Committee Looks at FDA Pediatric Exclusivity Provision
While members of the House Energy and Commerce subcommittee on health indicated yesterday that they are "inclined" to seek minor adjustments rather than a "complete overhaul" of the 1997 FDA Modernization Act, some questioned the value of the law's pediatric exclusivity provision, CongressDaily/AM reports. The provision -- which, along with the rest of the modernization act, is up for renewal in January -- allows drug companies to obtain a six-month patent extension if they conduct testing of a drug's effects on children. Several committee members praised the policy, saying it has led to a large increase in pediatric studies -- from 11 in the six years prior to the act to 332 now. However, some Democrats questioned the value of the exclusivity clause and "whether it has produced enough information about the drugs most important to pediatric medicine." Rep. Sherrod Brown (D-Ohio), the subcommittee's ranking member, said, "We should make sure that prescription drugs are thoroughly tested and correctly labeled for pediatric use. That does not mean we should actively contribute to grossly inflated drug prices." CongressDaily/AM reports that Sens. Christopher Dodd (D-Conn.) and Mike DeWine (R-Ohio), the "original authors of the pediatrics bill," plan to introduce a bill today that would "encourage drug makers to study drugs that are no longer profitable but are vital to pediatric medicine" (Fulton, CongressDaily/AM, 5/4).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.