The FDA has published an interim final rule amending definitions related to required notifications regarding drug shortages. 21 C.F.R. 314.81(b)(3)(iii) requires an applicant who is the sole manufacturer certain approved drug products to notify FDA in writing at least 6 months prior to discontinuing manufacture of the drug product. 21 C.F.R. 314.81(b)(3)(iii) now refers to

On December 13, 2011, FDA announced the availability of a draft report entitled “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” for public comment. The literature review was conducted pursuant to section 3507(a) of the Patient Protection and Affordable Care Act (Affordable Care Act) which required 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 the “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.”


Continue Reading FDA makes “Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review” available for comment

On December 9, 2011, the Food & Drug Administration (FDA) issued a notice announcing that a proposal to collect information for a “Experimental Study of Comparative Direct-to-Consumer Advertising” had been submitted to the Office of Management and Budget (OMB). FDA is required to submit the proposal to OMB for review and clearance under the Paperwork Reduction Act of 1995. FDA’s submission reveals its intent to study direct-to-consumer marketing of FDA-regulated products, with a focus on prescription drug advertising.

According to FDA, research findings on the effects of comparative versus noncomparative ads on purchase intentions indicate that comparative ads result in greater purchase intentions than noncomparative ads. Given the prevalence of comparative advertising, “FDA is embarking on the proposed research to ensure that it has adequate information to assess whether prescription drug comparative DTC ads provide truthful and nonmisleading information to consumers.”


Continue Reading FDA Proposes “Experimental Study of Comparative Direct-to-Consumer Advertising”

The Food and Drug Administration (“FDA”) recently completed an evaluation of the legal basis for federal preemption policy statements the agency has issued under the Federal Food, Drug & Cosmetic Act (“FDCA”) during the past 10 years. FDA initiated the review in response to a memorandum issued by President Obama in May 2009 which directed

On June 23, 2011, the Supreme Court rendered its decision in Pliva, Inc. v. Mensing holding that FDA regulations governing generic drug products directly conflict with and preempt state laws that would require generic drug manufacturers to modify the FDA-authorized labeling for their products to provide "adequate warnings" as defined by state law. The Court

The Food and Drug Administration (FDA) is expected to issue guidance and possibly regulations regarding use of social media. These policies will only be enforceable on marketers of prescription drugs and restricted medical devices; however, industry can expect that the rationale and policy behind the guidance and regulations will apply across the board to consumer

This Monograph, published by the Food and Drug Law Institute, is designed to assist lawyers, regulatory advisors and marketing professionals answer the question "Can we say that?" as they design and execute programs to promote consumer health products such as foods, dietary supplements, non-prescription drugs and medical devices, cosmetics and pet care products. It serves