Sen. Brown Launches Inquiry into FDA “Fast Track” Designation ProgramJanuary 10, 2008
Earlier today, The Plain Dealer, a Cleveland newspaper, reported that Senator Sherrod Brown (D-OH) submitted a request to the Congressional Research Service (“CRS”) requesting information on FDA’s “Fast Track” designation program. CRS provides policy and legal analysis to committees and to Members of both the U.S. House of Representatives and the U.S. Senate.
Fast Track was created by the FDA Modernization Act in 1997 to help facilitate the development and expedite the review of drugs and biologics for serious or life-threatening conditions that demonstrate a potential to address unmet medical needs. Under FDC Act § 506, companies may request Fast Track designation for their product at the time they submit an Investigational New Drug Application to FDA or at any time thereafter. FDA must determine whether to grant such designation within 60 calendar days after receipt of a designation request. The benefits of Fast Track designation include scheduled meetings to seek FDA input into development plans, the option of submitting an NDA for “rolling review” (i.e., submission in sections rather than all components simultaneously), and the option of requesting evaluation of studies using surrogate endpoints or clinically meaningful endpoints. In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a 6-month priority review instead of a 10-month standard review. Information on FDA’s Fast Track designations is available here, here, and here. FDA’s Fast Track guidance document is available here. Statutory Fast Track under FDC Act § 506 is very similar to FDA’s “Accelerated Approval” regulations, and, according to FDA, “essentially codifies in [the] statute FDA’s accelerated approval regulations.”
According to the report in The Plain Dealer, Sen. Brown requested the information on FDA’s Fast Track designation program “to help determine whether a case exists for changing or eliminating the 10-year-old initiative that was intended to speed the availability of drugs for serious diseases.” Sen. Brown’s request follows a series of articles that appeared in The Plain Dealer in December 2007 that concluded that Fast Track designation provides little actual benefit to consumers. According to the Plain Dealer’s research, “[Fast Track] designation has amounted to a government blessing, which has served as a marketing tool for drug companies and a boon for investors looking to make quick money on the stock market. . . . Since 1998 . . . Fast Track announcements for almost 200 drug treatments triggered one-day stock price increases that averaged 10 percent.” Copies of The Plain Dealer articles are available here, here, here, here, and here.