Should the FDA Disclose New Filings for Drugs, Biologics, and Biosimilars?

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.
Kelly Davio
June 11, 2019
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.

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