Was It Worth the Wait? - FDA Releases Two Social Media Guidance Documents for Drug/Device Industry

Earlier this week, the FDA issued two draft guidances on social media, and in this client alert, attorneys Colleen Davies, Celeste Letourneau, Kevin Madagan, and Jennifer Pike have analyzed them both in detail. The first guidance pertains to product claims and risk information on platforms like Twitter and sponsored links, and the second to correcting third party misinformation that appears in social media, such as in comments on a Facebook page or website.

A key date to keep in mind is that the deadline for comments is September 16, 2014.

To read the client alert, click here.

Don't Forget: FDA Frequents Facebook

This post was written by Jillian Riley and Kevin Madagan

In only the second Untitled Letter of the year, FDA’s Office of Prescription Drug Promotion warned a Swiss drug company about statements the company made on its Facebook page. Notably, FDA became aware of the company’s Facebook promotion through its own monitoring and surveillance program.

The alleged violations themselves were straightforward and similar to more traditional advertising actions: failure to include risk information and omission of material facts. What makes this letter interesting is that the activity occurred on a social network. On its Facebook page, the company suggested consumers talk to their doctor if they have been diagnosed with the condition for which the drug at issue is indicated. Nowhere on the page did the company warn consumers about the risks associated with the product – risks serious enough to require a boxed warning on the label. Neither did the company include any discussion about limitations of the drug’s use. FDA requested the company immediately cease this promotional activity – and the company has complied. The Facebook page at issue is no longer active.

The takeaway here is to remember that FDA’s advertising and promotion rules apply regardless of how or where you promote your product.  You must assume that all activity on social media networks, including Facebook and others, will be scrutinized by the FDA.

FDA Launches "Bad Ad Program" to Help Health Care Providers Detect, Report Misleading Drug Ads

This post was written by Areta Kupchyk and Kevin Madagan.

On May 11, 2010, the U.S. 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 the Division of Drug Marketing, Advertising, and Communications (DDMAC), a division within FDA’s Center for Drug Evaluation and Research, 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.

FDA introduced the Bad Ad Program through a dedicated website, an educational brochure for practitioners (Truthful Prescription Drug Advertising and Promotion: The Prescriber’s Role), and a letter from FDA Commissioner, Dr. Margaret Hamburg, introducing practitioners to the program.

“I am asking you to help FDA in our efforts to stop misleading prescription drug promotion,” states the Commissioner in her letter. “The Bad Ad Program can only succeed with your collaboration. Your help in this effort will be most beneficial to FDA in helping to ensure that prescription drug promotional information is accurately communicated to the medical community.” 

The Bad Ad Program website encourages health care practitioners to “play an important role” for FDA by “recognizing and reporting” misleading advertising and promotion. FDA wants practitioners to be “aware of the many advertisements and promotions that [they] see every day,” and help FDA stop violations by “reporting activities and messages” that may be false or misleading. 

The Bad Ad Program will be rolled out in three phases. In Phase 1, DDMAC will engage health care practitioners at specifically-selected medical conventions in 2010 and partner with specific medical societies to distribute educational materials. At these conferences, DDMAC reviewers will be speaking with practitioners regarding how to recognize misleading prescription drug promotion and how to report any potential violations to FDA. Phases 2 and 3 will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1. 

FDA Issues Proposed Rule Governing Major Statements in Television and Radio Advertisements

This post was written by Paul Sheives, Areta Kupchyk and Kevin Madagan.

FDA has released a proposed rule that would amend the regulations affecting direct-to-consumer (“DTC”) advertisement regulations to implement a provision of the Food and Drug Administration Amendments Act of 2007. The change in regulations would require DTC television or broadcast advertisements of prescription drugs to place the “major statement” in a “clear, conspicuous and neutral manner.” Under the 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.

To learn more about FDA's proposed rule on DTC advertising, please read our full alert.

China Launching National Essential Drug System

This post was written by Hugh T. Scogin, Gordon B. Schatz, Amanda Tao and Amanda Yang .

The Chinese government officially launched the National Essential Drug System (NEDS) Aug. 18, 2009 at a press conference held by the State Council, during which it explained the concentration of specific drug purchases in urban and county grass-roots health institutions as the first step in the implementation of NEDS. By 2009, NEDS will be implemented in 30 percent of government-run urban and county health care institutions in each province, region, or municipality. NEDS could have significant implications for the marketing, sale, distribution, and pricing of drugs by multinational and Chinese pharmaceutical companies in China.

As part of the implementation of NEDS, nine government ministries, including the Ministry of Health (MOH), National Development and Reform Commission (NDRC), Ministry of Industry and Information Technology (MIIT), Ministry of Supervision (MOS), Ministry of Finance (MOF), Ministry of Human Resources and Social Security (MOHRSS), Ministry of Commerce (MOFCOM), State Food and Drug Administration (SFDA), and State Administration of Traditional Chinese Medicine (SATCM), jointly issued the "Implementing Opinions on Establishing the National Essential Drug System," the "Administrative Measures on National Essential Drug List (Interim)," and the "National Essential Drug List – Section for Primary Medical and Public Health Institutions Use (2009 Version)."

NEDS is intended to more effectively manage the selection, production, distribution, usage, pricing, reimbursement, supervision, and evaluation of essential drugs, as well as to improve public health, medical services, and medical security. The new regulations note that all government-run grass-roots health care institutions are required to purchase and use essential drugs, while other types of health care institutions are required to use essential drugs based on standardized percentages for minimum use. 

To read the full alert, click here.

Prescription Drug and Medical Device Promotion Article Published in AHLA Health Lawyers Weekly

The article on "Prescription Drug and Medical Device Promotion – New FDA Draft Guidance on Presenting Risk Information" by Reed Smith lawyers Areta Kupchyk, Frederick Branding, Jennifer Goldstein and Kevin Madagan (previously discussed in this post) has now been published in AHLA's Health Lawyers Weekly (log in required).

Vermont Enacts Revised HCP Disclosure Requirements, Gift Ban

This post was written by Matthew Wetzel.

On June 9, 2009, Vermont’s governor signed S. 48, a new law that revises the state’s current pharmaceutical marketing disclosure requirements. The new statute expands the application of Vermont’s current requirement that pharmaceutical manufacturers annually disclose certain expenditures made in connection to interactions with Vermont health care professionals. Under the new law, the disclosure requirement now also applies to medical device companies. Further, the new law adds a ban on certain items and expenditures that was not included in the previous version. Notably, this gift ban goes into effect July 1, 2009.

For more information, please read Reed Smith's full alert summarizing the revised Vermont law, including key dates for compliance.

Prescription Drug and Medical Device Promotion - New FDA Draft Guidance on Presenting Risk Information

This post was written by Areta Kupchyk, Frederick Branding, Jennifer Goldstein and Kevin Madagan.

On May 27, 2009, the Food and Drug Administration (“FDA”) announced the availability of a draft guidance titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion” (“Draft Guidance”). The Draft Guidance sets forth the standards FDA intends to consider when evaluating promotional pieces to determine whether they effectively communicate risk information in a non-misleading manner. Under the Food, Drug & Cosmetic Act (“FDCA”) and FDA’s implementing regulations, promotional materials making claims about a product are deemed misleading if they fail to disclose certain information about the product’s risks. FDA is accepting comments on the draft through Aug. 25, 2009. Reed Smith’s full alert provides a brief outline of the Draft Guidance and identifies issues for possible comment to FDA.

Massachusetts Releases Final Drug and Device Marketing Restrictions and Disclosure Requirements

This post was written by Matthew E. Wetzel

On March 11, 2009, the Massachusetts Department of Public Health (the “Department”) released final regulations that impose restrictions on pharmaceutical and medical device manufacturers’ sales and marketing activities. The final regulations—which implement section 14 of the Massachusetts Act to Promote Cost Containment, Transparency and Efficiency in the Delivery of Quality Health Care (the “Act”)— also require companies to file annual disclosures of all fees, payments and economic benefits paid to health care professionals that total $50 or more.

Massachusetts now joins seven other jurisdictions that have issued similar requirements. Currently, California and Nevada both require manufacturers to adhere to restrictions on marketing activities, and the District of Columbia, Maine, Minnesota, Vermont and West Virginia all mandate periodic disclosures of payments and other economic benefits to health care professionals. Massachusetts, however, has the broadest regulations in two regards. First, Massachusetts is the only state to include both a marketing code of conduct that is specifically enumerated in detail in the regulations as well as annual financial disclosure obligations. Other jurisdictions require adherence to a marketing code or disclosure, but not both. Second, Massachusetts is the first state to require financial disclosure from medical device companies. Financial disclosure requirements in other states currently only apply to pharmaceutical companies.

For additional details regarding the final Massachusetts marketing restrictions and disclosure requirements, including a list of key dates for compliance and a chart detailing marketing restrictions, please see Reed Smith's full alert (.PDF), "Massachusetts Releases Final Restrictions on Drug and Device Marketing Activities, Annual Financial Disclosure Requirement."

Pharmaceutical Package: Safe, Innovative and Accessible Medicines and A Renewed Vision For the Pharmaceutical Sector

This post was written by Paule Droualt-Gardrat, Juliette Peterka and Julie Gottenberg.

On December 10, 2008, the European Commission published a series of political measures and legislative proposals, the so-called “Pharmaceutical Package.” This series included the “Communication on a renewed vision for the pharmaceutical sector,” which reflected on ways to improve market access and develop initiatives to boost European Union (“EU”) pharmaceutical research. Through the Pharmaceutical Package, the European Commission aims to make pricing and reimbursement more transparent, increase the development of pharmaceutical research within the EU, improve the safety of medicines worldwide, and reinforce cooperation with international partners.

The European Commission has published three separate sets of proposals amending Directive 2001/83/EC on the Community Code of medicinal products and Regulation 726/2004 on medicinal products obtained through centralized procedures:

1.  A proposal amending Directive 2001/83 as “regards information to the general public on medicinal products subject to medical prescription” (Information to patient);
2.  A proposal amending Directive 2001/83 and a proposal amending Regulation 726/2004 as “regards pharmacovigilance” (The EU pharmacovigilance system); and,
3.  A proposal amending Directive 2001/83 as “regards the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source” (Counterfeit Medicines).

Read Reed Smith's full alert outlining proposed amendments to Directive 2001/83/EC and Regulation 726/2004.

Commentary: FDA's New Good Reprint Practice Rule

This post was written by Areta L. Kupchyk, James M. Wood and Kevin M. Madagan.

FDA's Good Reprint Practice (GRP) Guidance went into effect in January 2009. The GRP Guidance establishes criteria that FDA will now use to determine whether the distribution of medical or scientific reprints and reference texts about off-label uses of a drug or device would constitute impermissible promotional activity under the Food, Drug and Cosmetic Act.

Read Reed Smith’s full commentary analyzing the GRP Guidance, which includes a Good Reprint Practice Checklist.