The Food and Drug Administration (FDA) recently announced the availability of a draft report entitled “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” (literature review report). A literature review was conducted to address a requirement of the Patient Protection and Affordable Care Act (Affordable Care Act). FDA is publishing the literature review report to allow the public to provide comment on the report as it relates to the Affordable Care Act.
Submit either electronic or written comments on the literature review report by February 13, 2012. Comments should be identified by Docket No. 2011-N-0813. For more information contact Helen Sullivan, Office of Prescription Drug Promotion,(301) 796-1200, email: helen.sullivan@fda.hhs.gov.
Background
Section 3507(a) of the Affordable Care Act requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to determine whether the addition of quantitative summaries of the benefits and risks of prescription drugs in standardized format (e.g., similar to “Drug Facts” on over-the-counter products) to the promotional labeling or print advertising of such drugs would “improve health care decision making by clinicians and patients and consumers” (section 3507(a), Pub. L. 111-148, 124 Stat. 530).
In making this determination, the law directs FDA to “review all available scientific evidence and research on decision making and social and cognitive psychology” (section 3507(b), Pub. L. 111-148, 124 Stat. 530), and to consult manufacturers and consumers, experts in health literacy, representatives of racial and ethnic minorities, and experts in women’s and pediatric health.
To fulfill this requirement, FDA has commissioned an objective review of science-based studies related to the communication of quantitative benefit and risk information. FDA is making available the literature review report and is providing a comment period for interested parties to comment on the literature review report as it relates to section 3507 of the Affordable Care Act.
Comments
Interested persons may submit to the Division of Dockets Management either electronic or written comments regarding the literature review report. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments.