EXECUTIVE SUMMARY Click here for the Full Report (Word Document format)
Using data from the federal Food and Drug Administration (FDA), this study examines the agency’s main areas of responsibility for approving new health products for the third consecutive year. Among this study’s findings are:
In fiscal year 1997, the FDA continued to flout the Food, Drug, and Cosmetic Act’s deadlines for approval of new health products.
The FDA maintained failing grades in seven of 11 categories: food and color additives (page 8), new drugs (page 13), generic drugs (page 14), new or “off-label” uses of existing drugs (page 15), new medical devices (page 17), new animal drugs (page 20) and generic animal drugs (page 21).
Despite four percent more reviewers, an 11 percent increase in funding, and a 13 percent lighter workload, the FDA took nine percent longer to review new drugs in fiscal year 1997 than in the previous year (page 13). These findings cast doubt on the contention that the FDA’s delays are a result of scarce resources, and that added resources will bring new medicines to patients sooner.
In fiscal year 1997, the FDA took 146 days (nearly 5 months) to decide the word “plus” is an acceptable synonym for the word “added” when used on food labels. This marks a substantial gain in efficiency over the two very thoughtful years the agency devoted to the question of whether the word “extra” can be substituted for the word “more” on food labels. This caused the FDA’s grade on so-called “nutrient content claim synonym petitions” to rise from an “F” to a “D” (page 12).
The FDA “earned” its first “A” in the history of this study simply by proposing to lift its censorship of the health benefits of two particular foods (page 10).
The FDA made modest, steady improvement on the approval of simple medical devices, though still earning a “D” in that category (page 18). This improvement is expected to accelerate under reforms enacted by Congress.
Congress should take steps to ensure the public fully understands the cost of FDA delays. These include reforms that would require the FDA to self-report on its performance in meeting the Food, Drug, and Cosmetic Act’s deadlines, as well as its performance vis-a-vis foreign regulatory agencies. Most importantly, with every product approved by the FDA, Congress should require the agency to estimate the human cost suffered during the time the agency took to make up its mind.
Click here for the Full Report (Word Document format)