Public Citizen, a consumer advocacy group with more than 350,000 members and supporters nationwide, strongly opposes the Food and Drug Administration’s (FDA’s) draft Guidance for Industry: Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices. The guidance, if finalized, would seriously undermine FDA’s existing drug safety laws and regulations and, therefore, should be withdrawn.
The guidance states that the agency “does not intend to object to the distribution of new risk information that rebuts, mitigates, or refines risk information in the approved labeling.” In other words, the FDA is proposing to allow pharmaceutical company salespeople to promote drugs to doctors with printed information that claims the medications are less risky than FDA-approved labeling says they are.
The FDA acknowledged its awareness of the danger of this proposed guidance in its June 6, 2014, response to two petitions from the drug and medical device industry seeking authority to engage in the distribution and communication of information regarding (a) investigational new drugs and investigational devices, and (b) off-label uses of marketed drugs and devices. The FDA stated then that “Information that emphasizes the drugs’ claimed benefits, while minimizing the drugs’ limitations and adverse effects, may inappropriately influence a physician’s prescribing decisions in a manner that is not in the patient’s best interest” (see http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-1079-0004, pages 5-6).
Despite the agency’s correct assessment of why adherence to current FDA laws and regulations concerning the assessment and labeling of drug safety is important and necessary, later in the same June 2014 response to the industry petitions the FDA stated that “FDA policies must protect the public health — the fundamental interest underlying FDA’s mission and the statutory framework — while harmonizing this goal with First Amendment interests in the dissemination of truthful, accurate, and non-misleading information regarding medical products.” The draft guidance clearly tilts more toward the industry’s view of the First Amendment than toward the protection of patients and public health. Yet because the agency has a substantial interest in providing accurate warnings about the risks of drugs, an interest protected by the requirement that the FDA approve drug product labeling, the draft guidance strikes the wrong balance.
For these reasons, as elaborated on in the attached article that Public Citizen’s Dr. Sidney Wolfe wrote for JAMA Internal Medicine (Wolfe SM. Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products: A Misguided Approach. JAMA Intern Med. 2014 Aug 15. doi: 10.1001), the proposed guidance should be withdrawn.
If a company believes that new information concerning a drug supports a reduction in risk, the company should inform the FDA and provide the evidence, as is required under current regulations; if the agency’s objective evaluation confirms that the labeling overstates the risk, the label can then be changed with agency approval. Off-label risk reduction is the wrong approach.