Articles Posted in Advertising

TVad.pngYou can hardly watch television without seeing a prescription drug advertisement. Often the most memorable part of the advertisement is the required voiceover disclosing a long list of all the risks associated with taking the drug. The problem becomes deciphering which risks are actually the serious ones. FDA seeks to find out if that long disclosure of risks results in “reduced consumer comprehension, minimization of important risk information, and potentially, therapeutic noncompliance due to fear of side effects.”

On February 18, 2014, FDA issued a notice seeking comments about its proposed collection of information – “Disclosure Regarding Additional Risks in Direct-to-Consumer (DTC) Prescription Drug Television (TV) Advertisements (Ads).” FDA proposes to investigate the impact of limiting the risk disclosure in prescription drug television advertisements to only those that are “serious and actionable” plus an alert that there are other risks associated with the drug but which are not disclosed in the advertisement.

FDA would like to hear from you by April 21, 2014 about: whether you think its investigation is necessary “for the proper performance of FDA’s functions;” whether the information will have practical utility; the validity of the methodology and assumptions its investigation will use; how the quality, utility and clarity of the information collected can be enhanced; and how the collection of information can be less burdensome on respondents.
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socialmedia.jpgEarlier this week, FDA released a new draft guidance, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics“. This Guidance is a long-anticipated guidance regarding how FDA views what it calls “interactive promotional media” including what is commonly referred to as “social media”, e.g., Facebook, Twitter, blogs, as well as networking sites, live podcasts, and online communities. In particular, FDA describes how applicants/sponsors (“firm”) are expected to comply with providing the firm’s promotional activities in this arena.

First, FDA explained that a firm is accountable for all promotional activities that are carried out by the firm or on the firm’s behalf, including communications about the firm’s product(s) that may be influenced or controlled in whole or in part by the firm. In this regard, FDA provided specific examples to illustrate the following principles:

  1. A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
  2. Under certain circumstances, a firm is responsible for promotion on third-party sites.
  3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.

Some of the nuances described in the examples clarify that a firm’s mere financial promotion of a site is not sufficient to trigger inclusion of the site as part of the firm’s promotional activities. If a firm merely provides information to be included in the site, then the firm is responsible to provide that content to FDA as promotional activities. Whenever the firm has some influence or control over the content or placement of content, then the firm needs to provide the full site or partial site. If only influencing placement, the actual information and surrounding pages may be provided to put the placement in context. FDA, however, will not review user-generated content (“UGC”), e.g., message boards and chat rooms, that is “truly independent of the firm (i.e., is not produced by, or on behalf of, or prompted by the firm in any particular).”
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doctorRx.jpgFLH Partner Brian J. Malkin’s Chapter, “Free Speech and Off-Label Drug Promotion: Should Recent Cases Change Your Business Practices?” is now available as part of an Aspatore Special Report, Navigating Recent Off-Label Promotion Developments: Understanding Government Regulations and the Potential Impact of Noteworthy Cases published on September 1, 2013. FLH and FDA Lawyers Blog bring to you as a special benefit a link to Mr. Malkin’s Chapter for your review and use available here.

Mr. Malkin’s Chapter provides an overview of the off-label promotion issue as well as addresses some of the most recent cases that have called into question FDA’s statutory scope of authority over such discussions. Broadly speaking, FDA permits unaffiliated doctors to prescribe and speak about offlabel uses of products approved by FDA for marketing but has limited the ability of a product’s sponsor or individuals acting on the sponsor’s behalf to do so. In some instances, violations have resulted in convictions for criminal felonies involving prison time and substantial fines, even in to the billions of dollars. A recent Second Circuit Case, United States v. Caronia, however, held that truthful, nonmisleading off-label promotion is constitutionally protectable commercial speech. FDA’s decision to not appeal the decision and official position that the ruling is very narrow and business is as usual has further complicated the issue. Mr. Malkin’s chapter takes a look at how FDA has proceeded since Caronia and provides “takeaways” for counsel when considering their products and marketing materials.
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antiaging.jpgOn October 5, FDA sent a warning letter to Avon Products, Inc. (“Avon”) concerning the cosmetic company’s online promotion of its anti-aging skin care products. The letter, which FDA posted last week, objects to Avon’s marketing claims for a variety of its anti-wrinkle products. Specifically, it warns that they “appear to be intended for uses that cause these products to be drugs under section 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act [‘FD&C Act’].”

The cited statutory provision (21 U.S.C. § 321(g)(1).) defines “drug” to include “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” FDA asserts that Avon’s marketing claims indicate that the creams and serums listed in the letter are intended to affect the structure of human skin tissue, in which case they would fall under that definition. For example, the company’s website describes that the Anew Clinical Advanced Wrinkle Corrector as “formulated to boost shock-absorbing proteins to help strengthen skin’s support layers,” and “start rebuilding collagen in just 48 hours.” While it is not out of the ordinary for anti-wrinkle products to claim to reduce the appearance of wrinkles and fine lines, FDA believes that Avon’s statements go too far. According to the letter, the products are “not generally recognized among qualified experts as safe and effective for the above referenced uses” and are thus new drugs, requiring marketing approval.

Written by Rachael P. McClure

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Congress has prohibited the introduction of new drugs into interstate commerce without filing, and subsequent approval of, a new drug application (“NDA”) as stated in 21 U.S.C. § 355(a). A new drug application (“NDA”) must include, among other things, “full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use.” Id. at § 355(b)(1). Other requirements address labeling information and manufacturing controls. Id. The warning letter asks Avon to review its website and product labels and requests a response within 15 days of receipt (October 20) detailing the steps the company has taken to correct the alleged violations. At least some of the accused descriptions still seem to remain on Avon’s website.
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generic-drugs.jpgA research letter published online in the Journal of the American Medical Association (“JAMA”) last Tuesday reports findings that pharmaceutical advertisements have a tendency to minimize potential adverse effects when the products they promote become available over-the-counter (“OTC”). The researchers attribute this shift in content to the differences in prescription drug advertising standards, governed by FDA, and those for OTC advertising, governed by the Federal Trade Commission (“FTC”). FDA requires that ads present a “fair balance” of the risks and benefits of a drug, a requirement that is absent from FTC’s “reasonable consumer” standard. Commentators note that the FDA regulations are better equipped to ensure against “active deception.”

The research endeavor, sponsored by CVS Caremark, considered four drugs that transitioned from prescription to OTC status within the last ten years: Claritin® (loratidine), Prilosec® (omeprazole), Xenical®/Alli® (orlistat), and Zyrtec® (cetirizine). It examined 133 total television and print advertising materials from twenty-four months prior to, through six months after, each transition, and found that the percentage of advertisements that referenced side effects plummeted from 70% while prescription only to 11% once available OTC. Conversely, the proportion describing drug benefits jumped from 83% to 97%. The study further reports that OTC advertisements frequently omit the generic names of drugs, “a powerful tool for the patient as a consumer in that it helps tie together scientific information on the drug from different places.” Roughly 50% of the OTC ads mentioned the generic name, while over 95% had when the drugs were available by prescription only.

Written by Rachael P. McClure

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“In many, many cases information about risks simply disappeared from the ads once the drugs became [OTC],” remarked head researcher Dr. Jeremy Greene. This likely contributes to erroneous consumer beliefs that relocation out from behind the pharmacy counter automatically indicates a safer product. With 106 ingredients, indications, or dosage strengths having made the Rx-to-OTC switch since 1976, it is unlikely that this is always the case. Greene highlighted the danger of this situation given the frequency of overdoses on some of the most commonly used OTC drugs, such as acetaminophen (Tylenol®) and ibuprofen (Advil®). A 2006 study, for example, estimated over 450 acetaminophen overdose-related fatalities each year.

This research raises the question of where consumers can turn to obtain important information on potential side effects, if they are not receiving it from product ads or prescribers/suppliers. While some information is available online (such as at or, tracking it down requires active effort. Consumer Healthcare Products Association (CHPA) policy does note that the OTC label “is the most important element of a nonprescription drug,” and “clearly lists a product’s active ingredient, purpose, uses, warnings, directions, other information, and inactive ingredients.” In an age dominated by electronic media, however, consumers are inevitably paying more attention to television and online/print advertising than drug labels. Also of note is that current OTC labeling requirements were promulgated by FDA, not FTC.

The Caremark study findings indicate that reform may be necessary to ensure transparency of consumer risks in the OTC pharmaceutical market, whether it be FDA oversight of OTC drugs or FTC adoption of stricter advertising criterion. With 240 million Americans currently using OTC medicines, according to a January 2012 CHPA report, it is a matter that deserves serious consideration.


Off-Label Communications:
The Definitive Legal and Regulatory Forum on the Evolving Off-Label Landscape Monday, June 25 to Tuesday, June 26, 2012 The Carlton on Madison, New York, NY
Attendees of ACI’s Off Label Communications Conference will:

  • Benchmark best practices against leading companies such as Endo Pharmaceuticals, Lundbeck Pharmaceuticals, Novo Nordisk, Pfi zer, Purdue Pharmaceuticals, Sandoz and many more
  • Learn how to reposition your company’s policies and protocols according to these shifting boundaries and determine what’s fair and foul in off-label communications and promotion
  • Master preparation skills for the new off-label framework based on the free speech defense
  • Hear directly from the FDA and DOJ and several former federal prosecutors on how to guard proactively against impermissible off-label communications
  • Over the years, previous attendees have demanded even more in-depth information on responding to government investigations so this year we are pleased to offer a customized post-conference Master Class on Creating a Culture of Compliance: Best Practices for Working with the FDA and DOJ in an Off-Label Investigation.

FDA Lawyer’s blog readers are entitled to a discount when referencing the code: FDA 200
For more information on how to register, please visit our website:

Thumbnail image for Pills with empty bottle.jpgOn May 9, Jonathan D. Rockoff of The Wall Street Journal reported that Pfizer Inc. said it plans to discontinue marketing efforts to promote its landmark, cholesterol-fighting drug Lipitor® (atorvastatin) in the U.S. The company had recently ceased sending sales representative to promote Lipitor® to physicians and discontinued print, television, and online advertisements. Pfizer’s actions conclude a novel experiment in brand marketing, where it aggressively marketed Lipitor® for a limited time even after the expiration of its patent on November 30, 2011.

Upon the expiration of Lipitor®’s patent protection, the first generic began selling its generic version of Lipitor®, enjoying the luxury of its 180 days of exclusive generic market exclusivity. Once this exclusivity period expires, however, subsequent ANDA filers may then enter their generic product on the market (i.e, the second generic wave). Generally, a drug maker will cease marketing its branded drug product once one or more cheaper generic versions enter the market. In this case, Pfizer aimed to extract as much revenue as it could from Lipitor® sales, while generic competition was still in its early stages, through heavy marketing, promotion, and price rebates.

According to The Wall Street Journal, Pfizer has been able to maintain approximately a 33% market share through the first quarter of 2012 through its marketing efforts. In order to wring out more sales from Lipitor®, Pfizer spent over $87 million on advertising, physician marketing, and samples since Lipitor® lost patent protection. In response to generic competition, Pfizer cut the price of Lipitor®, offered price rebates, and reached deals with 50 health plans that agreed to sell branded Lipitor® instead of the generic version. However, once the first generic applicant’s exclusivity expires and the second wave of generics enter, Pfizer expects the price for generic Lipitor® to drop further, reducing its market share considerably.
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aci_header_banner.gif Off-label communications cost a major biopharmaceutical company $322 million dollars just this week. As the very definition of “off-label” hangs in the balance and the tension surrounding liability reaches a fever pitch, the American Conference Institute’s (“ACI’s”) 8th Advanced Summit on Off-Label Communications provides a forum for in-house executives from leading pharmaceutical and device companies to unite with preeminent outside counsel and current and former government prosecutors to give the most comprehensive view of the new off-label landscape, including the major FDA guidance developments and evolving first amendment case law shaking the industry.

Here are the top 3 reasons why you need to join ACI to discuss the nuances of the new landscape:

1. Identify specific off-label triggers of government scrutiny… Featuring a DOJ enforcement panel including:

Marilyn May Assistant United States Attorney Healthcare Fraud Coordinator
U.S. Attorney’s Office, Eastern District of Pennsylvania

Sondra L. Mills (Invited)
Trial Attorney, Consumer Protection Branch U.S. Department of Justice

David S. Schumacher Assistant U.S. Attorney U.S. Attorney’s Office, District of Massachusetts

Wendy L. Weiss Assistant United States Attorney Chief, Civil Fraud Section U.S. Attorney’s Office, Central District of California

Plus don’t miss the customized post-conference Master Class on Creating a Culture of Compliance: Best Practices for Working with the FDA and DOJ in an Off-Label Investigation, featuring insights from former government prosecutors who have worked on the front lines of an off-label settlement.

2. Prepare for more individual prosecutions stemming from off-label practices… Featuring an FDA keynote address on The Park Doctrine and Off-Label Promotion:

Eric M. Blumberg Deputy Chief Counsel for Litigation Office of the Chief Counsel, U.S. Food and Drug Administration

3. Learn how the free speech defense is shifting the boundaries of what’s fair and foul in off-label communications as you benchmark your protocols against those of counsel from:

Abbott Laboratories * Biomet * Digitas Health * Endo Pharmaceuticals * Lundbeck Pharmaceuticals * Novo Nordisk * NuPathe * Pfizer * Purdue Pharma * Sanzoz *Zimmer and many more…

FDA Lawyer’s Blog readers are entitled to a discount when referencing the code: FDA 200
For more information, please visit ACI’s website.

Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn April 11, Arkansas State Court Judge Tim Fox entered judgment on fines totaling $1.2 billion against pharmaceutical giant Johnson & Johnson and its subsidiary Janssen Pharmaceuticals (collectively “J&J”) for wrongdoing surrounding their prescription antipsychotic medication, Risperdal® (risperidone). (No. CV07-15345.) FDA originally approved Risperdal® in 1993 for the treatment of psychotic disorders like schizophrenia.

Arkansas Attorney General Dustin McDaniel alleged, among other things, that J&J violated Arkansas’ false claims act and deceptive trade practices act in marketing and selling Risperdal®. In particular, he alleged that J&J caused improper reimbursement for prescriptions covered by Medicaid by falsely asserting that Risperdal® was safer and more effective than comparable medications and not adequately warning about serious side effects, including diabetes and neurological complications. According to the complaint, J&J sold and marketed Risperdal® for off-label uses, including the treatment of bipolar disorder, dementia, and mood, and anxiety disorders.

After a jury determined that J&J violated the Arkansas False Claims Act and Arkansas Deceptive Trade Practices Act, Fox evaluated damages. He found nearly a quarter million instances in which J&J violated the Arkansas False Claims Act, based on the number of Risperdal® prescriptions written in the state. He also found nearly 5,000 instances in which J&J violated the Arkansas Deceptive Trade Practices Act, based on the number of Risperdal® direct mailings to Arkansas physicians. As a result, he held that J&J improperly induced the state to spend Medicaid funds for Risperdal® prescriptions. The statutory minimum penalties–ranging from $2500 to $5000 per violation–resulted in a judgment of $1.2 billion. J&J has moved for a new trial, contending that the fines dwarf actual Medicaid payments for Risperdal®, which J&J argues are no more than $8.1 million. J&J further contends that the state showed no evidence that any patient suffered actual harm, that any doctor was misled into writing a prescription that was not warranted, or that any prescription did not warrant reimbursement. The Arkansas False Claims Act, however, requires only that a person “[k]nowingly makes or causes to be made any false statement or representation of a material fact in any application for any benefit or payment under the Arkansas Medicaid program.” J&J may be better off trying the Eighth-Amendment route. See United States ex rel. Bunk v. Birkart Globistics GmbH & Co., Nos. 1:02cv1168 & 1:07cv1198, 2012 U.S. Dist. LEXIS 18445 (E.D. Va. Feb. 14, 2012).
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by Brian Malkin

On March 14, FDA’s Office of Prescription Drug Promotion (“OPDP”) issued its first Warning Letter this year to Teva for its branded product Copaxone® (glatiramer acetate injection) (solution for subcutaneous injection based on promotional materials sent to FDA on a Form FDA-2253 (pre-dissemination form) as well as its Team Copaxone®” webpage and several associated webpages for “David Kyle” and “Karen Stewart” for Copaxone®.

Team Copaxone

OPDP states in the letter that Teva’s promotional materials are false and misleading because they overstate the efficacy, present unsubstantiated claims, broaden the indication of Copaxone®, omit and minimize risk information associated with the drug, present unsubstantiated superiority claims, and omit material facts. OPDP says it finds the violations “concerning from a public health perspective because they suggest that Copaxone is safer or more effective than has been demonstrated by substantial evidence or substantial clinical experience.”

Copaxone® is indicated for reduction of the frequency and relapses in patients with Relapsing-Remitting Multiple Sclerosis (“RRMS”), including patients who have experienced a first clinical episode and have magnetic resonance imaging (“MRI”) features consistent with multiple sclerosis. MRI is considered one of the best ways to diagnose multiple sclerosis.
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