The 21st Century Cures Act passed the House of Representatives on November 30. It authorizes $4.8 billion over a ten year period for targeted initiatives at the NIH and $500 million for the FDA. The bill is expected to be voted on in the Senate the week of December 5. The Office of Public Affairs has prepared an analysis of the bill's provisions.
National Institutes of Health Reauthorization
Reauthorizes the NIH for Fiscal Years 2018-2020.
National Institutes of Health Innovation Fund
Provides $4.77 billion over 10 years to the National Institutes of Health (NIH) earmarked for the Precision Medicine Initiative ($1.5 billion), the Brain Research Through Advancing Innovative Neurotechnologies Initiative ($1.5 billion), cancer research ($1.8 billion), and regenerative medicine using adult stem cells ($30 million for NIH/FDA). Ensures accountability by requiring a work plan and annual report. Appropriators would need to approve the dedicated funding each year from the innovation fund.
The Obama Administration supports the Cures Legislation because it includes dedicated funding for the President’s signature initiatives. The bill being voted on November 30 in the House authorizes NIH for a quarter of the funding which was in the House passed bill last year and cuts the FDA amount in half. The funding is now not mandatory, but subject to appropriations and there is no guarantee that appropriators will follow through with funding each year, which will affect continuity of research plans. Unless Congressional Appropriations Committees provided regular appropriations for NIH and treat Cures dedicated funding as supplemental funding, NIH’s yearly appropriations will be insufficient, or even flat, for most NIH research outside the initiatives in the bill. The Cures bill does not provide a significant amount of funding for NIH, and the Agency will continue to require less restricted, non-directed funding for promising research.
Food and Drug Administration Innovation Fund
Provides $500 million to the Food and Drug Administration (FDA) over 10 years to implement provisions in Title III to move drugs and medical devices to patients more quickly, while maintaining the same standard for safety and effectiveness. The funding is not sufficient to support the mandates in the bill.
EUREKA Prize Competitions
Directs NIH to utilize its prize authority to support innovation prize competitions to advance biomedical science and improve health outcomes for diseases that are serious and represent a significant burden in the U.S. Requires tracking on the effect of innovations funded by prize competitions under this section and their effect on federal expenditures. Requires this information to be included in the Triennial Report.
Precision Medicine Initiative
Encourages the Secretary of Health and Human Services (HHS) to carry out a “Precision Medicine Initiative” to augment efforts to address disease prevention, diagnosis, and treatment. Among other activities, the initiative may include developing new approaches for:
- Addressing scientific, medical, public health, and regulatory science issues;
- Applying genomic technologies; and
- Gathering information from volunteers to better understand health and disease.
Encourages the Secretary of HHS to coordinate with other federal departments, utilize public-private partnerships, and leverage existing data sources. Ensures that the Precision Medicine Initiative will comply with existing laws and regulations for the protection of human participants, protect the privacy of participants, and include a broad range of participants.
Privacy Protection for Human Research Subjects
Directs the Secretary of HHS to issue certificates of confidentiality to researchers that receive federal funding. Allows the Secretary of HHS to also issue certificates to privately funded researchers. Prohibits researchers to whom certificates are issued from disclosing the name of participants or any other identifiable data gathered during research, except when:
- Required by federal, state, or local law;
- Necessary to treat the individual in question;
- The individual gives consent; or
- Disclosure of information is for the purposes of other research in compliance with privacy laws.
Prohibits researchers who are issued certificates from being compelled to disclose identifiable, sensitive information about participants that was gathered during research. Grants immunity from the legal process to all identifiable, sensitive information gathered during research. Such information can only be used in legal proceedings with the consent of the research participant. The protections of this section are afforded in perpetuity. Directs the Secretary of HHS to minimize the burden of compliance for researchers. The requirements of this section apply to all ongoing research authorized under section 301(d) of PHSA.
Protection of Identifiable and Sensitive Information
Allows the Secretary of HHS to exempt individual biomedical research data from being disclosed if the data is identifiable, or could be used for identification. Requires the Secretary of HHS to submit written basis for each disclosure exemption, made available to the public upon request to the Chief Freedom of Information Act Officer at HHS.
Investing in the Next Generation of Researchers
Creates a “Next Generation of Researchers Initiative” in the Office of the Director at the NIH to coordinate, develop, modify, and prioritize policies and programs to improve opportunities for new researchers. Requires NIH to report to Congress on any actions taken in response to recommendations from the National Academy of Sciences as part of a study on policies affecting the next generation of researchers. Fiscal Year (FY) 2016 appropriations included direction for the National Academies to carry out such a study.
Improvement of Loan Repayment Program
Replaces NIH’s existing loan repayment programs for researchers with one program for intramural researchers with up to four subcategories and one loan repayment program for extramural researchers with up to six subcategories. Increases the maximum yearly loan repayment amount from $35,000 to $50,000. Allows the Director of NIH to better target the loan repayment programs to meet workforce or scientific needs related to biomedical research by eliminating loan repayment subcategories or by adding a limited number of new subcategories.
National Institutes of Health Research Strategic Plan
Requires the Director of NIH, in consultation with the directors of the national research institutes and centers, to develop a six-year coordinated strategy to outline the direction of biomedical research investments made by the NIH, facilitate collaboration among the research institutes and centers, and advance biomedicine. Requires the coordinated strategy to identify strategic research priorities, including:
- An assessment of biomedical and behavioral research, and opportunities for basic and translational research;
- Priorities and objectives to advance prevention, treatment, and cures;
- Emerging scientific opportunities, including public health challenges; and
- Near-, mid-, and long-term scientific needs.
Requires consideration of disease burden in the United States, rare diseases, and biological and social determinants of health.
Reducing Administrative Burden for Researchers Requires the Secretary of HHS, within two years of enactment, to:
- Lead a review of regulations and policies related to the disclosure of financial conflicts of interest, including the minimum threshold for reporting financial conflicts of interest.
- Make revisions to harmonize existing policies and reduce administrative burden.
Changes reports of the Director of the NIH from biennial to triennial. Requires a description of intra-NIH activities, including identification of the annual percentage of funds for conducting or supporting research that involves collaboration between two or more national research institutes or centers, and recommendations for promoting coordination. Specifies that “relevant age categories” must be identified in the demographic variables identified in the catalog of all research activities of the agency.
Increasing Accountability at the National Institutes of Health
Provides for the appointment of directors of national research institutes and national centers. Specifies that directors have five-year terms, may be reappointed at the end of a term, and clarifies that there is no limit to the number of terms that a director may serve. Clarifies that directors of national research institutes or national centers must review and make final decisions on funding awards. Requires the Secretary of HHS to submit a report to Congress on efforts to prevent and eliminate duplicative biomedical research that is not necessary for scientific purposes.
Reducing Administrative Burden for Researchers
Requires the Secretary of HHS, within two years of enactment, to:
- Lead a review of regulations and policies related to the disclosure of financial conflicts of interest, including the minimum threshold for reporting financial conflicts of interest.
- Make revisions to harmonize existing policies and reduce administrative burden.
- Modifying the timelines for reporting conflicts of interest;
- Ensuring that financial interest disclosure requirements are appropriate for awards that will directly fund research; and
- Updating any applicable training modules of the NIH related to federal financial interest disclosure.
Requires NIH to implement measures to reduce administrative burdens related to monitoring of sub-recipients of grants by primary awardees of funding from the NIH. Requires the Secretary of HHS, in consultation with the NIH Director, to evaluate financial reporting procedures and requirements for NIH funding recipients and take action to avoid duplication to minimize burden to funding recipients. Requires the NIH Director, the Secretary of Agriculture, and the Commissioner of the FDA to review and revise as appropriate laboratory animal regulations and policies to reduce administration burden on investigators. The review shall:
- Identify ways to ensure such regulations and policies are not inconsistent, overlapping, or unnecessarily duplicative;
- Take steps to eliminate or reduce identified inconsistencies, overlap, or duplication among such regulations and policies; and
- Take other actions to improve the coordination of regulations and policies with respect to research with laboratory animals.
Requires the Secretary of HHS to clarify the applicability of the requirements under the Office of Management and Budget (OMB). Uniform Guidance for management and certification systems adopted by entities receiving federal research grants through HHS regarding documentation of personnel expenses, including clarification of the extent to which any flexibility applies to entities receiving grants. Requires OMB to establish an advisory committee, called the “Research Policy Board”.
- Requires the board to provide information on the effects of regulations related to federal research requirements and make recommendations on how to modify and harmonize regulations and policies to minimize administrative burden. Activities of the board may include:
- Providing thorough and informed analysis of regulations and policies;
- Identifying adverse consequences of existing policies and making actionable recommendations to improve such policies;
- Creating a forum for the discussion of research policy or regulatory gaps, challenges, clarification, or harmonization of such policies or regulation, and best practices; and
- Conducting ongoing assessment and evaluation of regulatory burden, including development of metrics, periodic measurement, and identification of process improvements and policy changes.
- Requires the board, within two years of enactment, to submit a report containing formal recommendations on the conceptualization, development, harmonization, and reconsideration of scientific research policies, including the regulatory benefits and burdens.
- Requires GAO, within four years of enactment, to conduct an independent evaluation of the activities carried out by the board. This report is also required to review and access the Board’s activities.
Exemption for the National Institutes of Health from the Paperwork Reduction Act Requirements
Exempts voluntary information collected during NIH research from current paperwork reduction initiatives (44 U.S.C. 3501).
High-Risk, High Reward Research
Authorizes the national institutes and centers within NIH, with the approval of the Director of NIH, to use transactions other than a contract, grant, or cooperative agreement for the Precision Medicine Initiative, and for up to 50 percent of the funds available in the NIH Common Fund. In order to use this “other transactions authority,” the institute or center must submit a proposal and receive approval for the use of other transactions. Requires the Secretary of HHS, acting through the Director of NIH, to evaluate activities within NIH associated with this high-risk, high reward research and submit a report to Congress. Encourages NIH to conduct and support high-risk, high-reward research to address major current challenges.
National Center for Advancing Translational Sciences
Allows the National Center for Advancing Translational Sciences (NCATS) to support clinical trials through the end of phase IIB (previously IIA). Increases the clinical trial phase through which NCATS may support clinical trial activities for treatment of a rare disease of condition so long as–
- NCATS gives public notice for a period of at least 120 days of the Center's intention to support the clinical trial activities in phase II (previously IIB); No public or private organization provides credible written intent to NCATS that the organization has timely plans to further the clinical trial activities or conduct clinical trials of a similar nature beyond phase IIB (previously IIA); and NCATS ensures that support of the clinical trial activities in phase III (previously IIB) will not increase the Federal Government's liability beyond the award value of the Center's support.
Improves transparency, including by requiring reporting on the methods and tools that had been developed since the last NCATS report and those that are being used, if any, by FDA to support medical product reviews.
Collaboration and Coordination to Enhance Research
Requires the Director of NIH to assemble accurate data to be used to assess research priorities, including:
- Information to better evaluate scientific opportunity, public health burdens, and progress reducing health disparities;
- Data on study populations of clinical research funded by and conducted at each national research institute and national center that specify the inclusion of women, members of minority groups, relevant age categories, and other demographic variables determined necessary.
Requires the Director of NIH to foster and encourage collaboration between NIH-funded clinical research projects. Such collaboration would allow for an increase in the number of subjects studied and the utilization of diverse study populations, with special consideration given to biological, social, and other determinants of health that contribute to health disparities. Requires the Director of NIH to improve research related to minority populations. Encourages the Director of the National Institute on Minority Health and Health Disparities to foster partnerships and encourage the funding of collaborative research projects. Requires the Director of NIH to update guidelines for the inclusion of women in clinical research to reflect the most current science. Requires that the Director of NIH hold a workshop to get input on appropriate age groups in research and update policies, as appropriate.
Enhancing the Rigor and Reproducibility of Scientific Research
Requires the Secretary of HHS, acting through the Director of NIH, to convene a working group to develop recommendations for a formal policy to enhance the rigor and reproducibility of NIH-funded scientific research. The working group shall consider, as appropriate:
- Pre-clinical experiment design, including analysis of sex as a biological variable;
- Clinical experiment design; Applicable levels of rigor in statistical methods, methodology, and analysis, and
- Data and information sharing.
Requires the Director of NIH to consider the working group’s recommendations and develop or update policies as appropriate within 18 months. Requires the working group to report to Congress on recommendations and any subsequent policy changes within two years.
Improving Medical Rehabilitation Research at the National Institutes of Health
Specifies that NIH must update their Rehabilitation Research Plan periodically, or at least every five years, and requires the agency to develop objectives and benchmarks that will allow NCMRR to measure success and report to Congress on annual progress.
- The report shall include recommendations for revising and updating the Rehabilitation Research Plan.
- Specifies that the Rehabilitation Research Plan must also identify existing resources to support the purposes of the center.
- Ensures coordination and periodic review of the state of medical rehabilitation science and outreach to the research community in connection with revisions to the research plan.
Encourages coordination of medical rehabilitation research among agencies of NIH and other federal agencies, including through interagency agreements. Defines the term “medical rehabilitation research” to mean the science of mechanisms and interventions that prevent, improve, restore, or replace lost underdeveloped, or deteriorating function.
Streamlining National Institutes of Health Reporting Requirements
Trans-NIH Research Reporting – requires the head of each national research institute or center to submit a report, to be included in the triennial report, on the amount made available by the institute or center for conducting or supporting research that involves collaboration between the institute or center and one or more other national research institutes or national centers. Repeals the review and report on the Centers of Excellence.
Reimbursement for Research Substances and Living Organisms
Where research products are made available through contractors, allows the Secretary of HHS to direct such contractors to collect payments on behalf of the Secretary for the costs incurred to make available such research products.
- The amounts collected are to be credited to the appropriations accounts that incurred the cost to make the research product involved available.
Sense of Congress on Increased Inclusion of Underrepresented Populations in Clinical Trials
Encourages the National Institute on Minority Health and Health Disparities to include within its strategic plan ways to increase representation of underrepresented populations in clinical trials.
Technical Updates to Clinical Trials Database
Makes technical updates to the clinical trials data base requirements to allow information from device clinical trials to be posted prior to clearance or approval if the manufacturer requests that the information be posted earlier. Makes technical updates to the clinical trials database to clarify whether combination products are considered drug clinical trials or device clinical trials for purposes of the database.
Compliance Activities Report
Requires a report on actions taken to encourage compliance with the clinical trials database, including education and outreach. Requires a report on the status of clinical trials registered in the clinical trials database, as well as activities taken to encourage education and outreach on data bank registration.
Updates to Policies to Improve Data
Updates policies to ensure reporting of data from valid analyses for certain clinical trials.
Requires the Secretary of HHS to consult with agencies and other stakeholders to receive recommendations related to enhancements to the clinical trial registry.
National Neurological Conditions Surveillance System
Provides that the Secretary of HHS shall, as appropriate, improve the collection of information on the incidence and prevalence of neurological diseases and conditions, which may be through the establishment of a registry, in order to facilitate research and improve public health. This is intended to be carried out by the Centers for Disease Control and Prevention (CDC).
This section would help to accelerate improved methods for prevention, diagnosis, and treatment of tick-borne diseases, including Lyme disease. It would establish a working group to prepare a report summarizing federal research efforts related to Lyme disease and other tick-borne diseases. The working group terminates 6 years after the date of enactment of this Act.
Accessing, Sharing, and Using Health Data for Research Purposes
Requires the Secretary of HHS to issue guidance clarifying that certain researchers may remotely access protected health information if specific security and privacy safeguards are maintained. Requires the Secretary of HHS to issue guidance clarifying circumstances under which an authorization to use and disclose protected health information for future research purposes contains sufficient information. Establishes a working group to study and report on whether the uses and disclosures of protected health information for research purposes should be modified.
National Pediatric Research Network
Requires NIH to continue to support the National Pediatric Research Network. It would be composed of research institutions that would operate as a consortium in order to pool resources and coordinate activities related to pediatric rare diseases or birth defects
Global Pediatric Clinical Study Network
Sets forth a sense of Congress that NIH and FDA should work with the European Union, industry, and others to establish a global pediatric clinical study network.
Food and Drug Administration
Patient Experience Data
Requires the FDA to include a statement regarding any patient experience data that was used at the time a drug is approved. Patient experience data includes data collected by any persons (including patients, family members and caregivers of patients, patient advocacy organizations, disease research foundations, researchers, and drug manufacturers).
Patient-focused Drug Development Guidance
Requires the FDA to issue guidance regarding how to collect patient experience data. Such guidance documents shall address:
- Appropriate ways to collect data for use by the FDA for use in regulatory decisions;
- How patients wishing to propose draft guidance to FDA may submit such documents;
- How FDA will respond to patient experience data submissions to FDA;
- The format and content for patient experience data submissions
- FDA; and
- How the FDA plans to use relevant patient experience data and related information when evaluating the risks and benefits of a drug.
Streamlining Patient Input
Exempts FDA from going through the Paperwork Reduction Act clearance process when requesting information from patients regarding their disease or treatments, allowing FDA to get more timely feedback from patients.
Report on Patient Experience Drug Development
Requires FDA to report on FDA’s review of patient experience data and information on patient-focused drug development tools as part of approved drugs not later than June 1 of 2021, 2028, and 2031.
Qualification of Drug Development Tools
Establishes a review pathway at FDA for biomarkers and other drug development tools that can be used to help shorten drug development time and reduce the failure rate in drug development.
Targeted Drugs for Rare Diseases
Clarifies the authority of the FDA with regard to genetically targeted drugs for rare diseases. Allows sponsors of genetically targeted or variant protein targeted drugs to rely on data for the same or similar technology from previously approved applications by the same sponsor. Does not alter the existing approval standards for drugs.
Reauthorization of Program to Encourage Treatments for Rare Pediatric Diseases
Reauthorizes the pediatric rare disease priority review voucher program until 2020. However, if a drug is designated before October 1, 2020, it can continue to receive a voucher if approved before October 1, 2022.
GAO Study of Priority Review Voucher Programs
Requires GAO to study all the priority review voucher programs to see the impact on drug development and any unintended consequences.
Amendments to the Orphan Drug Grants
Updates the orphan drug grant program to clarify that grants may be used for observational studies that help understand the natural history of a rare disease or condition and in the development of a therapy for a rare disease or condition.
Grants for Studying Continuous Drug Manufacturing
Allows the FDA to issue grants to further the studying of continuous manufacturing for drugs.
Novel Clinical Trial Designs
Requires FDA to hold a public meeting and issue guidance documents that would assist sponsors in incorporating adaptive designs and novel statistical modeling into new drug applications.
Real World Evidence
Requires FDA to evaluate the use of real world evidence to help support the approval of a new indication for a previously approved drug and to help support or satisfy post-approval study requirements.
Protection of Human Research Subjects
Requires the Secretary of HHS to harmonize differences between the human subject regulations under the Common Rule and the Federal Food Drug and Cosmetic Act. Streamlines the institutional review board process for trials that are being conducted at multiple sites.
Informed Consent Waiver or Alteration for Clinical Investigations
Provides FDA the flexibility to waive or alter informed consent requirements for clinical trials with minimal risk, similar to existing flexibility for HHS and NIH under the Common Rule.
Patient Access to Therapies and Information
Summary Level Review
Allows FDA to rely upon qualified data summaries to support the approval of an application for a new indication of an already approved drug. Sponsors of the application still must submit all information to FDA.
Expanded Access Policy
Requires that pharmaceutical companies have publicly accessible compassionate use policies for drugs treating serious or life-threatening conditions.
Accelerated Approval for Regenerative Advanced Therapies
Allows FDA to grant accelerated approval for regenerative therapeutic products. Directs FDA to consider the unique characteristics of regenerative therapeutic products and provide a rationale with a determination of whether or not to grant accelerated approval. Does not change the standards of evidence or limit any other of the authorities of the FDA.
Classification of Devices Used with Regenerative Advanced Therapies
Establishes that devices used with a regenerative therapeutic product will be considered moderate risk devices, unless the Secretary determines that the device or intended use requires a higher risk classification.
Updated Regenerative Medicine Guidance and Regulations
Requires the FDA to update guidance and regulations with regard to regenerative therapeutic products, and hold a public meeting to encourage innovation.
Standards for Regenerative Medicine and Advanced Therapies
Requires FDA to consult with stakeholders and the National Institute of Standards and Technology in order to establish standards, to support the development, evaluation, and review of regenerative medicine and advanced therapies products. Defines “regenerative medicine and advanced therapies” – includes cell therapy gene therapy, gene-modified cell therapy, therapeutic tissue engineering products, human cell and tissue products, and combination products using any such therapies or products.
Health Care Economic Information
Clarifies the scope of permissible manufacturer communications regarding health care economic information to certain entities.
Combination Product Innovation
Improves the regulation of combination products – products that contain both a drug and device, for example – by requiring that FDA meet with sponsors and agree early in development how to best study the combination product to meet the standard for approval. Clarifies how dispute resolution works when the different centers of FDA do not agree. Includes provisions for reporting on combination product regulation.
Antimicrobial Resistance Monitoring
Requires reporting from CDC and FDA on information and data regarding human resistance to antimicrobial drugs. Requires CDC to distribute educational materials related to antimicrobial stewardship programs or practices to health care facilities, such as long-term care facilities and community and rural hospitals. Requires CDC to provide a mechanism where health care facilities can report antimicrobial data that will be made available to the public.
Limited Population Pathway
Provides FDA with the flexibility to approve antimicrobial drugs based on a limited population if the drug treats a life-threatening infection. If FDA approves a drug based on a limited population, the labeling and advertising of an antimicrobial drug shall contain “Limited Population” along with a proprietary name of the drug. Gives FDA the authority to review and approve promotional materials of a drug approved based on a limited population at least 30 days prior to drug dissemination.
Clarifies and reiterates that nothing in this section will restrict the prescribing authority of antimicrobial drugs or limit the practice of health care providers.
Susceptibility Test Interpretive Criteria for Microorganisms
Provides FDA with the authority to rely on third party experts when updating guidelines for how much of a drug to use and which infections the drug is useful in treating.
Medical Device Innovations
Establishes a breakthrough device pathway, which builds on the existing priority review device pathway.
Humanitarian Device Exemption
Provides FDA with the authority to apply the humanitarian device exemption to devices that treat diseases and conditions that affect up to 8,000 individuals in the U.S. The current cap is 4,000.
Recognition of Standards
Establishes a clear process at FDA for the submission, review, and recognition of standards established by a nationally or internationally recognized standard organization for purposes of medical device review.
Certain Class I and Class II Devices
Requires FDA to update lists regarding the appropriate regulation of Class I and Class II devices.
Improves the medical device classification panel review process at FDA to ensure adequate expertise among panel members to assess the device and allow for presentation by the device sponsor to the panel, among other things.
Institutional Review Board Flexibility
Strikes the requirement that a sponsor of a medical device trial always use a local institutional review board. This change will allow the use of centralized models.
CLIA Waiver Improvements
Requires that the FDA update its existing regulatory guidance to clarify the criteria for waiving CLIA requirements, which will expand patient access to point-of-care diagnostics.
Least Burdensome Device Review
Requires an audit by the FDA ombudsman and an assessment of the measurements used to track the implementation of the least burdensome requirements. Clarifies that FDA reviewers shall consider the least burdensome appropriate means necessary for demonstrating a reasonable assurance of safety and effectiveness when requesting additional information from manufacturers during the pre-market approval process.
Cleaning Instructions and Validation Data Requirement
Encourages and clarifies that the FDA requires cleaning and validation data for reusable medical devices.
Clarifying Medical Software Regulation
Identifies five specific categories of medical software that, given certain conditions, will not be regulated as a medical device by the FDA based on their low level of risk to patients. Provides FDA with the authority to regulate software in these categories if there is found to be safety concerns.
Improving Scientific Expertise and Outreach at FDA
Silvio O. Conte Senior Biomedical Research Service
Increases the number of positions in the research service, allows increased salary, and changes the qualifications to include engineers so the service can serve FDA in addition to other HHS agencies. Requires GAO to conduct a study of the program, including the impact of the changes made in this section.
Hiring Authority for Scientific, Technical, and Professional Personnel
Provides FDA with the authority to appoint outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products. Allows for the FDA commissioner to determine and fix the annual pay rate up to a limit to help attract and retain qualified employees. Requires FDA to publish a report on workforce planning that includes an analysis of the workforce needs at the FDA and a recruitment and retention plan for hiring qualified scientific, technical and professional candidates. Requires GAO to also report on this provision, including on the progress the FDA has made in recruiting and retaining qualified staff.
Establishment of Food and Drug Administration Intercenter Institutes
Requires FDA to pilot one or more intercenter institute(s) to help develop and implement processes for coordination of activities in major disease areas between the drug, biologics, and device centers.
Improves FDA and NIH scientists’ ability to attend scientific conferences so they can keep up with the newest advancements in science and collaborate with one another, and requires.
Makes targeted edits to FDA’s drug surveillance program to allow FDA to focus on risk.
Reagan-Udall Foundation for the Food and Drug Administration
Modernizes Reagan-Udall, an independent, non-profit organization established by Congress to help FDA keep up with the fast pace of science.
Medical Countermeasure Guidelines
Requires timely and accurate recommended utilization guidelines for qualified Medical Countermeasures (MCMs), including for products in the Strategic National Stockpile. Requires HHS to report to the appropriate committees of Congress when funding in the BioShield Special Reserve Fund (SRF) available for procurement of MCMs falls below $1.5 billion and how the amount of funding will impact identified MCM priorities. Clarifies the reporting requirement’s annual deadline and that such report shall be submitted to the congressional committees of jurisdiction.
Clarifying BARDA Contracting Authority
Ensures coordinated, timely, and efficient processes for executing MCM development and procurement programs by clarifying that the Director of the Biomedical Advanced Research Development Authority (BARDA) shall carry out the programs funded by the Special Reserve Fund, as well as the procurement contracts, grants, and cooperative agreements under BARDA.
Countermeasure Budget Plan
Requires HHS to annually develop a five-year budget plan based on identified MCM priorities. Clarifies that in addressing agents that present a national threat, the plan will include those that are novel or emerging infectious diseases, and the efforts to develop MCMs for such threats, including qualified pandemic and epidemic products. Clarifies when this plan is required to be submitted to Congress and that it will be made publicly available.
Medical Countermeasures Innovation
Provides BARDA with targeted authority to enter into an agreement with a Medical Countermeasure Innovation Partner to foster and accelerate the development and innovation of MCMs, including promising technologies that also address unmet public health needs in addition to MCM needs, such as multiuse platform technologies. This provision will sunset after September 30, 2022.
Streamlining Project BioShield Procurement
Updates current law to remove unnecessary steps that no longer reflect the execution of the BioShield SRF today. Ensures that there are no unnecessary delays in the development, procurement, and stockpiling of medical countermeasures to protect the American people.
Encouraging Treatments for Agents that Present a National Security Threat
Establishes a priority review voucher to encourage the development of drugs and vaccines for agents that present national security threats. Requires the HHS Secretary to award a priority review voucher to the sponsor of a material threat MCM application upon approval. Consistent with the targeted priority review vouchers under current law, this priority review voucher can be transferred and used to receive priority review of another drug application at a later date. This provision will sunset after October 1, 2023.
Paperwork Reduction Act Waiver During a Public Health Emergency
• Waives the Paperwork Reduction Act requirements during the investigation of, response to, and post-response review of an event when it is determined by the HHS Secretary to be a public health emergency and the circumstances necessitate a waiver.
Clarifying Food and Drug Administration Emergency Use Authorization
Clarifies that FDA’s authorities with respect to emergency use authorizations applies to animal drugs.
Predictable Review Timelines of Vaccines by the Advisory Committee on Immunization Practices
The Advisory Committee on Immunization Practices (ACIP) convenes meetings to consider the use of a new vaccine or a new indication for a vaccine following FDA licensure. In the event the vaccine is not considered at the first scheduled meeting, the ACIP will provide an update on the committees review.
Review of Processes and Consistency of Advisory Committee on Immunization Practices Recommendations
This section would require the director of the CDC to conduct a review of the process used by ACIP in formulating and issuing recommendations pertaining to vaccines, including consistency in doing so. Following such review, the CDC director shall publish a report on the results of the review, including recommendations on improving the consistency of the process.
Encouraging Vaccine Innovation
Vaccine Meetings – Requires the CDC Director to coordinate appropriate staff with respect to the public health needs, epidemiology, and program planning and implementation considerations related to immunization. Report on Vaccine Innovation – Requires the Secretary, within one year of enactment, to issue a report on ways to promote innovation in the development of vaccines that minimize the burden of infectious disease. The report shall review the current status of vaccine development and:
- Consider the optimal process to determine which vaccines would be beneficial and how to share that information to key stakeholders,
- Examine and identify whether obstacles exist that inhibit the development of beneficial vaccines,
- Make recommendations on how to remove any obstacles identified in order to promote and incentivize vaccine innovation and development.
Consultation – In preparing this report the Secretary may consult with: relevant federal agencies, academic researchers, developers and manufacturers of vaccines, medical and public health practitioners, representatives of patient, policy, and advocacy organizations, and others as determined appropriate. Updates the vaccine injury compensation program related to maternal immunization.
Makes technical corrections to the Food, Drug, and Cosmetic Act.
Strikes studies from the law that have been completed.