Tag: FTC

U.S. Sentencing Commission Weighing Recommendation to Increase Criminal Antitrust Penalties

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In June, the United States Sentencing Commission, which is appointed by the President to make recommendations to Congress on the criminal penalties for the violation of federal law, issued a request for comments regarding whether the guidelines for calculating antitrust fines should be modified. Currently, corporate fines for cartel price fixing are calculated on a sliding scale, tied to the amount of the “overcharge” imposed by the violators, with the standard maximum fine under the Guidelines for a corporation capped at $100 million and, for an individual, capped at $1 million. The deadline for such comments was July 29, and the views expressed on the issue varied considerably.

Contending that the current Guidelines do not provide an adequate deterrent to antitrust violations, the American Antitrust Institute urged the Commission to recommend an increase in the fines for cartel behavior. The AAI stated that the presumption in the Guidelines that antitrust cartels, on average, “overcharge” consumers for goods by 10% is greatly understated, and thus should be corrected to reflect more accurate levels. Pointing to economic studies and cartel verdicts, the AAI suggests that the median cartel “overcharge” is actually in excess of 20%, and therefore the presumption should be modified in the Guidelines. If adopted, the AAI’s proposal would double the recommended fines under the Guidelines for antitrust violations.

Perhaps surprisingly, the DOJ responded to the Commission’s Notice by stating that it believes that the current fines are sufficient, and that no increase in antitrust fines is warranted at this time. The DOJ indicated that the 10% overcharge presumption provides a “predictable, uniform methodology” for the calculation of fines in most cases, and noted that the Guidelines already permit the DOJ to exceed the fine levels calculated using the 10% overcharge presumption in some circumstances. Specifically, the DOJ noted that the alternative sentencing provisions of 18 USC 3571 already permit it to sidestep the standard guidelines and seek double the gain or loss from the violation where appropriate. Notably, the DOJ utilized this provision in seeking a $1 billion fine from AU Optronics in a 2012 action, although the court declined the request, characterizing it as “excessive”. The court did, however, impose a $500 million fine, an amount well in excess of the cap under the standard antitrust fine guidelines.

Finally, D.C. Circuit Court of Appeals Judge Douglas Ginsburg and FTC Commissioner Joshua Wright offered a completely different view on the issue in comments that they submitted to the Sentencing Commission. Suggesting that fines imposed on corporations seem to have little deterrent effect, regardless of amount, they encouraged the Commission to instead recommend an increase in the individual criminal penalty provisions for antitrust violations. Notably, they encouraged the Commission not only to consider recommending an increase in the fines to which an individual might be subjected (currently capped at $1 million), but also to recommend an increase in the prescribed range of jail sentences for such conduct (which currently permit for imprisonment of up to 10 years).

The Commission will now weigh these comments and ultimately submit its recommendations to Congress by next May. If any changes are adopted by Congress, they would likely go into effect later next year. Stay tuned.

ARTICLE BY

James M. Burns
 
OF 
Dickinson Wright PLLC

Too Good To Be True: FTC’s Crackdown On L’Occitane’s Body Slimming Almond Extracts

Sheppard Mullin Law Firm

L’Occitane Inc’s advertisements for its topically-applied body sculpting almond extracts seemed straightforward: “Almond Shaping Delight 3 out of 4 women saw firmer, lifted skin. This luxuriously lightweight massage gel instantly melts into the skin to help visibly refine and sculpt the silhouette” and “Almond Beautiful Shape Trim 1.3 inches in just 4 weeks. This ultra-fresh gel cream helps to visibly reduce the appearance of cellulite, while smoothing and firming the skin.”

Unfortunately for L’Occitane, an international skin care company with over 150 shops across the U.S., the Federal Trade Commission (FTC) found those claims dubious at best, and earlier this year charged the company with violating the Federal Trade Commission Act (“FTC Act”).

According to the FTC’s complaint, which was filed on January 7, 2014, L’Occitane had been manufacturing, advertising, and selling the two products at issue, “Almond Beautiful Shape” and “Almond Shaping Delight,” in interstate commerce and violated the FTC Act by promoting them as being able to slim and reshape the body. The FTC alleged that L’Occitane did not have sufficient scientific data to support L’Occitane’s advertising claims that the creams could trim the user’s thighs, reduce cellulite, and slim the body in just weeks. The FTC asserted that  L’Occitane based its advertising claims in large part on two unblinded and non-controlled clinical trials and greatly exaggerated the results from one of the studies. The FTC charged L’Occitane with violating Sections 5(a) and 12 of the FTC Act, which declare unfair or deceptive acts or practices unlawful and bar false advertisements likely to induce the purchase of food, drugs, devices, or cosmetics. As part of the final consent order, the FTC fined L’Occitane $450,000 and prohibited it from making future false and deceptive weight-loss claims.

L’Occitane, however, is not the only entity which the FTC has recently fined because of questionable advertising claims. The FTC has also charged Sensa Products, LeanSpa, and HCG Diet Direct with violations of the FTC Act for allegedly misleading the public with unfounded weight loss claims and misleading endorsements relating to their products. These complaints, along with L’Occitane’s, were part of the FTC’s recent “Operation Failed Resolution” initiative, aimed at combating deceptive weight-loss claims.

One of the companies charged, Sensa Products, which claimed weight loss results from one of its dietary supplements, had to pay a $26 million fine for FTC Act violations. As a part of “Operation Failed Resolution,” the FTC also released an updated media guide for spotting deceptive weight-loss claims in advertising, entitled “Gut Check: A Reference Guide for Media on Spotting False Weight-Loss Claims.”

Manufactures and marketers of health products, cosmetics, drugs, and dietary supplements should be mindful of the FTC’s continuing and increasing vigilance in taking action with respect to enforcement of the FTC Act to stop unfounded weight loss claims. Companies making weight-loss claims in advertising and marketing materials must make sure that their claims are defensible and supported by sufficient credible scientific data.

Jordan Grushkin contributed to this article.

Article By:

Theodore C. Max
Of:
Sheppard, Mullin, Richter & Hampton LLP

New Updated FTC Care Labeling Rules: “Do’s and Don’ts”

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The Federal Trade Commission (“FTC”) enforces federal labeling requirements that require manufacturers, importers, sellers and distributors of certain textile and wool clothing  to accurately label their products. For example, FTC rules require that manufacturers indicate the country of origin and fiber content in their clothing. In addition, the Care Labeling Rule requires that manufacturers and importers attach “care labels” to garments and certain piece goods.

Navigating these various labeling requirements can be tricky. On May 5, 2014, the FTC amendment of the labeling rules, known as the Textile Rules, became effective.

Care labels, which can influence consumers’ purchasing decisions more than labels indicating fiber content or country of origin or manufacture, are important to carefully consider.

“Do’s” for Clothing Manufacturers and Importers:

Place all care labels permanently, securely and visibly, so that consumers can easily see or locate them prior to purchase. Ensure that labels will remain legible not just at the point of sale, but throughout the lifecycle of the product.

Include a washing or drycleaning instruction (or both) if either method is safe for the product. If a product can be neither washed nor drycleaned, the label must state “Do not wash – Do not dry clean.” A simple “dryclean” instruction is acceptable in most cases, unless “any part of the drycleaning process would harm the product.” In that case, more specificity is required (e.g., “Professionally Dryclean” or “Dryclean. No Steam.”).

Indicate whether the product is to be washed by machine or by hand. The FTC has stated that water temperature settings must be indicated if “regular use of hot water will harm the product.” Similarly, if using chlorine bleach will harm the product, whereas other bleaches will not, the label must state “Only non-chlorine bleach, when needed.” The appropriate label in the event that no bleach is safe to use is “Do not bleach.”

State how to dry the product and how to iron it, if the product requires regular ironing. Temperature settings for drying and ironing are not needed unless the “regular use of high temperature will harm the product.”

If selling a garment with multiple pieces, only one label is required if the same instructions apply to all parts of the garment, and if the garment is sold as a single unit. The label should be attached to the “major piece” of the garment. In the event that the garment is not sold as a single unit, or if the instructions differ from one part of the garment to the next, then each separate piece of the garment needs its own care label.

If the garment cannot be cleaned without damaging the garment, potential customers must be warned on the label. It is imperative that following the care labeling instructions does not ordinarily lead to product damage. Along these lines, labels must inform consumers not to engage in certain procedures that they may erroneously but reasonably assume are acceptable, given the instructions of the label. For example, if a label indicates that clothes can be washed, a reasonable consumer might infer that the product can also be safely ironed. If these understandable assumption is incorrect, the FTC has stated that the label must indicate the risks involved.

One should always have a “reasonable basis” for everything written on a care labeling instruction. If a piece of clothing indicates that it cannot safely be ironed, there must be some proof (based upon experience, industry expertise or testing) known to the manufacturer or importer that ironing the clothing would cause damage. The FTC has alternatively stated that the manufacturer or importer must have “reliable evidence” to support all warnings or instructions on product labels. Guesswork is insufficient. However, what constitutes “reliable evidence” or a “reasonable basis” does depend on the circumstances. It is incumbent on manufacturers conducting tests to ensure that the results of any tests conducted on only one portion of multi-part garments do, in fact, have applicability to the entire garment.

Importers must ensure that these labels are placed on products before they sell them in the United States. It is not necessary for the labels to be attached as the products enter the country, however. Domestic manufacturers similarly must ensure that care labels are placed on finished products prior to sale.

“Don’ts” for Clothing Manufacturers and Importers:

Certain kinds of exempt apparel, including gloves, hats, and shoes, do not require care labels. Many items are also excluded from the care labeling requirements, including handkerchiefs, belts, suspenders, neckties, or non-woven garments made for one-time use. For piece goods sold for making apparel at home, it is not necessary to include care labeling instructions for any “marked manufacturers’ remnants of up to 10 yards when the fiber content is not known and cannot be determined easily.” These items are exempted from the Care Labeling Rule.

Garments custom-made from fabrics provided by consumers, or products sold directly to institutional buyers for commercial use (e.g., uniforms sold to Office Depot for use by clerks during business hours, and not purchased directly by the clerks), do not require care labels. This also includes items that the consumer may ask to be added to the garment (e.g. lining or buttons).

Use non-standard terms on labels. The FTC recommends, but does not expressly require, that manufacturers ensure that any terms they use on labels are in accord with the definitions in the Rule’s Appendix A glossary, where applicable. For example, the term “Warm” applies to initial water temperature ranging from 87 to 111 degrees F [31 to 44 degrees C]; “Hot” is from 112 to 145 degrees F [45 to 63 degrees C]; and “Cold” is up to 86 degrees F [30 degrees C].

*Gregg Re Summer Associate contributed to this article.

Article By:

Theodore C. Max
Of:
Sheppard, Mullin, Richter & Hampton LLP

Federal Trade Commission (FTC) Wins Appeal: ProMedica Merger with St. Luke’s Not Allowed

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On April 22, 2014, the U.S. Court of Appeals for the Sixth Circuit (Sixth Circuit) upheld the Federal Trade Commission’s (FTC) finding that the merger between Ohio-basedProMedica Health System, Inc. (ProMedica) and St. Luke’s Hospital (St. Luke’s), an independent community hospital that operates in the one of the same counties as ProMedica, would adversely affect competition in violation of federal antitrust law. Prior to the merger, ProMedica and St. Luke’s comprised two of the four hospital systems in Lucas County, Ohio. After the two systems merged, ProMedica held more than 50% of the applicable market share.

Accordingly, in 2011 the FTC ordered ProMedica to divest itself of St. Luke’s. ProMedica appealed the FTC’s order to the Sixth Circuit. In a unanimous opinion, the Sixth Circuit denied ProMedica’s petition to overturn the FTC order, citing concerns about anti-competitive behavior and the ability of ProMedica to unduly influence reimbursement rates with healthcare insurance companies.

The full 22-page court opinion may be accessed here.

Article By:

Patrick J. Cannon
Of: 
von Briesen & Roper, S.C.

Social Media Marketing – New FTC (Federal Trade Commission) Guidance On Generating “Buzz”

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For the first time since it issued its Guides Concerning the Use of Endorsements and Testimonials in Advertising in 2009, the FTC has provided new guidance on the use of social media to generate consumer interest (or “buzz”) in a brand.

Shoe manufacturer Cole Haan had a great social media marketing idea.  They would run a contest through Pinterest.  The winner would get a $1,000 shopping spree courtesy of Cole Haan.  To enter, Pinterest users had to “pin” images of Cole Haan shoes on Pinterest.  They even came up with a great slogan for the campaign: “Wandering Sole.”  Finally, so that people could find the images easily, contestants were required to include the hash tag “#wanderingsole” in their pin descriptions.

This was a great marketing idea.  Lots of Pinterest users would post pictures of Cole Haan’s product on Pinterest and generate buzz about Cole Haan shoes. Here is what one Pinterest page currently looks like:

Cole Haan Pinterest

There was only one problem; the Federal Trade Commission.

The FTC considered the posting of images of Cole Haan shoes by Pinterest users to be endorsements of the product.  To be clear, the issue was not whether the Pinterest users actually intended to endorse the brand.  Rather, the concern was whether viewers of the image might perceive the posting of the images to be endorsements.  As such, the FTC investigated the marketing practice and issued a closing letter to Cole Haan regarding their investigation.

As stated in the closing letter, the FTC thought that the since the Pinterest “pins” constituted an endorsement, there should have been a “clear and conspicuous” disclosure concerning the fact that the “endorsers” (i.e., the Pinterest users entering the contest) were being compensated for their endorsement, namely, the chance to win the $1,000 shopping spree.  The FTC did not believe that the “#Wanderingsole” hash tag was sufficient to provide this required disclosure.  Fortunately, the FTC did not take enforcement action against Cole Haan, recognizing that the FTC had not squarely addressed this issue before.

So finally, we get to the point of this post.  While I understand the FTC’s point (I really do), I think social media marketers will need more specific bright line guidance as to what type of disclosure is required.  The reason is that in the social media context, the amount of text that may be capable of devoting to such disclosure can be very limited.  It is noteworthy that the 2009 guidance issued by the FTC provided numerous examples to help us identify when endorsement disclosure s would be required.  Not one of those examples, however, indicated what would constitute a sufficient disclosure.

In fact, one of the comments submitted (by Heath-McLeod) in connection with the 2009 guidelines requested that the FTC provide “minimum standards for the size and clarity of disclosures.”  The FTC expressly rejected this request saying that:

“advertisers flexibility to meet the specific needs of their particular message is often preferable to attempting to mandate specific language, font, and other requirements applicable across-the-board to all ads.  Advertisers thus have always been free under the Guides to make their disclaimers as large and clear as they deemed appropriate to convey the necessary information to consumers”

That’s good, I suppose.  Advertisers need some freedom to do what they think is appropriate in the context of their marketing.  But how, as a practical matter, are advertisers supposed to get comfortable that the disclosure they give is sufficient?  For example, would it have been sufficient for the Pinterest users to have included the word “sponsored” in their pin description?  How about just the word “ad?”  Would that have been sufficient?  It’s not clear.

Consider, for example, the fact that a similar disclosure having to be made through Twitter or using SMS (i.e., texting) might be very difficult given the 140 character limit.  Now, consider further that the FTC guidelines for endorsements also require an additional disclosure when the person depicted in the endorsement is not a real consumer of the product.  Perhaps Cole Haan’s hash tag should have read:

“#These pins are part of a contest. Contestants may win prize for posting pins of Cole Haan products. Persons in such pins may not be actual consumers of the pinned product”

Darn, that’s 141 characters.  Maybe if I get rid of the “#” ….

Article By:

Kurt E. Anderson
Giordano, Halleran & Ciesla, P.C.

McSweeny Confirmed to Fill Vacancy at Federal Trade Commissions (FTC)

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The Federal Trade Commissions will soon be back to having a full complement of five commissioners.  Today, the U.S. Senate, by a vote of 95 to 1, confirmed Terrell McSweeny to fill a vacancy at the agency created by the departure of Jon D. Leibowitz more than a year ago.  Her term runs through September 26, 2017.

The White House announced the nomination of McSweeny in June 2013.  Although her nomination was not controversial, her confirmation was delayed because the Senate failed to take a vote before year’s end.

McSweeny is currently Chief Counsel for Competition Policy and Intergovernmental Relations at the Department of Justice Antitrust Division.  She has been at the Antitrust Division since 2012.  Prior to that, she served as Deputy Assistant to the President and Domestic Policy Advisor to the Vice President at the White House.  McSweeny received an A.B. from Harvard University and a J.D. from Georgetown University Law School.

McSweeny’s arrival at the FTC will provide the agency with a Democratic majority that should avoid two-to-two deadlocks and enable Chairwoman Edith Ramirez to pursue her agenda.

The FTC recently described itself as “collegial, bipartisan, and consensus-driven.”  However, there has certainly been some disagreement among the four current commissioners.

During questioning by the Commerce Committee last year, McSweeny discussed the need for offering guidance to business.  Noting that the FTC was primarily a law enforcement agency dealing with issues on a case-by-case basis, she said that it was incumbent on agency leaders to clearly articulate their reasoning, to apply the law as written, and to follow the case law.  She committed to doing just that if confirmed.

Article By:
Bruce A. Colbath

Of:
Sheppard, Mullin, Richter & Hampton LLP

McSweeny Joins FTC as Fifth Commissioner as Republican Commissioners Continue to Make Waves – Federal Trade Commission

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On April 9, 2014, Terrell McSweeny was confirmed by the Senate as the fifth and final Federal Trade Commissioner. She joins fellow Democrat appointees Chairwoman Edith Ramirez and Commissioner Julie Brill. It is the two Republican appointees, Commissioners Maureen Ohlhausen and Josh Wright, however, who have been making the most news in the last several months with dissents and speeches. Now that the FTC is at full-strength, clients should be on the lookout for a more active discussion of new FTC initiatives.

McSweeny is a relative newcomer to the antitrust community, serving as Senior Counsel for Competition Policy in the Justice Department’s Antitrust Division since 2012. She held several positions supporting Vice President Joseph Biden, both as Vice President and Senator, and worked on earlier Democratic presidential campaigns. At her confirmation hearing, she pledged to “continue the [FTC’s] tradition of collegiality and consensus-oriented decision making,” but described no specific initiatives she planned to pursue. She received support from the few Senators present at the hearing and her confirmation vote was 95-1.

During the many months when there were two Democrat and two Republican Commissioners, the FTC continued to be very active in clearing mergers, challenging fraudulent activities and issuing rules and guidance for businesses of all types. Almost all those actions that required votes of the Commissioners received unanimous support. The two Republican Commissioners, however, have publicly dissented from some current and past FTC actions involving intellectual property, FTC Act Section 5 and particular mergers. Also, the lack of a fifth vote caused a rare 2-2 split on claims of collusion in the recent McWane case.

On intellectual property, Ohlhausen vigorously dissented to a portion of the Commission’s late 2012 Robert Bosch consent agreement resolving merger issues. She objected only to the finding of an unfair method of competition when the patent holder sought injunctive relief on a standard essential patent over which there was dispute about a fair, reasonable and non-discriminatory license (FRAND). Ohlhausen saw that issue as one better left to courts or standard setting organizations adjudicating contract provisions. She similarly dissented early in 2013 when the FTC obtained a consent agreement in Google/Motorola Mobility that again required a patent holder to forego unrestricted use of injunction actions as part of a FRAND dispute. While Wright took no part in those actions, he reiterated his earlier academic writing in an April 2013 speech that patent and contract law were better than antitrust law in dealing with FRAND disputes involving standard essential patents. In a March 2014 speech, he called those decisions deviations from the principle embedded in past FTC decisions and guidelines that the antitrust analysis should be symmetrical whether the rights were for intellectual property or real property.

Wright has taken the lead on the Section 5 issues. As explained in our earlier alert, FTC Section 5 allows the FTC to go beyond the Sherman Act and prevent “unfair methods of competition,” but opinions about the extent of that power have varied with the identities of the commissioners. Wright proposed specific guidance to be issued by the FTC that would tether the FTC’s power here to modern antitrust’s “harm to competition” concept. In a July 2013 speech, Ohlhausen endorsed the concept of guidance from the FTC and suggested a limited use of Section 5 similar to Wright’s. Brill questioned the need for such guidance, pointing to the limited number of recent Section 5 actions and no groundswell from business for such guidance, and thought it only made sense when the Commission was back to full strength. On several occasions, Chairwoman Ramirez has said that the periodic Commission actions and Commissioners’ speeches were sufficient guidance on the issue.

Finally, Wright dissented (Ohlhausen was recused) from the September 2013 challenge to the Nielsen/Arbitron merger. The Commission was concerned about the effect of the merger on a market that does not now exist. While acknowledging that merger review necessarily involves some level of prediction, he thought the effects of a merger on such a “future market case” beyond the ability of any enforcer to predict. Finally, Wright was the lone dissent from the December 2013 decision to require changes in the Fidelity National/Lender Processing merger before allowing it to proceed. Wright would have allowed the merger to close with no changes, observing that “modern economics” required something more before concluding that the mere reduction in competitors would increase the likelihood of post-merger collusion in the industry.

In the McWane matter, FTC complaint counsel claimed the company excluded some competitors from a slice of the ductile iron pipe fitting market through a loyalty rebate program while also colluding with those same competitors to raise prices in the overall market. The FTC Administrative Law Judge found exclusion but not collusion. The four sitting commissioners missed two deadlines to issue an opinion because, according to media reports, they were deadlocked. Finally, the deadlock was broken but only on exclusion — Wright dissented from a finding that there was sufficient evidence that the rebate program constituted anticompetitive exclusive dealing. The commissioners deadlocked 2-2 on the collusion claims so the ALJ’s finding of insufficient evidence was allowed to stand and those claims were dismissed.

These dissents and deadlocks can overstate the differences among the commissioners. Since Chairwoman Ramirez rose to her current role last year and the Commission was left shorthanded, the FTC’s enforcement and education activities have continued apace, usually supported by unanimity from the four commissioners. Also, Ramirez has not publicly indicated any particular initiatives she had been unable to pursue because of the lack of a third Democratic vote. Still, the McSweeny addition will give her the opportunity to regain the initiative from her Republican colleagues. Clients should be alert for any changes in the debates or new initiatives now that the Commission is back to full strength.

Article By:

Steven J. Cernak
Gregory L. Curtner
Jacob K. Danziger
William M. Hannay
Sondra A. Hemeryck
Richard J. Hoskins
Of:
Schiff Hardin LLP

EEOC & FTC Issue Joint Background Check Guidance

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The U.S. Equal Employment Opportunity Commission (EEOC) and the Federal Trade Commission (FTC) issued joint informal guidance concerning the legal pitfalls employers may face when consulting background checks into a worker’s criminal record, financial history, medical history or use of social media.  The FTC enforces the Fair Credit Reporting Act, the law that protects the privacy and accuracy of the information in credit reports. The EEOC enforces laws against employment discrimination.

The two short guides, Background Checks: What Employers Need to Know andBackground Checks: What Job Applicants and Employees Should Know, explain the rights and responsibilities of both employers and employees.

The agency press releases state that the FTC and the EEOC want employers to know that they need written permission from job applicants before getting background reports about them from a company in the business of compiling background information. Employers also should know that it’s illegal to discriminate based on a person’s race, national origin, sex, religion, disability, or age (40 or older) when requesting or using background information for employment.

Additionally, the agencies want job applicants to know that it’s not illegal for potential employers to ask someone about their background as long as the employer does not unlawfully discriminate. Job applicants also should know that if they’ve been turned down for a job or denied a promotion based on information in a background report, they have a right to review the report for accuracy.

According to EEOC Legal Counsel Peggy Mastroianni, “The No. 1 goal here is to ensure that people on both sides of the desk understand their rights and responsibilities.”

Article by:

Jason C. Gavejian

Of:

Jackson Lewis P.C.

Clash Of Titans over Biosimilars at Federal Trade Commission (FTC) Workshop

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On Tuesday, February 4, the Federal Trade Commission (FTC) conducted an all-day public workshop at its headquarters in Washington, D.C. on competition issues involving biologics and biosimilars.1 During highly informative presentations and roundtable discussions, the FTC and various stakeholders, including top-level representatives from originators of biologics (Pfizer and Amgen), biosimilars developers (Sandoz, Momenta and Hospira), payors (Aetna), prescribers (CVS and Express Scripts) and academia (Harvard Medical School), analyzed the likely impact of recent state substitution laws and naming conventions on biosimilars.

No one denied nor debated that the future of the drug industry lies in the robust and dynamic area of biologics. In 2010, 4 of the top 10 drugs were biologics and it is anticipated that in 2016 biologics will account for 7 of the top 10 drugs worldwide.2 At the same time, all panelists were concerned that the costs associated with biologics are rising at a staggering rate and are therefore not sustainable for patients nor payors, and that many patients will be unable to afford biologics if competition is not introduced.

According to Harry Travis, Vice President at Aetna, patients currently spend about $1 a day on non-specialty medication (traditional drugs) whereas they spend roughly $100 a day for specialty medication (biologics).3 He stated that only 1% of Aetna’s customers use specialty products, which account for 50% of Aetna’s total drug spending. This trend was confirmed by Steve Miller, Chief Medical Officer at Express Scripts, who underlined that specialty products (biologics) currently account for 30% of total drug spending, but this number will rise to 50% in 5 years.

It is thus not surprising that all participants urged for FDA-approved biosimilars in order to improve access to biologics while at the same time protecting public health and safety. Participants were also virtually unanimous in their recommendations that fostering public confidence in biosimilars will be crucial to their success and that unnecessary obstacles to substitution may restrict competition.4

The following points were discussed, relying on a large amount of data and comparative studies between countries:

  • Competition between originators of biologics and biosimilars developers: Panelists agreed that competition is not expected to have the same effects on the biologics industry as it has had in the small-molecule drugs space when generics penetrated the latter. Because the dynamics are completely different, the entry of biosimilars is unlikely to result in either steep price discounting or rapid acquisition of market share by manufacturers of biosimilars.5
  • Premature state biosimilar substitution laws: 18 states have already decided to introduce bills to regulate biosimilars, and 4 of them have enacted laws, all of which may seem slightly premature given that the FDA has yet to approve a biosimilar. Certain provisions of these substitution laws appear controversial as they place onerous requirements on the substitution of biosimilars for branded biologics. Of particular concern are certain substitutions laws requiring pharmacists to promptly notify patients and/or prescribers when dispensing a biosimilar, and to keep special records. These state-level restrictions not only deter substitution by imposing on pharmacists burdensome recordkeeping and additional communications with the physician, they also contradict federal law, namely the Biologics Price Competition and Innovation Act (BPCIA), which expressly provides for substitution.6 These state laws are arguably inconsistent with the BPCIA and could undermine the attractiveness and access to more affordable biologics.
  • Impact of naming on biosimilars: There was debate as to whether biosimilars should bear different non-proprietary names and whether such a requirement would have anticompetitive effects. Some argued that requiring distinct non-proprietary names is simply an effort to cause doubt and distrust among physicians and patients by making biosimilars appear different from biologics. As noted by Bruce Leicher, General Counsel at Momenta, the Biotechnology Industry Organization opposes GMO labelling on genetically modified foods precisely for the same reason – requiring a different name for biosimilars would communicate a different (and perhaps suspicious) product and would therefore grant a competitive advantage to branded biologics. Other panelists argued that names and other types of identifiers were justified by the need for an effective pharmacovigilance system, while some speakers expressed the need for distinguishable naming or other identifiers for purposes of linking a responsible product to a specific adverse event in the event of product liability.

The FTC did not express its own views on the effect of state-level restrictions and naming conventions on competition in the biosimilars market, but did note that securing more prescribing physicians on the panel might have added to the debate.

We will continue to monitor federal and state activities in the regulation of biosimilars.

1 The Food and Drug Administration defines biologics as medical products made from a variety of natural sources (human, animal or microorganism).  Moreover, a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product.

2 As presented by Steve Miller, Senior Vice President and Chief Medical Officer at Express Scripts.

3 More alarming to Mr. Travis is that the cost of biologics increased by approximately 15% annually, as compared to the approximately 5% increase in the cost of small molecule drugs.

4 Substitution, by allowing the pharmacist to automatically substitute an interchangeable biosimilar for the branded biologic without the intervention of the physician, provides a strong incentive to use biosimilars.

5 According to Dr. Sumant Ramachandra, Hospira’s Senior Vice President and Chief Scientific Officer, it takes approximately $5 million and 2-3 years for a generic manufacturer to bring a small molecule drug to market, whereas it takes over $100 million and 8-10 years for a biosimilar manufacturer to bring a biosimilar to market.

6 The BPCI provides that “the [interchangeable] biological product may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product.”

Article by:

Of:

Bracewell & Giuliani LLP

Internet Peeping Toms and The Internet of Things Face New Hurdles: Federal Trade Commission (FTC) Settles with TRENDnet, Inc.

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The Federal Trade Commission (“FTC”) recently entered into a settlement agreement with TRENDnet, Inc., a company that sells Internet Protocol (“IP”) cameras that allow customers to monitor their homes remotely over the Internet.  Notably, this is the FTC’s first action against a seller of everyday products that connect to the Internet and other mobile devices, commonly referred to as the “Internet of Things.”

The Complaint

In its complaint, the FTC alleged that, despite representing to its customers that TRENDnet’s IP cameras are “secure,” TRENDnet failed to reasonably secure its IP cameras against unauthorized access by third parties.  According to the FTC, TRENDnet transmitted user login credentials in clear, readable text over the Internet and stored user credentials on a user’s mobile device in clear, readable text, despite the availability of free software to secure the transmissions and the stored credentials.  The FTC Further alleged that TRENDnet failed to employ reasonable and appropriate security in the design and testing of the software that it provided consumers for its IP cameras.

Due to TRENDnet’s inadequate security measures, in January 2012, a hacker exploited the vulnerabilities of the TRENDnet system and posted live feeds for nearly 700 of TRENDnet’s IP cameras, including customers that had not made their video feeds public.  These video feeds displayed people in their homes, including sleeping babies and young children playing.  Once TRENDnet learned of this flaw, it uploaded a software patch and attempted to alert its customers of the need to update their IP cameras through TRENDnet’s website.

The Settlement

Last week, TRENDnet entered into a settlement agreement with the FTC to resolve the FTC’s claims.  Pursuant to the settlement agreement, TRENDnet has agreed that it will not misrepresent:

  • the extent to which its products or services maintain and protect the security of its IP cameras;
  • the security, privacy, confidentiality or integrity of the information that its IP cameras or other devices transmit; or
  • the extent to which a consumer can control the security of the information transmitted by the IP cameras.

What’s more, TRENDnet is required to establish, implement and maintain a comprehensive security program that is reasonably designed to address security risks that could result in unauthorized access to the IP cameras or other devices, and to protect the security, confidentiality and integrity of the information that its IP cameras or other devices transmit.  TRENDnet is further required to conduct initial and biennial assessment and reports of such security program by an independent third-party professional every two years for the next twenty years.   Again, some real bottom line costs as a result of these settlements.

Finally, in addition to the measures that TRENDnet must take to protect its customers in the future, TRENDnet must also notify all of its current customers about the flaw in the IP cameras that allowed third parties to access the live feed of TRENDnet customers, and TRENDnet must provide these customers with instructions on how to remove this flaw.

The TRENDnet settlement is the FTC’s first step at regulating data security in the land of the Internet of Things.  Keep a look out to see whether this becomes the FTC’s next hot topic.

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