December 9, 2021

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Over-The-Counter Drugs: Information on FDA’s Regulation of Most OTC Drugs

13 min read
<div>The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a "rulebook" for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective. According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency's ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency's analysis of the effect of the CARES Act is still ongoing. FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency's adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug's labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed. According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA's ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug's labeling to mitigate a significant or unreasonable risk of a serious adverse event. OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA's ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs. The Sunscreen Innovation Act included a provision for GAO to review FDA's regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA's ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs. GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers. The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate. For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.</div>

What GAO Found

The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a “rulebook” for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs established conditions—such as active ingredients, indications for use, dosage forms, and product labeling—under which an OTC drug was generally recognized as safe and effective.

According to FDA officials, before the CARES Act, which was enacted in March 2020, the agency’s ability to update and finalize monographs in response to safety issues and to reflect new scientific information was limited by the rulemaking process the agency was required to follow, as well as insufficient resources. Agency officials estimated that it took at least 6 years to complete the required rulemaking process. Additionally, the agency reported it was critically under-resourced to regulate the estimated 100,000 OTC drugs marketed through the monograph process. However, the CARES Act provided for a new process to regulate these OTC drugs rather than the rulemaking process. FDA officials expect it will take less time to update and finalize requirements for OTC drugs using the new process. The CARES Act also authorized FDA to assess user fees to provide additional resources to regulate OTC drugs. Although FDA officials said this new process and user fees should improve its regulation of OTC drugs, the agency’s analysis of the effect of the CARES Act is still ongoing.

FDA officials told GAO that prior to the CARES Act, they used various methods to identify and respond to safety issues related to OTC drugs. For example, to identify these issues, FDA officials said they read medical literature related to safety issues and reviewed reports submitted to the agency’s adverse event reporting system. To respond to these issues, FDA took steps such as issuing drug safety communications to consumers and requesting that manufacturers make changes to a drug’s labeling. For example, in 2015, two FDA advisory committees recommended that cough and cold drugs with codeine be removed from the relevant OTC monograph for use in drugs in children. In 2018, FDA also issued a drug safety communication stating the risks outweighed the benefits for the use of these drugs in children. However, FDA officials said these methods were not a substitute for rulemaking because manufacturers could legally market their OTC drugs without making requested safety changes until the rulemaking process was completed.

According to FDA officials, the new process for regulating OTC drugs included in the CARES Act could improve FDA’s ability to address identified safety risks in a more timely and efficient manner in the future. The act established an expedited process to address safety issues that pose an imminent hazard to public health or to change a drug’s labeling to mitigate a significant or unreasonable risk of a serious adverse event.

Why GAO Did This Study

OTC drugs prevent and treat a variety of conditions; for example, sunscreen is used to help prevent sunburn. FDA officials and stakeholders, such as industry representatives and patient and provider groups, have questioned whether the monograph process used to regulate most OTC drugs has been overly burdensome and has limited FDA’s ability to quickly update and finalize monographs in response to potential safety issues for consumers. Enacted in March 2020, the CARES Act changed how FDA regulates OTC drugs.

The Sunscreen Innovation Act included a provision for GAO to review FDA’s regulation of OTC drugs. This report describes, among other issues, (1) the factors that affected FDA’s ability to regulate OTC drugs and (2) how FDA identified and responded to safety issues associated with these drugs.

GAO reviewed federal statutes and agency documents and interviewed FDA officials and stakeholders familiar with the monograph process. These stakeholders included representatives from the OTC drug industry, health care provider and consumer groups, and researchers.

The Department of Health and Human Services provided technical comments on this report, which GAO incorporated as appropriate.

For more information, contact John E. Dicken at (202) 512-7114 or dickenj@gao.gov.

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  • Haiti Reconstruction: Factors Contributing to Delays in USAID Infrastructure Construction
    In U.S GAO News
    On January 12, 2010, a powerful earthquake struck Haiti, resulting in an estimated 230,000 deaths, including more than 16,000 Haitian government personnel, and the destruction of many ministry buildings. In addition to immediate relief efforts, in July 2010, Congress appropriated $1.14 billion in supplemental funds for reconstruction, most of which was provided to the U.S. Agency for International Development (USAID) and the Department of State (State). USAID and State are administering about $412 million in supplemental and regular fiscal year appropriations for infrastructure construction activities. In May 2011, in response to a congressional mandate, GAO reported on overall U.S. plans for assistance to Haiti. This report addresses infrastructure construction activities, including (1) USAID and State obligations and expenditures; (2) USAID staffing; (3) USAID planning; and (4) potential sustainability challenges USAID faces. GAO reviewed documents and interviewed U.S. officials in Washington, D.C., and Haiti, and visited ongoing and planned construction sites in Haiti..USAID and State have obligated and expended a small amount of funds for infrastructure construction activities in six sectors: energy, ports, shelter, health, food security, and governance and rule of law. As of September 30, 2011, USAID and State had allocated almost $412 million for infrastructure construction activities, obligated approximately $48.4 million (11.8 percent), and expended approximately $3.1 million (0.8 percent). Of the almost $412 million, about 87 percent was allocated from the 2010 Supplemental Appropriations Act and 13 percent from regular fiscal year appropriations. USAID accounts for about 89 percent of the $412 million, including funds for construction in the energy, ports, shelter, health, and food security sectors. State activities in the governance and rule of law sector account for the remaining 11 percent. USAID had difficulty staffing the Haiti mission after the earthquake, a factor that has contributed to delays in infrastructure construction activities. Soon after the earthquake, 10 of the 17 U.S. citizen Foreign Service Officers, known as U.S. direct-hire staff, in Haiti left. USAID, lacking a process for expediting the movement of staff to post-disaster situations, had difficulty replacing them and recruiting additional staff. These staff included key technical personnel such as engineers and contracting officers needed to plan and implement infrastructure activities in sectors such as energy and ports, where the mission had not previously worked. With limited U.S. direct-hire staff on board, the mission relied heavily on temporary staff, and remaining staff assumed duties outside their normal areas of expertise. The mission plans to have all U.S. direct-hire staff on board by February 2012. Since infrastructure activities will continue until at least 2015, the mission will need to maintain sufficient staff for several years to manage the activities supported by the increase in Haiti reconstruction funds. USAID and State are planning activities in Haiti, but various challenges have contributed to some of USAID's delays. As of October 2011, USAID had drafted eight Activity Approval Documents (AADs) that include planned activities, costs, risks, and assumptions. AADs for the education, energy, food security, governance and rule of law, health, and shelter sectors have been approved. The AAD process has been more comprehensive and involved than is typical for such efforts, according to USAID officials. Although USAID made progress in planning, construction of some activities was delayed for various reasons, and some activities do not yet have planned start dates. For example, the mission was delayed in awarding contracts in the shelter sector due to issues such as identifying sites for shelter and obtaining land title. The sustainability of USAID-funded infrastructure depends, in part, on improvements to the Haitian government's long-standing economic and institutional weaknesses. USAID has considered various sustainability issues and is planning institutional strengthening activities, such as management reform of the power utility, but USAID planning documents acknowledge that these reforms will be challenging and that infrastructure activities face risks. These challenges are consistent with prior GAO reports that address sustainability of U.S. infrastructure projects in other countries. To facilitate USAID's progress in planning and implementing its many post-earthquake infrastructure construction activities in Haiti over the next several years, particularly those requiring key technical staff, GAO recommends that the USAID Administrator ensure that U.S. direct-hire staff are placed at the mission within time frames that avoid future staffing gaps or delays. USAID described certain actions it is currently taking that, if continued, could address the recommendation.
    [Read More…]
  • DHS Office of Inspector General: Preliminary Observations on Long-Standing Management and Operational Challenges
    In U.S GAO News
    What GAO Found GAO's preliminary work has identified a number of management and operational challenges, including frequent leadership turnover, since fiscal year 2015 that have impeded the overall effectiveness of the Department of Homeland Security (DHS) Office of Inspector General (OIG). DHS OIG senior leaders have acknowledged that these challenges have contributed to organizational weaknesses, and have taken steps to begin addressing some of them. GAO's preliminary work has identified issues in the following areas, among others: Strategic planning: DHS OIG has not consistently developed strategic plans, which are a necessary input for developing the organization's other guiding documents and governance framework. Specifically, DHS OIG has operated for 4 of the past 6 years without a strategic plan, and the plan it adopted for fiscal years 2018–2019 included some, but not all, of the elements considered standard for federal entities. In 2020, DHS OIG contracted with a nonprofit academy of government experts to develop a strategic plan for fiscal years 2021–2025, with expected delivery in June 2021. Quality assurance: Internal and external reviews have reported on concerns about quality assurance in some of DHS OIG's work. In 2017 and 2018, after an internal review found that some reports issued by DHS OIG may not have adhered to the professional standards cited, DHS OIG retracted 13 audit reports that had been issued over a 5-year period. In 2018, an external review determined that DHS OIG needed to improve its system of quality control. Though DHS OIG concurred with all of the recommendations from that external review, it did not fully implement them. In addition, DHS OIG has not established roles and responsibilities for an organization-wide quality assurance program. Moreover, GAO's preliminary work indicates that current staff allocations may limit DHS OIG's quality assurance reviews to focusing on audit work and not on the other types of work it produces, including inspections, evaluations, special reviews, and management alerts. Timeliness: DHS OIG project time frames for work from its offices of Audits and Special Reviews and Evaluations have increased over the 4 fiscal years GAO assessed. For example, in fiscal year 2017, 79 of 102 Office of Audits projects were completed in 1 year or less and eight of 102 took more than 18 months. In fiscal year 2020, seven of 67 reports were completed in 1 year or less and more than half (35 of 67) took more than 18 months. In addition, DHS OIG has not assessed time frames for work completed by these offices, though timeliness in reporting is a key element of effective oversight and DHS OIG staff considered it an organizational weakness. GAO will complete its evaluation of these and other management and operational areas, and will issue a final report in the coming months. Why GAO Did This Study DHS OIG has a critical role in providing independent and objective oversight of DHS, which encompasses multiple operational and support components. OIGs are expected to maintain high standards of professionalism and integrity in light of their mission, according to quality standards developed by the community of federal Inspectors General. However, DHS OIG has faced a number of challenges that have affected its ability to carry out its oversight mission effectively. This statement is based on GAO's draft report on DHS OIG's management and operations, which is currently at the agency for comment. It provides preliminary observations on DHS OIG's strategic planning processes; quality assurance processes; and reporting time frames for work from DHS OIG's offices of Audits and Special Reviews and Evaluations. To develop these preliminary observations, GAO reviewed relevant federal laws and quality standards for federal OIGs as well as DHS OIG documentation, including organizational policies; internal communications such as emails and memoranda; and DHS OIG's semiannual reports to Congress and published reports. GAO also analyzed DHS OIG project data from fiscal years 2015 through 2020, and interviewed DHS OIG leaders and other staff.
    [Read More…]
  • Transportation Security: Federal Action Needed to Help Address Security Challenges
    In U.S GAO News
    The economic well being of the U.S. is dependent on the expeditious flow of people and goods through the transportation system. The attacks on September 11, 2001, illustrate the threats and vulnerabilities of the transportation system. Prior to September 11, the Department of Transportation (DOT) had primary responsibility for the security of the transportation system. In the wake of September 11, Congress created the Transportation Security Administration (TSA) within DOT and gave it primary responsibility for the security of all modes of transportation. TSA was recently transferred to the new Department of Homeland Security (DHS). GAO was asked to examine the challenges in securing the transportation system and the federal role and actions in transportation security.Securing the nation's transportation system is fraught with challenges. The transportation system crisscrosses the nation and extends beyond our borders to move millions of passengers and tons of freight each day. The extensiveness of the system as well as the sheer volume of passengers and freight moved makes it both an attractive target and difficult to secure. Addressing the security concerns of the transportation system is further complicated by the number of transportation stakeholders that are involved in security decisions, including government agencies at the federal, state, and local levels, and thousands of private sector companies. Further exacerbating these challenges are the financial pressures confronting transportation stakeholders. For example, the sluggish economy has weakened the transportation industry's financial condition by decreasing ridership and revenues. The federal government has provided additional funding for transportation security since September 11, but demand has far outstripped the additional amounts made available. It will take a collective effort of all transportation stakeholders to meet existing and future transportation challenges. Since September 11, transportation stakeholders have acted to enhance security. At the federal level, TSA primarily focused on meeting aviation security deadlines during its first year of existence and DOT launched a variety of security initiatives to enhance the other modes of transportation. For example, the Federal Transit Administration provided grants for emergency drills and conducted security assessments at the largest transit agencies, among other things. TSA has recently focused more on the security of the maritime and land transportation modes and is planning to issue security standards for all modes of transportation starting this summer. DOT is also continuing their security efforts. However, the roles and responsibilities of TSA and DOT in securing the transportation system have not been clearly defined, which creates the potential for overlap, duplication, and confusion as both entities move forward with their security efforts.
    [Read More…]

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