Bush signed Pediatric Research Equity Act

Bush signed Pediatric Research Equity Act

Fri, 5 Dec 2003

Bush signed the Pediatric Research Equity Act into law, ensuring additional income for the drug industry and for an army of physicians who are in the drug testing business at universities, clinics, and in private practice. This collaborative business arrangement has put company interests above the health and welfare of children. And this arrangement has corrupted the scientific literature. Company paid doctors help those companies conceal clinical trial data– they fail to disclose severe, adverse drug effects, and lend support to false company claims about the safety and effectiveness of newly marketed drugs.

None of those who lobbied for this legislation recommended safeguards to ensure children are not exploited. Indeed, none of the stakeholders in clinical trials considered the adverse impact on children who are increasingly sought as drug testing subjects. Since passage of the FDA Modernization Act (1997), which provided drug companies with windfall financial incentives–such as six months additional marketing exclusivity–children have been put at increased risks of harm and have suffered in clinical trials. Few children have benefited from their enrollment as human guinea pigs in drug trials.

To gain insight about how this legislation will likely exacerbate the plight of vulnerable child subjects whose enrollement is facilitated by cash payments to referring physicians and caregivers, see: CHILDREN IN CLINICAL RESEARCH: A CONFLICT OF MORAL VALUES online at: http://mitpress.mit.edu/journals/AJOB/3/1/sharav.pdf

See also, THE IMPACT OF THE FDA MODERNIZATION ACT ON THE RECRUITMENT OF CHILDREN FOR RESEARCH, published in Ethical Human Sciences and Services online at: http://www.ahrp.org/testimonypresentations/FDAmodernization03.php

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FDA press release

http://www.fda.gov/bbs/topics/NEWS/2003/NEW00989.html

President Bush signed the Pediatric Research Equity Act 2003 on December 4, a legislative move that will boost pharmaceutical safety amongst the nation’s children. The bill, formally titled The Pediatric Research Equity Act of 2003, confers upon the Food and Drug Administration the authority to require pediatric studies of drugs to ensure they are safe for children. Many of today’s drugs have only been tested on adults.

“Children need access to effective drugs to treat their ailments, and those drugs should be properly tested for pediatric use rather than just prescribed and sold based on adult testing,” said Department of Health and Human Services Secretary Tommy Thompson upon the bill’s passage. “This legislation will allow the FDA to require such studies when appropriate and will better assure doctors and parents alike that the drugs used to treat our children are safe and will work as expected.” Added FDA Commissioner Mark McClellan, “Prescription drugs can do more than ever to cure diseases, including illnesses in children. But it is not good medicine to assume that children can be treated like little adults. Parents and health professionals deserve confidence that medicines used to treat children are safe and effective. FDA will use this important new law to require pediatric studies, when necessary, to give parents and doctors the confidence they deserve.”