Less than a month after the US Food and Drug Administration (FDA) first unveiled its long-awaited social media guidance documents , the agency has chided Gilead Sciences for its misuse of a "text-limited" Internet platform covered by its guidance documents, Google Sitelinks. Background In July 2014, FDA released two guidance documents covering the use of social media. One of those documents, Internet/Social Media Platforms with Character Space Limitations— Pres...

The AIDS Healthcare Foundation (AHF), a DC-based advocacy group, has won yet another legal battle against the US Food and Drug Administration (FDA), forcing it to turn over significant documents related to the approval of Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/ emtricitabine). Background The legal victory for AHF is its second in the last year. In 2013, FDA announced it would expedite the review of Truvada based on its expected cl...

When it comes to patient groups interacting with the US Food and Drug Administration (FDA), some relationships are more adversarial than others. And while plenty of patient groups have their problems with FDA-its regulatory processes, its standards, its conclusions and its approvals-few do anything to escalate those gripes beyond a letter to the commissioner or a call to their congressperson. And then there's the AIDS Healthcare Foundation (AHF). Background The Washi...

The US Food and Drug Administration (FDA) this week published a citizen petition denial to a group seeking to pre-emptively block the approval of a supplemental New Drug Application (sNDA) for Gilead Sciences' Truvada for preventing the transmission of HIV-1. The group, the AIDS Healthcare Foundation (AHF), had filed the petition on 7 March 2012-part of a subsequent campaign by the group to call attention to the drug. In a series of advertisements, AHF asked, "What rotte...

The US Food and Drug Administration's (FDA) drug regulatory division announced the approval of a new indication for Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate), making it the first drug with an approved indication to prevent the transmission of the Human Immunodeficiency Virus (HIV). The drug was first approved in August 2004 under priority review for the treatment of existing HIV. FDA said under the new indication, approved 16 July 2012 via a supple...

The US Food and Drug Administration (FDA) will take an additional three months to review Gilead Science's pre-exposure prophylaxis (PrEP) drug Truvada (tenofovir/emtricitabine) to assess newly-submitted plans to reduce the possible misuse of the drug, reports The Associated Press . Truvada, currently seeking marketing clearance from FDA to reduce the risk of contracting HIV when used in conjunction with other risk reduction methods, was cleared by an FDA Advisory Com...