In 2006, the U.S. Food and Drug Administration approved the Gardasil HPV vaccine after being “fast-tracked” in just six short months. The FDA’s fast-track process is designed to facilitate the development and expedite the review of drugs or vaccines to treat serious conditions and fill an unmet medical need like providing a treatment for an epidemic which has no existing treatment. Gardasil met neither of these criteria. Cervical cancer was far from epidemic status and the existing PAP smear plus follow up removal of abnormal cervical tissue had substantially controlled most cervical cancers. In fact, according to the National Cancer Institute’s Surveillance, Epidemiology and End Results Program (“SEER”), the incidence of deaths from cervical cancer prior to the introduction of Gardasil in the U.S., was on a steady decline with a rate of 2.4 per 100,000 women.
Notwithstanding, in its bid to fast-track Gardasil and prove that the vaccine treats a serious condition and fills an unmet medical need, Merck allegedly presented misleading data to the FDA suggesting that HPV infections and some abnormal cervical tissue–cervical interepithelial neoplasia (CIN) lesions–inexorably result in cancer, hence the urgent need for the HPV vaccine. The complaint indicates those contentions are untrue.