On October 21, 2016, at the end of the week of AdvaMed 2016, FDA’s Center for Devices and Radiological Health (CDRH) unveiled its new page, “Reporting Allegations of Regulatory Misconduct.” According to the new page:
An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices may be doing so in a manner that violates the law. Reporting these allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise. This information can help the FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation.
Anyone may file a complaint reporting an allegation of regulatory misconduct. The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously. The FDA will not share your identity or contact information with anyone outside the FDA unless required to do so by law, regulation, or court order.
The page goes on to explain the types of allegations that may be reported, including failing to register or list a device, marketing unapproved medical devices, failing to follow quality system requirements, or misleading advertising and promotion. Interestingly, the first example listed concerns off-label promotion: “Promotion or advertising of a device outside the FDA-cleared or approved indications for use.” The page further describes how to submit allegations about a medical device to FDA, the information to include in the reported allegation of regulatory misconduct, and how to find out the outcome of the allegation submitted to FDA. Regarding the latter, information is obtained via the Freedom of Information Act (FOIA), which FDA suggested should not be initiated until at least 180 days after submitting the allegation to permit the investigation to take place.
On a related note, during AdvaMed on October 19, 2016, there was a panel on off-label communications, including Lauren Silvis, FDA/CDRH’s Deputy Policy Director. Silvis acknowledged that FDA is holding the public hearing to assess the impact of recent court decisions addressing off-label communications, as well as what incentives could offer additional clinical data generation for off-label uses other than requiring preapproval for those uses. Panelists expressed concern how the Department of Justice has been approaching prosecution for off-label uses in view of the need for scientific exchange and truthful promotion. Silvis said that the issue is about how to educate about the uncertainty surrounding clinical data that suggests an off-label use, noting that there is more health information available now that just manufacturer’s labeling, e.g., information from health care providers. FDA’s new page appears to be addressing an awareness by CDRH that off-label communications may be presented and experienced by a variety of stakeholders.
Silvis further reminded attendees that FDA plans to hold a 2-day public hearing on off-label communications on November 9-10, 2016, Manufacturer Communications Regarding Unapproved uses of Approved or Cleared Medical Products. Background information on the Public Hearing provided the key questions FDA is seeking answers to:
- FDA is interested in input from stakeholders on how increased communications from firms about unapproved uses could impact the public health, and on whether the impact would differ across different categories of medical products.
- FDA is aware of changes happening in the health care system that are outside of FDA’s role, which may provide an impetus for the development of high-quality data to fully assess the risks and benefits of new uses of medical products.
To what extent do changes occurring in the health care system that give payors and formulary committees more influence on prescribing decisions (including by denying, limiting, or endorsing coverage of unapproved uses of approved medical products) provide incentives for firms to generate the high-quality data needed to demonstrate safety and effectiveness for new uses?
To what extent do these changes affect (to preserve, enhance, or suppress) incentives for firms to seek FDA approval/clearance of new uses?
- FDA recognizes that information about medical products, including information about unapproved uses of approved/cleared medical products, is now broadly available from a wide variety of sources (e.g., academic and governmental organizations, scientific journals, professional societies, compendia) in both traditional and new communication vehicles and platforms, particularly electronic communication platforms (e.g., the Internet). What is the impact of the increasing availability of this information on firms’ incentives to communicate information about unapproved uses of approved/cleared products? FDA is also interested in input on other factors that firms may consider when making decisions about providing information about unapproved uses of their approved/cleared medical product, including financial considerations.
- Given the importance of the scientific integrity of the information that may be relied on in making decisions about the use of medical treatments, FDA is interested in input from stakeholders on the standards that should apply to unapproved use communications to minimize the potential of these communications to be misleading or otherwise cause harm.
- FDA is interested in input from stakeholders on factors that the Agency should consider in evaluating whether firms’ communications about unapproved uses of approved/cleared medical products are truthful and non-misleading, including what information firms should disclose in these communications to help ensure audiences are not misled, and on general considerations related to the audience for these communications and on communication vehicles and techniques.
- Another important consideration in the changing health care environment is transparency, including the growing expectation that data from human studies will be made available for public review. If a firm bases a communication on data that is not publicly available, should information be provided publicly to ensure that the quality and integrity of the supportive scientific information can be adequately evaluated before any prescribing or use decision? If so, how should transparency of this information be monitored?
- FDA is interested in public input on how the Agency should monitor firms’ communications about unapproved uses of their medical products, and what actions FDA should take with respect to firms’ communications that are determined to be false or misleading or that otherwise raise public health issues. For example, what kinds of surveillance and monitoring could be undertaken to measure and assess the public health impacts of unapproved use communications and by whom?
- As discussed previously, the Agency is evaluating its regulations and policies governing firms’ communications about unapproved uses of approved/cleared medical products and considering whether revisions are appropriate in order to provide greater legal certainty and clarity to regulated entities. As an initial step, in the Federal Register of September 25, 2015 (80 FR 57756), FDA issued a notice of proposed rulemaking that proposed changes to existing regulations at 21 CFR 201.128 and 801.4 to provide clarity for drug and device firms regarding FDA’s interpretation and application of its existing intended use regulations.
FDA said that its registration to attend the meeting is now closed, but there will be a live webcast available, which will be posted along with a transcript as soon as it as available, and written comments may be filed up to January 9, 2017.