AIDS Group Wins Legal Battle With FDA Over Confidential Data
Over the past three years, the AIDS Healthcare Foundation waged a losing battle against Truvada, which is sold by Gilead Sciences, for AIDS prevention. The Los Angeles-based advocacy group, which also provides medical care in clinics, very vocally fought FDA approval on the grounds that prevention will unintentionally lead to riskier sexual behavior and, subsequently, more HIV infections (back story).
Last week, though, AHF won a different kind of victory against the FDA. A federal judge ruled the agency improperly withheld Truvada safety and efficacy data in response to a Freedom of Information Act requested filed by the advocacy group two years ago. The FDA had argued the data did not have to be disclosed because Gilead trade secrets and confidential information would have been compromised.
As a result, the agency must provide “complete and unredacted” copies of Truvada safety and efficacy records to AHF. In her ruling, US District Court Judge Margaret Morrow wrote that the FDA failed to prove that the documents that had been withheld were “confidential” financial and commercial records or that disclosure of data summaries and analyses would cause Gilead “substantial competitive injury.”
In reaching her conclusion, Morrow noted, for instance, that the agency made unsubstantiated arguments that Gilead faced competition in the market for AIDS prevention medicines and that releasing certain information, such as statistical methods and analyses applied to third-party data that was used to obtain FDA approval for Truvada, could potentially harm Gilead (GILD) at a later date. We should note that Morrow also decided that redacted correspondence was properly withheld since the information expressed incomplete agency views not reflected in the final labeling of the product (here is the ruling).
Of course, the initial issue that prompted AHF to seek the documents is no longer on the table – the FDA approved Truvada last year for AIDS prevention. But the advocacy group did manage to score points on a larger issue by successfully arguing against FDA efforts to make blanket determinations about releasing certain data and subsequent harm to drugmakers.
The AHF, however, suggested the ruling underscores concerns that the FDA and Gilead worked surreptitiously to ensure Truvada was approved. In particular, AHF seized on statements by David Pizzuti, vp of regulatory affairs at Gilead, that the FDA and drugmaker held talks about Truvada trials results and data submissions needed for approval.
“This ruling confirms one of our deepest suspicions: the FDA colluded with Gilead to fast-track approval of Truvada as PrEP regardless of the results of clinical trials. (The ruling) suggests the FDA advised Gilead how to conceal unfavorable clinical trial results and coached them on what to say to get those unfavorable results spun in such a way that the FDA deemed them sufficient to approve the drug,” AHF president Michael Weinstein said in a statement. “All the while, the FDA was illegally denying our FOIA requests on this issue. Today’s ruling is a huge victory for increased government transparency, and one which will hamper the government’s ability to withhold information about a drug’s safety and efficacy.”
Added AHF general counsel Tom Myers: “While the FDA is supposed to act as a neutral entity, the court ruling today confirms the FDA had private discussions with Gilead, and even fought on Gilead's behalf to withhold documents submitted to them by Gilead. The lack of neutrality shown by the FDA here is breathtaking.”
In response, a Gilead spokeswoman sent us this: “As you know, with any regulatory submission, there will be dialogue between the FDA and the sponsor company. And with regard to the data, both the FDA advisory committee and the FDA felt the safety and efficacy data submitted as part of the sNDA supported the use of Truvada for PrEP,” or pre-exposure prophylaxis.
As for the FDA, the agency late last week began filing a new index of documents with the court.
STORY ENDS HERE
Last week, though, AHF won a different kind of victory against the FDA. A federal judge ruled the agency improperly withheld Truvada safety and efficacy data in response to a Freedom of Information Act requested filed by the advocacy group two years ago. The FDA had argued the data did not have to be disclosed because Gilead trade secrets and confidential information would have been compromised.
As a result, the agency must provide “complete and unredacted” copies of Truvada safety and efficacy records to AHF. In her ruling, US District Court Judge Margaret Morrow wrote that the FDA failed to prove that the documents that had been withheld were “confidential” financial and commercial records or that disclosure of data summaries and analyses would cause Gilead “substantial competitive injury.”
In reaching her conclusion, Morrow noted, for instance, that the agency made unsubstantiated arguments that Gilead faced competition in the market for AIDS prevention medicines and that releasing certain information, such as statistical methods and analyses applied to third-party data that was used to obtain FDA approval for Truvada, could potentially harm Gilead (GILD) at a later date. We should note that Morrow also decided that redacted correspondence was properly withheld since the information expressed incomplete agency views not reflected in the final labeling of the product (here is the ruling).
Of course, the initial issue that prompted AHF to seek the documents is no longer on the table – the FDA approved Truvada last year for AIDS prevention. But the advocacy group did manage to score points on a larger issue by successfully arguing against FDA efforts to make blanket determinations about releasing certain data and subsequent harm to drugmakers.
The AHF, however, suggested the ruling underscores concerns that the FDA and Gilead worked surreptitiously to ensure Truvada was approved. In particular, AHF seized on statements by David Pizzuti, vp of regulatory affairs at Gilead, that the FDA and drugmaker held talks about Truvada trials results and data submissions needed for approval.
“This ruling confirms one of our deepest suspicions: the FDA colluded with Gilead to fast-track approval of Truvada as PrEP regardless of the results of clinical trials. (The ruling) suggests the FDA advised Gilead how to conceal unfavorable clinical trial results and coached them on what to say to get those unfavorable results spun in such a way that the FDA deemed them sufficient to approve the drug,” AHF president Michael Weinstein said in a statement. “All the while, the FDA was illegally denying our FOIA requests on this issue. Today’s ruling is a huge victory for increased government transparency, and one which will hamper the government’s ability to withhold information about a drug’s safety and efficacy.”
Added AHF general counsel Tom Myers: “While the FDA is supposed to act as a neutral entity, the court ruling today confirms the FDA had private discussions with Gilead, and even fought on Gilead's behalf to withhold documents submitted to them by Gilead. The lack of neutrality shown by the FDA here is breathtaking.”
In response, a Gilead spokeswoman sent us this: “As you know, with any regulatory submission, there will be dialogue between the FDA and the sponsor company. And with regard to the data, both the FDA advisory committee and the FDA felt the safety and efficacy data submitted as part of the sNDA supported the use of Truvada for PrEP,” or pre-exposure prophylaxis.
As for the FDA, the agency late last week began filing a new index of documents with the court.
STORY ENDS HERE
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