February 14, 2014

BioCentury This Week: The Battle Over Biosimilar Business Models

BioCentury This Week.pngSunday, February 16: The Battle Over Biosimilar Business Models.

Biosimilars -- lower-cost versions of expensive biologics -- are coming to pharmacy shelves in the U.S. But biosimilars players disagree about how they should compete.

Should biosimilars be sold like inexpensive generic drugs? Or should they be sold at higher prices like branded drugs?

On Sunday, February 16, BioCentury This Week television examines the policies the two sides are fighting over with:

  • Geoffrey Eich, Executive Director of R&D Policy at Amgen Inc.

  • Craig Wheeler, President & CEO of Momenta Pharmaceuticals Inc.

  • Brian Malkin, Partner at Frommer Lawrence & Haug LLP and former Regulatory Counsel in the Office of the FDA Commissioner and the Center for Drug Evaluation and Research

Key opinion leaders; sophisticated questions
Always on BioCentury This Week television

Watch the Broadcast
8:30 - 9:00 a.m. EST
WUSA Channel 9
in Washington, D.C.

Watch on the Web
Continuously available
starting at 9:00 a.m. EST

Get BioCentury This Week alerts on your mobile phone every week
text "BIO" to 25543 (standard text messaging rates apply).

February 7, 2014

FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition

DNApurple.jpgOn February 4, 2014, the U.S. Federal Trade Commission ("FTC") held a Workshop entitled: "Follow-On Biologics Workshop: Impact of Recent Legislative and Regulatory Naming Proposals on Competition". The Workshop was well attended and sought to solicit a variety of views on the marketing of follow-on biologics, currently referred to as "biosimilars" under the Biologics Price Competition and Innovation Act ("BPCIA").

Briefly, the BPCIA defines "biosimilarity" as "[T]he biological product is highly similar to the reference product notwithstanding minor differences in clinically inactive components" and "there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product." A biosimilar is submitted as a 351(k) application, which must contain, among other things, information demonstrating that the biological product is biosimilar to a reference product based upon data derived from analytical studies, animal studies, and a clinical study or studies, unless FDA determines, in its discretion, that certain studies are unnecessary. To meet a higher standard of "interchangeability," an applicant must provide sufficient information to demonstrate biosimilarity, and also to demonstrate that the biological product can be expected to produce the same clinical result as the reference product in any given patient and, if the biological product is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between the use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch. According to the BPCIA, interchangeable biosimilar products may be substituted for the reference product without the intervention of the prescribing healthcare provider.

As explained by Edith Ramirez, FTC Commissioner, many state legislatures have either passed or are considering legislation to explain how to handle biosimilars that are not interchangeable (and sometimes including interchangeable biosimilars), which may affect competition for the market at this juncture before even one biosimilar has been approved. In particular, many of the state laws or bills include provisions for prescriber notification of possible biosimilar substitution for the referenced innovator biologic product. FDA and other regulatory bodies are still considering universal nomenclature for biosimilars, which may either create the same or similar names for biosimilars and their referenced innovator biologic products. The FTC sees similarities between biosimilars and how generics were first perceived and opportunities to either facilitate or hinder acceptance of biosimilars in the market that they wanted to explore in this Workshop.

Continue reading "FTC Biosimilars (Follow-On Biologics) Workshop Tackles State Substitution Legislation and Naming Proposals on Competition" »

February 3, 2014

REMS Summit Hosted by ExL Pharma Delivers Thought-Provoking Stakeholder Discussion

Banner REMS.pngOn January 28-29, 2014, ExL Pharma hosted its 6th Annual Risk Evaluation and Mitigation Strategies ("REMS") Summit in Alexandria, Virginia. For the first time since the Summit has been held, key members from the FDA's Division of Risk Management attended. In particular, Claudia Manzo, Director, FDA Division of Risk Management, spoke in the main opening panel along with FLH Partner Brian J. Malkin and Yola Moride, Ph.D., FISP, Professor, Université de Montréal. The opening panel featured a discussion of some key take aways from FDA's Public Meeting on Standardizing and Evaluating REMS in July 2013 and follow-up meeting in December 2013 to identify and discuss new methods for communicating risk information as part of REMS to health care providers and its target populations. The Summit also featured a pre-conference workshop on regulatory negotiation and internal and external audits for REMS, as well as a concluding roundtable session, which focused on some of the key topics raised. The Summit was closed to the media to help encourage a free exchange of ideas.

As promised, the Summit built upon recent REMS events and discussions featuring the most experienced professionals from a cross section of small to large companies, pharmacy organizations, hospitals, academia and government agencies to share their perspectives, experiences, and leverage the discussions in a well-rounded and interactive platform to take a proactive approach covering:

  • Recent developments and initiatives

  • Possible frameworks for standardization

  • Tools for evaluation

  • Best practices for modification

  • Methods to measure the burden

  • Lessons learned from various REMS programs

  • Innovative approaches to improve REMS effectiveness

  • What can be learned from other industries

  • Challenges working in single shared REMS.

Tempered by thoughtful observational comments provided by the Summit's Chairperson, Mibhor D'Silva, Vice President Safety and Pharmacovigilance, Astellas, and insight from the various keyholders, Summit participants were not only challenged to provide their opinions but also their insight for improving REMS going forward. While many of the discussions focused on the impact of REMS on healthcare settings or health care providers, the goal of REMS to provide better patient risk information and treatment outcomes was also emphasized. Many of the participants commented that they learned much from each other, in particular the logistics of REMS implementation in health care settings, where updates are a constant challenge.

If you have any comments or ideas to share or are interested in speaking at the 7th REMS Summit in 2015 please contact Kai Hahn, Senior Conference Director, khahn@exlpharma.com.

January 31, 2014

Liquid Dietary Supplements and Beverages: How Do You Distinguish?

liquids.jpgWhether a beverage or a dietary supplement, liquid products are marketed more than ever before--now containing a wider array of ingredients, for many more intended uses and including traditional food substances, but at levels far exceeding previously used amounts. So how does one know if a liquid product is a beverage or a dietary supplement? And what regulations must be followed? To answer those questions, FDA has issued nonbinding recommendations in two new guidances this month: Distinguishing Liquid Dietary Supplements from Beverages and Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements. FDA hopes that these guidances will help the industry avoid misbranding with inconsistent product category labeling and adulteration for failure to meet the proper regulations.

When distinguishing between beverages and dietary supplements, as a general rule, dietary supplements are meant to supplement the diet, and beverages are for quenching thirst and providing fluid, nutritive value, taste or aroma. FDA's Guidance sets out the following factors to consider in distinguishing between the two types of liquid products: labeling and advertising, product name, product packaging, serving size and recommended daily intake, recommendations and directions for use, marketing practices, and composition of the liquid product. The Guidance provides examples of how the factors can come into play in a determination. It is likely that a combination of factors, not one, will be determinative of a product's category. For example, even if the label of a liquid product contains a Supplement Facts Panel, it could still be considered a "beverage" if it also contains a statement that the product "refreshes," or the product could be a "food" if the label contains a picture of the liquid being poured onto a salad. The product name could also be determinative that a product is likely a "beverage", if the product name contains conventional terms for beverages, like "drink", "soda", "orange juice", "iced tea", "bottled water", or "coffee". The product packaging is another determinant and, if the packaging is reclosable, is shaped similar to a common beverage package, or contains a single serving, then it is likely a "beverage". The serving size or recommended daily intake may also indicate which category a liquid product falls under. For example, if the product is intended to be consumed all at once or contains a significant part of the entire daily drinking fluid intake for the average person then it is likely a "beverage". Interestingly, marketing practices, another factor, such as metatags for "sodas," "juices" or "beverages," or paying for store shelf placement with other beverages could be determinative of a "beverage". But the product is not necessarily a "beverage" if the marketing says the product should be taken with a meal, since dietary supplements are often recommended for use along with a meal. Finally, the composition of a liquid product may be determinative, although there is a lot of overlap now with both categories containing amino acids, proteins, and vitamins. Similarly, merely adding a dietary ingredient does not make a product a "dietary supplement".

Once the factors are considered to determine whether a liquid product is a "beverage" or a "dietary supplement", the type of product controls which regulations must be met. For beverages, a substance can be generally recognized as safe ("GRAS") for its intended use based upon generally-available evidence of safety recognized by experts. But unless GRAS for its intended use or exempt, substances intentionally added to "beverages" are "food additives", which require premarket approval based upon safety data. FDA issues regulations for approved food additives that specify the conditions for which the substance is safe and can be used. Accordingly, non-dietary ingredients added to supplements, such as binders, excipients and fillers, however, must meet food additive requirements or be GRAS. On the other hand, dietary ingredients included in dietary supplements are not required to be GRAS and are exempt from food additive regulations but still must not be adulterated, and, if new, must meet new dietary ingredient requirements. No matter a "beverage" or "dietary supplement", the guidances remind the industry to make sure the labeling is not false or misleading, and if included, to make sure health claims, nutrient content claims, and structure function claims are proper.

January 28, 2014

Pay For Delay -- Supreme Court's Actavis Decision Is Limited to Monetary Payments

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.

Continue reading "Pay For Delay -- Supreme Court's Actavis Decision Is Limited to Monetary Payments" »

January 22, 2014

FDA Approval: JAMA Takes a Closer Look to Help Evaluate the Strength of Evidence for Physicians and Patients

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.

Continue reading "FDA Approval: JAMA Takes a Closer Look to Help Evaluate the Strength of Evidence for Physicians and Patients" »

January 17, 2014

Interactive Promotional Media Guidance (Social Media Plus) Issued in Draft by FDA

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)."

Continue reading "Interactive Promotional Media Guidance (Social Media Plus) Issued in Draft by FDA" »

January 16, 2014

FLH's Brian Malkin Quoted In The Pink Sheet on Generic Drug Review Changes

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."

Continue reading "FLH's Brian Malkin Quoted In The Pink Sheet on Generic Drug Review Changes" »

January 15, 2014

The FDA Is Speaking at the 6th REMS Summit

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.


Hot topics include:

  • Get an update on the FDA's report and an outlook on what to expect in 2014

  • Highlight Antitrust issues raised by REMS programs

  • Address challenges and opportunities in a single shared REMS and REMS that involve CME

  • Discuss standardization approaches and initatives

  • Leverage risk mitigation tools and strategies from other industries for Life Sciences

  • Evaluate differences and similarities of RMP vs REMS

  • Outline recent studies on the impact of eHealth

  • Discuss meaningful metrics to measure the burden

  • Hear case studies on REMS modification

  • Engage in Roundtables to discuss REMS challenges with peers
Check out the Agenda

For information on exhibiting & sponsorship opportunities, please contact Eric Morrin at 212-400-6228 or emorrin@exlpharma.com

Press Contact: Shari Gelfand, 917-258-5145 or sgelfan@exlpharma.com

January 14, 2014

Biosimilar Naming the Subject of Recent J&J Citizen Petition

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.

Continue reading "Biosimilar Naming the Subject of Recent J&J Citizen Petition" »

January 9, 2014

FLH's Brian Malkin Speaks at Montgomery County Department of Economic Development Program: Innovative Strategies for New Product Development

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.

Planned topics include:

  • Drug Development Trends
  • Special Regulatory Approval Strategies
  • Opportunities for Extending the Market
  • Protecting Your Investment
  • Raising Capital to Finance Research and Commercial Products
  • Other Regulatory Considerations.

Specific topics include special FDA regulatory approval strategies (e.g., priority review, fast track, breakthrough therapy, accelerated approvals, orphan drugs, and 505(b)(2) NDAs), drug repurposing, patent protection and exclusivities, labeling, and manufacturing considerations.

A light breakfast will be served along with refreshments. Following an initial networking session, Mr. Malkin will cover the above topics in an intimate setting where the audience can participate and ask questions and offer additional insight to one another in a dynamic and informal environment.

If you would like to attend, please RSVP by January 29, 2014 to:

Janis Pitts
Director, Life Sciences Strategy
Montgomery County Department of Economic Development
111 Rockville Pike, Suite 800
Rockville, Maryland 20850

January 8, 2014

Dietary Supplements Under Closer Scrutiny

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."

Continue reading "Dietary Supplements Under Closer Scrutiny" »

January 3, 2014

Mylan Comments on Gilead's Stribild® Citizen Petition for Five-Year NCE Exclusivity

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.

Continue reading "Mylan Comments on Gilead's Stribild® Citizen Petition for Five-Year NCE Exclusivity" »

January 2, 2014

Cellular and Gene Therapy Advisory Committee Meeting Rescheduled for February 2014

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.

Continue reading "Cellular and Gene Therapy Advisory Committee Meeting Rescheduled for February 2014" »

December 20, 2013

Antibacterial Soap Rule Proposed by FDA: Could your Antibacterial Hand Soap Be Doing More Harm Than Good--FDA Intends To Find Out

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).

Continue reading "Antibacterial Soap Rule Proposed by FDA: Could your Antibacterial Hand Soap Be Doing More Harm Than Good--FDA Intends To Find Out" »