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The Filing of New Drug Applications, Generally Kept Secret by FDA, is Almost Always Disclosed by Drug Companies

CSPI Urges Greater Transparency in Drug Applications, Rejections

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The Food and Drug Administration typically treats the existence of new drug applications as confidential commercial information, not even acknowledging that they have been filed. But according to new research published in JAMA-Internal Medicine today, the filing of almost 90 percent of new drug applications (and similar applications for new biologic products) filed between 2010 and 2016 was disclosed by drug companies themselves in the form of press releases, filings with the Securities and Exchange Commission, or both—and typically within a week of the submission of the application to the FDA.

Researchers from the FDA’s Office of Public Health Strategy and Analysis examined 249 applications for new drugs and biologics submitted to the FDA. 222 of those, or 89.2 percent, were disclosed in at least one public medium, including 196 in press releases, 157 in SEC filings, and 136 in both. The researchers found that overall rates of disclosure increased from 87.5 percent in 2010 to 97.6 percent in 2016.

The FDA’s policy of treating the filing of new drug applications as confidential means that the agency is tying its hands behind its back, according to Dr. Peter G. Lurie, president of the Center for Science in the Public Interest and co-author of the JAMA-Internal Medicine paper (Lurie was FDA Associate Commissioner for Public Health Strategy and Analysis until 2017 and the research was undertaken when he was with the agency). Typically, agency staff do not confirm to patients whether an NDA for a treatment for their disease has been filed, and the agency is less accountable for complying with target times for drug review established by Congress.

“It makes no sense for the FDA to keep the filing of new drug applications secret from the public at the same time the drug companies are putting out press releases about them,” said Lurie, who has also called on the FDA to make public the rejection letters, known as complete response letters, it sends companies when pending drug applications are not approved. Presently, the FDA only discloses drug decisions that permit a drug to be marketed—but not decisions that deny it.

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Contact Jeff Cronin (jcronin[at]cspinet.org) or Richard Adcock (radcock[at]cspinet.org).