Consumer alert files suit on Pediatric rule.
The court action seeks a declaratory judgment finding the pediatric rule to be contrary to law, in excess of FDA's authority, arbitrary, capricious, and an abuse of discretion.
CA, CEI and AAPS first petitioned FDA in December 1999 to reconsider the so-called "Pediatric Rule." Using their pediatric rule, the FDA has unilaterally seized authority to decide which drugs are to be labeled for pediatric use and to order drug companies to conduct clinical trials on children. This is a turnaround from accepted practice -- under the FDA Modernization and Accountability Act of 1997 (FDAMA), and in fact since the first federal drug regulations were passed in 1906, it is the drug manufacturer, not the FDA, that determines what the "intended use" of a drug is. That intended use incorporates both the medical condition the drug would address as well as the patients for whom the drug was designed and tested.
But now, even when a drug is developed with no intended pediatric use, manufacturers, before introducing the drug, would have to test the drug on children. This additional layer of pre-market testing will drive up pharmaceutical costs for consumers, as well as delay the introduction of new drugs to the consumer market -- all with little, or no benefit to children. In fact, the rule, through its requirement for pediatric testing at earlier stages, could increase risks to children. CA points out in the lawsuit that this hinders CA members "from receiving the most effective pharmaceuticals for the treatment of disease, illness, or other afflictions."
In the normal course of events, after a drug is determined to be safe and effective for one use, it enters the market, and physicians start prescribing the drug for that use as well as other, "off-label" uses -- including prescriptions of smaller doses to pediatric patients. The FDA has shunted aside all that, though, under the rhetorically omnipresent banner of "The Children." In its place now is a command-and-control system in which FDA arbitrarily decides itself that a drug has the potential to be used for pediatric patients and orders further testing and reformulation of the drug before it can go on the market. This process delays even longer the release of needed drugs to adult consumers, inconveniencing and crippling the sick and dying -- but at least they'll have a longer label to read in the meantime.
And during that delay, FDA's Pediatric Rule would also mandate potentially dangerous drug trials be conducted on children. Drugs and new pharmaceutical formulations that have not been tested by the market, or even necessarily declared safe and effective for use in the adult population by the FDA, would be administered to children in a clinical setting. Without the Pediatric Rule, pediatricians who better know their patients and administer individualized care can more fully evaluate the risks and benefits of prescribing to children drugs approved for use in adults. They also have access to information on how a drug is performing with similarly situated adult patients, a much greater data set than anything available from a laboratory setting.
With any luck, this "law" and its attendant unintended consequences will soon be overturned.