socialmedia.jpgEarlier this week, FDA released a new draft guidance, “Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics“.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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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.

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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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petition.pngIn a previous post, we covered Gilead’s Citizen Petition to the FDA requesting FDA change its policy on how it allocates five years marketing exclusivity. Gilead argued that the current ruling whereby the five year exclusivity cannot be granted if even one active ingredient in the new drug application (“NDA”) has been previously approved should be altered. Stribild®, which has two previously-approved active ingredients and two new active ingredients, is currently precluded from obtaining the five years new chemical entity (“NCE”) exclusivity.

Mylan filed a Comment in Response, supporting FDA’s current FDA interpretation, arguing against the various points raised in Gilead’s Citizen Petition. First, Mylan points out that FDA’s interpretation is not a matter of policy but governed by the plain language of the statute passed by Congress. The relevant statute is “The Drug Price Competition and Patent Term Restoration Act of 1984” (“Hatch-Waxman” or “the Act”) which states in the section dealing with allocation of the five-year new chemical entity (“NCE”) marketing exclusivity: “[I]f an application submitted under subsection (b) of this section for a drug, no active ingredient … of which has been approved in any other application under subsection (b) of this section.” Mylan argued that: (i) despite Gilead’s attempts at re-interpreting the meaning of “drug” and “active ingredient”, the statute still plainly says that there must be no active ingredient in the NDA that has been previously approved for the five year exclusivity to be granted and (ii) when Congress wrote “an application submitted under subsection (b) for a drug”, it reasonably understood the word “drug” as used in this phrase to mean drug product and, not as Gilead would like to believe, a single component of the drug, such as the active ingredient.

As further support, Mylan pointed to the language of the three-year new clinical data marketing exclusivity provision:

Section 505(j)(5)(F)(iii) states:
If an application submitted under subsection (b) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under subsection (b), is approved after the date of the enactment of this subsection and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under this subsection for the conditions of approval of such drug in the subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) for such drug.
Thus, Mylan argued, taken together the plain language of the statute for both exclusivities leads to the conclusion that the current FDA interpretation is correct.

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genetherapy.jpgOn February 25-26, 2014, FDA will hold a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. A majority of the meeting will concern oocyte modification in assisted reproduction for the prevention of transmission of mitochondrial disease or treatment of infertility. While FDA will post meeting materials at least two business days before the meeting, one item that will likely be discussed is a workshop held in September 2002 on Evidence Based Assisted Reproductive Technologies (ART) that concerned oocyte modification. Approximately half of the second day will focus on considerations for the design of early-phase clinical trials of cellular and gene therapy products, which was the topic of a revised guidance published on July 2, 2013. This meeting was originally scheduled for October 22-23, 2013 but was postponed “due to resource constraints arising from the government shutdown.”

The July Draft Guidance provided recommendations to assist in designing early-phase clinical trials of cellular therapy (“CT”) and gene therapy (“GT”) products, collectively referred to as “CGT products”, which covers most Phase 1 trials and some Phase 2 trials. FDA considers clinical study designs for CGT products to be different because of the way the products work and the potential for substantial risk. In the past, FDA halted CGT therapies due to experiences that included: (1) multiple-organ failure and death of a subject receiving a GT product for ornithine transcarbamylase deficiency, (2) late-onset T-cell leukemia in subjects who received a GT product for X-linked severe combined immunodeficiency, and (3) the development of tumors in the brain and spinal cord of a patient who received intrathecal allogenic stem cells for ataxia telangiectasia.

FDA’s Guidance on early-phase clinical trials explained that unlike many small molecule drugs, there is much less experience across a broad population with CGT products, leading to more uncertainty with clinical study design and controls. Some CGT products persists in humans for an extended time period and the administration may involve surgery or other invasive procedures that may require use of an investigational medical device. Allogenic CT products, GT vectors, and proteins that may be produced by CGT products have the potential to produce an immune response that may produce an unintended adverse reaction or sensitivity to a CGT product in the future. CGT products are cellular products and so mimic the complex, dynamic nature of living cells, which can migrate within the recipient’s body.
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handsoap.jpgOn December 17, 2013, the FDA issued a Proposed Rule for consumer antiseptic wash drug products. Prior to this Proposed Rule, the last Tentative Final Monograph (“TFM”) issued for antiseptic active ingredients was in 1994 (59 Fed. Reg. 31,402), which classified 22 active ingredients for over-the-counter (“OTC”) antiseptic handwash use.

The new Proposed Rule affects manufacturers of antibacterial hand soap and hand and body wash products containing OTC antiseptic active ingredients for repeated daily use, to be used with water. Those products do not include hand sanitizers or wipes. Additionally, the Proposed Rule is only to evaluate consumer antibacterial products and not health care setting antibacterial products, which have distinct proposed use settings, target populations, and risks for infection.

The Proposed Rule requires manufacturers of antibacterial soaps and washes to: (1) demonstrate the products are safe for long-term daily use; and (2) demonstrate with clinical data that the products are more effective than plain soap and water in the prevention of illness and the spread of infection. The manufacturers have one year to submit new data demonstrating that safety and effectiveness. If a manufacturer cannot demonstrate those two requirements, then it will have to reformulate the product (remove the antibacterial active ingredient).
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unifedpatentcourtmap.jpgOn December 11-12, 2013, IBC Legal Conferences held its annual International Patent Litigation Conference. This Conference has historically brought together an impressive cast of speakers, and the 2013 Conference was no exception.

Opened by the Rt. Hon. Sir Robin Jacob, Hugh Laddie Professor of Intellectual Property Law, UCL and former Lord Justice of Appeal Court of Appeal of England and Wales, the audience was regularly treated throughout to his strong views on the burning issues. Kevin Mooney, Partner, Simmons & Simmons, chaired the Conference, which began with an update on the Unified Patent Court (“UPC”) and a panel commentating on the multitude of possible scenarios and outcomes. Neil Feinson, International Policy Director of the United Kingdom’s (“UK’s”) Intellectual Property Office (“IPO”), also provided a number of updates. He expects that the UK will ratify the Unified Patent Court Agreement by March 2015, and he reiterated that the whole project was expected to be self funding in the long run, cost effective, and competitive. But there are still a lot of unknowns, Feinson explained, such as the likely number of cases and court running costs, making calculations of costs and therefore fees to be charged difficult to estimate. The UK is working on addressing the unknowns, he said, and it is expected that as the Court gets underway, there likely will be fee reviews on a regular basis. The UK IPO is ultimately responsible for the information technology system, and Feinson expects that an “off the shelf” solution will be purchased rather than a new design.

A free 361-page book covering the 15th Draft on Rules of Procedure in three languages was made available to participants, but the book is likely to be out of date fairly soon, as Mooney and his team of rules drafters are well on the way to coming out with clarifications and updates. The final version of the Rules could be out as early as June 2014.
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