This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.
In 2010, the FDA issued draft recommendations on increasing the transparency of the FDA’s processes and about expanding disclosure of information while protecting companies’ trade secrets. Among the FDA’s recommendations was that applications for new products be publicly disclosed at the time of the filing.
To date, however, regulations have not been updated to allow the FDA to publicly disclose filings for new drugs, biologics, or biosimilars. In fact, the FDA rarely asks for the public disclosure of information outside of convened advisory committees that discuss individual product applications.
This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.
The letter, authored by Harinder Singh Chahal, PharmD, MSc, of the FDA, and coauthors, reports on a cross-sectional study of all New Drug Applications (NDAs) for new molecular entities and all Biologics License Applications (BLAs) for biosimilars and biologics submitted to the FDA between 2010 and 2016.1 The primary outcomes of their study included the disclosure of applications via press releases, Securities and Exchange Commission (SEC) filings, and other media.
Chahal and colleagues found that, of 249 applications, 222 (89.2%) were disclosed in at least 1 public medium, including a press release in 196 cases (78.7%). Additionally, 157 (63.1%) of applications were disclosed in SEC filings. Median time to any public disclosure was 6 days (interquartile range, 9-63), and overall, the rate of public disclosure increased from 87.5% in 2010 to 97.6% in 2016.
Additionally, say the authors, the Pharmaprojects database, a subscription-based resource, listed 98.8% of study drugs, including 11 drugs that had applications that were not disclosed in public media. In 43 applications, the listing date on the database preceded the FDA’s receipt of the application.
“We found that information that the FDA treats as confidential with regard to applications for NDAs and BLAs was in most cases already available to the public,” write the investigators.
In an editorial comment, JAMA Internal Medicine’s editor at large, Robert Steinbrook, MD, asked the question, “Why should the FDA treat as confidential information that in most cases has already been made public?”2
According to Steinbrook, disclosure of basic submission information would not necessarily require Congress to take legislative action. The FDA, he says, has broad enough authority to amend its regulations and redefine the kinds of information that should be considered confidential.
“Disclosing basic information about the filing of marketing applications would be a long overdue and modest advance for an agency that has not been known for its embrace of transparency,” Steinbrook writes, adding that such a move would be an appropriate first step to facilitate more extensive reforms, such as disclosure of Complete Response Letters for drugs that do not gain approval.
References
1. Chahal HS, Szeto D, Chaudhry AH, Sigelman DW, Kim S, Lurie PG. Public disclosure of the filing of new drug and therapeutic biologics applications with the US Food and Drug Administration [published online June 3, 2019]. JAMA Intern Med. doi:10.1001/jamainternmed.2019.1213.
2. Steinbrook R. Increasing transparency at the US Food and Drug Administration [published online June 3, 2019]. JAMA Intern Med. doi: 10.1001/jamainternmed.2019.1194.
What Stands in the Way of Biosimilar Use Across MENA Countries?
May 21st 2025Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the Middle East and North Africa (MENA) region is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High
May 17th 2025While the Trump administration’s latest executive order touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Biosimilar Market Development Requires Strategic Flexibility and Global Partnerships
April 29th 2025Thriving in the evolving biosimilar market demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.
Eye on Pharma: Sandoz Files Antitrust Suit; Yuflyma Interchangeability; Costco’s Ustekinumab Pick
April 22nd 2025Sandoz's antitrust suit against Amgen, the FDA’s interchangeability designation for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.