US public calls for tougher, more transparent drug safety system

By Emilie Reymond

- Last updated on GMT

Related tags: Drug safety, Pharmacology, Food and drug administration, Clinical trial, Fda

The American public is calling for a tougher set of drug safety
reforms and a more transparent system for clinical trial results, a
new consumer survey reveals.

Nine out of 10 respondents said drug makers should make public the results of all their clinical trials, which test a drug's efficacy and safety. The survey findings come just two days before a US Senate Health Committee is expected to vote on what Consumer Reports called the most significant prescription drug safety legislation in 45 years. The transparency with which drug companies disclose their clinical trials resulting data has been questioned in the past few years and recently a number of firms have made much of their commitment to make all information on their studies public. Furthermore, the survey revealed that 96 per cent of respondents agree that the government should have the power to require warning labels and follow-up studies if safety problems are identified. Currently, the US Food and Drug Administration (FDA) must conduct a lengthy negotiation process before it can get changes to drug labelling, and has no authority to require manufacturers to carry out safety studies on drugs already on the market. Last year, separate investigations by the US Government Accountability Office (GAO) and Department of Health and Human Services concluded that the FDA was not meeting its obligations in monitoring information for post-marketing studies. The probes backed up an earlier internal FDA probe that found two-thirds of all post-marketing or Phase IV studies committed to by manufacturers are still pending. The poll, conducted by the Consumer Reports National Research Center on more than 1,000 Americans, found that a majority of people support the government taking whatever steps needed to ensure the safety of prescription drugs, with 84 per cent of respondents agreeing that it should have the authority to take any action necessary. In addition, more than 60 per cent of people surveyed said the FDA and Congress have failed to adequately protect consumers from harmful prescription drugs. "The message we're hearing from consumers couldn't be clearer - they want strong laws to ensure our prescription drugs are as safe and effective as possible,"​ said Jim Guest, CEO of Consumers Union, publisher of Consumer Reports. "Right now drug companies can game the system by touting the positive results from their drug studies, while downplaying information about harmful side effects,"​ Guest added. "Americans are fed up with being kept in the dark about critical health and safety information, and they overwhelmingly want change."​ The Senate Committee is expected to vote tomorrow on a bill that includes new drug safety measures, as well as reauthorising the Prescription Drug User Fee Act (PDUFA) to support the FDA drug-approval and safety process. Congress will consider whether to allow the FDA to continue to collect fees from pharmaceutical companies to help pay for the drug approval process. Critics of the scheme say that industry fees lead to a corrupting influence putting commercial interests before American consumer's wellbeing. Drug safety concerns intensified after Merck pulled arthritis pill Vioxx (rofecoxib) from the market three years ago when a study showed long-term use doubled the risk of heart attack and stroke. More recently, the FDA came under scrutiny when a report on the regulator's drug approval process by the Institute of Medicine (IoM), published last September, said that the agency needs more budget and manpower to ensure it keeps its focus on the safety of the drugs it regulates, not only before approval, but also throughout the time they are on the market. The FDA admitted in response that more needed to be done to ensure the safe and effective use of prescription drugs, however, it pointed out that much progress and reform of its safety oversight enterprise was already underway.

Related topics: Clinical Development

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