In the third quarter of 2023, Congressman Paul Tonko reintroduced the Scientific Integrity Act, and some government agencies requested feedback on the draft Scientific Integrity Policy. The CDC faced backlash for its apparent attempt to ignore the evidence on how best to control infectious disease transmission within hospitals. While the FDA followed the advice of its advisory committee in approving its first over-the-counter drug, comments from advocates concerned whether the agency has sufficiently listened to staff and advisory committee concerns in approving other drugs. I also heard.
Scientific Integrity Act and Agency Policy Draft
In July, Congressman Paul Tonko et al. reintroduced the Scientific Integrity ActThis would legislate requirements for federal agencies to adopt and enforce scientific integrity policies that prohibit political interference in scientific research. This bill has bipartisan support.
Enshrining requirements for government agencies’ scientific integrity policies into law would help give those policies more restraint and staying power, but the Biden-Harris administration is not waiting for Congress to act. do not have. One of President Biden’s first acts as president was to presidential memorandum Require all government agencies to adopt new scientific integrity policies or revise policies already in place. The process began with development by an interagency working group. Scientific integrity policy frameworkCurrently, each government agency is drafting a framework that complies with that framework.
Biden’s presidential memo encourages government agencies to seek public feedback on draft scientific integrity policies. In July, the Department of Health and Human Services (HHS) Draft policy published for comment. 11 organizations responded Commends and strengthens several aspects of the policy, including specifying that violations of the clearance policy for scientific research results that result in unreasonable suppression or delay may constitute a violation of the scientific integrity policy; Recommendations on methods were made. For example, the groups say the HHS draft policy includes a problematic prohibition on scientists making statements that “could be construed as making judgments or recommendations” about agency policy. He pointed out that there was. “Malicious actors seeking to harass scientists conducting objectionable research could claim to have ‘interpreted’ virtually any statement as a government policy judgment,” the group said. explained. (This problematic provision also appears in the framework’s model policy, Advocates also voice concerns About that at that stage. )
The 11 groups also recommended that HHS ban some of the problematic actions Trump administration officials took to abruptly end the program. Teenage pregnancy prevention research and Research used It also established rules that require the use of human fetal tissue to develop vaccines and treatments and require health care providers receiving funding from Title X family planning programs to provide care that is not evidence-based. . Title X “Gag Rule” required by the provider Refer pregnant patients for prenatal care rather than abortion, regardless of what the patient wanted. As a result, many providers are leaving the program and title x system In 2019, after the ban took effect, the number of low-income customers served decreased by more than 500,000 compared to 2018. To prevent such problems in the future, the organizations recommend that HHS’s revised scientific integrity policy 1) prohibit the termination of research funding; reasons other than breach of contract, fraud, or gross mismanagement; and 2) a requirement for the grantee to adopt procedures that are not evidence-based. They also said anyone found to have violated the scientific integrity policy would be barred from receiving new HHS contracts for two years, and proposed a revised policy to hold grant recipients accountable. .
Sponsored by the National Science Foundation in September Two virtual listening sessions The conference allows the public to provide feedback on all aspects 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 her 11 organizations that submitted group comments to HHS, highlighting several points made in the comments. Speakers’ comments also mentioned the need to address the following challenges: Not only attempted but completed Violation of Scientific Integrity Policy. The importance of diversity, equity, and inclusion for scientific integrity. and the need to eliminate inappropriate pressure on those who report or investigate policy violations.
Future outlook: Several additional government agencies are required to publish draft policies for comment by the end of the year.
Will the CDC rely on evidence to protect health care workers?
parable evidence shows that N95 offers better protection Better than surgical masks for airborne infections like COVID-19. The draft guidelines, which were not made available to the public but were explained in slides at the HICPAC meeting in June, also seem to ignore the importance of ventilation to control exposure of health care workers to airborne diseases. Looked.
More than 900 experts in infectious diseases, public health, industrial hygiene, aerosol science, and ventilation engineering sent the letter below. New CDC Director Mandy Cohen Urges her to scrap HICPAC’s draft guidelines and begin a new, more transparent guideline process with input from health care professionals, industrial hygienists, engineers, research scientists, and respiratory protection experts Ta. national nurses united (NNU) has submitted a petition signed by approximately 11,000 individuals and organizations to the CDC calling on HICPAC and the agency to “implement multiple controls that have been proven to effectively prevent the transmission of respiratory pathogens. It called for updated guidance to be developed, including the use of methods.
At HICPAC’s August meeting, several public participants spoke out about shortcomings in the draft guidelines and the process for their development. Judy Stone reports for Forbes magazine “Several speakers expressed concern that the HICPAC draft also does not include ventilation, UV disinfection, and HEPA filtration, which are essential to controlling airborne pathogens.” , also criticized HICPAC’s seemingly secretive process.” HICPAC was scheduled to vote at this meeting on whether to finalize the guidelines, but the committee did not vote. Public health advocates hope this pause in the process will allow HICPAC to revise 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 healthcare workers, and patients at risk by suggesting, for example, that surgical masks are adequate protection against aerosol-borne infections. and other worrying updates.” NNU President Zenei Triunfo-Cortés said:.
In response to NNU’s request for increased transparency, CDC sent NNU a limited number of summaries of working group meetings on updated guidance. NNU sees this as a positive step towards transparency, but says: summary raises “Additional concerns that CDC/HICPAC is not following the science and prioritizing the profit motive of the medical industry over the protection of healthcare workers and patients.” Their website includes a portal available to individuals. I am. Email the CDC/HICPAC Leader It calls for “the publication of an updated draft of the Isolation Precautions Guidance, a public meeting, and a thorough understanding of the science on aerosol transmission and respiratory protection.”
Future outlook: HICPAC is It is scheduled See you on November 2-3, 2023.
FDA approves first-ever over-the-counter drug. Will my insurance company cover it?
In July, FDA approves Opil, the first oral contraceptive pill intended for over-the-counter sale. Opill is a progestin-only pill and has fewer contraindications than combined oral contraceptives that contain both estrogen and progestin.
Prior to approval, FDA staff reviewed extensive documentation submitted by the manufacturer, and the advisory committee ( Questions were posed to external experts who provide input to, but do not decide, drug approval decisions. Taking tablets effectively as directed without intervention from a health care provider. Although FDA scientists were not concerned about the safety or effectiveness of the pills themselves, the findings of this study are important for correct use of the pills for contraception (e.g., non-hormonal pointed out, suggesting confusion about how to use etc. What to do about missed pills), and the study participants were unlikely to have been under the age of 15. public comment During some of the advisory committee meetings, young people, health care providers, researchers, and reproductive justice advocates discussed the evidence, barriers to access, and the importance of obtaining oral contraceptives without visiting a health care provider. testified about sex.After hearing both staff concerns and public testimony, the FDA The expert advisors voted unanimously In order to approve Opill’s application, it is important to note that the involvement of health care providers does not guarantee that users will take the medication accurately, and that facilitating access to this effective method of contraception goes a long way. He pointed out that there are advantages. They also emphasized that decades of scientific evidence have demonstrated the safety and effectiveness of progestin-only contraceptives, and contraindications are even rarer in adolescents compared to adults. FDA leadership followed their advice and approved Opill.
Future prospects: Opil manufacturer Perrigo expects the pill to be available over the counter in early 2024. Insurance companies must pay for prescription contraceptives; request information The Federal Department of Health, Labor, and Treasury have issued coverage notices for various over-the-counter preventive services, increasing the likelihood that insurance companies will be required to cover over-the-counter preventive products. Sectors have expressed the importance of considering no-cost coverage of non-prescription over-the-counter contraceptives to ensure maximum access. Requests for Information are an opportunity for members of the public to submit information regarding the benefits and impact of such reporting. Comments are due by December 4, 2023.
Role of FDA staff and advisors in drug approval decisions
The FDA Center Director’s approval decisions are influenced by the votes of FDA experts and advisory committees, and disputes arise when there is significant disagreement. The Patient, Consumer, and Public Health Coalition sent a letter to FDA Commissioner Robert Califf stating that the center’s directors agree that their own scientists (and sometimes their advisory committees) agree with some recent drug approval decisions. They expressed concern that the product had been approved as not proven to be safe. And it’s effective.their Letter to the Caliphate We expressed concern about these decisions and recommended several measures to improve the meetings of the Advisory Committee. These include providing training to advisory committee members, ensuring scientific freedom for FDA scientific staff to express their opinions, and ensuring that these opinions are presented to advisory committees. This includes things to do.
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