FOR IMMEDIATE RELEASE
Contact:
Mark Grayson August 13, 1997
(202) 835-3460
PHARMACEUTICAL INDUSTRY COMMITTED TO CHILDREN'S HEALTH; WILL WORK WITH CLINTON ADMINISTRATION TO PROMOTE THAT GOAL
PhRMA President Alan F. Holmer issued the following statement today in response to a White House proposal mandating clinical studies of drugs in children:
As a parent -- more specifically, as the father of two children with cystic fibrosis -- I want more than anything in the world to see more and better medicines developed to help and heal children.
The pharmaceutical industry is committed to this goal. A 1997 survey found 146 new medicines in development for children, including 36 for cancer, the leading disease killer of children; 9 for AIDS, the prime cause of death among young children in some cities; and 5 for cystic fibrosis, the most common fatal genetic disease in the United States. All 146 medicines have been or are being tested in children; all of the 75 companies developing these medicines intend to seek the Food and Drug Administration's approval for pediatric use of these drugs.
In view of all the ongoing testing and studying of medicines in children, we question whether a government mandate is needed. However, we are committed to working with the President and others in the Administration, on a collaborative and constructive basis, regarding their proposed regulation to advance the goal of better medicine for children -- a goal we all share.
With that goal in mind, any regulation should:
-- First and foremost, protect the safety of children and avoid exposing them to premature or unnecessary risk.
For example, before beginning testing on kids, we want to ensure that a potential drug is truly viable, and that we adequately understand how adult patients respond to it.
-- Recognize the enormous practical difficulties of testing drugs in children and developing formulations of medicines appropriate for children.
For example, one manufacturer has tried and failed more than 1,000 times to develop a pediatric formulation of one antibiotic drug. Another company unsuccessfully spent more time, money, and human resources on a failed syrup than on the adult formulation and the chewable version combined.
-- Be precisely worded and flexibly applied so that testing in children does not delay the drug development and approval process.
We need to get safe and effective medicines to all Americans -- children and adults -- as rapidly as possible. But under no circumstances should a drug be withheld from the market after it has been found to be safe and effective for either adults or children.
Pharmaceutical companies are leading the way in the search for cures for the diseases that kill and disable both children and adults. We believe the best way the government can help patients is to enact S. 830, the FDA Modernization and Accountability Act of 1997, which will ensure that all patients -- children, their parents, their grandparents, other adults -- have timely access to the fruits of biomedical research.
PhRMA represents the country's leading research-based pharmaceutical and biotechnology companies, which are devoted to inventing medicines that allow patients to lead longer, happier, healthier and more productive lives. PhRMA companies are investing nearly $19 billion this year in discovering and developing new medicines.
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PhRMA Internet Address: http://www.phrma.org
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