- The Food and Drug Administration on Wednesday released two draft guidance documents detailing its current thinking on drug manufacturers' product communications, extending a streak of regulatory rulemaking in recent weeks.
- Additionally, the agency published a memo on its views surrounding off-label communications, or communications that relate to unapproved uses of approved medical products.
- Regulating off-label communications has been a point of dispute between the industry and the FDA, which is tasked with protecting public health. Drug and device makers have argued that off-label communications which aren't false and misleading can help patient care.
The memorandum from the FDA follows a two-day hearing the agency held in November to discuss off-label communications. The document does not suggest any forthcoming policy, however.
Instead, the FDA carefully lays out — from its viewpoint — the case for regulating off-label communications more strictly and the arguments for looser restrictions. It goes into particular depth addressing potential solutions which have been considered or suggested in the past, such as creating caps on unapproved use or limiting reimbursement to only approved indications.
In general, the agency finds currently proposed approaches to be insufficient for handling the complexities of the issue.
"FDA is concerned that none of them appear to integrate the complex mix of numerous, and sometimes competing, interests at play and thus do not best advance those multiple interests," the document states.
The FDA acknowledges that communicating potential off-label uses for approved products can, in some cases, help healthcare providers better care for patients. On the other hand, such use can also lead to patient harm, potential fraud and misbranding.
Two examples help illustrate the competing interests. Roche's cancer drug Avastin (bevacizumab) is often used to treat macular degeneration — a use for which it is not currently approved. Avastin, a relatively cheaper drug, seems to have comparable efficacy to Roche's pricier Lucentis (ranibizumab) or Regeneron's Eylea (aflibercept), although the risk of infection could be higher.
In its memo, the FDA details a long list of medications that have resulted in patient harm when used off label. Atypical psychotics, for example, are mostly approved to treat schizophrenia or bipolar disorder. But a number of drug companies, including Bristol-Myers Squibb and Eli Lilly, promoted the use of their atypical psychotic drugs for off-label use in elderly patients with dementia. Later studies showed use in that patient population led to increased mortality, leading the FDA to issue a public health advisory warning in 2005.
In association with the memo, the FDA reopened its docket for public comments on the issue for an additional 90 days to April 19. This was done to give stakeholders a chance to review the other two guidance documents and submit comments which touch on all three.
One of the draft guidance documents relates to communications of product information not explicitly on, but consistent with the product label, while the other concerns communications to payers and other organizations.