InfoMail for April 19, 2002

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Commentary by Vera Hassner Sharav

April 19, 2002

DHHS / FDA flip-flopsecond time re: " pediatric rule"

FYI

Tommy Thompson, Secretary of The Department of Health andHuman Services has reversed the FDA’s reversal of the 1999 Pediatric Rule.

On March 19 the Washington Post reportedthat the FDA informed U.S. District Court in Washington DC (March 18) that itwill suspend for two years its "Pediatric Rule" requiring drugcompanies to test new drugs on children. [See: 
http://www.washingtonpost.com/ac2wp-dyn/A47229-2–2Mar18?language=printer

As we noted in AHRP’s March 19 Infomail:

"The 1997 FDA Modernization Act (FDAMA) gave pharmaceutical companieslucrative financial incentives if they tested drugs in children–ie., six monthpatent exclusivity extension. The law was adopted, however, without the FDA orthe Department of Health and Human Services conducting an impact evaluation todetermine whether, and how children would be affected adversely. The law and thePediatric Rule were adopted despite a body of documented

evidence demonstrating widespread ethical violations andharmful consequences at the nation’s most prestigious research institutions.

It is most disturbing that neither the administration norCongress has seen fit to request an annual report detailing information aboutpediatric research in order to ensure that children are not being harmed orexploited. Congress does mandate detailed annual reports about the conduct ofanimal research. Animals are protected under the Animal Welfare Act of 1966:children who are recruited into clinical trials–with cash payments toparents–are unprotected.

Does the Administration or Congress really care more aboutthe welfare of hamsters than children?"

Shouldn’t policy makers be informed about the number ofchildren involved in medical experiments, the nature of the risks they are beingexposed to, the adverse events that occurred in pediatric trials? How manychildren have suffered pain for patent exclusivity?

Today the announced "Drug Safety Initiative" isan example of bureaucratic doublespeak.

What is NOT DISCLOSED are the key questions upon whichthis policy rests:
1.  Whose children are going to be selected to test (possibly) dangerousdrugs?
2.  Are these the children whom DHHS has desginated (in a 2000 draft policystatement)?
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

From: "Henneghan, Martha (HHS/OS)"

martha.henneghan@HHS.gov

To: HHSpress@list.nih.gov

Date: 4/19/02 1:51PM 
Subject: HHS RELEASE —
NEW PEDIATRIC DRUG SAFETY INITIATIVE

Date: April 19,2002 For Release: Immediately Contact: FDAPress Office (301) 827-6250

Headline: 
HHS LAUNCHES NEW PEDIATRIC DRUG SAFETY INITIATIVE

HHS Secretary Tommy G. Thompson today launched a newinitiative to further ensure the safety and effectiveness of drugs used to treatchildren and promised to continue to enforce the Food and Drug Administration(FDA) rule requiring companies to take steps to ensure drugs are properlylabeled 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 meansconducting appropriate clinical trials," Secretary Thompson said. "Wewill enforce and improve the FDA’s pediatric rule as we simultaneously takeadditional steps made possible when President Bush signed new legislation topromote the development of drugs that can save children’s lives."

Key elements of HHS’ pediatric drug initiative include:
FDA will continue to enforce the pediatric rule as it has since the ruletook effect in 1999. The rule is an important tool in assuring that childrenreceive safe and effective medical care. FDA will continue to defend the legalauthority of the pediatric rule in court and will not pursue a stay oflitigation.

FDA will seek public comment on what additional steps itcan take to assure adequate study of drugs in children in light of the BestPharmaceuticals for Children Act (BPCA), which President Bush signed intolaw in January 2002. The law’s provisions include new funding mechanisms forpediatric studies that companies choose not to conduct and other provisions thatencourage the development of better information on the effective use of drugs inchildren. To get maximum benefit from these new authorities, the "pediatricrule" needs to be updated. The FDA will issue an Advanced Notice ofProposed Rulemaking that will be published shortly in the Federal Register. Acopy of the notice is available at http://www.fda.gov/OHRMS/DOCKETS/98fr/oc02105.pdf

· HHS’ National Institutes of Health (NIH) will requestproposals this year using new contracting approaches authorized by BPCA to studycertain drugs for pediatric use when manufacturers choose not to do so. NIHexpects to award initial contracts under BPCA in fiscal year 2003. The new lawalso permits the NIH Foundation to fund pediatric studies of certain drugs withprivate donations received for that purpose, providing an additional fundingsource.

· NIH also will provide $7 million in fiscal year 2002funds to support pediatric drug research at its affiliated PediatricPharmacology Research Units. These funds will allow these units to studyadditional pediatric drugs.

"Through today’s actions, we hope to use all thetools Congress has given us to ensure that drugs used in the treatment ofchildren are indeed safe and effective," FDA Deputy Commissioner Dr. LesterCrawford said. "In addition, we want to ensure that adequate, goodscientific information on the use of these products in children is made known topractitioners and parents so that they can make truly informed decisionsregarding the use of these products."

"NIH will continue to work with the FDA and thepediatric community to get the BPCA program successfully initiated," saidDr. Duane Alexander, director of NIH’s National Institute of Child Health andHuman Development. "The sooner we get this program underway, the soonerAmerica’s children can benefit from it."

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