Tight FDA Deadlines Responsible for Defective Drug Approvals, Study SaysMar 27, 2008 | Parker Waichman LLP
Defective drugs are more likely to be approved by the Food & Drug Administration (FDA) because of tight time constraints the agency must work under, new research has found. A new study by Harvard researchers who have analyzed decades of drug approvals has revealed that those drugs that are approved under quick reviews tend to be more likely to cause problems and be recalled. Take, for instance, some of the medications which have been recalled in the recent past, such as Vioxx, Bextra, Rezulin, and Baycol. The Harvard research team noticed that those drugs that received approval by the FDA exactly on their deadlines seem to be more likely than not to have had safety problems versus those medications which were cleared by the FDA with time to spare.
Critics of the tight deadlines oppose the fact that Congress had set strict time limits for the FDA to rush approvals for new medications. The Harvard team’s study was published in today's New England Journal of Medicine and provides the first scientific evidence supporting some critics of speedy FDA drug passage. The FDA disagreed and provided its own numbers to back its claims.
"The article is a wake-up call," said Dr. Steven Nissen, the Cleveland Clinic's influential cardiology chief adding that, "It puts the FDA in a very difficult situation when they're trying to make complex decisions under these very, very tight deadlines.”
Such deadlines were imposed on the FDA under a 1992 law permitting drug makers to pay millions in fees directly to the FDA so that it could hire more reviewers and resolve an overload of pending drug applications. Because of this, the FDA would have to pronounce a decision on the majority (90 percent) of all drug candidates within a 12-month period following their application. If not, the FDA would lose the money. The deadline for very new or potentially lifesaving drugs that are classified as “high-priority” was six months. Congress shortened the deadline for most drugs down to a10-month time frame in 1997.
Meanwhile, in Great Britain figures reveal the startling fact that over 8,000 people have died in the past decade due to medications meant to help them. Last year alone, there were 1,031 deaths linked to adverse drug reactions, the highest figure yet, up from 447 in 1997. Over the past decade, 8,077 deaths were reported. And, nearly 42,000 other patients were hospitalized after suffering either harmful side effects or serious allergic reactions to prescription drugs and other medications.
The number of deaths from adverse drug reactions has more than doubled since 1997, rising by 131 percent. Adverse reactions are negative responses to medicines due to medical error or side effects. Also in the same period, the number of prolonged hospitalizations caused by medicines increased to 82 per cent. Reports of prolonged hospitalizations—in which the patient averaged around eight days in the hospital—rose from 2,484 to 4,545; the total for the past ten years was 41,935. The Government's National Patient Safety Agency has been beset with problems. Labour's obsession with financial and waiting time targets still gets in the way of the right set of priorities for patients."