September 12, 2013

ANDA Labeling / USP Featured at GPhA/FDA Conference Part 1 of 2

ANDA drugs.jpgOn September 11-12, 2013, the Generic Pharmaceutical Association ("GPhA") in coordination with FDA and the United States Pharmacopeia ("USP") hosted an ANDA Labeling Workshop/USP User Forum in Bethesda, Maryland. The first day featured FDA speakers from FDA's Office of Generic Drugs ("OGD") who focus on labeling and filing/approval issues, and the second day featured speakers from USP.

Peter Rickman, M.S., Director, Division of Labeling and Program Support, OGD, kicked off the program, noting that OGD had a lot of challenges implanting the efficiency goals of the Generic Drug User Fee Act of 2012 ("GDUFA"), including their new 10-month review goals. Rickman stressed that for OGD to meet those goals, abbreviated new drug applications ("ANDAs") will need to be high quality, which is why FDA is spending time educating industry about quality.

Rudy Wu, Pham. D., M.P.H., Team, Leader, Labeling Branch, OGD, explained that labeling reviews can take longer when a consult is needed, i.e., checking with another FDA office for labeling acceptability, including the Office of Chief Counsel ("OCC"), Office of New Drugs ("OND"), surveillance, epidemiology, pediatric, and other centers. When a consult is requested, OGD must wait for the other entity to respond, which may create additional delays. Wu said there are many reasons why labeling reviews may take longer than expected: waiting for a final United States Pharmacopeia standard to issue or be met, standardizing the generic risk evaluation mitigation strategies ("REMS"), consults, citizen petitions, pending regulations or guidances, new clinical experience, patents and exclusivity may cause generic applicants to submit formulations that differ from the reference listed drug ("RLD) or include labeling carve-outs, and nomenclature differences. For example, regarding nomenclature, Wu said sometimes the RLD may use non-compendia-standard terms where the Orange Book uses another term, and FDA is concerned that both the RLD and the generic versions include labeling to ensure that pharmacists understand that they are substitutable for one another.

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September 11, 2013

Functional Foods and Dietary Ingredient Safety Considered at FDLI Conference

functional foods.jpgOn September 10, 2013, the Food and Drug Law Institute ("FDLI") hosted a conference, "Safeguarding the Functional Food and Dietary Ingredient Supply Chain". The Conference concerned a variety of emerging requirements and compliance issues for functional foods and dietary ingredient or supplement manufacturers and distributors in view of the FDA Food Safety Modernization Act ("FSMA"). Signed into law on January 4, 2011, FSMA has been called "the most sweeping reform of our food safety laws in more than 70 years." Among other things, FSMA shifts the focus from responding to contamination to preventing it to ensure the U.S. food supply is safe.

The Conference Keynote, Daniel Fabricant, Ph.D., FDA's Director, Division of Dietary Supplement Programs, Center for Food Safety and Applied Nutrition, Office of Foods and Veterinary Medicine, remained throughout the program and provided insights regarding FDA's view on "functional foods" and dietary ingredients. First off, FDA has not officially recognized that there are "functional foods", despite understanding that many people are self-treating based on information gleaned on the Internet or elsewhere with the hopes to either prevent or mitigate potential or current health issues. According to Fabricant, while dietary supplements may make certain health (structure/function) claims with adequate scientific evidence, FDA does not authorize foods to make health claims; instead, FDA considers foods to make statements about taste, aroma, and nutritive values.

In Fabricant's view, it is not clear where industry should go when looking for guidance on functional foods, which are viewed by industry as foods with legal structure/function claims. FDA is concerned about the potential for harm: (1) invisible (hard to detect), (2) conscious (deliberately tainted), or (3) catastrophic (affects many people). Fabricant suggested that energy drinks, for example, have been suggested as a functional food, but many of these products include caffeine, which is a drug or conventional food. But the physical attributes of the product is not the primary determinant. Here, FDA is developing guidance to distinguish liquid dietary supplements from conventional, food-type beverages. What FDA has seen is that companies engage in "category hopping" to pick the category that where they best meet the requirements, but good manufacturing practices ("GMPs") often remain an issue. And in FDA's view, many products over rely on "bad" information rather than "competent and reliable scientific evidence." Here, FDA looks whether a particular claim is substantiated-- what is the meaning of claim, the relationship of scientific evidence to the claim, the quality of evidence, and the totality of evidence in view of the claim. The biggest "pitfall" Fabricant mentioned is an over-reliance on disease treatment studies and confusion regarding intended use.

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September 9, 2013

Clinical Data Management Innovation Conference

Thumbnail image for Thumbnail image for Thumbnail image for Q1 ProductionisPreserving the Integrity and Quality of Captured Data through the Utilization of Innovative Technologies and EDC Systems while Effectively Managing Limited Resources and Oversight of Outsourced Clinical Data Management Team

Throughout the life science industry, executives responsible for clinical data management face a host of escalating challenges as regulatory authorities and internal stakeholders continually demand increased levels of data from clinical studies. As trials have evolved and taken on a role where they are exploring a wide variety of concerns, from regulatory clearance to reimbursement and economic support, the amount of data, and therefore the role of the clinical data manager have become increasingly complex. Adding to this challenge are clinical sites overburdened with multiple studies being conducted simultaneously, varied systems for data collection and entry as well as pressure from clinicians who want the data accessible as soon as possible. Within all of these challenges caused by varied stakeholders, clinical data managers are harnessing technology and new solutions in ways not seen previously, to enable their corporations to excel in research and development and to meet their scientific goals.

This two day conference will take place in Alexandra, Virginia on October 28-29, 2013. Innovative strategies and technologies used by forward thinking companies will be the cornerstone of this conference program, as presenters and audience members discuss methods for ensuring the integrity and quality of clinical data, the evaluation and selection of new technological systems, as well as strategies for ensuring data meets increasingly rigorous FDA requirements. Case studies will show hands on application of advanced technologies, allowing participants an opportunity to road-test the latest and greatest technologies available on the market.

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September 5, 2013

E-Cigarette Use Increase Among Teens Elevates Public Health Concern

Thumbnail image for 120px-Components_of_a_MiniCiggy_e-cigarette.jpgOn September 5, the Centers for Disease Control and Prevention ("CDC") released a Morbidity and Mortality Weekly Report "Electronic Use Among Middle and High School Students - United States, 2011-2012". According to the Report, electronic cigarette or "e-cigarette" use among middle and high school students doubled in just one year from 4.7 percent in 2011 to 10.0 percent in 2013. In the same period, high school students using e-cigarettes within the last 30 days rose from 1.5 to 2.8 percent. Yet among current e-cigarette users in high school (2012), 80.5% reported current conventional cigarette smoking, and current use of both e-cigarette and conventional cigarettes increased from 1.2% to 2.2%.

E-cigarettes are designed to look and feel like conventional cigarettes but do not ignite tobacco leaf products. Instead, they include a vaporizer or atomizer, powered by a battery and controlled by a sensor and microcomputer chip, which heats and vaporizes fluid in a cartridge containing various chemicals. These chemicals often include liquid nicotine derived from natural tobacco plants. Back in 2011, we blogged on an FDA announcement that the Agency would regulate e-cigarettes as "tobacco products" under Family Smoking Prevention and Tobacco Control Act of 2009. At that time, FDA was reacting to a loss that the Agency had in Sottera, Inc. v. FDA, where FDA first had attempted to regulate e-cigarettes as combination drug/devices. In Sottera, the D.C. Circuit Court of Appeals concluded that unless the e-cigarettes were marketed with therapeutic claims, such as smoking cessation or reduction, FDA had the authority to regulate e-cigarettes as "tobacco products," because the nicotine used in the products was obtained from tobacco leaves.

To date, however, FDA has not issued regulations to expand its jurisdiction for "tobacco products" to include e-cigarettes, and, as a result, FDA has little information to understand the types of components or potentially-harmful ingredients contained therein. According to the CDC's Press Release covering this topic, FDA's Director for the Center for Tobacco Products, Mitch Zeller, said reacting to the CDC's Report, "These data show a dramatic rise in usage of e-cigarettes by youth, and this is cause for great concern as we don't yet understand the long-term effects of these novel tobacco products. . . . These findings reinforce why the FDA intends to expand its authority over all tobacco products and establish a comprehensive and regulatory framework to reduce disease and death from tobacco use." So while it remains unclear when FDA will act to regulate e-cigarettes, FDA still seems committed to do so.

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August 30, 2013

FLH's Brian Malkin Quoted in InsideHealthPolicy Article on Call for Shared REMS Rulemaking

RISK.jpgFLH Partner Brian J. Malkin was recently featured in an InsideHealthPolicy's article, "Buprenorphine Decision Spurs Further Call For Shared REMS Rulemaking" The article focused on various suggestions for FDA to initiate rulemaking for shared REMS programs in view of a failed attempt to share a risk evaluation and mitigation strategies program ("REMS") for buprenorphine-containing transmucosal products for opioid dependence ("BTOD"). In the end, FDA permitted a group of generic manufacturers to form their separate but similar shared BTOD REMS.

FDA has not explained the expectations for a shared REMS other than it is up to the parties to negotiate one or request a waiver from FDA if certain conditions are met. The Food and Drug Administration Amendments Act of 2007 ("FDAAA") required generic manufacturers to share certain REMS with Elements to Assure Safe Use ("ETASU"). ETASU REMS include some form of restricted distribution, such as only in hospital settings or certain "registered" pharmacies or prescribed only by physicians with special training or following evidence of safe-use conditions. FDA may waive the shared REMS requirement, if FDA determines the burden of creating a single, shared REMS between competitors outweighs the benefits or an aspect of the ETASU is claimed by a patent, the patent has not expired, and the generic applicant(s) has/have sought a license but was unable to secure a license. If waived, the generic applicant(s) must use a comparable element to assure safe use of the product.

Some of the quotes from Mr. Malkin the article include:

Brian Malkin, a partner at Frommer Lawrence & Haug, said FDA should initiate rulemaking and issue guidance on the shared REMS negotiation process, and consider providing branded companies an incentive like exclusivity to encourage participation in shared risk mitigation plans. The comments came during a public meeting where FDA sought input on standardizing REMS. Drug industry groups and other stakeholders encouraged FDA to limit standardization efforts to drugs with similar risk profiles

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August 28, 2013

IRB Guidance Issued by FDA Requires IRBs to Be Proactive

research.jpgOn August 27, 2013, FDA issued a new guidance, "IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed". An IRB is an appropriately-constituted group that has been formally designated to review and monitor biomedical research involving human subjects. Following FDA's regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. Accordingly, IRBs serve an important role in the protection of the rights and welfare of human research subjects.

The Guidance applies to drugs, biologics, and medical devices and was developed in consultation with the Department of Health and Human Services Office for Human Research Protections ("OHRP"), largely based on recommendations from previously-issued resources. FDA said that it issued the guidance to clarify the Institutional Review Board ("IRB's") responsibilities related to the selection of clinical investigators and research sites, because these items are normally considered a sponsor's responsibility yet they have an impact on the rights and welfare of study subjects. The recommendations in the guidance apply to any IRB, whether serving as a local or centralized review process for multi-site studies. This guidance was developed as part of FDA's and OHRP's efforts to harmonize the agencies' requirements and guidance for human subject protection.

While sponsors of clinical research select clinical investigators who are "qualified by training and experience as appropriate experts," IRBs have a role in reviewing the investigators' qualifications to conduct clinical research as proposed in a study protocol. Depending on the IRB's relationship to the institution conducting the investigation and knowledge of the research, the IRB may already know that a proposed investigator is qualified to conduct the research or may need to dig deeper. In particular, for more high risk investigations, FDA and OHRP expects IRBs to apply a greater amount of scrutiny, especially if the study involves a sponsor-investigator, is outside the investigator's expertise, or involves other characteristics that may increase risk to human subjects. For example, an IRB may observer, or have a third party observe, the consent process and the research.

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August 26, 2013

3rd Annual Medical Device Regulatory Clearance & Approval Conference

Thumbnail image for Thumbnail image for Q1 ProductionisStreamlining Clearance & Approval Processes by Thoroughly Understanding Implications of New FDA Guidances Surrounding 510(K) Device Modifications & Refuse-to-Accept Policy while Successfully Addressing Inconsistency in Reviewer Feedback

The medical device regulatory landscape continues to evolve as new guidances are released by FDA, & global regulatory bodies are emerging or developing stricter guidelines for product approvals. Regulatory affairs executives in the device industry must stay abreast of these changing regulations in order to implement forward-thinking strategies for streamlining product approvals, & ultimately bring new & innovative products to market that will advance healthcare outcomes. The 3rd Annual Medical Device Regulatory Clearance & Approval Conference will build off the success from previous meetings by bringing together perspectives & insights from leading regulatory affairs professionals & innovative device manufacturers on how to ensure positive regulatory clearance & approval decisions in the US & internationally.

This two day conference will take place in Alexandria, Virginia on October 28-29, 2013. Attendees of this year's program will have an exclusive opportunity to gather the latest insights into new & evolving FDA guidances & the implications for device manufacturers. Two key guidances of concern for regulatory affairs executives include the re-release of the 510(K) Device Modifications guidance along with the recent Refuse-to-Accept Policy. Presentations will also address internal strategies for tackling inconsistencies amongst FDA reviewer feedback & an increase in data requirements

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August 21, 2013

GSK Flulaval® Quadrivalent Vaccine Receives FDA Approval

boywithflu.jpgOn June 28, 2013, FDA approved GlaxoSmithKline Biologicals' ("GSK") Flulaval® Quadrivalent (Influenza Virus Vaccine) for the 2013-2014 flu season. Flulaval® Quadrivalent protects against two influenza-A virus strains and two influenza-B virus strains and is approved for ages 3 and older. This season is the first time that vaccines protecting against more than three influenza strains will be commercially available. The other quadrivalent vaccines that are currently available include: Astrazeneca/Medimmune's FluMist® Quadrivalent, GSK's Fluarix Quadrivalent, and Sanofi's Fluzone® Quadrivalent.

Seasonal flu is caused by either type-A influenza strains or type-B influenza strains. Each year, the World Health Organization recommends that vaccines address the two type-A strains that are most common in humans, and the type-B strain that is expected to be the most predominant in the upcoming flu season. Vaccines that protect against three influenza strains are referred to as trivalent vaccines. "Trivalent influenza vaccines have helped protect millions of people against flu, but in six of the last 11 flu seasons, the predominant circulating influenza B strain was not the strain that public health authorities selected," said Dr. Leonard Friedland, V.P. and Head, GSK North America Vaccines Clinical Development and Medical Affairs. Dr. Friedland also noted that, "Trivalent vaccines do reduce influenza risk even in years when a vaccine strain-mismatch occurs, though quadrivalent influenza vaccines are the important next step in broadening strain coverage." For the 2013-2014 flu season, the World Health Organization recommended protection against a second type-B influenza strain.

Three other quadrivalent vaccines have been approved by FDA for the 2013-14 flu season. Fluarix Quadrivalent is an intramuscular vaccine that requires 1-2 doses depending on a person's age and/or vaccination history. It is approved for ages 3 and older. FluMist® Quadrivalent is a live, attenuated vaccine that is administered via intra-nasal spray in 1-2 doses depending on a person's age and/or vaccination history. It is approved for ages between 2 and 49 years. Fluzone® Quadrivalent is an intramuscular vaccine that requires 1-2 doses depending on a person's age and/or vaccination history. It is approved for ages 6 months and older.

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August 20, 2013

Eisai Files Writ of Mandamus to Compel DEA Action Following Citizen Petition to Request Full NCE Exclusivity for BELVIQ® and FYCOMPA® Despite DEA Scheduling Delay

Thumbnail image for DEA Badge.jpgOn August 19, Eisai Incorporated ("Eisai") filed a Writ of Mandamus to Redress Unreasonable Delay by the Drug Enforcement Administration ("Writ") to compel the Drug Enforcement Agency ("DEA") to issue a Notice of Proposed Rulemaking ("NPRM") within ten days of the Writ and otherwise expedite its drug scheduling for Fycompa® (perampanel). According to Eisai, DEA's failure to initiate the scheduling of Fycompa® almost seven months after receiving a scheduling recommendation from the Assistant Secretary for Health ("ASH") "constitutes unreasonable and egregious delay warranting mandamus." In Eisai's opinion, mandamus is warranted because: "(i) many thousands of patients who may benefit from the drug cannot obtain it, (ii) the drug's sponsor is unable to benefit from FDA's approval [of Fycompa®, and (iii) the burden on DEA of scheduling this drug is very small."

Eisai's Writ explained the process where FDA sends its drug scheduling recommendation through the ASH to DEA to initiate a scheduling proceeding "within a reasonable time" to permit the drug to be marketed with the appropriate scheduling safeguards. Under the Controlled Substances Act ("CSA"), if a drug has the potential for abuse, it must be subject to DEA scheduling, which considers "the eight-factor analysis" indicative of abuse potential and places the drug in one of five drug schedules. Schedule II is the most restrictive category where the drug is still accepted to have an accepted medical use, and Schedule V is the least restrictive schedule with an accepted medical use yet a low potential for abuse, physical dependence, or psychological dependence relative to other drugs or substances in Schedule IV.

The CSA permits DEA to add, change, or delete a substance's schedule at any time by FDA/Health and Human Services or by petition from ay interested person or entity. The process that Eisai referred to, however, is the initial approval of a new chemical entity ("NCE"), where there was previously no schedule for the drug substance, and FDA recommends that a drug be scheduled prior to marketing. Although FDA lacks the direct authority to restrict marketing of products with pending DEA scheduling orders, FDA includes FDA Form 356h as a cover sheet for all new drug applications ("NDAs") with a statement that the sponsor will not market until DEA makes a final scheduling decision. In the past, sponsors have honored these commitments to wait for a final scheduling decision before marketing their FDA-approved NDAs. Sponsors have waited despite FDA starting the clock for the five-year NCE exclusivity from the date of FDA's approval letter rather than the final DEA scheduling, i.e., losing exclusive marketing time.

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August 19, 2013

Global Supply Chain Highlighted in FDA Public Meeting Discussing FDASIA's Title VII

globalmap.pngEarlier this month, FDA released the transcript of its July 12, 2013 Public Meeting on Implementation of Drug Supply Chain Provisions of Title VII of the Food and Drug Administration Safety and Innovation Act ("FDASIA"). The day-long public meeting concerned the drug supply chain provisions and was meant to discuss how the Agency means to implement those provisions, and for FDA to hear public comment about those provisions that specifically address imported drugs and importers.

The morning session opened with Margaret A. Hamburg, M.D., Commissioner of Food and Drugs, who spoke on "The Challenges of Globalization." Hamburg praised the passage of FDASIA and recognized FDA's expanded authorities under the legislation. In a theme that was repeated throughout the morning session, Hamburg stressed that the drug supply was becoming "progressively more complex and more global" and that while FDA's mission and focus remain domestic, the reality is that the agency rapidly becoming a global agency. In fact, nearly 40% of all U.S. drugs are made elsewhere, 80% of the sites that manufacture active pharmaceutical ingredients ("APIs") are located outside the U.S, and imports are now coming in from over 150 countries. This global expansion has forced FDA to increase its collaboration with its international regulatory counterparts. The Commissioner highlighted the higher penalties for counterfeit drugs, the proposed rule for the administrative detention of drugs, and the draft guidance on penalties for manufacturers that refuse, delay, limit, or deny FDA inspections as key new developments that should help FDA secure the safety and integrity of the supply chain.

John M Taylor III, Counselor to the Commissioner and Acting Deputy Commissioner for Global Regulatory Operations and Policy, spoke next on "FDA's Globalization Strategy." Echoing the comments of the Commissioner, Taylor noted the increase in U.S. imports that has "eliminated the distinction between domestic and imported products" and recognized the trouble FDA has had keeping up with a more complex drug supply chain that involves more ingredients and more players. Threats to that supply chain include: (1) adulteration of products, (2) counterfeit products, and (3) cargo theft. In particular, Taylor noted how FDA was not prepared--both technologically and statutorily--for the alarming rise in Internet pharmacies and drug products being shipped through the mail and air courier systems.

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August 15, 2013

4th Annual Medical Device and Diagnostic Ethics and Compliance Conference

Thumbnail image for Thumbnail image for Q1 ProductionisKeeping Current on Domestic and International Compliance Regulations, Exploring Best Practices and Lessons Learned in Implementing Sunshine Reporting while Encouraging and Creating a Culture of Compliance

The 4th Annual Medical Device and Diagnostic Ethics and Compliance Conference will take place in Chicago, Illinois on October 21-22, 2013. This annual program will bring together prominent compliance executives as well as representatives from government agencies to discuss current challenges and forward thinking solutions to some of the industry's major hurdles. Through keynote presentations providing high-level perspectives, to roundtable peer-to-peer discussions where attendees will have the opportunity for close-knit conversations, this program will provide compliance teams with the information needed to remain at the forefront of good compliance practices. With Sunshine reporting starting August 2013, the conference will provide attendees with a unique experience; the opportunity to discuss best practices and challenges exposed within the first few months of implementation and execution.

Sessions will explore cutting-edge topics focusing specifically on the top concerns of device and diagnostic compliance professionals. Due to increased scrutiny on international compliance and a growing effort to expand into emerging markets, the conference will focus not only on U.S. compliance regulations but will concentrate on specific international statutes as well. From communicating transparency to health care professionals to fostering a culture of compliance within an organization, attendees will leave with a well-rounded understanding of lessons learned and best practices for compliance in the Device and Diagnostic Industry.

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August 13, 2013

ETASU REMS Sample Process to Be Explained in Upcoming FDA Guidance and FDA to Continue Referring Shared REMS Antitrust Issues to FTC

shareball.jpgOn August 7, FDA issued a response to a Citizen Petition filed by Dr. Reddy's Laboratories, Inc. regarding generic versions of products subject to certain risk evaluation and mitigation strategies ("REMS"). As with many of FDA's responses to citizen petitions in general, FDA granted in part and denied in part the Petition.

According to Dr. Reddy's Petition, certain REMS with elements to assure safe use ("ETASU") may have restricted distribution programs that "significantly limit drug product availability and prevent a prospective generic applicant from obtaining a sufficient quantity of a drug product to conduct required bioequivalence testing and for retained samples." As a result, Dr. Reddy's requested in its Petition, among other things, that: (1) FDA issue guidance for how generic applicants can obtain samples from the reference listed drug ("RLD") for its generic version in these situations, (2) certain statements to be included into REMS that restricted distribution systems will not be used to delay or block generic competition, (3) enforce the Federal Food, Drug, and Cosmetic Act ("FD&C Act") against RLD sponsors who refuse to sell sufficient quantities of the RLD to generic applicants for bioequivalence testing, and (4) refer to the U.S. Federal Trade Commission ("FTC") any complaints that REMS have been used in an anticompetitive manner.

In the Petition, Dr. Reddy's listed as an example where obtaining samples has been problematic Celgene Corporation's ("Celgene's") REMS for Thalomid® (thalidomide) and Revlimid® (lenalidomide). Dr. Reddy's explained how Celgene either ignored Dr. Reddy's requests for samples or said that it had no obligations to provide samples and declined to do so. Dr. Reddy's further cited to statements from a patent litigation between Celgene and Barr Labs., Inc. ("Barr"), now part of Teva, where, according to Barr, Celgene not only refused to supply Barr with samples but also interfered with Barr's ability to obtain the active pharmaceutical ingredient. Celgene, in turn, asserted that Barr engaged in illegal or inequitable conduct by "improperly purchasing the drug from a pharmacy" that was not in accordance with the REMS for Thalomid®.

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August 9, 2013

Non-Biologic Complex Drug at Issue in AMAG Citizen Petition Challenging Bioequivalence Requirements

redbloodcells.jpgAMAG Pharmaceuticals ("AMAG") recently filed a Citizen Petition requesting that FDA apply more stringent bioequivalence standards to potential generic versions of its Feraheme® (ferumoxytol) Injection. Feraheme® is a non-biologic complex drug ("NBCD") indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. Specifically, AMAG requested that FDA: (1) refrain from approving any generic products referencing Feraheme® until post-marketing studies evaluating the therapeutic equivalence another IV iron replacement product to its reference listed drug ("RLD") are complete (Nulecit™ to its RLD Ferrlecit®); (2) require sponsors of generic Feraheme® to show bioequivalence using a comparative study in patients with clinical endpoints; and (3) require generic Feraheme® sponsors to demonstrate bioequivalence using the additional assays being evaluated in the Nulecit™ post-marketing studies.

Ferumoxytol is a colloidal crystal of polynuclear ferric oxyhydroxide encased within a carbohydrate. It is a large, complex chemical entity (approximately 750 kDa) and its chemical structure has not been fully characterized. The carbohydrate serves to encase and sequester the iron moiety until it is taken up by its site of action, the macrophages of the reticular endothelial system ("RES"). In other words, the iron becomes bioavailable only inside the macrophage vesicles. This sequestration function is important because free iron is toxic and causes oxidative stress. Indeed, iron is normally sequestered in the body (e.g. hemoglobin, ferritin) because of this toxicity.

AMAG requests that FDA refrain from approving any generic Feraheme® products until the Nulecit™ post-marketing studies demonstrate that the standards currently established for generic IV iron replacement products are sufficient to therapeutic equivalence. FDA approved Nulecit™ as a generic version of Ferrlecit® in 2011. However, FDA issued a "Sources Sought" notice in April 2013 to determine the availability of third-party businesses to evaluate the therapeutic equivalence of Nulecit™ to Ferrlecit®. In particular, FDA proposed studies of: (1) in vitro phagocytosis to compare RES uptake of generic and RLD; (2) the time-dependent iron content in the major target organs and a comparison of biodistribution in animal models; (3) a prospective, randomized, 2-way crossover study to compare non-transferrin bound iron levels in hemodialysis patients treated with generic and RLD products. AMAG argues that a moratorium on generic approvals of IV iron products is reasonable pending the outcome of these studies. In addition, AMAG requests that FDA require prospective generic applicants perform these studies.

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August 5, 2013

FLH's Brian Malkin Quoted in NYC "Soda Ban" Article in MedPage Today

soda.jpgNew York City has been attempting to take on various health problems by thinking locally by banning or discouraging unhealthy activities such as banning smoking in public places or by disclosing information about trans fats or high calorie foods to discourage their consumption. More recently, New York City proposed a prohibition on certain sugary beverages over 16 ounces in establishments regulated by the city's health department, including food chains such as Subway and Dunkin' Donuts (but not establishments not regulated by the city's health department, such as 7-Eleven and grocery stores). The New York State Supreme Court Appellate Division Panel agreed with a lower court decision from March 2013 finding the ban unconstitutional.

Associate Justice Dianne T. Renwick wrote in an unanimous four-judge panel decision:

The regulatory scheme is not an all-encompassing regulation . . . It does not apply to all sugary beverages. The Board of Health's explanations for these exemptions do not convince us that the limitations are based solely on health-related concerns."

Renwick's sentiments echoed what was said in the lower court by Judge Milton Tingling who wrote in his decision that the proposed regulation was "fraught with arbitrary and capricious consequences" and "loopholes in this rule effectively defeat the state purpose of the rule."

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August 2, 2013

4th Annual Clinical Affairs & Regulatory Approvals for Diagnostics Conference

Thumbnail image for Q1 ProductionisAdvocating for Diagnostic Innovation through Examination of Key Stakeholder Insight Regarding Regulation of Lab Developed Tests, Open and Frank Dialog with FDA Reviewers to Ensure Precise & Compliant Data Collection during Diagnostic Clinical Trials Resulting in Timely Approvals

Diagnostic testing has reached monumental heights providing physicians and patients with lifesaving information and healthcare opportunities. As innovation continues to evolve and tests advance in their complexity, the challenges in assuring regulatory approval increases in tandem. Manufacturers face numerous hurdles in defining clinical evidence to support and secure timely regulatory approval in an increasingly competitive marketplace.

This conference will take place in Alexandria, Virginia on October 21-22, 2013. This comprehensive two-day program will bring together prominent diagnostic clinical and regulatory thought leaders from a variety of leading organizations to share lessons learned as well as expert practices and forward thinking solutions. This dynamic meeting will provide attendees speakers and sponsors with an ideal opportunity to network, knowledge share, and openly discuss challenges and opportunities surrounding clinical affairs and regulatory approvals for diagnostic tests.

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