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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August 1, 2013

Physician Gift Provisions of the Affordable Care Act Kick In Today

gift.pngStarting today, the reporting of all gifts or payments to physicians or teaching hospitals that total over $100 in a year will be required for drug and medical device companies per the new reporting requirements for the Affordable Care Act. These donations will be posted on a publically-accessible, Centers for Medicare and Medicaid Services ("CMS") Internet site starting in September 2014. By decreasing the reporting threshold, this new law will likely make it harder for ethically-suspect activities to slip under public perception, at a cost of greater reporting requirements and an increase in the possible number of false accusations of unethical behavior. Because the reporting is based on the activity of the companies, physicians need not take any affirmative action or even be aware of the activity for their name to be posted.

The detection and prevention of ethics violations presents a trade off between under- and over-diagnosis. As a society, we want a system where ethical lapses are identified and resolved. However, due to the powerful stigma of accusation, it is no surprise that many physicians would prefer to avoid situations that later could be misconstrued as ethically suspect. For example, no physician wants their attendance at an educational conference to result in a random charge of violation of professional responsibilities to patients. This concern may cause physicians to avoid certain educational or other activities rather than worry about the impact of reporting on their reputation. CMS has addressed some of these issues and provided guidelines on what activities are not required to be disclosed, however, there will continue to be uncertainty until the regulation has been practiced for a while and appropriate norms and procedures are developed and agreed upon.

Gifts or payments to physicians fall into a number of different categories with varying levels of public utility. On one side, the sponsorship of medical conferences, continuing education seminars, and research grants are examples of gifts that provide significant public benefit as well as significant personal benefit to physicians. Reducing corporate sponsorship of such events will increase the cost to participants, resulting in a reduced participation in such activities. Physicians are already giving up their time and incurring the opportunity costs to improve their skills and knowledge by attending such events. The reporting aspect may further reduce attendance and learning.

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July 31, 2013

FLH's Brian Malkin Quoted in Unique Device Identifier Rule Article in Medpage Today

UDIdevice.bmpFDA continues to be late in issuing its final rules to implement the unique device identifier ("UDI") system authorized in 2007. Congress had requested that FDA finalize the rule by June 19, 2013, but FDA's latest action has been its proposed rules published in the Federal Register on July 10, 2012.

A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date. A UDI system has the potential to improve the quality of information in medical device adverse event reports, which will help FDA identify product problems more quickly, better target recalls and improve patient safety.

FDA is also reportedly creating a database that will include a standard set of basic identifying elements for each UDI, which it plans to make generally available to the public so that medical device users can easily find more information about specific devices. The UDI does not indicate and FDA's database will not contain any information about who uses a device, including any personal privacy information.

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July 30, 2013

FDA REMS Public Meeting Highlights from the Bench--Part 2 of 2

RISK.jpgThis is part two of a summary of an FDA public meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies ("REMS") held in FDA's White Oak campus on July 25-26, 2013. On both days, public speakers offered their views on how to standardize REMS and better evaluate whether individual REMS elements are working to reduce the risks intended. FDA requested speakers to post their slide decks on the docket for this meeting, Docket No. FDA-2013-N-0502, as well as additional comments prior to September 16, 2013 to be considered for the REMS Integration Initiative Report.

While a variety of comments were made by speakers, many of the comments circled back to similar themes. Below is an attempt to capture a flavor of many of the comments, but more details will be made available in the coming month or so in FDA's Docket. None of the speakers knew who was going to speak or on what topics/viewpoints, and many of the comments reflected company speeches that had been approved in advance of the meeting. Therefore, there was a certain amount of repetition of topics, which I have tried to reduce where possible, which resulted in a somewhat skewed summary leaning towards earlier speakers. For example, multiple speakers, including pharmacy chains such as CVS Caremark, recommended a single REMS portal to process claims in a more efficient workflow rather than multiple websites and portals that put an increased burden on the healthcare system.

  • On the first day, the Pharmaceutical Research and Manufacturers of America ("PhRMA") (Sarah A. Spurgeon) kicked off the public session with a request for using the same REMS elements for the same risks, a "one-stop-shop" for all REMS systems on the Internet with a link to all REMS websites with less paperwork, an FDA logo for REMS-official programs, and templates for risk communication. Another PhRMA speaker on the second day (Sarah A. Spurgeon) supported research to determine the most effective REMS elements and asked FDA to consider selectively removing elements from REMS after proper assessment tools are validated. Also on the second day, FDA asked PhRMA to go its members and try to gather data concerning assessment tools and data whether those REMS tools are working, as well as whether post approval REMS are being streamlined or additional elements are being added in the interest of further risk management that may be increasing the burden on the healthcare system.

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July 29, 2013

FDA REMS Public Meeting Highlights from the Bench--Part 1 of 2

RISK.jpgOn July 25 and 25, 2013, FDA held a public meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies ("REMS"), which we previously announced here. During the two days, FDA heard from a variety of public speakers from the healthcare and regulated industry, trade associations, the risk management support community, and law, which was interspersed with FDA's observations and activities to date.

FDA's Chair for the meeting, Theresa Toigo, R.Ph., M.B.A., Associate Director for Drug Safety Operations, Center for Drug Evaluation and Research ("CDER") provided opening remarks and managed the diverse group of speakers. Toigo explained that the most recent Prescription Drug User Fee Act ("PDUFA") V provided FDA with the authority and mandate to take a closer look at REMS under its REMS Integration Initiative and determine ways to reduce the burden on the healthcare system to administer the myriad of REMS programs. One thing FDA has already done, Toigo explained, was reduce the number of REMS from about 200 REMS in the beginning of 2013 to 72 REMS as of July 2013--many of these being MedGuide-only REMS. Of these 72 REMS, there are 66 individual drugs with 6 shared REMS programs included in approximately 84 applications, she explained.

According to Toigo, FDA has been hearing that some physicians have been avoiding REMS products because of the extra paperwork and other requirements, whereas the intent for REMS is to better control the risk factors for a particular therapy. In FDA's view, Toigo explained, REMS are more than just filling out paperwork or providing repetitious messages, and FDA continues to hear in the standardization meetings that "one size does not fit all." FDA's requirements for and review of REMS has been facilitated by industry's view point, in particular the business processes and assessments, which FDA hoped to hear more of during the two-day meeting.

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July 25, 2013

ADHD-Diagnosing Device NEBA Approved--First of its Kind

ADHDBrainWaveDevice.jpgOn July 15, FDA announced its approval of the first brain- function-based medical device to help diagnose attention deficit hyperactivity disorder ("ADHD") in children and adolescents. The approved device, the Neuropsychiatric Electroencephalogram-Based Assessment Aid ("NEBA") System, uses an electroencephalogram ("EEG") to measure brain waves with sensors attached to a child's head, which are wired to a computer. After fifteen to twenty minutes of information-gathering, it provides a read-out of the types and timing of electrical impulses, i.e., waves, emitted by brain nerve cells. Because two kinds of brain waives--theta and beta--may be more common in ADHD children, physicians can use this information to confirm an ADHD diagnosis or direct further diagnostic testing.

EEG technology has been around since the early 1900s and is often used to diagnose sleep disorders, measure unconsciousness, evaluate the brain post-head trauma, and monitor the brain during surgery. ADHD, which results in attention difficulties, hyperactivity, impulsivity and behavioral problems, is one of the most common neurobehavioral disorders in childhood. According to the American Psychiatric Association, nine percent of U.S. adolescents have ADHD and the average age of diagnosis is seven years. "Diagnosing ADHD is a multistep process based on a complete medical and psychiatric exam," explained Christy Foreman, director of the Office of Device Evaluation at the FDA's Center for Devices and Radiological Health ("CDRH")

The manufacturer of the NEBA System, NEBA Health of Augusta, Georgia, provided FDA with data including a clinical study that evaluated 275 children and adolescents (ages 6 to 17 years) with attention/behavioral issues, using both the approved device and standard diagnostic testing such as questionnaires and physical exams. An independent group of ADHD experts also reviewed the data and reached a consensus as to whether each subject had ADHD. According to FDA, the side-by-side results "showed that the use of the NEBA System aided clinicians in making a more accurate diagnosis of ADHD when used in conjunction with a clinical assessment for ADHD, compared with doing the clinical assessment alone."

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July 23, 2013

ITC Investigations Faster than Before

ITC Building.pngSection 337 investigations before the International Trade Commission ("ITC" or "Commission") already proceed at a fast pace. But in keeping with its goal of completing investigations expeditiously, on June 24, 2013, the Commission announced its plan to speed up the process. The Commission stated in a press release that it will select certain investigations for inclusion in a new dispositive-issue pilot program. For an investigation that contains potentially case-dispositive issues--including the existence of a domestic industry, whether proof of importation of an accused product exists, and whether the complainant has standing to participate in an investigation--the Commission will direct the assigned Administrative Law Judge ("ALJ") to resolve the dispositive issues within 100 days of institution of the investigation.

Under current ITC practice, an ALJ does not rule on such dispositive issues until the summary-determination stage of an investigation or until he or she issues an initial determination after a trial-type hearing. Both of these events, however, occur after months of discovery have taken place on all issues, dispositive and non-dispositive alike. And in the summary-determination stage, the ALJ may find that issues of fact prevent resolution of the investigation without holding a hearing on all pending issues. By this time, the parties have expended considerable resources litigating the investigation. The pilot program seeks to "limit unnecessary litigation, saving time and costs for all parties involved."

For an investigation assigned to the program, the Commission will direct the ALJ to rule on a specific dispositive issue early in the investigative process. For instance, under 19 U.S.C. § 1337(a)(2)-(3), complainants accusing respondents of importing products that infringe the complainants' intellectual-property rights must establish that a domestic "industry" exists or is in the process of being established in the United States with respect to those rights. If the Commission determines at the institution of the investigation that a particular complainant likely cannot establish the existence of a domestic industry, it will direct the ALJ assigned to that case to "rule on that issue early in the investigation through expedited factfinding and an abbreviated hearing limited to the identified issue."

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July 22, 2013

Patent Troll Legislation Receives Increasing Support

troll.jpgLarge companies have long pointed to non-patent entities ("NPEs") for abusing the patent system by buying patent portfolios and using litigation, or the threat thereof, to force licensing fees and settlements. In contrast, the patent-holding companies argue that they are asserting legally-obtained rights against huge corporations that are using other people's innovations for profit. Based on legislation in Congress, as well as a proposal from President Barack Obama, it appears that the desire for anti-"patent troll" measures is gaining traction by both parties. The legislation has primarily taken a practical approach of targeting problematic tactics used by NPEs. Six pieces of legislation have been introduced or proposed in Congress including the Shield Act, the Patent Abuse Reduction Act, the End Anonymous Patent Act, the Patent Quality Improvement Act, and an act introduced by the leaders of the House and Senate Judiciary Committees.

The Saving High-Tech Innovators from Egregious Legal Disputes Act of 2013, or Shield Act, (H.R. 6245) was introduced in the House in February. It defines a "troll" as a patent owner who did not do the inventing behind the patent and does not exploit it by making a product. A patent owner that fits those criteria and loses an infringement case would be responsible for its opponents' costs under the Bill. The Bill would also allow an accused infringer to move early in the case for a judgment that the patent owner is a NPE required to pay litigation costs if it loses.

The Patent Abuse Reduction Act (S. 1013), introduced in the Senate in May, would mandate that any patent infringement complaint include 14 separate pieces of information that are not currently required. The requirements include identifying each product or feature alleged to infringe the patent, including name or model number; an explanation of how the asserted claim corresponds with the accused function "with detailed specificity," a description of the plaintiff's principal business and right to assert the patent; and a list of every other suit in which the patent has been asserted. To reduce discovery costs, the Bill would require any party in patent litigation to cover the cost of discovery beyond "core documentary evidence," which includes documents that relate to the conception of the patent and potentially invalidating prior art. The Bill would also mandate that the prevailing party in patent litigation be awarded reasonable costs and expenses, including attorneys' fees, unless "the position and conduct of the nonprevailing party were objectively reasonable" or "exceptional circumstances make such an award unjust."

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July 18, 2013

Gilotrif® with Therascreen EGFR PCR Kit Approved for Lung Cancer Treatment

lung-cancer-500x360.jpgFriday, FDA approved Boehringer Ingelheim's drug, Gilotrif® (afatinib), to treat patients with late-stage metastatic Non-Small Cell Lung Cancer ("NSCLC"). Gilotrif® is a tyrosine kinase inhibitor that inhibits cancer-causing proteins. NSCLC is any type of epithelial lung cancer other than small cell lung cancer ("SCLC"). The most common types of NSCLC are squamous cell carcinoma, large cell carcinoma, and adenocarcinoma. Although NSCLCs are associated with cigarette smoke, adenocarcinomas may be found in patients who have never smoked. As a class, NSCLCs are relatively insensitive to chemotherapy and radiation therapy compared with SCLC.

Gilotrif® targets specific proteins caused by epidermal growth factor receptor ("EGFR") gene mutations, which are present in about 10 percent of NSCLC patients. Specifically, Gilotrif® targets proteins expressed by EGFR exon 19 deletions and exon 21 L858R substitutions. The drug is being approved concurrently with a companion diagnostic kit that helps determine if a patient's lung cancer cells express EGFR mutations. The kit is called therascreen EGFR RGQ PCR Kit, and is made by Qiagen N.V.

FDA approval of Gilotrif® for NSCLC is a big deal. Lung cancer is the number one cause of cancer-related deaths and NSCLC makes up about 85% of all lung cancers. An estimated 160,000 people will die in the U.S. from lung cancer this year, according to the National Cancer Institute, and 1.38 million deaths worldwide are attributable to lung cancer. Lung cancer is the cause of 18% of all cancer deaths.

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July 17, 2013

Facility Inspection Guidance Issued by FDA: Delaying, Denying, Limiting, or Refusing a Drug Inspection

magnifying glass.jpgOn July 12, 2013 FDA issued new Guidance for Industry: Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection. The Guidance document illustrates circumstances where the FDA will treat the occurrence as contrary to section 501(j). These are divided into four sections: (1) Delay of Inspection, (2) Denial of Inspection, (3) Limiting of Inspection, and (4) Refusal to Permit Entry.


FDA, under the jurisdiction of the Federal Food, Drug & Cosmetic Act ("FD&C Act") Section 704(a), has the authority to carry out inspections of facilities by duly appointed FDA employees. These inspections are to be undertaken at reasonable times, within reasonable limits and in a reasonable manner.

FDA has not always been able to carry out its tasks. Consequently, in light of the recent Food and Drug Administration Safety and Innovation Act ("FDASIA"), which was signed into law in July 2012, and in particular Section 707 of FDASIA, which added 501(j) to the FD&C Act, the FDA now deems as adulterated a drug that "has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection". (emphasis added)

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July 15, 2013

Q1 Global Risk Management Conference Provides Insight for Upcoming FDA Public REMS Meeting

RISK.jpgOn July 11-12, Q1 Productions hosted a conference, Global Risk Management & Regulatory Policy. In some ways, the conference served as an industry-focused prelude for discussion of many of the topics that plan to be discussed at an upcoming FDA meeting on July 25 and 26 on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies ("REMS"). The Conference featured presenters from industry, academia, consultants, and law, where controversial topics such as REMS assessments and shared REMS could be discussed by both innovator and generic companies in a collaborative setting.

The Conference started off with two presentations designed to provide a set of tool kits for optimizing REMS for maximum risk management effectiveness (Barbara Troupin, MD, MBA, Vice President, Scientific Communications & Risk Management, Vivus), and streamlining them for efficiency (Charles Tressler, Senior Director of Safety Surveillance & Risk Management). Christopher Milne, DVM, MPH, JD, Director of Research, Tufts Center for the Study of Drug Development, next presented an overview of a REMS report issued by the Office of Inspector General ("OIG"), Department of Health and Human Resources, entitled, "FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety" issued in February 2013. Milne explained that the OIG found that FDA's experiment of essentially renaming risk management programs from Risk Minimization Action Plans ("RiskMAPs") to REMS did not appear to be much of an improvement (only 22% thought it was better). The OIG found that sponsors were developing REMS too late in the product development, inconsistently submitting the required assessment reports, and the assessment reports were either incomplete or not useful to determine whether the product's risks were being appreciably reduced by the REMS.

Milne believes that FDA is holding the upcoming public REMS meeting and has proposed a five-year analysis and integration plan to prevent further Congressional attention to REMS in the next prescription drug user fee act ("PDUFA"), expected in 2017. According to Milne, every year FDA plans to carefully review one REMS with Elements to Assure Safe Use ("ETASU"), e.g., restricted pharmacy settings or specialized training for physicians and pharmacies, registries, to improve its efficiency and risk minimization tools. Milne suggested (and various conference attendees agreed) a REMS 101-type of class is likely needed to make REMS more productive. For instance, it would be useful to collect public information about the pros and cons of all REMS tools, as well as consider ways to make REMS implementation less burdensome for physicians and patients alike. Milne noted that there are now case studies demonstrating that REMS place a large burden on patients and the health system, denying patients access to certain needed drugs with a REMS. And at the same time, sponsors are unsure what elements to include in their REMS, because FDA can at the same time complain that a REMS fails to disclose offlabel use risks, while at the same time allege that the REMS misbrands the product by suggesting the offlabel uses.

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