News Stories on Human Research
April 19, 2002
DHHS / FDA flip-flop second time re: " pediatric rule"
Tommy Thompson, Secretary of The Department of Health and Human Services has reversed the FDA's reversal of the 1999 Pediatric Rule.
On March 19 the Washington Post reported
that the FDA informed U.S. District Court in Washington DC (March 18) that it
will suspend for two years its "Pediatric Rule" requiring drug
companies to test new drugs on children. [See:
As we noted in AHRP's March 19 Infomail:
evidence demonstrating widespread ethical violations and harmful consequences at the nation's most prestigious research institutions.
It is most disturbing that neither the administration nor Congress has seen fit to request an annual report detailing information about pediatric research in order to ensure that children are not being harmed or exploited. Congress does mandate detailed annual reports about the conduct of animal research. Animals are protected under the Animal Welfare Act of 1966: children who are recruited into clinical trials--with cash payments to parents--are unprotected.
Does the Administration or Congress really care more about the welfare of hamsters than children?"
Shouldn't policy makers be informed about the number of children involved in medical experiments, the nature of the risks they are being exposed to, the adverse events that occurred in pediatric trials? How many children have suffered pain for patent exclusivity?
Today the announced "Drug Safety Initiative" is an example of bureaucratic doublespeak.
What is NOT DISCLOSED are the key questions upon which
this policy rests:
From: "Henneghan, Martha (HHS/OS)"
Date: 4/19/02 1:51PM
Date: April 19,2002 For Release: Immediately Contact: FDA Press Office (301) 827-6250
HHS Secretary Tommy G. Thompson today launched a new initiative to further ensure the safety and effectiveness of drugs used to treat children and promised to continue to enforce the Food and Drug Administration (FDA) rule requiring companies to take steps to ensure drugs are properly labeled for pediatric use based on scientific studies.
"Children need access to the same kinds of safe, effective treatments that are available to their parents, and that means conducting appropriate clinical trials," Secretary Thompson said. "We will enforce and improve the FDA's pediatric rule as we simultaneously take additional steps made possible when President Bush signed new legislation to promote the development of drugs that can save children's lives."
Key elements of HHS' pediatric drug initiative include:
FDA will seek public comment on what additional steps it can take to assure adequate study of drugs in children in light of the Best Pharmaceuticals for Children Act (BPCA), which President Bush signed into law in January 2002. The law's provisions include new funding mechanisms for pediatric studies that companies choose not to conduct and other provisions that encourage the development of better information on the effective use of drugs in children. To get maximum benefit from these new authorities, the "pediatric rule" needs to be updated. The FDA will issue an Advanced Notice of Proposed Rulemaking that will be published shortly in the Federal Register. A copy of the notice is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/oc02105.pdf
· HHS' National Institutes of Health (NIH) will request proposals this year using new contracting approaches authorized by BPCA to study certain drugs for pediatric use when manufacturers choose not to do so. NIH expects to award initial contracts under BPCA in fiscal year 2003. The new law also permits the NIH Foundation to fund pediatric studies of certain drugs with private donations received for that purpose, providing an additional funding source.
· NIH also will provide $7 million in fiscal year 2002 funds to support pediatric drug research at its affiliated Pediatric Pharmacology Research Units. These funds will allow these units to study additional pediatric drugs.
"Through today's actions, we hope to use all the tools Congress has given us to ensure that drugs used in the treatment of children are indeed safe and effective," FDA Deputy Commissioner Dr. Lester Crawford said. "In addition, we want to ensure that adequate, good scientific information on the use of these products in children is made known to practitioners and parents so that they can make truly informed decisions regarding the use of these products."
"NIH will continue to work with the FDA and the pediatric community to get the BPCA program successfully initiated," said Dr. Duane Alexander, director of NIH's National Institute of Child Health and Human Development. "The sooner we get this program underway, the sooner America's children can benefit from it."
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