New FDA transparency push begins with J&J's Erleada
- The Food and Drug Administration has published a more detailed explanation of why it OK'd Johnson & Johnson's prostate cancer medication Erleada, part of a larger push by the agency to increase transparency surrounding approval decisions.
- Through a recently launched pilot program, the FDA posted a 136-page summary of clinical trials, data and protocols that supported its decision on Erleada. For instance, the summary disclosed how, in the Phase 3 SPARTAN study, treatment with J&J's drug plus androgen deprivation therapy (ADT) significantly decreased the risk of prostate-specific antigen progression by 94% compared to placebo and ADT.
- Though the agency normally discloses key efficacy and safety results upon approving a drug, "often there is no complete description of the important efficacy trials, including the trial protocols, descriptions of any modifications made during the trial itself, and an explanation of all of the results," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, wrote in a blog post Monday.
Transparency is one of the biggest buzzwords in pharma right now.
In many instances, the move for greater transparency has centered on clinical trial data. Drugmakers have taken noticeable steps to ensure such data is more easily accessible — an analysis from Bioethics International Inc., a healthcare ethics-focused organization, found 96% of the in-human clinical trials for drugs approved by the FDA in 2014 had results that were publicly available.
Lawmakers and patient groups have also pressed for more clarity on another pharma buzzword: drug pricing.
For its part, J&J has tried to stay ahead of the curve in both categories. The big pharma tied for first in Bioethics' most recent Good Pharma Scorecard, which evaluates companies on their clinical trial transparency. And in early 2017, it began releasing annual reports that provide information on average list and average net price changes for the company's products.
J&J appears to be continuing such efforts by participating in the FDA's Clinical Data Summary Pilot program, which launched in January. The program aims to publish pieces of scientific documents called Clinical Study Reports (CSRs), which contain the most important information regulators consider when voting yes or no on a potential new therapy.
"Currently FDA posts its review documents on line — material we call drug approval action packages. While the action packages include a significant amount of information pulled in from the sponsor’s application, that information is frequently separated into different sections and does not provide a complete summary of the results of any given study," Woodcock wrote in the March 19 blog post.
"This makes it difficult for academic researchers, regulators in other agencies, and other stakeholders to gain an in-depth understanding of the studies supporting approval."
The FDA intends to publish CSRs for up to nine recently approved treatments by the end of the program's pilot phase. Following that phase, the agency will open the floor for public feedback about the program.
"[W]e look forward to learning more about the benefits of expanding this effort, and how to support our stakeholders’ needs," FDA Commissioner Scott Gottlieb wrote in January in a blog post.
- FDA Blog post
Follow Jacob Bell on Twitter