They observe that the FDA has 1,400 employees working on approving new drugs, but only 52 monitor the safety of 5,000 drugs already in the pharmacies or available over the counter. They noted that the agency's Division of Pharmacovigilance and Epidemiology has only seven physicians and one epidemiologist. In a reorganization expected later this year, the office will become the Office of Post-Marketing Drug Risk Assessment, with 10 additional slots. No one at the FDA is routinely collecting such information, nor is anyone else in the government. The FDA estimates that only 1 percent of adverse events are ever reported.
Digoxin is prescribed for heart failure.
Some adverse reactions are disguised because an event might naturally be expected with the disease being treated. Even boxed warning labels have little effect. Safety monitoring should include surveillance of the most important known and expected risks and regular public reporting on the response of the public and prescribing physicians. The authors also say that the new office should identify the priority targets for prevention efforts. The funds to pay for this expanded safety program should come from user fees collected from pharmaceutical companies.