More Access to U.S. Drug Safety Data Urged
Posted on: Tuesday, 6 March 2007, 15:01 CST
Harvard School of Public Health officials urged the U.S. Food and Drug Administration to allow more access to drug safety data from clinical trials.
FDA rules allow data to be kept secret and that, said the researchers, hinders discovery of dangerous side effects.
Pharmaceutical companies have sought to restrict public access to drug safety data collected during clinical trials on the basis it is proprietary information and might aid competitors in developing their own products.
But the Harvard researchers noted several recent cases in which drugs were found to have dangerous side effects after coming to market, thereby raising concerns about safety data being treated as confidential.
In an analysis by the Harvard School of Public Health, in collaboration with Brigham and Women's Hospital, researchers determined allowing greater access to safety data would enable medical scientists to independently evaluate risks, resulting in more timely risk detection.
The review and a commentary appear in the March/April issue of the journal Health Affairs.
Source: United Press International
Related Articles
- Final Economic Stimulus Bill Permits Americans' Personal Health Information to Be Sold for Research and Public Health Purposes WITHOUT Patients' Consent
- Ramsell Public Health Rx Partners With HealthTrans(R) to Provide Free Drug Discount Program to Public Health Program Participants
- Patient Safety Act is Approved By Public Health Committee
- Prescription Drug Abuse: An Emerging Public Health Threat; Congressional Briefing Sponsored By The Friends of NIDA
- Influenza, Disaster Preparedness, Bioterrorism, Reproductive Health and Health Care Access Among Top Public Health Concerns
- Influenza, Disaster Preparedness, Bioterrorism, Reproductive Health, Health Care Access Among Top Public Health Concerns at APHA Meeting, Dec. 10-14
- Harvard Public Health Doctor Nets $500G in `Genius' Grant
- Partners in Information Access for the Public Health Workforce Website
- Health Services Research Tools for Public Health Professionals
- Influenza, Obesity, Bioterrorism, Prescription Drugs, EnvironmentalThreats Among Top Public Health Concerns at APHA Meeting Nov. 6-10
 |
 |
User Comments (0)
RSS Feeds