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Key Points Question What are the real-world outcomes for Medicare patients with metastatic cancer receiving recently approved oncology drugs and how do they compare with pivotal clinical trial outcomes? Findings In this retrospective cohort study, outcomes were compared between clinical trial participants and treated Medicare patients across 22 cancer drugs approved by the US Food and Drug Administration for 29 indications. Median duration of therapy and overall survival among treated Medicare patients were generally shorter than among trial participants, and dose reductions were common among Medicare patients. Meaning Pivotal clinical trials may provide inadequate data for the purpose of clinical decision-making among Medicare beneficiaries with advanced cancer.

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Background. Oncologists who author clinical practice guidelines frequently have financial relationships with the pharmaceutical industry. It is unknown whether participation on clinical practice guideline committees is associated with differences in the amounts of industry money received. Materials and Methods. We conducted a nested casecontrol study from August 2013-December 2018. We manually abstracted membership records of NCCN Guidelines committees for the 20 most common cancers and linked to Open Payments. The study sample included medical oncologists selected to join an NCCN Guidelines committee ("joiners") during the study period. Joiners were matched 1:2 to medical oncologists who had no participation on NCCN committees (controls) by gender, NCCN institution, and medical school graduation year. We performed difference-in-differences (DiD) estimation to assess whether selection to an NCCN committee was associated with the dollar value of payments received from industry, using generalized estimating equations to address correlation between matched pairs and between repeated observations of the same pair. Results. 54 physicians joined an NCCN Guidelines committee during the study period. These physicians received more payments than matched controls in the year prior to joining

Background: The Prescription Drug User Fee Act (PDUFA) is due for reauthorization in 2022. Beyond creating the user fee program which now generates a majority of the Food and Drug Administration (FDA) Human Drugs Program budget, PDUFA has made numerous additional changes to FDA policy during its 29-year history. FDA's budgetary dependence on user fees may advantage the industry in negotiating favorable policy changes through PDUFA. Methods:The full texts of all prior PDUFA reauthorization bills and all submitted public comments and meeting minutes for the 2022 reauthorization were reviewed. Provisions affecting FDA regulatory authority and processes were identified.Findings: PDUFA legislation has instituted a broad range of changes to FDA policy, including evidentiary standards for drug approval, accelerated pathways for approval, industry involvement in FDA decision-making, rules regarding industry information dissemination to providers, and market entry of generic drugs. Negotiations over the 2022 reauthorization suggest that industry priorities include increased application of real-world evidence, regulatory certainty, and increased communication between FDA and industry during the drug application process. Conclusions:The need for PDUFA reauthorization every 5 years has created a recurring legislative vehicle through which far-ranging changes to FDA have been enacted, reshaping the agency's interactions and relationship with the regulated industry. The majority of policy changes enacted through PDUFA legislation have favored industry through decreasing regulatory standards, shortening approval times, and increasing industry involvement in FDA decisionmaking. FDA's budgetary dependence on the industry, the urgency of each PDUFA reauthorization's passage to maintain uninterrupted funding, and the industry's required participation in PDUFA negotiations may advantage the industry.

Background: Personal payments from the pharmaceutical industry to US physicians are common and are associated with changes in physicians’ clinical practice and interpretation of clinical trial results. We assessed temporal trends in industry payments to oncologists, with particular emphasis on payments to authors of oncology clinical practice guideline and on payments related to immunotherapy drugs. Methods: We included US physicians with active National Plan and Provider Enumeration System records and demographic data available in the Centers for Medicare & Medicaid Services Physician Compare system who had a specialty type of medical oncology or general internal medicine. Medical oncologists serving on NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) Panels were identified manually. Industry payments, and the subset associated with PD-1/PD-L1 drugs, were identified in Open Payments, the federal repository of all transactions of financial value from industry to physicians and teaching hospitals, from 2014 to 2017. Results: There were 13,087 medical oncologists and 85,640 internists who received payments. The mean, annual, per-physician value of payments to oncologists increased from $3,811 in 2014 to $5,854 in 2017, and from $444 to $450 for internists; the median payment increased from $152 to $199 for oncologists and remained at $0 for internists. Oncologists who served on NCCN Guidelines Panels received a greater value in payments and experienced a greater relative increase: mean payments increased from $10,820 in 2014 to $18,977 in 2017, and median payments increased from $500 to $1,366. Among companies marketing PD-1/PD-L1 drugs, mean annual per-oncologist payments associated with PD-1/PD-L1 drugs increased from $28 to $773. Total per-oncologist payments from companies marketing PD-1/PD-L1 drugs experienced a 165% increase from 2014 to 2017, compared with a 31% increase among similar companies not marketing PD-1/PD-L1 drugs. Conclusions: Pharmaceutical industry payments increased for US oncologists from 2014 to 2017 more than for general internists. The increase was greater among oncologists contributing to clinical practice guidelines and among pharmaceutical companies marketing PD-1/PD-L1 drugs. The increasing flow of money from industry to US oncologists supports ongoing concern regarding commercial interests in guideline development and clinical decision-making.

2068 Background: The high frequency of financial relationships between the pharmaceutical industry and influential oncologists who author clinical practice guidelines may influence guideline recommendations. Therefore, we assessed the financial relationships held by NCCN Guidelines panelists before and after joining the panel, compared to those held by a matched set of oncologists. Methods: Membership of NCCN Guidelines panels for the 20 most common cancers was obtained from archival guidelines and linked manually to Open Payments records of industry payments. We identified physicians who newly joined an NCCN panel during the August 2013-December 2018 study period, and we included medical oncologists who had at least 1 year of Open Payments data before and after joining. These medical oncologists who joined an NCCN panel (panelists) were matched 1:2 to medical oncologists with the same gender, institutional affiliation, and medical school graduation year, who did not join an NCCN panel (non-panelists). The dollar value of industry payments was then calculated over the 1 year before (pre-join) and after (post-join) the date that each panelist joined. We used generalized linear models to assess differences in industry payments between the panelists and matched non-panelists in the pre-join period. We used difference-in-difference estimation (DiD) to assess whether joining an NCCN panel was associated with increased payments in the post-join period. Results: There were 54 panelists and 108 non-panelists (matched from 1447 eligible oncologists at NCCN institutions). Mean per-oncologist payments among panelists were greater than non-panelists in the pre-join period ($11,259 vs $3,427, p = 0.02). From the pre-join to post-join period there was a similar increase in mean per-oncologist payments among panelists and non-panelists ($2,236 vs. $1,569, DiD estimate +$667, p = 0.77). Conclusions: Medical oncologists who were selected to an NCCN Guidelines panel had greater financial ties to industry compared to peer oncologists who were not selected. This difference was present prior to joining; oncologists did not experience a greater increase in financial payments from industry in the 1-year period after joining an NCCN panel. These results suggest an opportunity to reduce the potential influence of industry in oncology clinical practice guidelines through the selection of guideline panelists with fewer ties to industry.

1582 Background: Payments from the pharmaceutical industry to US health care providers were made public through Open Payments in 2013. Since then, industry payments to individual physicians have been studied extensively, but payments to hospitals remain uncharacterized. The goal of this study was to examine trends in industry payments to US cancer centers. Methods: We identified all US cancer centers that were National Comprehensive Cancer Network (NCCN) members or were National Cancer Institute (NCI) comprehensive cancer center as of 2019. Each institution was manually mapped to Open Payments, which contains industry payment data. Where applicable, subsidiary hospitals were included with the parent center. Among the NCCN centers, we used National Plan and Provider Enumeration System data to identify medical oncologists practicing there. Oncologists were linked to Open Payments by name and address. We analyzed “research payments” (RP), which include payments related to preclinical and clinical research, and “general payments” (GP), which include non-research-related payments in categories such as speaker fees, consulting fees, meals, grants, charitable contributions, and licensing fees. We ascertained public research support from NIH data, and included all research project grants. We used correlation analysis and linear regression models to assess the association between industry payments to a cancer center and to oncologists practicing at that center. All dollar values were inflation-adjusted to 2019 dollars using the Consumer Price Index for medical care from the US Bureau of Labor Statistics. Results: Overall industry RP to US cancer centers increased from $527 million in 2014 to $653 million in 2019, while GP increased from $346 million to $786 million. NCI research funding increased from $1,397 million in 2014 to $1,583 million in 2019 (13.3% increase) while overall industry payments (RP+GP) increased from $873 million to $1,439 million (64.8% increase). Industry payments were highest as a portion of total income (industry + NCI) at MD Anderson (64.2%) and lowest at St. Jude (0.1%). Among NCCN institutions, industry payments to cancer centers and the oncologists practicing at those centers were correlated (coefficient = 0.382). A $1,000 increase in GP to a cancer center from a given pharmaceutical company was associated with a $1.00 ($0.61 - $1.30) increase in GP from that company to oncologists at that cancer center. Conclusions: From 2014-2019, cancer center funding from industry sources grew quickly, driven by an increase in non-research payments, and now approaches the amount of public research funding cancer centers receive. Cancer center acceptance of industry payments is associated with increased industry payments to its employed physicians, which are known to sway prescribing practices. These trends raise concerns regarding the ability of these institutions to fulfill their public missions.