Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

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 on, among other things, the necessity of the information collection, ways to enhance the utility of the information to be collected, and ways to minimize the burden of the collection of information on respondents. Comments will be accepted until March 19, 2012.

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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 The guidance finalizes the draft guidance published in January 1999. Comments on FDA guidance documents may be submitted at any time.

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This post was written by Kevin Madagan and 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 On December 27, 2011, FDA announced the availability of draft guidance entitled "Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices."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 guidance describes FDA's current thinking about how manufacturers and distributors of prescription drugs and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use related to their FDA approved or cleared products. The guidance updates and clarifies FDA's policies on such unsolicited requests for information, and is the agency’s first foray into guiding the industry on how it may use social media and the Internet to engage with customers. This is a first step in what has been (and will continue to be) a long process within the Agency to establish a framework for regulating the Internet and social media, provide guidance to the industry, and find a way to adapt to emerging technologies. FDA is expected to issue multiple guidance documents in 2012 on the Internet and social media. Comments on the draft guidance are due March 29, 2012. 

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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 processclinical efficacy information and how they interpret approved product labelinformation; (2) determine physicianpreferences for alternative presentationsof clinical efficacy information in direct-to-consumer (DTC)advertising, and (3) examine howdifferent presentations of clinicalefficacy information in DTC advertisingaffect consumers’ perceptions of efficacyand safety. The study is focused on how physicians andconsumers make risk/benefitassessments in response to variations in presentation of the efficacy information on the first page of the document. FDA is accepting written comments until January 3, 2011. 

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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 drug ads have on consumer’s (1) perception of product risks and benefits, (2) comprehension of product risks and benefits, and (3) strongly-held beliefs that may act as potential moderators. FDA is accepting written comments on the study design until November 22, 2010. 

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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 to the healthcare and pharmaceutical industries.” For instance, according to Mr. Grindler, the DOJ expects to increase the use of the Foreign Corrupt Practices Act (FCPA) to prosecute kickbacks and bribes paid to foreign government officials by pharmaceutical companies, given that “in some foreign countries, nearly every aspect of the approval, manufacture, import, export, pricing, sale and marketing of a drug product may involve a “foreign official” within the meaning of the FCPA.” He warned that DOJ “will not hesitate to charge pharmaceutical companies and their senior executives under the FCPA if warranted to root out foreign bribery in the industry.” The DOJ also will continue to focus on intellectual property theft involving the pharmaceutical industry, including efforts to combat the sale of counterfeit and dangerous drugs.

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This post was written by Areta Kupchyk and Kevin Madagan.

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, FDA, through its Division of Drug Marketing, Advertising, and Communications (DDMAC), is now actively seeking to "collaborate with health care professionals" to increase the effectiveness of the agency's marketing and advertising surveillance program. DDMAC is responsible for assuring prescription drug information is truthful, balanced, and accurately communicated, and guarding against false and misleading advertising and promotion through comprehensive surveillance, enforcement, and educational programs. For more information, see the summary on our sister blog, Life Sciences Legal Update.

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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 “clear, conspicuous and neutral manner.” Under the proposed regulation, FDA would use the following standards to determine whether the information meetings the clear, conspicuous and neutral requirement: (1) information is presented in language that is readily understandable by consumers; (2) audio information is understandable in terms of the volume, articulation, and pacing used; (3) textual information is placed appropriately and is presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily; and (4) the advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement. FDA is accepting comments on the proposed rule until June 28, 2010.

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