Embracing 21st Century Information Sharing: Defining a New Paradigm for the Food and Drug Administration's Regulation of Biopharmaceutical Company Communications with Healthcare Professionals
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Embracing 21st Century Information Sharing:
Defining a New Paradigm for the Food
and Drug Administration's Regulation of
Biopharmaceutical Company Communications
with Healthcare Professionals
By JAMES M. SPEARS, JEFFREY K. FRANCER,
AND NATALIE A. TURNER*
INTRODUCTION
The U.S. Food and Drug Administration (FDA) plays a unique role in protecting
the public health and minimizing the risk of the distribution of unsafe or ineffective
medicines in the United States. Perhaps equally as important for public health, however,
is the need for healthcare professionals to be well informed about the benefits and risks
of the medicines they prescribe. In this way, information sharing is critical to healthcare
delivery, including information about approved uses of medical treatments as well as
medically accepted alternative uses of FDA-approved medicines. Because medical
technologies rapidly evolve, a physician's ability to prescribe treatments for approved
as well as alternative, but medically appropriate, uses can enhance the delivery of
healthcare to patients.' It is not feasible for the drug approval process for supplemental
uses of approved medicines to keep pace with all medical advancements. As one FDA
leader has noted, [i]t is inevitable that there will be preliminary support for off label
uses before definitive information becomes available.2
FDA's current interpretation of laws and regulations governing healthcare
communications prohibits biopharmaceutical companies from sharing certain accurate,
data-driven information about FDA-approved uses and medically accepted3 alternative
* James M. Spears is Executive Vice President and General Counsel at the Pharmaceutical Research
and Manufacturers of America (PhRMA). Jeffrey K. Francer is Vice President and Senior Counsel at PhRMA.
Natalie A. Turner was a legal fellow at PhRMA.
1 See Joseph W. Cranston et al., Report of the Council on Scientific Affairs: Unlabeled Indications of
Food and Drug Administration-Approved Drugs, 32 DRUG INFO. J. 1049 (1998).
2 Testimony on Supplemental Indications for Approved Prescription Drugs Before the H. Comm on
Government Reform & Oversight, Subcomm. on Human Resources & Intergovernmental Relations, 104th
Cong. 2 (1996) [hereinafter Testimony] (statement of Michael Friedman, then-Deputy Commissioner for
Operations, FDA) (Off label uses, particularly for oncology, rare diseases, and pediatrics, can be of great
value. Some off label uses have been of great historical importance. Use of beta blockers in hypertension and
angina preceded labeling for these uses by many years. It is inevitable that there will be preliminary support
for off label uses before definitive information becomes available. Physicians confronted with patient needs,
may choose to act on such data, especially where there are no good alternatives.).
3 In this article, the term medically accepted alternative use means a use that is outside of FDA-
approved labeling that is nevertheless listed in specific compendia, supported by clinical practice guidelines,
or reimbursed by the federal government or a majority of commercial health insurers. We also note that
information or data that is deemed off-label by FDA may include (1) information that is consistent with
the approved use but that has not been demonstrated by FDA's evidentiary standards for approval (typically
two double-blind placebo controlled studies), (2) information pertaining to medically accepted alternative](ViewImageLocal?handle=hein.journals/foodlj70&div=13&collection=&method=preview&ext=.png&size=3)
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