; renewals The provisional approval for a drug under this section is effective for a 2-year period. The sponsor may request renewal for provisional approval status for up to 3 subsequent 2-year periods. Provisional approval status with respect to a drug shall not exceed a total of 8 years from the initial date the sponsor was awarded provisional approval status. (2) Marketing requirement If any drug that receives provisional approval under this section is not brought to market within 180 days of the provisional approval, such provisional approval shall be rescinded. (j) Limitation on liability With respect to any claim under State law alleging that a drug sold or otherwise made available pursuant to a grant of provisional approval under this section is unsafe or ineffective, no liability in a cause of action shall lie against a sponsor or manufacturer, unless the relevant conduct constitutes reckless or willful misconduct, gross negligence, or an intentional tort under any applicable State law. (k) Right To petition an advisory committee for approval (1) In general The sponsor of a drug granted provisional approval pursuant to this section may request, at any time after provisional approval is granted under this section, a meeting with the appropriate advisory committee (or advisory committees) to present safety and efficacy data for the purposes of receiving a recommendation from such an advisory committee for approval under section 505 of this Act or section 351 of the Public Health Service Act of the provisionally approved drug. Such a requested meeting shall be granted not later than 90 days after a request is made. Nothing in this paragraph shall be construed to alter the processes and timeframes for recommendation for approval by such an advisory committee of the provisionally approved drug or for approval of the provisionally approved drug under section 505 of this Act or section 351 of the Public Health Service Act. (2) Waiver of adequate and well-controlled study requirements (A) In general In