Tag Archives: Drug Advertising

Upcoming FDA Public Meeting on Speech and Medical Products

As a reminder, the Food and Drug Administration (FDA) is holding a two-day public meeting on November 9 and 10, 2016 regarding “Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.”  The meeting comes at a time where recent litigation has raised hot-button issues regarding the relationship between FDA, off-label use of drugs … Continue Reading

FDA One Step Closer to New Direct-To-Consumer Television Ad Requirements

Last February, the Food and Drug Administration (FDA) asked for public feedback on a proposed research study related to prescription drug television advertisements. In a notice published in the Federal Register on January 13, 2015, FDA announced its intention to continue to move forward with the proposed study. Specifically, the notice announced that the Agency … Continue Reading

FDA Issues Draft Guidance on Communicating New Risk Information about an Approved Drug Product – Comment Opportunity

This post was written by Jillian W. Riley. On June 6, 2014, the US Food and Drug Administration (FDA) issued a draft guidance addressing the distribution of new risk information to health care providers (HCPs) and health care entities (HCEs). The draft guidance defines “new risk information” as “information that becomes available after a drug … Continue Reading

Drug Companies are Reminded – FDA is Following Facebook

Our Life Sciences Legal Update blog reports today that the FDA’s Office of Prescription Drug Promotion has warned a Swiss drug company about statements the company made on its Facebook page, suggesting that consumers talk to their doctor about a drug without disclosing the risks associated with the product (risks serious enough to require a boxed … Continue Reading

Coming to a TV Near You? FDA Seeks Public Input on Limiting Risks Presented in Direct-to-Consumer Television Ads

In a notice published in the Federal Register on February 18, 2014, the Food and Drug Administration (FDA) asked for feedback on a proposed research study related to prescription drug television advertisements. The study, Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads), would investigate the impact of limiting the risks … Continue Reading

FDA Provides Direction on “Dear Doctor” Letters

This post was written by Jillian W. Riley. On January 16, 2014, the Food and Drug Administration (FDA) issued a final guidance document for industry providing specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. DHCP letters are an important means of communicating new information to the … Continue Reading

FDA Seeks Comments on Drug Company Social Media Guidance

As reported on our Life Sciences Legal Update blog, the FDA has issued draft guidance addressing the unique challenges of drug promotion in the age of social media. Specifically, the draft guidance addresses how to submit interactive promotional media for postmarket review.  Comments on the document, “Draft Guidance for Industry on Fulfilling Regulatory Requirements for Postmarketing … Continue Reading

Draft FDA Guidance Targets Direct-to-Consumer Television Marketing

This post was written by Erin A. Janssen. FDA has released draft guidance for industry entitled “Direct-to-Consumer Television Advertisements—FDAAA DTC Television Ad Pre-Dissemination Review Program.”  The draft guidance is intended to assist sponsors of human prescription drug products, including biological drug products, who are subject to the pre-dissemination review of television advertisements provision of the … Continue Reading

FDA Seeks Comments on Prescription Drug Promotion Survey

On January 17, 2012 the FDA announced an opportunity for public comment on its Healthcare Professional Survey of Prescription Drug Promotion. This survey is designed to explore the opinions and perceptions of physicians, nurse practitioners, and physician assistants with regard to the promotion of prescription drugs to consumers and healthcare providers. FDA is inviting comments … Continue Reading

FDA Guidance on Product Name Placement in Advertising and Promotional Labeling

The FDA released a guidance document entitled ‘‘Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling’’ on January 25, 2012. The guidance is intended to clarify for applicants the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human and animal drugs and biological products. The … Continue Reading

FDA Guidance Regarding Responding to Unsolicited Requests for Off-Label Information

This post was also written by Erin Janssen. With only days to spare in 2011, and after two years of anticipation, FDA’s Internet and social media policy is finally starting to emerge. On December 27, 2011, FDA announced the availability of draft guidance entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.” The … Continue Reading

FDA Seeks Comments on Clinical Benefit Information in Professional Labeling, Direct-to-Consumer Print Advertisements

This post was written by Paul Sheives. FDA has announced plans to conduct a study entitled “Clinical Benefit Information in Professional Labeling and Direct-to-Consumer Print Advertisements for Prescription Drugs.”  The purpose of the study is to: (1) understand how physicians process clinical efficacy information and how they interpret approved product label information; (2) determine physician preferences … Continue Reading

FDA Seeks Comment on Study Regarding Influence of DTC Promotional Offers on Consumer Perception

This post was written by Paul Sheives. FDA seeks comments on the design of a study entitled “Experimental Study: Effect of Promotional Offers in Direct-to-Consumer (DTC) Prescription Drug Print Advertisements on Consumer Product Perceptions.” The study intends to assess the effect that promotional offers (e.g., free trial offers, discounts, money-back guarantees, rebates, sweepstakes) in DTC prescription … Continue Reading

DOJ Health Fraud Activities, Focus on Pharmaceutical Companies

Deputy Attorney General Gary G. Grindler addressed the National Institute on Health Care Fraud on May 13, 2010 to discuss Obama Administration efforts to combat health fraud. In addition to discussing health reform legislation and the Health Care Fraud Prevention and Enforcement Action Team, he highlighted other ways DOJ “is seeking to combat crimes relating … Continue Reading

FDA Launches “Bad Ad” Initiative

This post was also written by Areta Kupchyk. On May 11, 2010, the Food and Drug Administration (FDA) launched a new initiative – the “Bad Ad Program” – designed to educate health care practitioners about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading. With the launch of this program, … Continue Reading

FDA Issues Proposed Rule on Clear and Conspicuous Standard for DTC Advertisements

The Food and Drug Administration (FDA) is seeking comments on a proposed rule to amend the requirements for direct-to-consumer (DTC) advertisements as mandated under the Food and Drug Administration Amendments Act of 2007 (FDAAA). The change in regulations would require DTC television and broadcast advertisements of prescription drugs to place the “major statement” in a … Continue Reading