House Committee Votes to Renew Pediatric Exclusivity Law
The House Energy and Commerce Health Subcommittee yesterday voted 24-5 to pass a bill (HR 2887) that renews a law giving pharmaceutical companies an extra six months of patent protections for drugs tested on children, CongressDaily/AM reports. The bill, the "Best Pharmaceuticals for Children Act," would renew the pediatric exclusivity provisions of the 1997 FDA Modernization Act. If the provisions are not renewed, they will expire at the end of the year. Before passing the bill, however, the committee spent five hours defeating attempts to "scale back" the measure by Democrats, who say the law has been a "windfall" for drug companies. Subcommittee ranking member Rep. Sherrod Brown (D-Ohio), noting that the cost of pediatric testing is about $4 million per drug, said, "Lost consumer savings associated with the six-month exclusivity provisions averages $61 million per drug. [The drug industry is] holding consumers hostage [by refusing] to conduct pediatric tests if we offer anything less than a 1,500% return on their investment." Rep. Henry Waxman (D-Calif.) proposed an amendment that would have replaced patent extensions with payments to drug firms of twice the cost of conducting pediatric clinical trials. That amendment, however, was defeated by a vote of 20-9. The committee also voted down a proposal by Rep. Gene Green (D-Texas) that would have prohibited patent extensions for drugs that receive "substantial investments" from the NIH; a proposal by Rep. Frank Pallone (D-N.J.) that would have "disallowed" patent extensions for drugs that have annual sales of more than 100 times the cost of the pediatric study; and a proposal by Rep. Peter Deutsch (D-Fla.) to "graduate the extension time" for better-selling drugs.
CongressDaily/AM reports that the bill's supporters said the patent exclusivity provision "works too well" to change the program. Rep. Michael Bilirakis (R-Fla.), chair of the subcommittee, said, "In the six years prior to the enactment of pediatric exclusivity, six drugs were tested in children at the request of the FDA; in the four years since the provision was enacted, manufacturers have agreed to conduct more than 400 pediatric studies." The full committee could vote on the bill as soon as next week. The Senate Health, Education, Labor and Pensions Committee passed its version of the bill before the August recess, but it has not been scheduled for a floor vote (Rovner, CongressDaily/AM, 10/5).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.