biomarkers for targeted and immunotherapies. Improvements in how cancer drugs are studied and doses are selected have the potential to accelerate the pace of progress against cancer. Addressing Cancer Drug Shortages In addition to ensuring that new cancer therapies are safe and effective, FDA is responsible for regulating the supply of drugs so that patients can get the medications they need. Unfortunately, there have been record shortages of cancer drugs this year. In December 2022, there were 295 prescription medications in short supply (778). Shortages of cisplatin and carboplatin are particularly impacting care options for patients, which are estimated to be prescribed for 10 to 20 percent of patients with cancer (779). The underlying causes of the shortages are varied and incredibly complex, and include supply chain disruptions, manufacturing quality issues, limited economic incentives to manufacture generic drugs, and increasing reliance on fewer manufacturers. To help alleviate the shortage of cisplatin, FDA issued a temporary authorization to import cisplatin from China. Congress has held several hearings this year to better understand the issue and identify potential solutions in coordination with the White House, FDA, and cancer-focused professional organizations (780). FDA-NCI Collaborations to Promote Innovative Clinical Research FDA and NCI have recently established several collaborations to promote innovation in clinical research. In February 2023, the Clinical Trials Innovation Unit (CTIU) was established to fund novel trial designs, with a focus on expanding access to historically underserved communities (781). This collaboration pairs funding from NCI and trial design advice from FDA with the goal of expanding trial eligibility, investigating new endpoints, utilizing streamlined data collection strategies, and other novel methods and technologies to improve equity in cancer research. Another collaboration created in 2019, called the Connecting Awardees to Regulatory Experts (CARE) program, is focused on small businesses funded by NCI to begin developing new therapies (782). The CARE program provides additional opportunities for NCI-funded small businesses to meet with FDA to discuss their development plans and promote successful regulatory submissions. From 2019 to 2022, 141 small businesses have participated in CARE, with 90 percent recommending the program to other companies. Advancing Policy to Strengthen Cancer Prevention and Screening Programs Approximately 40 percent of cancer cases in the United States can be attributed to preventable risk factors, such as tobacco use, infections, and UV exposure (see Reducing the Risk of Cancer Development, p. 38, and Figure 24, p. 162). Routine screenings using evidence-based approaches to detect common cancers greatly improve treatment options and outcomes (see Screening for Early Detection, p. 54). However, inequities remain in access to cancer screenings and follow-up care, which are major contributors to delayed diagnoses among underinsured and uninsured populations. CDC’s National Breast and Cervical Cancer Early Detection Program and Colorectal Cancer Control Program provide routine cancer screenings for medically underserved populations across the United States. Funding limitations prevent these crucial programs from providing screening services to all eligible people. According to the most recent data available, 6.8 percent of eligible people receive cervical cancer screenings and 15 percent of eligible people received breast cancer screenings through these programs (783,784). Medicaid expansion has helped increase cancer screenings in medically underserved populations (785) and is A provision in the Inflation Reduction Act allows Medicare to implement price negotiation for small molecules after nine years, compared to 13 years for biologic therapies such as antibodies and cell therapies. There is concern among industry that this provision disincentivizes innovation for small molecules because it takes a similar amount of time and resources to develop both small molecules and biologics. In 2023, close to 300,000 women in the United States will be diagnosed with invasive breast cancer and over 13,000 people will be diagnosed with invasive cervical cancer. Reauthorization of the Screening for Communities to Receive Early and Equitable Needed Services for Cancer Act is crucial to continue to support the National Breast and Cervical Cancer Early Detection Program. AACR Cancer Progress Report 2023 158 Advancing the Future of Cancer Research and Patient Care Through the Adoption of Evidence-Based Policies
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