August 25, 2014
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: FDA Docket No. FDA-2014-D-0758-0001 Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices
The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance for Industry on Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products – Recommended Practices (Draft Guidance).
BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
I. General Comments
As with the FDA’s recently published revised Draft Guidance for Industry on Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices (Revised Draft Reprint Guidance), BIO continues to support FDA efforts to clarify its views on biopharmaceutical manufacturer communication to health care professionals of truthful and non-misleading medical or scientific information, including, in this instance, certain “new risk information” that may be inconsistent with the risk information contained in the product label. BIO agrees with FDA’s
acknowledgement of the significant public health value of the provision of truthful and nonmisleading scientific and medical publications on new risk information to health care professionals. Information about new risk information can be of critical importance for physicians and their patients. As FDA explains in the Draft Guidance, “FDA recognizes that the safety profile of a drug evolves throughout its lifecycle as the extent of exposure to the product increases, and
it can be helpful for health care practitioners to receive significant new risk information about an approved product in a timely manner.” BIO concurs that health care professionals should be able to receive truthful and non-misleading published information from the manufacturer regarding new risk information about a product, in a timely manner.
We further note that, as BIO has commented previously,2 the provision by a manufacturer of such truthful and not misleading information has constitutional protection under the First Amendment as speech.3 Accordingly, so long as the information distributed by the firm is truthful and not misleading, even if the content or distribution method may be inconsistent with this Draft Guidance, the speech itself should not be the basis of an enforcement action.
In this regard, BIO appreciates FDA’s confirmation that this Draft Guidance, like other FDA guidance documents, does not impose a legally enforceable responsibility on manufacturers, and also that FDA’s use of “should not” in the Draft Guidance does not create an independent legal prohibition.4 In other words, FDA acknowledges that manufacturer distribution of information in a manner other than as recommended in the Draft Guidance is not in and of itself prohibited, and further that there may be other appropriate means of communicating truthful and non-misleading information concerning new risk information.
To the extent that FDA utilizes this Draft Guidance, or later issued final guidance, however, to restrict truthful and non-misleading communication, FDA should ensure that the recommendations are narrowly tailored to meet compelling public health goals. Certainly BIO supports the importance of the information contained in FDA-approved product labeling, and does not argue that the distribution of new risk information should substitute for FDA-approved product labeling. At the same time, however, BIO believes prescribers and other professionals in the health care process are sophisticated and discerning consumers of scientific and medical content. FDA should be cautious about placing undue or broad restrictions on manufacturers sharing truthful and non-misleading scientific and medical information with health care professionals and individuals at health care entities that may be relevant to patient care and the exercise of sophisticated professional judgment. On the whole, the Draft Guidance provides helpful information for manufacturers about how FDA would view or interpret manufacturer sharing of such truthful and non-misleading new risk information that appears in medical or scientific publications. BIO’s detailed comments are below.