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Pharmacovigilance

FDA Faulted for Problems With Drug Tracking

Sunshine Act, Open Payments, Transparence Santé

WASHINGTON JAN. 14, 2016 Federal investigators said Thursday that there were flaws in the way the Food and Drug Administration tracked drugs after they came to market, raising questions about the agency’s effectiveness as the country’s main drug overseer. Once the agency approves a drug, it is required to monitor the drug’s safety as well as efforts by the company that makes it to study how the drug is doing in the marketplace, for example whether many patients are reporting problems while taking it. The investigators, from the Government Accountability Office, a nonpartisan investigative arm of Congress, looked at how …

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FDA details tracking of medical device ’emerging’ safety signals

The FDA just released a guidance formalizing its practice of notifying the public of « emerging signals, » or situations in which the agency is monitoring risks that have not yet been fully validated, and for which the agency does not have specific recommendations. The latest guidance appears to be inspired by that episode, and includes a list of considerations for determining when to notify the public of an « emerging signal, » as well as the template for communicating the issue. The issuance of a formal policy suggests the FDA anticipates increased communication of emerging signals as it beefs up its surveillance capabilities …

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Senate report says FDA fails to ensure medical devices are safe

America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released Wednesday. The report, from Sen. Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, and the Food and Drug Administration for infections that sickened at least 250 people worldwide since 2012 and that may have contributed to dozens of deaths. The series of outbreaks went on for years before safety problems with the endoscopes came to light in the media in 2015. The report says the events expose systemic weaknesses in the FDA’s approach …

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How pharma companies are using social media to learn about drugs’ affects on patients

In an attempt to gain more health information, United Kingdom-based pharmaceutical company GlaxoSmithKline has begun collecting data from social media sites such as Facebook and Twitter that mention any of a company’s 1,000 different drugs. In its partnership with United States-based informatics company Epidemico, the two found over six million Twitter mentions and more than 15 million Facebook hits. Epidemico assists GSK in filtering the data, getting rid of irrelevant posts and standardizing the language around complex drug names and medical conditions. To read the article by Eric Harding

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Social media and pharmacovigilance: A review of the opportunities and challenges

Adverse drug reactions come at a considerable cost on society. Social media are a potentially invaluable reservoir of information for pharmacovigilance, yet their true value remains to be fully understood. In order to realize the benefits social media holds, a number of technical, regulatory and ethical challenges remain to be addressed. We outline these key challenges identifying relevant current research and present possible solutions. To read the article by the British Journal of Clinical Pharmacology

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