CER Daily Newsfeed

Biden’s Drug Price Plan Still Flawed Under Trump, Opponents Say

(7/8, Nyah Phengsitthy, Bloomberg) reports “...The industry also raised uncertainty about the agency's discretion for drugs eligible for renegotiation and what framework it will use to determine prices. The concern is spurred by previous industry pushback that questioned the government's explanations for selecting medicines and determining their negotiated drug price in the program's first cycle. ‘We are concerned that given the limited details on renegotiation, manufacturers will have administrative burden to complete the timeline for renegotiation,’ the National Pharmaceutical Council said.” Full

FDA Should Judge Drugs on What They Do in Real Life, Not Just in Companies’ Clinical Trials

(7/8, Aaron Kheriaty, The Hill) comments “...Physicians practice medicine in the complex and messy real world, not under the artificially pure conditions of a controlled clinical trial. While the initial studies submitted for FDA approval have their merits, they also have built-in limitations. These should be complemented—and where necessary, corrected—by real world clinical data. To fulfill its mandate, the FDA cannot ignore the importance of ongoing safety and efficacy testing once a drug goes to market, even after its initial work of drug approval is finished. Lives depend on this work of ongoing vigilance.” Full

Effect of AI/ML, Real World Evidence and Master Protocols on Trial Success

(7/7, Janel Shelton-DeMagnus, MS, MPAS, Yun Lu, PhD, Sowmya Kaur, Applied Clinical Trials) comments “...Increasingly used to evaluate the effectiveness of therapies in broader populations, monitor post-market safety, and support regulatory decision-making, RWE provides critical data on a large-scale capacity. Despite its potential, integrating RWE into clinical research presents challenges, including data standardization, ensuring data quality, and addressing privacy concerns. Collaborative efforts between industry stakeholders, academia, and regulatory agencies are essential to overcome these barriers.” Full

Driving Value via Outcomes-Based Pricing and EHR Interoperability: Tyler Sandahl, PharmD

(7/7, Cameron Santoro, The American Journal of Managed Care) reports “Tyler Sandahl, PharmD, clinical pharmacist at Mayo Clinic, emphasized that with the high cost of chimeric antigen receptor (CAR) T-cell therapies and bispecific antibodies, an outcomes-based pricing model holds significant promise. In this interview with The American Journal of Managed Care® (AJMC®), she advocates for a cost-benefit analysis approach to ensure patients are getting the most ‘bang for their buck.’ She believes this approach would help pass some of the savings directly to patients.” Full

Trump Says He'll Set 50% Copper Tariff, Wait Year On Drug Levies

(7/8, Joe Deaux and Stephanie Lai, Bloomberg) reports “...Trump said he expected to offer pharmaceutical manufacturers some time to bring their operations to the US before implementing the tariffs on their products. ‘We're going to give people about a year, a year and a half, to come in,’ Trump said. ‘And after that they're going to be tariffed if they have to bring the pharmaceuticals into the country, the drugs and other things, into the country. They're going to be tariffed at a very very high rate, like 200%. We'll give them a certain period of time to get their act together.’” Subscription Required

Trump's Tax Cut Law Expands Orphan Drug Exclusions, Could Upend 340B Program

(7/7, Zachary Brennan, Endpoints News) reports “...Because of the cuts to Medicaid, hospitals in the 340B program will see fewer Medicaid patients and may risk losing their 340B status. Hospitals' participation in the 340B program, in which drugmakers provide steep discounts on certain outpatient drugs to those hospitals, is contingent on the number of Medicaid patients treated by them. ‘It absolutely would be a windfall for the pharmaceutical industry,’ Maureen Testoni, president and CEO for the hospital nonprofit 340B Health, told Endpoints.” Subscription Required

Bayesian Statistics In EU Clinical Trials: EMA Discusses Balancing Efficiency With Rigor

(7/8, Eliza Slawther, Pink Sheet) reports “...Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.” Subscription Required