An article in Compliance Week discusses recent actions by the Federal Trade Commission (FTC) and Food and Drug Administration concerning advertisement disclosures. The FTC launched Operation Full Disclosure in fall 2014, which involved sending warning letters to more than 60 companies across "a wide range of industries" for failing to properly disclose information in their advertisements. These letters serve as a reminder to all companies, even those that did not receive letters, to review their disclosures in order to minimize the likelihood of a violation in the future.… Continue Reading
The U.S. Court of Appeals for the District of Columbia Circuit ruled on January 30th that the Federal Trade Commission can prohibit POM Wonderful LLC from making the advertising claim that its products can help in fighting afflictions and ailments such as heart disease, prostate cancer and erectile dysfunction. The appeals court also decided that POM Wonderful requires the support of one clinical trial before it can make any subsequent claims that its products are effective in fighting disease. POM Wonderful had maintained that its advertisements and claims are protected under the First Amendment, a position that was rejected by the appellate court's decision.… Continue Reading
The Federal Trade Commission (FTC) voted to fine two manufacturers of green coffee bean extract $9 million for making claims that consumers could lose body weight and fat by using the extract. The FTC alleges that the manufacturers' advertised claims were deceptive and the result of a flawed research study. However, two dissenting FTC commissioners believe that the amount of the fine was excessive because it took into account sales attributed to televised statements that were constitutionally protected and non-commercial in nature.… Continue Reading
Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No. 650) China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the New Regulation). The State Council Legislative Affairs Office worked more … Continue Reading
The social media phenomenon has radically transformed the ways in which commercial businesses promote their services and products. However, as a result, companies must consider potential legal risks from an entirely new angle. To become a successful user of social media, a company must draft, review, disseminate and enforce a social media policy that addresses potential legal issues while at the same time emphasizing positive exposure for the business.… Continue Reading
Drug and medical device manufacturers are often faced with difficult challenges in determining the country of origin for their products, which are often sourced, processed and manufactured in multiple countries. As detailed by the article "Origin of the Pieces: How to Determine a Pharmaceutical Product's 'Country of Origin,'" written by Reed Smith lawyers Jeffrey Orenstein and Lorraine Campos, there are a variety of factors that must be taken into consideration when answering the country of origin question for a pharmaceutical product - chief among which is who is asking the question. This article provides an overview of the principal regulatory schemes and their country of origin standards in order to help provide clarity to pharmaceutical companies in an often confusing and frustrating process.… Continue Reading
FDA's Office of Prescription Drug Promotion has warned a Swiss drug company about failing to include risk information and omitting material facts regarding its products. What makes these particular violations noteworthy is that they occurred on the company's Facebook page. FDA became aware of the company's Facebook promotion through its own monitoring and surveillance program.… Continue Reading
Today FDA has proposed updates to the Nutrition Facts label for foods. According to FDA, the goal of these proposed changes is not to dictate what consumers should or should not be eating, but rather to expand and highlight the information consumers need most to make well-informed choices regarding food. FDA will be accepting comments on the proposed updates for 90 days.… Continue Reading
As mentioned on our Health Industry Washington Watch blog, the Food and Drug Administration issued a final guidance document on January 16, 2014 which provides specific recommendations on the content and format of Dear Health Care Provider (DHCP or “Dear Doctor”) letters. The recent guidance finalizes a draft guidance FDA published in November of 2010. To read … Continue Reading
FDA has issued draft guidance designed to shed light on how drug companies should comply with FDA's postmarket submission requirements when interactive promotional media constantly changes. In laying out the criteria for how and when to submit interactive promotional media for postmarket review, FDA provides important insight into the type of social media promotion in which it is most interested.… Continue Reading
Recent posts on www.lifescienceslegalupdate.com include:
"Supreme Court Rules That Juries - Not Judges - Must Determine Facts Supporting Large Criminal Fines"
The Reed Smith Global Regulatory Enforcement Law blog has an interesting post about a recent U.S. Supreme Court ruling that protects the Sixth Amendment rights of defendants in high-stakes criminal cases. In Southern Union Co. v. United States, the Court ruled that any fact supporting a "substantial" criminal fine must be found by a jury applying the "beyond a reasonable doubt" standard. In this post, Efrem M. Grail and Kyle R. Bahr explain the opinion and discuss the wide impact it will have on criminal actions, from investigation to sentencing.
View the entire entry:
"Life Sciences Health Industry China Briefing - June 2012 (July 20, 2012)"
Reed Smith's Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China's Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries.… Continue Reading
This post was written by John Tan, Jay J. Yan, Mao Rong, Katherine Yang, and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments during May include: Introduction … Continue Reading
This post was written by Jay J. Yan, Mao Rong, Zack Dong, Katherine Yang, Joyce Sun, Sara Lai and Gordon B. Schatz. Reed Smith’s Life Sciences Health Industry China Briefing provides a summary of the monthly news and legal developments relating to China’s Pharmaceutical, Medical Device, and Life Sciences/ Health Care Industries. Some important developments … Continue Reading
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.… Continue Reading
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.… Continue Reading
As noted by our colleagues at Legal Bytes, on December 1, 2009, the revised "Guides Concerning the Use of Endorsements and Testimonials in Advertising" released by the Federal Trade Commission ("FTC") came into effect. Washington, D.C. partner John P. Feldman, an authority in advertising regulations and compliance, recently outlined some considerations every advertiser should take … Continue Reading
Following a decade-long hiatus, the Food and Drug Administration ("FDA") appears ready to finally address industry Internet communications. FDA's Center for Drug Evaluation and Research ("CDER") in collaboration with other divisions within FDA, held a two day hearing on November 12th and 13th to help the Agency determine how the statutory provisions, regulations, and policies governing advertising and promotional labeling should be applied to product-related information on the Internet and emerging technologies...… Continue Reading
On November 12 and 13, 2009, the FDA hosted public hearings to vet the potential need for regulation of prescription pharmaceutical and medical device marketing on social media outlets such as YouTube, Wikipedia, Facebook, and Twitter. The FDA specifically sought input on these five questions: (1) For what online communications are manufacturers, packers or distributors accountable? (2) How can manufacturers, packers, or distributors fulfill regulatory requirements in their Internet and social media promotion, particularly when using tools that are associated with space limitations and tools that allow for real-time communications? (3) What parameters should apply to the posting of corrective information on Web sites controlled by third parties? (4) When is the use of links appropriate? and (5) Questions specific to Internet adverse event reporting...… Continue Reading
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).… Continue Reading
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...… Continue Reading
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.… Continue Reading
The European Court of Justice ("ECJ") recently had the opportunity to opine on limits on the scope of advertising for medical products in the European Union, when a journalist who had reprinted factual information about a pain medication sold in Norway but prohibited in Denmark, was made an example under Danish legal provisions prohibiting advertising for medicinal products that are not lawfully marketed in Denmark. As exmplained by Paule Drouault-Gardrat, Julie Gottenberg and Juliette Peterka in "Advertising of medicinal products versus freedom of expression of a journalist - European Court of Justice Decision dated 2 April 2009 (C-421/07) 'Frede Damgaard'" (available also in French), the ECJ concluded the issue was a matter for the national court in the first instance, relying in part on a line of French cases holding that any publication praising the merits of a medicinal product must be considered as advertising whomever its author, regardless of whether the manufacturer sought or paid for publication.… Continue Reading
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.… Continue Reading
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).… Continue Reading