We’re still tracking government’s performance under the Open Government Directive, and we’re also asking for specific information to be released. Here’s the data we’d like to see on food and drug safety, which we posted over at the Department of Health and Human Services “open” Web page. The agency set up this commenting system as part of President Barack Obama’s open government directive. Please take a moment to visit and vote for our suggestions. (Unfortunately the HHS comment format made our paragraphs run together and slightly truncated our comment. This is fixed below.) We’ll be posting more of these at other /open pages in the coming days and weeks.
Wed like to see database(s) that contain all relevant information for food, drug, and medical device recalls. Right now much of this information is available only in the form of posted press releases, which are difficult to search. Any posted database on food recalls should include information on the food item, pathogen, and date, as well as be consistent in the amounts recalledounces, units, pounds, lots, cans, and so forth. These are all suggestions made by the Center for Science in the Public Interest (CSPI) in testimony before the Food and Drug Administration (FDA) transparency taskforce. (June 24, 2009)
Another item of great value for consumers would be a searchable database of food inspection results for both domestic and imported foods. Wed like to see the results of inspections posted within 24 hours, another CSPI recommendation.
Also on the food safety information wish list: the FDAs food inspection work plans, which should include information on how often inspectors are visiting food processing facilities. In the past, the group Food and Water Watch has successfully sued under the Freedom of Information Act (FOIA) for these documentsthey ought to be available online, as we reported here.
The FDA issues warning letters to companies that violate labeling laws for offenses such as false health claims. On the FDAs website, you can search them by company, date, and download them, which is helpful. However, it would be good to post this database at HHS.open/gov and also on Data.gov. It is also important to ensure these data are complete. Recently the U.S. General Accountability Office (GAO) criticized the agency because it had neglected to post at least 220 warning letters and had also posted some duplicates.
Its possible to search for documents associated with new drug approvals (NDAs) of prescription drugs and medical devices here. However, the data underlying this search are not available in a database format for downloading, which would be quite useful. In addition, the documents returned here are often in awkward pdf formats that are not searchable by key word, and many documents associated with widely prescribed drugs are often not available, as we reported here.
Its good to see clinicaltrials.gov among the datasets available at HHS.gov/open. However, there are acknowledged problems that these data are incomplete. Last year a study in the Journal of the American Medical Association reported that fewer than half of these trials are reported. In addition, data generally are not available on drugs or medical devices that do not go not go to market, as we reported here. This matter that has been under discussion by the FDAs transparency task force, as we reported here.