Federal regulations require drug manufacturers to report previously unknown side effects and complications of their products to the Food and Drug Administration (FDA) within 15 days of receiving reports of patient injury or death. Many companies, however, haven’t done their due diligence, having only done so in fewer than 1 out of 10 cases, a recent study finds.
Researchers at the University of Minnesota School of Public Health in Minneapolis analyzed 1.6 million side effect reports submitted to the FDA between 2000 and 2014. For each report, they calculated the number of days that lapsed between the moments doctors alerted the drug companies to the submission of documents.
The analysis, published in JAMA Internal Medicine, showed drug manufacturers didn’t disclose more than 160,000 serious adverse events within the 15-day time frame. Nearly 40,500 of those delayed reports involved patient deaths. The study also found drug makers reported 91 percent of nonfatal complications and 88 percent of fatal situations in accordance with FDA guidelines.
“Timely reporting of adverse drug events is critical for ensuring patient safety,” Pinar Karaca-Mandic, the senior author of the study and a researcher at the University of Minnesota School of Public Health, told Reuters. “Ours is the first study to empirically examine the extent of delays in reporting.”
The FDA currently monitors drugs and therapeutic products post-release through its Adverse Event Reporting System, a database that contains information about medication error reports. Agents use the data to evaluate drug manufacturers’ compliance with federal guidelines and launch a follow-up investigation, if necessary. Those evaluations may involve use of the FDA’s Sentinel System and other databases. The FDA will use that information to determine the course of action needed to inform consumers and ensure product safety.
Though the onus lies on drug manufacturers to disclose side effects to the FDA, patients and health care professionals don’t have the same obligation — a loophole that experts say carries risks. For instance, doctors often fail to tell patients about possible adverse drug reactions while recruiting them for clinical studies. If doctors learn of complications from drugs, they may be slow to tell drug manufacturers and federal officials out of fear of legal recourse.
In their report, the researchers proposed that the FDA create a regulation allowing patients to directly report side effects to the federal agency. JAMA Internal Medicine Editor Dr. Rita Redberg also called on the FDA to ban drug sales and implement reverse drug approval when manufacturers don’t report drug complications in a timely manner.
But Dr. Kenneth Getz, a researcher at the Center for Study of Drug Development at Tufts University School of Medicine, says agency leaders shouldn’t act hastily against noncompliant drug companies, citing the “labor-intensive process” of verifying and reporting adverse effects.
“Inaccuracies may lead drug safety professionals to draw incorrect conclusions, manufacturers may be wrongly forced to suspend and withdraw medications and interventions, health professionals may mistakenly alter their clinical practices, and patients may be denied safe and effective treatments,” Getz told Reuters.
The University of Minnesota study comes amid great scrutiny about the safety and efficacy of prescription medication. For instance, statins, a cholesterol-reducing medication, has recently been linked with nearly 20,000 reports of side effects — including irreversible muscle breakdown, blood disorders, and diabetes — and 227 deaths. Last month, the FDA heightened warnings of heart attack and stroke risks for non-steroidal anti-inflammatory drugs currently on the market. The federal agency also launched an online side effect reporting network in partnership with PatientsLikeMe.org, perhaps in an attempt to hold drug manufacturers and doctors more accountable.
But experts say that catching mistakes before a drug’s release — and holding the FDA more accountable to consumers — might be the safest strategy.
A 2014 study, for example, suggested that an expedient drug-approval process and increasing workload for FDA drug prescription reviewers may have caused an influx of warnings, recalls, and side effect reports for prescription medications. Authors of the study pointed to the Prescription User Drug Fee Act, a 1992 law that authorized the FDA to collect processing fees from pharmaceutical companies. Drug safety advocates argue Big Pharma’s financial influence has since tainted the drug-approval process. Such was the case earlier this year when research highlighted cases when the FDA didn’t disclose scientific fraud among drug manufacturers.