Although current regulations prohibit the public disclosure of pending New Drug Applications (NDAs) or Biologics License Applications (BLAs) by the US Food and Drug Administration (FDA) unless they have been publicly disclosed or acknowledged previously, investigators found that most information treated as confidential with regard to applications was already available to the public, and most of these disclosures occurred within one week of applications being submitted, according to a research letter published in JAMA Internal Medicine.
This letter discussed a cross-sectional study of all BLAs for new and biosimilar biological products and NDAs for new molecular entities that were submitted to the FDA from January 1, 2010 to December 31, 2016, with data collected in July 2017. Primary outcomes included application disclosures in Securities and Exchange Commission (SEC) filings, press releases, and other media. If disclosures were not found, investigators performed Google searches for disclosures in other media, such as annual reports or investor materials. Investigators also searched Pharmaprojects, a subscription-based drug development database, as part of the determination of the percentage of submissions disclosed, although this was not considered a public disclosure.
Among 249 applications (61 BLAs and 188 NDAs), 89.2% (n = 222) were disclosed in ≥1 public medium, 78.7% (n = 196) of which included a press release. Among the total applications, 63.1% (n = 157) were disclosed in SEC filings and 54.6% (n = 136) were disclosed in both SEC filings and press releases. The overall public disclosure rate increased from 87.5% to 97.6% between 2010 and 2016, and publicly traded companies were more likely to disclose than nonpublic (relative risk 1.43; 95% CI, 1.09-1.9) whereas private companies were less likely (relative risk 0.7; 95% CI, 0.53-0.92). The median time until disclosure was 6 (interquartile range [IQR] 1-63) days for press releases, 55 (IQR 9-86) days for SEC filings, and 6 (IQR 1-63) days for any public media. In the Pharmaprojects database, 98.8% (246/249) of the study drugs were listed, but only 162 (65.9%) references to FDA submissions were found, including 11 that were not disclosed on public media. The listings preceded the FDA’s receipt of the application by a median 59 (IQR 13-195) days for 43 of the 162 applications.
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The study is limited by the underestimation of disclosure for older applications, as associated materials may no longer be Internet-accessible, as well as for newer applications that may not have been disclosed at the time of data collection. Investigators also did not review for foreign securities filings or for any other subscription databases.
Although the overall disclosure rate for BLA and NDA applications was high, investigators concluded this is not generalizable to other types of FDA applications, as these may have different rates of disclosure.
Two study authors were employed by the FDA when the manuscript was conceived, researched, and drafted.
Reference
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
