Senate Committee Approves Drug Patent Bill

The Senate Health, Education, Labor and Pensions Committee yesterday approved a bill that would extend the 1997 FDA Modernization Act by almost six years, CongressDaily/AM reports (CongressDaily/AM, 8/2). The pediatric exclusivity rule allows drug companies to receive a
six-month patent extension if they conduct clinical research on a drug's effectiveness in children. The program has been a "boon" for pharmaceutical companies that use the law to delay the "dramatic" declines that their brand-name drug sales experience after generic versions enter the market. Generic drug makers say that the program "has exacted a steep price" for consumers. The bill (S 838), sponsored by Sens. Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio), included an amendment by Dodd which clarified how the six-month period should be calculated. Sen. Edward Kennedy (D-Mass.), chair of the committee, supported the bill but said "more needs to be done to address problems in the way the program works" (CongressDaily/AM, 8/2). Sen. Hillary Clinton (D-N.Y.) withdrew from committee consideration an amendment to the bill that would reduce exclusivity to three months for drugs that generate more than $800 million in annual sales. Clinton said she would try to re-submit the amendment as well as another one to "encourage pediatric access to experimental cancer drugs" at a later time. Sen. Christopher Bond (R-Mo.) also hopes to submit an amendment that would give an additional three months of exclusivity to companies that study drugs in newborns (Richwine, Reuters 8/1).