Provisional approval bill introduced in House

Rep. Morgan Griffith (R-Va.) introduced a bill that would create a provisional approval process for drugs granted Fast Track designation by FDA. The Patient Choice Act of 2013 (H.R. 2090) would allow companies to request provisional approval for Fast Track compounds by submitting only safety data showing the risk of death or morbidity from the disease outweighed the risk of death from the treatment. According to Kelly Lungren McCollum, chief of staff for Rep. Griffith, companies would be required to continue to work towards regular or accelerated approval by FDA and the provisional approval would be withdrawn if a drug is reviewed but not approved by FDA.

Lungren McCollum told BioCentury the legislation does not impose limitations on off-label prescribing, though FDA could impose such limitations as part of a REMS. Patients receiving provisionally approved drugs would be required to provide informed consent. ...