To Gain Access to Confidential FDA Documents
On August 6th of this year, the US District Court for Central California ruled that the FDA must give the AIDS Health Foundation (AHF) more information surrounding Gilead’s new AIDS prevention drug, Truvada. The AHF originally requested to see all documents pertaining to Gilead’s application for Truvada by filing a Freedom of Information request with the FDA.
Truvada, the drug in question, was fast tracked and approved by the FDA in July of last year as a preventative daily pill for those at high risk of contracting HIV.
The AIDS Health Foundation contends that “the FDA improperly withheld safety and efficacy data and data summaries; correspondence with non-governmental entities; opinions of third parties; and internal agency documents not subject to the deliberative process exception…[the FDA] does not sufficiently describe or justify the withholding of these documents.”
The FDA does not argue that disclosure will impair its ability to obtain information from Gilead in the future. Instead, it asserts that Gilead will suffer substantial competitive harm if the records are disclosed.
AHF counters that the FDA has failed to show the records it withheld are “confidential” because it has not shown that there is actual competition in the market. Nor has the FDA shown that Gilead is likely to suffer “substantial competitive harm” from disclosure of the safety and efficacy records.
One wonders what the true motivation AHF has in seeking these records. In the field of public health, controversy surrounds the idea of using a prophylactic drug to prevent HIV infection. Conventional methods of using protection during sexual encounters also prevent pregnancy, and other sexually transmitted diseases. Additionally, the HIV virus can develop resistance to Truvada if not taken consistently–a challenge for those in high risk groups. Perhaps the goal of the Freedom of Information Act (FOIA) filing is merely to document these discussions between government agencies. The FDA may find some of this material embarrassing, hence, they are claiming possible disclosure of material that will harm Gilead commercially.
Nonetheless, this novel use of the FOIA could possibly lead to a more sinister path: endangerment of trade secrets for pharmaceutical companies. Only time will tell, as the case continues through the courts.
The views expressed by DeeAnn Visk are solely her opinion, not those of her clients, NPR, WordPress, or your local public radio station.
DeeAnn Visk, Ph.D., is a freelance science writer, editor, and blogger. Her passions include cell culture, molecular biology, genetics, and microscopy. DeeAnn lives in the San Diego, California area with her husband, two kids, and two spoiled hens. You are welcome to contact her at email@example.com