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Last Updated: 02/23/2018

 Article of Interest - Medication

Pediatric Drug Testing Struck Down by Court

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An effort by the federal Food and Drug Administration (FDA) to require drug manufacturers to conduct tests on children to determine if new drugs will be safe and effective for pediatric use was struck down by a federal court October 17. In a challenge to the "pediatric rule" by the Association of American Physicians and Surgeons, Inc., the U.S. District Court for the District of Columbia said Congress didn't authorize the FDA to set a pediatric requirement when it passed the Food, Drug and Cosmetic Act years ago.


The court pointed out that because of the difficulty in finding substantial pediatric populations to undergo tests, along with the ethical complications associated with testing new drugs on children, many drugs are tested for safety and effectiveness in adults only. "As a result, even though there are many diseases that are common to both children and adults, physicians with pediatric patients often find their treatment options limited," with doctors forced to choose between prescribing drugs without well-founded dosage and safety information or utilizing other, possibly less effective, therapy. Most often, doctors respond by prescribing adult-approved drugs to children, but in smaller doses.


In an effort to encourage pediatric testing, Congress in 1997 passed the Food and Drug Administration Modernization Act (FDAMA), which established an experimental program giving manufacturers an extra five years of market exclusivity on drugs that they agreed to test in children. But the incentive for voluntary tests didn't increase pediatric testing as much as the FDA had hoped, so in 1998 the agency issued a rule requiring manufacturers to submit pediatric tests for new products that are likely to be used by children, beginning in December 2000. The regulation would also allow the FDA to require tests of already marketed drugs that it suspects are risky for children. 


With that "pediatric rule" now barred by the federal district court, it's unclear what will happen next in pediatric drug testing. The FDA could take its case to appeals courts and possibly even to the Supreme Court, or Congress could amend the Food, Drug and Cosmetic Act to give the FDA specific authority to require pediatric testing. Meanwhile, the incentive for voluntary pediatric testing by drug companies in return for market protection remains in place under the Best Pharmaceuticals for Children Act, Public Law 107-119, passed by Congress earlier this year. The case decided October 16 was Association of American Physicians and Surgeons, Inc., v. United States Food and Drug Administration.


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