In the third quarter of 2023, Representative Paul Tonko reintroduced the Scientific Integrity Act while some agencies requested feedback on their draft scientific integrity policies. The CDC faced pushback over an apparent attempt to ignore evidence about how best to control infectious disease transmission in hospitals. The FDA followed the advice of its advisory committee in approving the first over-the-counter birth control pill — but also heard from advocates concerned about whether the agency has sufficiently heeded staff and advisory committee concerns in approvals for other drugs.
The Scientific Integrity Act and draft policies at agencies
In July, Representative Paul Tonko and colleagues reintroduced the Scientific Integrity Act, which would put into law the requirement that federal agencies adopt and enforce scientific integrity policies that prohibit political interference with scientific work. The bill has bipartisan support.
Although having the requirements for agency scientific integrity policies enshrined into law would help give those policies teeth and staying power, the Biden-Harris administration isn’t waiting for Congress to act. One of President Biden’s first acts as president was to sign a presidential memorandum requiring all agencies to adopt new scientific integrity policies or revise those already in place. The process began with an interagency working group developing a framework for scientific integrity policies, and now agencies are producing drafts that adhere to the framework.
Biden’s presidential memorandum encourages agencies to seek public feedback on their draft scientific integrity policies. In July, the Department of Health and Human Services (HHS) released its draft policy for comment. Eleven organizations responded with praise for some aspects of the policy—such as specifying that violations of clearance policies for scientific work products can constitute violations of the scientific integrity policy when they result in unjustified suppression or delay—and recommendations for ways to strengthen it. For instance, the organizations noted that HHS’s draft policy contains a problematic prohibition against scientists making statements that “could be construed as being judgments of, or recommendations on” agency policy. The organizations explained, “A bad-faith actor seeking to harass a scientist whose work they find distasteful could claim to have ‘construed’ virtually any statement as a judgment of government policy.” (This problematic provision also appeared in the framework’s model policy, and advocates also raised concerns about it at that stage.)
The eleven organizations also recommended that HHS prohibit the some of the problematic actions that Trump administration officials took to abruptly halt teen pregnancy prevention research and studies that used human fetal tissue to develop vaccines and treatments, as well as a rule that required providers funded by the Title X family planning program to deliver non-evidence-based care. The Title X “gag rule” required that providers refer pregnant patients for prenatal care and not for abortions regardless of what the patient wanted; as a result, many providers left the program, and the Title X system served more than half a million fewer low-income clients in 2019, after the gag rule took effect, than in 2018. To prevent such problems in the future, the organizations advise that HHS’s revised scientific integrity policy prohibit 1) the termination of research funding for reasons other than breach of contract, abusive behavior, or gross mismanagement and 2) any requirements for grantees to adopt non-evidence-based procedures. They also propose that the revised policy hold grantees accountable by stating that those found to have violated the scientific integrity policy will be barred from receiving new HHS contracts for two years.
In September, the National Science Foundation hosted two virtual listening sessions at which members of the public could provide feedback on any aspect of the process of developing the framework, individual policies, and the infrastructure for evaluating policies and their implementation. Eight of the comments were from speakers from the eleven organizations that submitted the group comment to HHS, and they emphasized several of the points made in that comment. Speakers’ comments also addressed the need to address attempted as well as completed violations of scientific integrity policies; the importance of diversity, equity, and inclusion for scientific integrity; and the need to eliminate inappropriate pressure placed on those who report or investigate policy violations.
Looking ahead: Several more agencies should release draft policies for comment before the end of the year.
Will CDC rely on evidence to protect health care workers?
CDC’s Healthcare Infection Control Practices Advisory Committee (HICPAC) faced substantial pushback when it appeared to be moving toward new guidelines for hospital infection control that deemed surgical masks and N95 respirators to provide the same level of protection—even though evidence shows that N95s offer better protection than surgical masks against infection from airborne diseases like COVID-19. The draft guidelines, which were not released to the public but were described on slides at HICPAC’s June meeting, also appeared to ignore the importance of ventilation for controlling health care workers’ exposure to airborne infectious diseases.
More than 900 experts in infectious disease, public health, industrial hygiene, aerosol science, and ventilation engineering wrote to new CDC Director Mandy Cohen urging her to scrap HICPAC’s draft guidelines and start a new, more transparent guideline process with input from health care personnel, industrial hygienists, engineers, research scientists, and experts in respiratory protection. National Nurses United (NNU) delivered to CDC a petition signed by nearly 11,000 individuals and organizations urging HICPAC and the agency to produce updated guidance that “includes the use of multiple control measures that have been shown to effectively prevent transmission of respiratory pathogens.”
At HICPAC’s August meeting, several members of the public spoke about shortcomings in the draft guidelines and the process that produced them. Judy Stone reported in Forbes that “several speakers expressed concern that HICPAC’s draft proposal also fails to include ventilation, UV disinfection, and HEPA filtration—all essential for controlling an airborne pathogen” and that “several speakers also criticized HICPAC’s seemingly secretive processes.” HICPAC had planned to vote at this meeting on whether to finalize the guidelines, but the committee did not do so. Public health advocates hope the pause in the process will allow HICPAC to revamp its guidelines to incorporate the latest evidence on how best to prevent airborne transmission of pathogens. The guidelines presented in June “are anti-science and put nurses, other health care workers, and patients at risk by proposing that surgical masks are adequate protection against aerosol-transmitted diseases, among other alarming updates,” said NNU President Zenei Triunfo-Cortez.
In response to NNU’s calls for greater transparency, CDC sent NNU a limited number of summaries of work group meetings about updating the guidance. NNU considers this a positive step toward transparency, but states that the summaries raise “even more concerns about the CDC/HICPAC not following science and prioritizing the profit motives of the health care industry over protecting health care workers and patients.” Their website contains a portal individuals can use to email CDC/HICPAC leaders and urge them to “release the draft Isolation Precautions guidance updates, hold public meetings, and fully recognize the science on aerosol transmission and respiratory protection.”
Looking ahead: HICPAC is scheduled to meet again November 2-3, 2023.
FDA approves first-ever over-the-counter birth control pill; will insurers cover it?
In July, FDA approved Opill, the first birth control pill intended for over-the-counter sale. Opill is a progestin-only pill, with fewer contraindications than combined oral contraceptives containing both estrogen and progestin.
Prior to the approval, FDA staff who reviewed the extensive materials submitted by the manufacturer raised questions for its advisory committees—outside experts whose input informs, but does not determine, drug approval decisions—about whether the studies showed convincing evidence that users could safely and effectively take the pill as the instructions direct, without the involvement of a provider. The FDA scientists were not concerned about the safety and efficacy of the pills themselves, but they pointed out that findings suggested some confusion about how to use the pills correctly to prevent pregnancy (e.g., using a non-hormonal method when first starting the prescription and what to do about missed pills) and that few study participants were under age 15. In the public comment portion of the advisory committee meeting, young people, providers, researchers, and reproductive justice advocates testified about the evidence, barriers to access, and importance of being able to access birth control pills without visiting a health care provider. After hearing both staff concerns and public testimony, FDA’s expert advisors voted unanimously to approve Opill’s application, noting that provider involvement does not guarantee that users will take medication accurately and that there are substantial benefits to easing access to this effective form of contraception. They also emphasized that decades of scientific evidence have demonstrated the safety and effectiveness of progestin-only birth control pills, and that contraindications are even rarer among adolescents compared to adults. FDA leadership followed their advice and approved Opill.
Looking ahead: Opill manufacturer Perrigo anticipates the pill will be available in stores in early 2024. Insurance companies are required to pay for prescription birth control products, and a request for information from the federal Departments of HHS, Labor, and Treasury on coverage of a range of over-the-counter preventive services raises the possibility of requiring that insurers cover over-the-counter preventive items. The departments express the importance of considering no-cost-sharing coverage of over-the-counter contraception without a prescription to maximize access. The request for information is an opportunity for the public to submit information on the benefits and impacts of such coverage; comments are due December 4, 2023.
Role of FDA staff and advisors in drug approval decisions
FDA Center Directors’ approval decisions are influenced by FDA experts and advisory committee votes, and controversies arise when there are major disagreements. Organizations from the Patient, Consumer, and Public Health Coalition wrote to FDA Commissioner Robert Califf expressing concern that in some recent drug approval decisions, Center Directors approved products that their own scientists (and sometimes advisory committee as well) agreed were not proven to be safe and effective. Their letter to Commissioner Califf expressed concerns about these decisions and recommended several steps to improve advisory committee meetings, including providing training for advisory committee members and ensuring that FDA scientific staff have the scientific freedom to express their views and ensure these views are presented to advisory committees.