The Government Accountability Office released a report today, finding that "in several key areas, FDA rules for drug approval fail to guarantee the safety and effectiveness of drugs for seniors." Among the problems identified:
- Inclusion of seniors in clinical trials. GAO found that drug manufacturers “generally included elderly persons and reported safety and effectiveness data for elderly persons in clinical trials.” However, in a number of cases, selected drug trials excluded participants on the basis of age, restricting the participation of seniors.
- Inadequate FDA guidance. FDA has failed to clarify important requirements in the drug evaluation process for seniors, resulting in potential information gaps. For example, FDA does not require that medical officers determine whether a sufficient number of seniors participated in drug trials.
- Failure to document safety and effectiveness. According to GAO, one-third of new drug reviews failed to include documentation of FDA medical officers’ review of drug safety and effectiveness data for seniors.
Of these, excluding or failing to recruit adequate numbers of seniors for drug trials is the most troubling. Since the clinical trials are the only data that the FDA has to determine whether a drug is safe and effective for the population that will be using it after approval, it is vitally important that the clinical trial participants be a microcosm of the much larger patient population that is likely to use the drug once it's approved.
We know that some side effects don't show up in clinical trials, either because of the smaller number of people taking the drug or because some side effects only surface after patients have used the drug for longer periods. The FDA at times requires drug makers to conduct "post-marketing studies" after the drug has been approved -- studies designed to ferret out the drug's true risks and side effects once the "real world" data from millions of uses are available. Yet last year, the Office of the Inspector General issued a report documenting the incredibly shoddy job the FDA does at following up and making sure that drug companies actually do these studies.
The FDA's failure to ensure that post-marketing studies are conducted makes it all the more important that clinical trials conducted to get the drug approved accurately reflect the patient population that is likely to take the drug once it's approved. This is doubly important for seniors, who take more drugs, are likelier to suffer side effects, and far likelier to have other, complicating conditions.