320000 doctors who prescribed the drugs on how to do so safely and to inform patients about the significant risks of taking the drugs but the hopkins researchers who relied on thousands of pages of internal fda documents obtained through the freedom of information act found the agency repeatedly could not determine whether the companies safety strategies were working because of poor study designs which the agency itself had approvedin a statement jeremy kahn a spokesman for the food and drug administration disputed the authors contention that the agency had abandoned efforts to evaluate the success of its program pointing to a number of steps it had taken in the last three years to study the effects of education on prescribing patterns we understand and acknowledge that there is still much work to do to bring down opioid abuse mr kahn said in the statementabout 60 drugs or classes of drugs are subject to such riskmanagement programs including the narcolepsy drug sodium oxybate the antipsychotic drug olanzapine and the acne drug isotretinoin which used to be branded as accutane and can cause severe birth defects imagecreditdon emmertagence francepresse getty imagesbut more than a decade after congress authorized such safety programs there is sparse evidence of their effectiveness and the fda has come under fire not only for putting pharmaceutical companies in charge of monitoring their own safety practices but for not doing enough to ensure the quality of the prescriber training it requires the companies to pay forthere were early warning signs that the safety program for longacting opioids had weaknesses in 2010 an fda advisory committee of experts in the treatment of pain voted 2510 against the proposed program design committee members suggested that the agency require training for prescribers and that it redesign curriculums to lessen industry influence the fda moved forward anywaya 2013 report by the inspector general of the department of health and human services found that only 14 percent of the safety programs reviewed by the fda met their goals and another inspector general report last year noted that the agency did not have the authority to take enforcement actions against companies that dont provide it with enough information to assess their safety programs a common problem it found if fda does not have comprehensive data to monitor the performance of the program the report said it cannot ensure that the public is provided maximum protection from a drugs known or potential risksin the case of longacting opioids the fda wanted 60 percent of prescribers to take the classes developed as part of the program but only about 27 percent did so within the specified time frame 2012 to 2016 surveys conducted by manufacturers found modestly greater knowledge of safe prescribing practices among doctors who took the classes than among those who did not but opioid prescribing was dropping overall at that point and the surveys were not designed in a way that could determine whether doctors who took the classes prescribed less as a