On Wednesday, we blogged about the innovative proposals put forth by the Food and Drug Administration Transparency Task Force regarding drug safety, which we commented on. The initiatives are part of the FDA’s three-phase effort to increase Agency transparency, an effort that Community Catalyst fully supports. Today, we look at what consumer advocates, health professionals, and the pharmaceutical industry said about these potential reforms.
The overwhelming response to these proposals has been positive. Across the spectrum, disparate organizations from the drug industry trade group PhRMA to the consumer watch dog group Public Citizen voiced their support for movement toward a more transparent FDA. As the Advanced Medical Technology Association (AdvaMed) stated in comments, “greater transparency in FDA operations is a desirable goal.” However, as always, the devil is in the detail. There was disagreement over the types of disclosures that would best serve the public and just how much transparency is enough. Here are three issues that were most prominently commented upon, illustrating the accord and dissent among the groups.
Proprietary Research versus Proper Research
Public Citizen and some other consumer groups issued comments generally aligned with ours, praising the Task Force’s proposals, and offering additional steps the Agency should take toward useful transparency. Like us, Public Citizen urged the FDA to release all summary safety and efficacy data from pre-approval and marketing applications. The group points out that despite industry claims, releasing summary data would not harm firms, citing a Task Force finding that “industry has not demonstrated that blanket protection of aggregate information is warranted to maintain incentives for innovation.” Instead, Public Citizen explains, “release of all summary safety and efficacy data is in the interest of public health, because it enhances scientific innovation and discovery.” Beyond the clear safety benefits of releasing the raw clinical data, which we outlined Wednesday, Public Citizen makes a compelling case that such disclosures are legal, citing legal victories that they have won over the years to establish that, absent some proof that a competitor would gain an advantage, “generally . . . clinical data submitted to FDA is not confidential commercial information.” More public access to data on drug safety research, not less, benefits us all.
Adverse Event Reporting
While industry and consumer groups differed on how much data should be disclosed and in what format, the groups generally supported the Task Force proposal to increase public access to and user-friendliness of information on adverse events associated with drugs. PhRMA, AdvaMed and others also noted the importance of disclaimer information that should be provided along with adverse events data. This is a concern we share – and commented on. Ensuring that the public understands and can make use of the newly accessibly data should be a priority.
Many groups also welcomed the transparency proposals for their anticipated effect on the Freedom of Information Act process. The American Association for Justice wrote that the additional disclosures the Initiative would, particularly in regards to adverse event information, “relieve some of the burden on the FDA FOIA office and allow them to complete other requests in a more timely fashion.” How significant is this burden? Public Citizen notes that even after spending $29 million in 2009 handling FOIA requests, there remained a ‘backlog’ of 4,818 FOIA requests at the end of 2009 fiscal year (September 30, 2009).
Prescribers, too, want better access to this information. The American College of Cardiology (ACC) said the disclosures would greatly benefit practitioners who depend on accurate adverse event information to guide their prescribing practices. “Medical professionals, such as practicing cardiologists, are unlikely to go through the time, expense and hassle of filing a Freedom of Information Act (FOIA) request to obtain this information,” the ACC commented. “Providing the information without the need for FOIA requests will reduce the number of FOIA requests, thus decreasing FDA expenses in this area.” ACC also noted that a more open adverse events data system would encourage doctors to report more of the events that occur among their patients, building a better database that stands to benefit us all.
Many consumer and professional groups raised concerns over the FDA’s lack of drug recall authority. Recent events, including an unofficial, “phantom recall” of some Johnson & Johnson products and another incident resulting in the recall of over 130 million bottles of common over-the-counter children’s medications, have no doubt focused public attention on FDA’s current lack of authority to initiate a recall, as well as limited requirements for manufacturers to notify FDA of drug safety and quality issues. We are supportive of proposals 18, 19 and 20, because they would help to eliminate the uncertainty that has often shrouded industry practices and sometimes even FDA actions around issues of drug safety.
We have long supported expanded authority for FDA to require a drug recall when patient safety is at risk, and it is becoming clear that a growing number of groups have adopted similar positions. The Academy of Managed Care Pharmacy supported the Task Force’s proposal to seek authority to require manufacturers and distributors to inform the Agency when they initiate a recall. This would likely help avoid another “phantom recall.” The Academy goes on to encourage the FDA to expand its authority even further and pursue legislative power to initiate the recall of medications. The group added that “Patient safety should be the primary concern of the FDA, and legislative authority to initiate the recall of medications is necessary to allow action to ensure the safe use of medications.” The American Society of Health-System Pharmacists asserted that improving the recall process should be an FDA priority and outlined a standard recall notification process that the FDA should develop as the Agency is “in the best position to ensure that useful, actionable information is provided to the public if a problem arises with an FDA-regulated product.”
While the FDA proposals and comments cover many more components of the FDA’s transparency initiative, all of which are important in improving the safety of prescription drugs, the comments highlighted here remind us that there is a general consensus among consumer, professional and—to some extent—industry groups in a call for greater transparency. The FDA has taken a proactive approach to transparency and provided for an open process that allows everyone’s voice to be heard. We look forward to seeing the outcome of Phase II, when the Transparency Task Force will consider public comments and make its final recommendations to Commissioner Hamburg.
– Joy Lee, Policy Intern