By guest blogger Mira Kolodkin
The Food and Drug Administration (FDA), after reviewing years of clinical trials, will often approve the release of a pharmaceutical drug to treat specific problems with precise dosages. Despite this thorough process, drugs are sometimes prescribed for off-label uses, which means they are given for conditions or patient populations that they have not been approved for. It is legal for doctors to prescribe drugs for off-label uses (and they do pg. 6), but illegal for drug companies to promote the drugs for disorders that have not been thoroughly tested in the lab. This makes sense as the doctor is theoretically not profiting off his prescription decisions, while the same is obviously not true of pharmaceutical companies. Thus, an additional responsibility of the FDA is to ensure that drug companies are not promoting drugs for off-label uses.
An example of this is Neurontin, a drug manufactured by Pfizer and approved by the FDA in 1993 for the treatment of seizures. The Pfizer subsidiary Warner-Lambert utilized promotional material to promote Neurontin for off-label uses, and doctors soon began prescribing it for pain and psychiatric conditions. In 2004, Warner-Lambert was forced to pay $430 million (pg 6)in fines after it admitted to charges of promoting off-label use of the drug. On the one hand, Neurontin probably helped a number of people who were severely depressed and would have had to wait years for symptomatic relief as the drug underwent a new series of clinical tests. On the other hand, drugs can have different side-effects depending on what’s going on inside a body with one health problem versus another. Thus, while the drug may have limited side-effects in one physiological context, it can cause death in another. That is why drugs are tested so thoroughly: to keep people safe and keep businesses from being sued.
The Government Accountability Office recently reviewed how the FDA oversees the promotion of off-label uses of prescription drugs, and what actions have taken place to address off-label promotions. The review found that
- The staff relies on a process to evaluate which promotional materials and violation submissions present the largest potential impact on public health. However, due to overload (over 68,000 submissions received in 2007 alone), not all are read.
- Of the 42 regulatory letters released between 2003 and 2007, it took on average 7 months from the point of original drafting to issuance of letter. Additionally, drug companies did not alter material until an average of 4 months after FDA complaint.
It is unconscionable that a portion of violation submissions and promotional materials are not even read, and when read, nearly a year elapses before companies comply. Nonetheless, these seem like solvable issues. As hiring more people is an economic impossibility, the next best route is to make the process more efficient. The GAO rightly suggests that the FDA actions would be more effective if a tracking system existed to systematically prioritize information received. The GAO then gives little suggestion of how to go about doing that cheaply and efficiently. A computer database could help develop a systematic approach to seeing what drugs or drug companies are receiving the most complaints, and whether review of specific cases has already occurred. One of the reasons the amount of submissions is so high is because of the vast array of promotional mediums that currently exist. This could decrease the amount of time spent on each individual submission.
The FDA often works with the Department of Justice (DOJ) when it enforces legal actions against drug companies. An additional benefit of a detailed tracking system would be to increase the ease of communication between different groups with a related cause, increasing the amount of time workers can review new material. Now how many technologically attuned workers will they have to hire to get this computer database underway?
Mira Kolodkin is a graduate student at the University of Wisconsin at Madison
