The US Institute of Medicine said on Friday that there are serious deficiencies in the way the safety of medicines is overseen and regulated once they reach the market, and that the Food and Drug Administration needs new funding and powers to get the situation back on track.
“The FDA needs increased enforcement authority and better enforcement tools directed at drug sponsors, which should include fines, injunctions, and withdrawal of drug approval,” according to the report, which said the agency and the pharmaceutical industry had lost credibility because they “do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion.”
Meanwhile, a coalition of patient groups, regulators and industry – including the last three heads of the Department of Health and Human Services which governs the FDA – added their voices to the call for reforms today, saying the agency badly needs more resources to allow it to function effectively.
More details from the IoM report and its potential impact on the FDA and pharmaceutical industry will be published on PharmaTimes.com tomorrow.
