In 2007, the Food and Drug Administration (FDA) approved 19 new drugs. This was the fewest number of new medicines approved in 24 years. At the same time, they announced nearly 75 new or revised black-box warnings about the risks of side-effects. Furthermore, approvable letters the FDA sends out when they believe more data is necessary, increased 40%. According to drug makers the FDA’s focus on safety is delaying new drugs, and many of these drugs are potentially life-saving. So what’s with the delay?
In 2004, the drug maker Merck, withdrew the painkiller called Vioxx after it was reportedly linked to heart attacks and strokes. As a result, Merck was flooded with criticism and 28,000 lawsuits. Accusations about the drug maker putting profits ahead of customers’ safety and the FDA allowing the drug onto the market were made very public. While the FDA may hold some of the responsibility, the drug industry has allegedly manipulated data, concealed dangerous side-effects, and promoted products it knows are dangerous. Evidence points to this episode beginning a sea-change in policy at the FDA. According to Kenneth Kaitlin, director of the Tufts Center for the Study of Drug Development, the FDA is “viewed as an agency that is supposed to keep unsafe drugs off the market, not to speed access to life-saving drugs.” Either situation is not likely to gain the government agency points with an already wary public.
While Vioxx is one of the most widely publicized drug recalls, others, such as GlaxoSmithKline’s diabetes drug, Avandia, Pfizer Inc.’s smoking-cessation drug, Chantrix, and the recent contaminated heparin debacle have all become part of the public record. As a result, several senators have taken the FDA to task for not being vigilant enough.
Matter of Balance
Though the FDA has approved drugs whose side-effects have led to devastating injuries and death, one of the central parts of this story is that of balancing risks that may affect only a small percentage of users against the possibility of improving quality of life, or even saving lives of hundreds of people. However, the problem certainly goes beyond this. According to the FDA, they have 500 vacancies for its staff of reviewers, and claim that having to train new hires delays the reviewing drug applications. They also claim that the low number of approved drugs is simply because fewer new drugs were proposed. According to Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, 33% fewer applications were submitted in 2006. Still, is this an industry response to fears of lawsuits when side-effects do harm users? Or is it that research showed the drugs had problems, and would never be green-lighted by the FDA? Dr. Woodcock denies that the FDA has become more conservative in its approvals, so it’s unclear.
What is clear is that there are several drugs being held up that may, or may not, benefit users. Recently, Novartis quit trying to gain US approval for the diabetes drug Galvus and the painkiller Prexige even though Galvus is already on the market in Europe and Prexige has been approved in 50 countries. Glaxo’s cancer vaccine Cervarix, Schering-Plough’s sugammadex, a post-surgical drug designed to negate muscle relaxants, and Merck’s pain medicine Arcoxia, were either delayed or rejected outright. These drugs are also on the market in Europe.
The outcome between balancing drugs to help people and drug safety is important, and this is part of the FDA’s job. However, we, as current and potential future users need to know that we have access to them. And the drug makers and doctors need to rest assured that they will not encounter lawsuits for putting them on the market or prescribing the dosage.
Still, if you or a loved one has been harmed in anyway by a defective drug, please contact an experienced personal injury lawyer in your area.
