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The oncology landscape is at an intersection of regulatory developments: from a proposal to reduce the FDA\u2019s review time on drugs to the 15% tariff rate on imported goods from the European Union (EU), including pharmaceuticals. Nevertheless, both sides have their advantages and disadvantages, according to Kashyap Patel, MD, and Sucharu Prakash, MD.<\/p>\n
\u201cI’m glad that [the FDA is] taking advantage of incorporating new changes. I commend the FDA for the right approach,\u201d Patel, the vice president for the Community Oncology Alliance, said in an interview with OncLive\u00ae. \u201cI don’t deny that safety is the number 1 policy; however, at the same time, when patients are living between life and death, it’s important [to have more available treatments].\u201d<\/p>\n
In June 2025, the FDA unveiled its Commissioner\u2019s National Priority Voucher (CNPV) program, in which drug developers could participate by redeeming the FDA\u2019s voucher that reduces the drug review time from approximately 10 to 12 months to 1 to 2 months with a submission of the sponsor\u2019s final drug application.1 Of note, the updated process is designed for experts from FDA offices to convene for a collective review, which contrasts the historical review system, consisting of a drug application being sent to several FDA offices. With the new system, a team of physicians and scientists can pre-review clinical information and gather for a 1-day meeting.<\/p>\n
\u201cFor a long time, the FDA\u2019s standard review time for a new drug [application (NDA)] has been about 10 to 12 months. This includes an initial process of submission and filing\u2014up to 2 months\u2014where the drug sponsor submits an NDA and the FDA checks completeness before formally accepting it for review,\u201d Prakash added in a separate interview. \u201cThen there is a review phase, which is another 6 to 8 months, where multidisciplinary teams\u2014including clinicians, pharmacists, and statisticians\u2014analyze safety, efficacy, and manufacturing data. Also, advisory committees may be consulted. Finally, there is the labeling and risk evaluation, which is another 1 to 2 months, where the exact label of the drug is negotiated. Then comes the final FDA decision to either approve or deny [the drug].\u201d Prakash is a medical director at Texas Oncology in Paris, Texas.<\/p>\n
FDA\u2019s Reduced Drug Review Time<\/strong><\/p>\n Within the first year of the CNPV program, the FDA aims to offer vouchers to a limited number of drug developers that are aligned with United States (US) national priorities. Specifically, these national health priorities include addressing a health crisis in the US, delivering innovative cures to Americans, addressing unmet needs in public health, and increasing domestic drug manufacturing as a national security issue. Notably, the FDA could grant accelerated approval to drugs from companies that are eligible for the program.<\/p>\n \u201cQualifications for this [CNPV] program are [currently] vague; [however,]\u2026this is an accelerated process and allows for expedited filing checks and immediate assignment of a review team. A multidisciplinary team is assembled to review the application,\u201d Prakash added. \u201c[The FDA] may focus on critical efficacy and safety end points, rather than detailed data. A key element is allowing companies to submit a large part of the application before clinical trials are completed.\u201d<\/p>\n Given the advances in technology and communication, Patel explained that these should be leveraged in expediting review times.<\/p>\n \u201cDespite all of these [advances] in the past decade, it’s been difficult to comprehend why it should take such a long time from the time of submission of the dossier to the FDA, the decision that would take up to a year,\u201d Patel noted. \u201cIt\u2019s appropriate for society as a whole to use the power of technology, the power of innovation, the power of computers to analyze the data and come to a decision quickly.\u201d<\/p>\n Between 2015 and 2022, data from a cross-sectional study revealed that 244 NDAs were submitted and approved, of which 45.5% of the FDA approvals did not involve an expedited program, and 54.5% of approvals used at least 1 expedited program.2 Of note, there were 120 oncology and hematology FDA approvals within this period, and 23.3% and 76.7% of approvals did not involve expedited programs or used at least 1 expedited program, respectively. The expedited drug review process with the CNPV program could reduce up to 10 months of review time without compromising the FDA\u2019s standards for safety, efficacy, and quality.1<\/p>\n \u201cThe biggest benefit with this [CNPV program] is faster patient access to potentially lifesaving therapies, especially oncology and in some rare diseases,\u201d Prakash said. \u201cThe reduction in drug review time may also encourage drug development and innovation by companies once they see a shorter time to market.\u201d<\/p>\n An Overlap in Change<\/strong><\/p>\n The 4 prominent national health priorities remain the focus of the CNPV program. Nevertheless, the priority to increase domestic drug manufacturing plays a role in the July 2025 announcement from the White House, where President Donald Trump announced a trade deal with the EU.3 In particular, the announcement detailed that the EU will pay the US a tariff rate of 15% on imported items, including pharmaceuticals.<\/p>\n \u201cAcademic centers typically deliver cutting-edge therapies and run clinical trials, and [they] may now face higher drug acquisition costs. Community practices already face financial challenges because of lower drug margins and the underinsured populations that they serve, and could struggle and even shut down,\u201d Prakash advised. \u201cOverall, oncologists may see restricted formularies and be forced to deliver inferior, cheaper therapies.\u201d<\/p>\n As both academic and community centers potentially face the effects of the 15% tariff rate on oncology drugs could lead to anxiety within the space, Patel added. However, he expressed concern regarding whether tariffs will be imposed on active pharmaceutical ingredients or solely on the drugs being imported from the EU.<\/p>\n Based on the agreement made on a Framework on an Agreement on Reciprocal, Fair, and Balanced Trade established in August 2025, the US is committing to apply a 15% tariff rate effective as of September 1, 2025, on goods originating from the EU, particularly including generic pharmaceuticals and their ingredients and precursor chemicals.4<\/p>\n \u201cOne of the concerns that I have is that during the COVID-19 pandemic, there was a huge shortage of cancer drugs across the US, and that led to many changes in the protocol that we use,\u201d Patel said. \u201cInsecurity about the tariff does breed in lot of anxiety, stress, and concerns within the provider community, both at hospitals and any place that infuses or administers drugs.\u201d<\/p>\n Considerations of Higher Drug Costs<\/strong><\/p>\n The 15% tariff rate on pharmaceuticals from the EU could pose a similar situation seen with the chemotherapy shortage in early 2023, ultimately affecting the cost of treatments, Patel emphasized.<\/p>\n \u201cWhen the [platinum-based] chemotherapy was in short supply, physicians started switching the class of the drugs from one that was available right then. There may be a time when there’s always a possibility of substituting some drugs, because every cancer has multiple different treatment options,\u201d he explained. \u201cPhysicians may lead to something that can be afforded, that can be accessed easily, and that may be administered without any anxiety from the effects of the tariff.\u201d<\/p>\n Nonetheless, Prakash noted that, \u201cHigher costs of drugs and supplies may force clinicians to potentially prescribe older, cheaper, or less optimal drugs; instead of following guideline-based therapy, they may opt for cheaper therapies. There may be increased insurance approval and prior authorization hurdles [and an] increase in disparities because some centers could afford newer therapies while rural centers may lag behind.\u201d<\/p>\n Although there are still many unknowns regarding the effect of the tariff on drugs, Patel underscored the potential to think \u201ccreatively and substitute\u201d agents with nationally available treatments without experiencing a significant effect from the tariff.<\/p>\n \u201cWe all learned our lesson [from the chemotherapy shortage] about how to substitute what was available at hand,\u201d Patel said. \u201cIt may inspire human ingenuity to look at the alternatives and see what [we] can do without affecting patient care.\u201d<\/p>\n References<\/strong><\/p>\n\n