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AAPS Wins Pediatric Drug Case!
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FDA overstepped authority
Children should not be regulatory guinea pigs
Help fund future court cases
Read the AAPS statement & judge’s decision
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Today, AAPS won what our attorney, Andrew Schlafly, calls a “stunning court victory.” A federal judge has ruled that the FDA overstepped its authority with the “Pediatric Drug Rule.”
This rule would have required pediatric trials of all new drugs, including off-label uses and those intended only for adult use.
AAPS has taken some heat from some prominent members of Congress (you know who they are), and been accused of trying to keep pharmaceuticals from children. But the fact is, our concern has been just the opposite. We filed the suit to prevent children being subjected to unnecessary and potentially dangerous clinical trials. Also, the requirement would have resulted in further delays of drug approvals.
This is another example of the excellent work achieved through the AAPS Legal Foundation, which is funded solely through your contributions. Click here to make a donation to the Foundation.
Read the AAPS news release below, and click on the links to read the judge’s ruling.
Association of American Physicians & Surgeons
1601 N. Tucson Blvd. Suite 9
Tucson, AZ 85716
(800) 635-1196
(520) 325-4230 Fax
www.aapsonline.org
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CONTACT: Kathryn Serkes
202.333.3855
www.aapsonline.org
October 18, 2002
For Immediate Release:
AAPS WINS PEDIATRIC DRUG CASE
FDA Overstepped Authority
Washington, D.C. - The FDA exceeded its authority by requiring trials of all new drugs on pediatric populations as a condition of approval, according to a ruling issued late yesterday by the United States District Court in the Washington, D.C.
BACKGROUND
The lawsuit, AAPS et al v. FDA, was brought by the Association of American Physicians and Surgeons, the Competitive Enterprise Institute and Consumer Alert.
Under the rule, the FDA could require tests on children for off-label uses of drugs, even if they are intended only for adult use. AAPS and the other plaintiffs argued that the “Rule exceeds the FDA’s statutory authority and that the Rule’s promulgation was arbitrary and capricious.” The court agree, writing, “…the court finds that the Pediatric Rule exceeds the FDA’s statutory authority, and is therefore invalid.”
Further, physicians and consumer groups filing the lawsuit believe the result would be further delays of life-saving medicines, and exposing children to unnecessary danger.
EXCERPTS FROM THE RULING
“If [the rule] truly gave the FDA the authority that it claims, the door would be open to the FDA’s regulation of all off-label uses, based solely on the manufacturer’s knowledge that those uses are common-place. This authority would sure conflict with Congress’s will, and would eviscerate the long-established foundation of food and drug law, which allows, not the FDA…but the manufacturer of the article…to determine the use to which the article is to be put.” [Pg. 24]
“Congress adopted an incentive scheme while the FDA adopted a command and control approach. The two schemes differ in almost every possible regard…Far from complementing Congress’s voluntary incentive scheme, the Pediatric Rule usurps it by superimposing an often-incompatible regime.” [Pgs. 29-30]
STATEMENT BY AAPS EXECUTIVE DIRECTOR
The following statement was issued by Jane M. Orient, MD:
”Children are not guineas pigs in a regulatory grab for power. It's senseless
for the FDA to require pediatric testing for drugs that expressly disclaim any
use on children. We are gratified that the court agreed with us. We don't
want the government requiring drug companies and doctors to expose children to
unnecessary risks. Would you volunteer your child for experimental, clinical
trials?
“No tears will be shed for
curtailing the FDA’s power to delay new drugs. The FDA has withheld innovative
drugs from needy patients for too long, and interferes with new treatments for
terminal illnesses. Doctors, not the FDA, should be recommending prescription
drugs for patients.
”There needs to be a housecleaning at the FDA before it seizes any more power
for itself.
Hillary Clinton's ‘for the children’ rationale for expanding government power
has run out of steam. We're thrilled that a court has limited the FDA's power
to delay new drugs, and children will ultimately benefit.”
Court ruling posted at:
http://www.dcd.uscourts.gov/00-02898.pdf
AAPS complaint posted at: www.aapsonline.org/legis/fdaped.htm