CRS Issues Report on “Fast Track” in Response to Congressional Inquiry

March 4, 2008

Earlier this year, we reported on Senator Sherrod Brown’s (D-OH) request to the Congressional Research Service (“CRS”) for information concerning 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.”  The request was made after The Plain Dealer reported in December 2007 that “[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.”  Fast Track was created in 1997 by the FDA Modernization Act (FDC Act § 506) 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. 

In February, CRS, which provides policy and legal analysis to committees and to Members of both the U.S. House of Representatives and the U.S. Senate, issued a 6-page report, which concludes that there is insufficient information available from FDA to determine whether Fast Track Product designation is more likely to lead to product approval than those products without such designation.  “Are products that receive Fast Track designation more likely to have their NDA/BLA approved by FDA than products that receive no such designation?” asks CRS in its report.  “The answer is we don’t know, because, while FDA provides statistics on the products it designates as Fast Track, it does not make public information on the NDA/BLAs it receives unless and until the product is approved/licensed.”

In a follow-up article, The Plain Dealer reported that Sen. Brown is unhappy with the CRS report.  “My concern is that neither the market nor the government has enough information to make intelligent decisions,” said Sen. Brown.  The Plain Dealer also reported that Sen. Brown’s staff is planning to meet soon with Sen. Edward Kennedy’s (D-MA) staff to discuss Fast Track designation.  It is unclear whether the Senators will propose legislation to change or eliminate FDC Act § 506.

By Kurt R. Karst    

Categories: Drug Development