Legis Daily

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

USA116th CongressS-2740| Senate 
| Updated: 12/14/2019
Johnny Isakson

Johnny Isakson

Republican Senator

Georgia

Cosponsors (5)
Mike Braun (Republican)Lamar Alexander (Republican)Robert P. Casey (Democratic)Kyrsten Sinema (Independent)Patty Murray (Democratic)

Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce Committee

  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs. The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug. The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval. The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients. The FDA must establish a user fee program for OTC drugs.

Bill Text Versions

View Text
4 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Oct 30, 2019
Introduced in Senate
Oct 30, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 31, 2019
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Nov 5, 2019
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Nov 5, 2019
Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.
Dec 10, 2019
Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
View Vote
Dec 11, 2019
Referred to the House Committee on Energy and Commerce.
Dec 11, 2019
Message on Senate action sent to the House.
Dec 11, 2019
Received in the House.
Dec 14, 2019
Referred to the Subcommittee on Health.
  • October 30, 2019
    Introduced in Senate


  • October 30, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • October 31, 2019
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.


  • November 5, 2019
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.


  • November 5, 2019
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.


  • December 10, 2019
    Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
    View Vote


  • December 11, 2019
    Referred to the House Committee on Energy and Commerce.


  • December 11, 2019
    Message on Senate action sent to the House.


  • December 11, 2019
    Received in the House.


  • December 14, 2019
    Referred to the Subcommittee on Health.

Health

Related Bills

  • HR 116-748: CARES Act
  • HR 116-3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
  • HR 116-269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
  • HR 116-19: Lower Costs, More Cures Act of 2019
Administrative law and regulatory proceduresAdministrative remediesChild healthCongressional oversightCosmetics and personal careDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesGovernment studies and investigationsInflation and pricesJudicial review and appealsMarketing and advertisingUser charges and fees

Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019

USA116th CongressS-2740| Senate 
| Updated: 12/14/2019
Over-the-Counter Monograph Safety, Innovation, and Reform Act of 2019 This bill makes significant changes to the regulation by the Food and Drug Administration (FDA) of nonprescription (i.e., over-the-counter or OTC) drugs. The bill establishes a new approval process for OTC medications. Specifically, it creates an FDA administrative order process for the evaluation of OTC products, replacing the present notice and comment rulemaking approach. Under the new process, the FDA may issue an administrative order determining that a specific OTC drug, class of drugs, or combination is generally regarded as safe and effective and not subject to the new drug application process. The FDA may also use the administrative order process to (1) determine that a drug, class of drugs, or combination poses an imminent hazard to the public health; or (2) require labeling changes to mitigate a significant or unreasonable risk of a serious adverse event associated with use of the drug. The bill provides for market exclusivity under certain circumstances. For drugs determined to be generally regarded as safe and effective pursuant to an administrative order requested by a sponsor (rather than initiated by the FDA), the requestor is granted 18 months of market exclusivity. This market exclusivity applies to an OTC drug with a new active ingredient or if the requestor conducted new human studies to get approval. The bill allows a sponsor of a nonprescription sunscreen active ingredient or a combination of such ingredients that was subject to a proposed sunscreen order to transition to the administrative order process. Market exclusivity provisions also apply to new sunscreen active ingredients. The FDA must establish a user fee program for OTC drugs.

Bill Text Versions

View Text
4 versions available

Suggested Questions

Get AI-generated questions to help you understand this bill better

Timeline
Oct 30, 2019
Introduced in Senate
Oct 30, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Oct 31, 2019
Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.
Nov 5, 2019
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.
Nov 5, 2019
Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.
Dec 10, 2019
Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
View Vote
Dec 11, 2019
Referred to the House Committee on Energy and Commerce.
Dec 11, 2019
Message on Senate action sent to the House.
Dec 11, 2019
Received in the House.
Dec 14, 2019
Referred to the Subcommittee on Health.
  • October 30, 2019
    Introduced in Senate


  • October 30, 2019
    Read twice and referred to the Committee on Health, Education, Labor, and Pensions.


  • October 31, 2019
    Committee on Health, Education, Labor, and Pensions. Ordered to be reported without amendment favorably.


  • November 5, 2019
    Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander without amendment. Without written report.


  • November 5, 2019
    Placed on Senate Legislative Calendar under General Orders. Calendar No. 290.


  • December 10, 2019
    Passed Senate without amendment by Yea-Nay Vote. 91 - 2. Record Vote Number: 389. (consideration: CR S6921-6930; text: CR S6921-6930)
    View Vote


  • December 11, 2019
    Referred to the House Committee on Energy and Commerce.


  • December 11, 2019
    Message on Senate action sent to the House.


  • December 11, 2019
    Received in the House.


  • December 14, 2019
    Referred to the Subcommittee on Health.
Johnny Isakson

Johnny Isakson

Republican Senator

Georgia

Cosponsors (5)
Mike Braun (Republican)Lamar Alexander (Republican)Robert P. Casey (Democratic)Kyrsten Sinema (Independent)Patty Murray (Democratic)

Health, Education, Labor, and Pensions Committee, Health Subcommittee, Energy and Commerce Committee

Health

Related Bills

  • HR 116-748: CARES Act
  • HR 116-3443: To clarify the regulatory framework with respect to certain nonprescription drugs that are marketed without an approved drug application, and for other purposes.
  • HR 116-269: Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2019
  • HR 116-19: Lower Costs, More Cures Act of 2019
  • Introduced
  • In Committee
  • On Floor
  • Passed Chamber
  • Enacted
Administrative law and regulatory proceduresAdministrative remediesChild healthCongressional oversightCosmetics and personal careDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesGovernment studies and investigationsInflation and pricesJudicial review and appealsMarketing and advertisingUser charges and fees