On January 30, 2014, FLH Partner Brian J. Malkin will speak at the New York State Bar Association’s (“NYSBA’s”) Annual Meeting of the Food, Drug and Cosmetic Law Section. Mr. Malkin will introduce and speak with Molly Muldoon, FDA’s former Chief of Staff, on “FDA Regulation: The Intersection of Policy and Politics, The Opportunities and Challenges for Innovation–Perspectives from Two Former FDA Officials”. Ms. Muldoon was formerly an FDA Chief of Staff, overseeing operations and liaising with senior FDA leadership on key issues including the Affordable Care Act, Deepwater Horizon, food safety regulations and food borne outbreaks. Mr. Malkin is a former regulatory counsel at the FDA, who specializes in the strategic analysis of how policy affects FDA and IP innovation. Ms. Muldoon will discuss how effective communication, cooperation and collaboration remain critical to implement policy within FDA. She will also discuss the role of patient groups and other valuable stakeholders to work with FDA in shaping the development of FDA policies and how to achieve all of this in an increasingly political environment. In addition, the Meeting will feature the following presentations: Les Weinstein, Esq. former Ombudsman for the Center for Tobacco Products and for the Center for Devices and Radiological Health speaking on “The Role of the FDA Ombudsman–Who They Are, What They Do and How They May Assist You”; Frederick H. Fern, Harris Beach PLLC; John A. Murphy III, Assistant General Counsel, Pharmaceutical Research and Manufacturers of America; and Irving L. Wiesen, Law Offices of Irving L. Wiesen, P.C. speaking on “Compounding Pharmacies: Regulatory Solutions to a National Health Crisis”; George J. Annas, William Fairfield Warren Distinguished Professor and Chair Department of Health Law, Bioethics & Human Rights, Boston University School of Public Health, School of Medicine and School of Law and David S. Weinstock, LifeCell Corporation, speaking on “Ethical Conflicts in Clinical Medicine and Research: Consent to DNA Screening, Research on Extremely Premature Infants and International Drug Trials”. The Section’s meeting will conclude with its Annual Business Meeting.

Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for Thumbnail image for drugmoney.jpegOn January 24, 2014, Judge Walls of the U.S. District Court for the District of New Jersey dismissed the In re Lamictal Direct Purchaser Antitrust Litigation after concluding that the U.S. Supreme Court’s FTC v. Actavis ruling concerning the antitrust implications of so-called “pay-for-delay” settlements of Hatch-Waxman patent infringement cases only “applies to patent settlements that contain an unjustified reverse payment of money.”

The settlement in this case ended a patent infringement action between branded pharmaceutical manufacturer GlaxoSmithKline (“GSK”) and generic manufacturer Teva Pharmaceuticals (“Teva”). The settlement “allowed Teva to market generic lamotrigine [Lamictal®] before the relevant patent expired and ensured that once it did so, its generic tablets and chewables would not face competition from GSK’s own ‘authorized generic’ for a certain period of time.”

Direct Purchaser plaintiffs Louisiana Wholesale Drug Company and King Drug Company of Florence brought the present antitrust action against GSK and Teva, “alleg[ing] that the settlement violates federal antitrust laws.” The district court dismissed the case a first time in December 2012 for failure to state a claim under the then-existing antitrust laws. The Direct Purchasers appealed. While the appeal was pending, the Supreme Court issued its Actavis decision. As a result, the Third Circuit Court of Appeals remanded the case back to the district court for reconsideration of its earlier dismissal based on Actavis.
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On January 28, 2014, FLH Partner Brian J. Malkin will speak on a panel “Understand the FDA Report [Risk Evaluation and Mitigation Strategies (“REMS”) Standardization] and the Impact on the Industry” at ExL Pharma’s 6th Risk Evaluation and Mitigation Strategies Summit held on January 28-29, 2014 in Alexandria, Virginia. Joining Mr. Malkin in the panel will be Yola Moride, Ph.D., FISP, Professor, Université de Montréal to help provide an international perspective of this Report with planned topics to include:

  • Outlining of the FDA’s findings since the public meeting in July 2013
  • Explore the implications and impact on the industry

AMAHQChicago.pngOn January 22, 2014, the Journal of the American Medical Association (“JAMA”) took a closer look at the FDA approval process for drugs and medical devices. On the surface these studies were designed to characterize the type of pivotal data relied on by FDA for approval (or denial) of new drugs and devices. The conclusions from these studies and some of the associated “Opinion” articles suggest, however, that the editors of JAMA, and perhaps its members, believe that FDA should make physicians and patients more acutely aware of the information relied on for new approvals, as well as side effects observed following approval.

The main article, entitled “Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012“, took as a starting point that physicians and patients do not understand or have the tools to evaluate the different strengths of clinical evidence used by FDA to approve new drug and device therapies. Based on an Internet-based study, for example, the study reported that a national sample of 4316 adults (68% response rate) found that 39% believe FDA approves only “extremely effective” drugs and 25% only drugs without adverse events, which the authors said may reflect the opinions of some physicians.

Taking a closer look at these approvals, the authors concluded:

Our characterization of pivotal efficacy trials . . . demonstrates that the quality of clinical data evidence used by FDA to make approval decisions varied widely across indications. Although the vast majority of indications were supported by at least 1 randomized, double-blinded trial, there was wide variation in trials’ choice of comparators and end points, duration, size, and completion rate. In addition just more than one-third of indications were approved on the basis of a single pivotal efficacy trial.

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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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drugs.pngOn January 6, 2014, FLH Partner Brian J. Malkin was quoted in an article by Derrick Gingery in The Pink Sheet entitled “Generic Drugs 2014: OGD Creates Internal Review Goals, May Make OND-Inspired Changes”.

Gingery’s article focused on FDA’s Office of Generic Drugs (“OGD”) taking steps to meet review deadlines that will be imposed by the Generic Drug User Fee Act (“GDUFA”), and enacted by the Food and Drug Administration Safety and Innovation Act (“FDASIA”) of 2012. For example, sixty percent of all applications accepted for filing in fiscal year 2015 must be reviewed within 15 months, which is included in a GDUFA commitment letter. According to the article, as of December 1, 2013, OGD’s project managers started setting internal goals to help reviewers get used to a review clock–a new concept for OGD but something that has been around since the Prescription Drug User Fee Act (“PDUFA”) first implemented in the 1990s for FDA’s Office of New Drugs (“OND”). Acting OGD Director Kathleen Uhl, M.D. (“Cook”) commented there, “We need to have all the reviewers practice the review to a goal date and then we need to monitor what’s our predictability of meeting those goal dates.” Uhl also told Gingery that the “primary purpose” of the goal dates was to help OGD determine the time it will take to complete various parts of the abbreviated new drug application (“ANDA”) reviews and would not be shared with sponsors.

Malkin was asked to comment on the internal goals, which appeared in the article as follows:

Attorney Brian Malkin, of Frommer, Lawrence and Haug LLP, agreed that the internal goals likely would not be helpful to sponsors.

“They’re not going to be able to react to FDA’s deadlines unless FDA shares additional information with them, except perhaps to set some of their own timetables for what FDA may be doing on their end,” Malkin said in an interview.

Malkin said the aim appears to be finding areas where the process can become more efficient.

“It’s tied to FDA’s realistic expectations of what they can do to meet their timeframes, but also … it may not be exactly what industry thought they were getting,” he said. “The concept would suggest shorter review times, but we’ll have to see.”

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Banner REMS.pngDon’t miss your chance to learn and network with REMS experts from organizations such as the FDA, Pfizer, Novartis, the University of Michigan, Vivus, Purdue Pharma, Biogen, New Haven Hospital, Lehigh University, Sanofi and many more at the 6th REMS Summit. Join our outstanding speaker faculty and reserve your seat now – RESERVE YOUR SEAT TODAY

The OIG report in 2013 stated a lack of comprehensive data to determine whether risk evaluation and mitigation strategies improve drug safety. In response to that the FDA held a public meeting in July and December to discuss how REMS programs can be improved, standardized and evaluated. To foster the exchange between the different stakeholders further, EXL Pharma has put together an event that features a cross section of small to large pharmaceutical companies, pharmacy organizations, hospitals, academia and solution providers, who will leverage key ideas presented at those meetings.


Jnj.jpgJohnson and Johnson (“J&J”) recently joined the discordant chorus of stakeholders and commentators who have weighed in on the issue of naming for biosimilar products. On the one hand, some advocate for shared International Non-Proprietary Naming (“INN”) system names between a biologic approved under Section 351(k) of the Biologics Price Competition and Innovation Act of 2010 (“BPCIA”) and the reference protein product (“RPP”). Conversely, others argue that biosimilars and RPPs should be assigned unique INNs. Whether biosimilar products are given the same or unique names matters: biosimilar products with unique names will likely require independent marketing and detailing (i.e., automatic substitution will not be available). For its part, J&J requests that FDA “require biosimilars to bear nonproprietary names that are similar to, but not the same as, those of their reference products or other biosimilars.”

J&J cites to its experience with Eprex®/Erypo® recombinant human erythropoietin (epoetin alfa), to inform its position on biosimilar naming. In particular, J&J identified four considerations that arose from its experience: (1) reliable pharmacovigilance mechanisms are necessary for postmarket safety; (2) products may undergo clinically-meaningful changes over time; (3) effective pharmacovigilance can only occur when it is possible to identify the product administered to a patient; and (4) switching products can interfere with determining which product is responsible for any given adverse effect. For example, J&J received reports of erythopoetin antibody-mediated pure red cell aplasia in Thailand between 2004-2007 but were unable to pinpoint the adverse event reports to a specific epoetin product due to incomplete documentation and frequent product switching.

Based on this experience, J&J argues that giving a biosimilar product the same name as the RPP would interfere with pharamacovigilance. For example, J&J states that, “to the extent that adverse event reports identify a product solely by nonproprietary name, shared names would complicate if not prevent tracing a safety signal to a specific product.” J&J also states that physicians may submit adverse event reports that incorrectly identify the responsible product if switching occurs without the knowledge of the physician.
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MontgomeryCountyEconomicDevelopment.jpgOn February 5, 2014, FLH Partner Brian J. Malkin will present a special breakfast program for early-phase biotechnology companies: “Innovative Strategies for New Product Development”. The event will be held at the Montgomery County Department of Economic Development offices in the Shady Grove Innovation Center, 9700 Great Seneca Highway, Rockville, Maryland 20850 from 8-10 am.

The program will begin with networking and then launch into Mr. Malkin’s presentation designed to help you take your innovative biomedical research to the commercial product stage. Mr. Malkin will share his insight from working with biotechnology companies and working as a Regulatory Counsel at FDA for over 9 years at FDA in the Office of the Commissioner and the Center for Drug Evaluation and Research, where he was worked on all types of FDA-regulated products.

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Written by Brian J. Malkin

dietary supplements.jpgIn mid to late December 2013, FDA appeared to be taking a closer look at dietary supplement claims and products, particularly those with health claims or potentially dangerous ingredients. Three recent actions/notifications that took place within days of each other worth note include actions against Risingsun Health (bloodroot-containing products with claims to treat cancer), Star Scientific, Inc. (anatabine-containing products with claims to treat traumatic brain injury (“TBI”) and other ailments), and Blunt Force Nutrition (synthetic anabolic steroid with claims for muscle growth).

On December 19, 2013, FDA posted a News Release that on December 4, 2013, Risingsun Health, a Livingston, Montana dietary supplement maker was found in civil contempt of violating the terms of a consent decree of permanent injunction that had resolved a case brought by FDA against the company and its owner in February 2010. The consent decree had barred the company from developing and selling topical bloodroot and graviola products, new drugs, new animal drugs, and dietary supplements. The 2010 case concerned the company’s advertisements on various websites and sales of unapproved drugs that claimed to treat cancer, and the decree was entered in November 2010. In February 2013, the U.S. sought an order of civil contempt, because Toby McAdam, owner of Risingsun Health, and his company continued to manufacture and distribute products, including products containing bloodroot, which violated the decree, after FDA sent several letters concerning the alleged violative conduct. Federal judge Sam E. Haddon, District of Montana, held a hearing on the government’s contempt motion on October 21, 2013. The Court found McAdam in contempt, requiring him to cease selling dietary supplements and new drugs and to pay both $80,000 in liquidated damages and $4,936.48 in attorneys’ fees. Regarding the finding, Melinda K. Plasier, Associate Commissioner for Regulatory Affairs, stated, “The court’s ruling will ensure that this business cannot harm consumers physically or economically by selling unapproved and deceptive dietary supplements.”
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