Diagnostics & Imaging Week Washington Editor
WASHINGTON — The FDA this week released a public notice to address "consumer confusion" concerning tests used to check for drug use. The tests in question screen for such drugs as cocaine, marijuana, opiates, PCP and methamphetamine and are used by both businesses and individuals.
"Some people think that they don't need FDA clearance for these kits," Don St. Pierre, deputy director for new device evaluation in the Office of In Vitro Diagnostics Evaluation and Safety within the FDA's Center for Devices and Radiological Health, said in a statement.
"There has been a lot of confusion in industry — both from manufacturers of the test kits and the companies using them." According to the agency, some companies in this market believe that FDA clearance is not required for such tests and that they don't need to be regulated because they aren't considered medical devices.
"That's the gray area," he said. "They see them as not being used to diagnose a medical condition. They're being used in sports settings or prior to employment, and there has been some ambiguity."
The FDA has in place regulations that address premarket review of these screening tests, which involves performance data and labeling. The agency reviews performance data to assure that in the hands of the intended user the assay meets current standards for accuracy and reliability — whether used by a laboratory worker, a trained non-laboratory healthcare worker or a lay user.
Manufacturers of tests with FDA approval or clearance have provided the FDA with data to assure that their tests generate reliable results for the specimens being tested.
Labeling is reviewed to make sure that intended users can understand the instructions for use and that the labeling conveys other important information, including the need for confirmatory testing when the results of the screening test are positive.
The FDA said that tests not cleared may not meet current laboratory standards, and consumers and businesses would not have the same assurance that the results of that test are correct, as with an FDA-cleared test. If consumers are unsure whether a particular test has undergone FDA premarket review, an online search is available through the agency's web site, it said.
St. Pierre said the process of looking at tests in the market not cleared by the agency has been going on "for at least a couple of years" and there is no exact timeline to release more specific guidelines or regulations.
AHRQ releases info on 5 costliest diseases
According to new statistics released by the Agency for Healthcare Quality and Research (Washington), the five costliest medical conditions in the U.S. in terms of total spending for hospital and doctor visits, prescriptions drugs and other treatments are: heart conditions, cancer, accidents and other trauma, mental disorders and lung conditions.
As a percentage of total healthcare expenditures, heart conditions made up the largest share: 10.4% in 1997 and 8.3% in 2002.
Cancer cost the most per person, but had the fewest number of people with expenses compared with the other four conditions. Average spending per person in the cancer category was $6,351 in 2002, up from $4,462 in 1997.
The next highest was heart conditions at $4,120 in 2002 and $3,434 in 1997. Out of the top five, the lowest costs were associated with pulmonary conditions at $901 in 2002 and $854 in 1997.
The data were gathered as part of AHRQ's Medical Expenditure Panel Survey, or MEPS. MEPS is a system for collecting information each year from a national sample of U.S. households about healthcare use, expenses, access, patient health status and quality.
The data released by MEPS showed that between 1997 and 2002, total spending for hospital and doctor visits, prescriptions drugs and other treatments for mental disorders rose by more than $11 billion, adjusted for inflation, and the number of people being treated rose by more than 11 million, the biggest jumps among the top five most costly medical conditions.
More than 50 million Americans had health expenses related to asthma and other lung conditions in 2002. Medical expenditures for pulmonary conditions increased by $10 billion. About 36 million had expenses related to accidents and other trauma, according to the survey.
Between 1997 and 2002, the number of people with medical expenses increased for all of the top five conditions except trauma. The largest percentage increase was for mental disorders at 55% (20.1 million to 31.2 million people). The second-highest increase was the percentage of people reported with cancer increased 24.3% from 8.7 million to 10.9 million. Cancer was followed by pulmonary problems at 21.7%, 41.3 million to 50.2 million.
According to AHRQ, MEPS, as a government survey effort, is unique because of the degree of detail in its data as well as its ability to link data on health services spending and health insurance to demographics, employment, economics, health status and other characteristics of both individuals and families.