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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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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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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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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On July 25 and 26 FDA will hold a Public Meeting at its White Oak campus on risk evaluation and mitigation strategies (“REMS”). FLH Partner Brian J. Malkin plans to attend to take advantage of many of the lessons learned at a recent Q1 Productions Global Risk Management Conference blogged on here. Mr. Malkin is schedules to speak on a panel on Thursday, July 25, on shared REMS. According to FDA’s website for the Public Meeting topics to cover include:

[I]nput on issues and challenges associated with the standardization and assessment of risk evaluation and mitigation strategies (REMS) for drug and biological products. As part of the reauthorization of the Prescription Drug User Fee Act (PDUFA), FDA has committed to standardizing REMS to better integrate them into, and reduce their burden to, the existing and evolving health care system. As part of the PDUFA commitments, FDA will also seek to develop evidence-based methodologies for assessing the effectiveness of REMS.

To obtain input from stakeholders about REMS standardization and evaluation, FDA will hold a public meeting to give stakeholders, including health care providers, prescribers, patients, pharmacists, distributors, drug manufacturers, vendors, researchers, standards development organizations, and the public an opportunity to provide input on ways to standardize and assess REMS.

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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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.

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Written by Shelly Fujikawa. Ph.D

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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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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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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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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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