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does the f.d.a. encounter adverse events with o.t.c. medicines? dr. woodcock: i would say fairly frequently. to rise to a serious level, maybe once every several years. mr. butterfield: frequently or infrequently? dr. woodcock: fairly frequently. given what they are and the exposure of the population to them but once perhaps every two years we re facing an issue that we would like to get out rapidly to the public to notify them and our hands are really tied and we have to use this guidance process. mr. butterfield: all right. two other examples you highlighted in your written testimony related to pediatric issues with certain medicines. would you say that a dispr portionate number of safety concerns with o.t.c. medicines are related to pediatrics? dr. woodcock: i would say in the last decade that is true, a decade or so, and the reason is starting in the late 1990 s i think everyone became aware that you should study children and not just treat them as tiny adults and j ....
minutes. subcommittee on health will now come to order. i ll recognize myself five minutes for an opening statement. today s hearing marks the health subcommittee s first public discussion on modernizing the current system at the united states food and drug administration to review, approve and update over-the-counter drugs. this hearing provides us and the american public with an opportunity to better understand the food and drug administration s regulatory framework to regulate over-the-counter drugs and to consider a proposal to reform the monograph system. today we will convene two panels of witnesses. first i want to welcome dr. woodcome back to our subcommittee woodcock back to our subcommittee. later we will hear from other key stakeholders, and i would like to commend all for their efforts throughout the negotiation process and for offering their insight to the committee. both the energy and commerce health subcommittee and the full committee have a strong r ....
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