NP0 (_PUL 2008_CRD )_PUR note_VVB that_CJT the_AT0 FDA_NN1 's_POS incentive_NN1 to_TO0 provide_VVI overly_AV0 stringent_AJ0 regulation_NN1 generates_VVZ "_PUQ dynamic_AJ0 considerations_NN2 ,_PUN "_PUQ which_DTQ hinder_VVB the_AT0 agency_NN1 's_POS ability_NN1 to_TO0 provide_VVI effective_AJ0 regulation_NN1 (_PUL p._NN0 96_CRD )_PUR ._SENT Consequently_AV0 ,_PUN the_AT0 agency_NN1 's_POS approval_NN1 process_NN1 results_NN2 in_PRP higher_AJC costs_NN2 to_TO0 develop_VVI products_NN2 and_CJC longer_AJC times_NN2 to_TO0 reach_VVI patients_NN2 ,_PUN but_CJC with_PRP potentially_AV0 little_DT0 additional_AJ0 assurance_NN1 of_PRF product_NN1 safety_NN1 (_PUL p._NN0 96_CRD )_PUR .7_CRD Higgs_NP0 (_PUL 2004_CRD )_PUR notes_VVZ that_CJT side_NN1 effects_NN2 from_PRP FDA_NN1 medications_NN2 deemed_VVN safe_AJ0 for_PRP use_NN1 constitute_VVB the_AT0 fourth_ORD leading_AJ0 cause_NN1 of_PRF death_NN1 in_PRP the_AT0 United_AJ0 States.8_NN1 While_CJS these_DT0 findings_NN2 could_VM0 be_VBI interpreted_VVN as_PRP a_AT0 need_NN1 for_PRP more_DT0 regulatory_AJ0 stringency_NN1 ,_PUN further_AJC research_NN1 finds_VVZ deregulatory_AJ0 processes_NN2 occurring_VVG in_PRP the_AT0 early_AJ0 2000s_CRD provided_CJS faster_AJC approvals_NN2 with_PRP sacrificing_VVG safety_NN1 ._SENT Philipson_NP0 et_NP0 al._NP0 (_PUL 2008_CRD )_PUR examine_VVB the_AT0 Prescription_NN1 Drug_NN1 User_NN1 Fee_NN1 Acts_NN2 ,_PUN which_DTQ allowed_VVD for_PRP prescription_NN1 drugs_NN2 to_TO0 undergo_VVI an_AT0 expedited_AJ0 review_NN1 by_PRP the_AT0 FDA_NN1 for_PRP a_AT0 fee_NN1 ._SENT 
