PhRMA: FDAMA working

The Food and Drug Administration Modernization Act is working just as Congress intended for the benefit of patients, according to Tim Franson of Indianapolis-based Lilly Research Laboratories, who testified in front of the House Energy and Commerce Subcommittee on Health on behalf of the Washington-based Pharmaceutical Research and Manufacturers of America.

"The 1997 law has promoted increasingly efficient and effective working relationships between FDA and patients, doctors and regulated industries … and - most significantly and importantly - speedier access for patients to safer and more effective new products and to experimental medicines still in clinical testing," said Franson.

In particular, Franson praised a program established by the FDAMA to encourage research on medicines for children.

"Prior to enactment of FDAMA, FDA and pediatricians had attempted several times to spur the development of drugs for pediatric patients and to increase the labeling on products used for children by encouraging more pediatric studies to be conducted," Franson testified. "Notwithstanding these efforts, many medicines continued to be used for children without adequate labeling information for pediatricians and parents. The pediatric provisions of FDAMA have dramatically improved that situation." According to Franson, 411 studies, funded by pharmaceutical companies, on the use of medicines in children have been generated by the law.

Urging renewal

Franson urged the committee to reauthor-ize the pediatric provision, known as the Better Pharmaceuticals for Children Act, which will expire in January 2002. He also urged the renewal of the Prescription Drug User Fee Act in 2002.

"PDUFA has provided FDA with the necessary funds to hire additional reviewers, update the agency's information technology infrastructure and act in a more timely and predictable manner on drug applications," testified Franson. PR