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Big Pharma Should Take Reporting Adverse Events to FDA More Seriously




The FDA is the United States’ regulatory agency responsible for dealing with the regulation and supervision of various products affecting human health.

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are rare, fortunately, but the fact that some are failing to follow it can spell danger for consumers.

FDA System That Lists Drugs’ Side Effects Can Save Lives

The Adverse Event Reporting System managed by the FDA aims to protect consumers by disclosing a comprehensive list of side effects caused by marketed prescriptions that have been approved. When a company learns, for example, that the Essure birth-control device has led to instances of abdominal perforation, pelvic pain and severe rashes, it is incumbent upon officials to alert the agency, which then can add to, alter or amend the warning label. Without such crucial information, accidents, injuries and death can result from taking products intended to improve health.

The FDA recently called out Heritage Pharmaceuticals, which describes itself as a provider of “high quality generic medicines that help patients and practitioners achieve affordable healthcare solutions,” for disregarding its duties 10 times. The Eatontown, N.J., company was cited for failure to report adverse events and failure to develop proper procedures for receiving, evaluating and reporting adverse events.

ucm171427“Without adequate written procedures, we cannot be assured that you will accurately capture and report important safety information about your drug products to FDA,” states a Nov. 5, 2015, letter addressed to the CEO of Heritage Pharmaceuticals. “Failure to report ADEs (Adverse Drug Experiences) to FDA at the required intervals raises concerns about your firm’s ability to monitor the safety of drug products, as well as the reliability and integrity of the information submitted to FDA.”

Heritage Pharmaceuticals isn’t the only company singled out for noncompliance. Gilead Sciences, a research-and-development outfit that “commercializes innovative medicines in areas of unmet medical need,” and GlaxoSmithKline, whose mission is “to help people to do more, feel better, live longer,” both were named in a Pharmacoepidemiology & Drug Safety analysis. The analysis found each lacked information in key categories when reporting its products’ side effects – the key categories being patient age, patient gender, the date of the adverse event and a medical explanation of the problem.

“By these measures, report completeness from drug manufacturers was poor compared with direct submissions to the agency,” according to the analysis, titled “Completeness of serious adverse drug event reports received by the US Food and Drug Administration in 2014.” “The FDA needs to update reporting requirements and compliance policies to help industry capture better adverse event information from new forms of manufacturer interactions with health professionals and consumers.

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Posted By: Samantha Saundry