GAO To Investigate Whether FDA Has Adequate Resources
The request was made by House Oversight and Government Reform Committee Chair Henry Waxman (D-Calif.), staff for Senate Health, Education, Labor and Pensions Committee Chair Edward Kennedy (D-Mass.), House Energy and Commerce Committee Chair John Dingell (D-Mich.) and House Energy and Commerce Oversight and Investigations Subcommittee Chair Bart Stupak (D-Mich.).
According to CongressDaily, Dingell and Stupak "have grown increasingly frustrated with what they say is FDA officials' inability to level with them on funding." In addition, Kennedy and Waxman are concerned with FDA's food-safety budget, "which some say isn't enough to fund monitoring the increasing number of imports," CongressDaily reports. Waxman, Dingell, Stupak and House Energy and Commerce Health Subcommittee Chair Frank Pallone (D-N.J.) also requested that FDA's science advisory board subcommittee on science and technology assess the agency's needs, which the subcommittee accepted. The subcommittee in December 2007 released a report that found FDA cannot ensure the safety of any of the products it oversees because of underfunding (Edney, CongressDaily, 2/25). Drug Alerts
Since November 2007, FDA has issued 14 drug safety advisories -- more than the agency has issued in some entire years, the Washington Post reports. Paul Seligman, director of the FDA's Office of Surveillance and Epidemiology, said the increase is not because of more dangerous drugs but marks the fulfillment of a 2005 promise by HHS Secretary Mike Leavitt to notify the public sooner when FDA learns of adverse reactions to approved drugs. Seligman said, "We are trying to act in a responsible way."
Dingell, who has criticized FDA for taking too long to issue warnings, said the recent increase is "a quantum improvement." Marc Scheineson, a former FDA deputy commissioner, agrees, saying, "There was certainly too little information back then." However, he added that, since the problem has been reversed, "patients and their doctors will need to filter the news."
The agency also is working to improve its notification system by classifying advisories and providing physicians with information about patients who have risk factors that might contribute to adverse reactions to drugs. In addition, FDA is working with medical organizations to help physicians understand the differences between the advisories so that they can pass the information along to their patients (Lunzer Kritz, Washington Post, 2/26).
Reprinted with kind permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation© 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Gao FDA pentru a investiga dacã are resurse adecvate - GAO To Investigate Whether FDA Has Adequate Resources - articole medicale engleza - startsanatate