US regulators are planning to release several additional guidance documents by the end of the year relating to scientific exchanges of information and other promotional-like activities, including a long-awaited guidance document on the use of healthcare economic information.
The US Food and Drug Administration (FDA) recently released two draft guidance documents intended to clarify how it treats scientific and medical literature. The first of those guidance documents was focused on unapproved new uses, such as literature on the efficacy of a drug product used off-label. The second guidance focused on the publication of risk information, such as information that might draw attention to research indicating a drug is safer than originally thought.
But quietly buried within the second guidance document's Federal Register was another important piece of information: More of those guidance documents are on their way.
"FDA also plans to issue, by the end of the calendar year, additional guidance that addresses manufacturer responses to unsolicited requests, distributing scientific and medical information on unapproved new uses, manufacturer discussions regarding scientific information more generally, and distribution of health care economic information to formulary committees and similar entities."
The revelation follows a Citizen Petition filed by the law firm Ropes & Gray LLP in July 2011, which specifically requested the release of those documents. In a 9 June 2014 response to that petition—filed the same day as FDA's Federal Register announcement—FDA said it was granting the law firm's request for "more clarity on truthful, non-misleading scientific communications and activities related to investigational new drugs and investigational devices and off-label uses of marketed drugs and devices."
Section 114 and HIE
One of those guidance documents, on the distribution of healthcare economic information, has long been sought after by industry.
A 1997 law known as the Food and Drug Administration Modernization (FDAMA) first called for pharmaceutical companies to be able to market products using healthcare economic data, such as information indicating that a drug would save a consumer money relative to another, similar drug.
Section 114 of the law states:
"Health care economic information provided to a formulary committee, or other similar entity, in the course of the committee or the entity carrying out its responsibilities for the selection of drugs for managed care or other similar organizations, shall not be considered to be false or misleading under this paragraph if the health care economic information directly relates to an approved indication for such drug and is based on competent and reliable scientific evidence. The requirements set forth in section 505(a) or in section 351(a) of the Public Health Service Act shall not apply to healthcare economic information provided to such a committee or entity in accordance with this paragraph …. The term `healthcare economic information' means any analysis that identifies, measures, or compares the economic consequences, including the costs of the represented health outcomes, of the use of a drug to the use of another drug, to another healthcare intervention, or to no intervention."
However, while FDA has gone as far as to send an Untitled Letter to a company chiding it for using healthcare data to market its drug, it has not established any guidance on the use of the data since the law was passed in 1997.
That has left the pharmaceutical trade group PhRMA annoyed, and in December 2013 it released a white paper calling for the institution of guidelines to assist the industry in using the data, saying Congress' intent was clear: Companies should be able to market their products using healthcare economic information.
Federal Register Notice