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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 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.

DOWNLOAD THE COMPLETE BROCHURE HERE

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

December 6, 2013

Working Together in a Single Shared REMS System ...

is a beneficial yet challenging task. In May 2013 Prometheus Laboratories submitted a Citizen Petition to the FDA, requesting more guidance on rulemaking on the standards and processes for establishing a single, shared Risk Evaluation and Mitigation Strategies ("REMS") System. One of the stated reasons why Prometheus asked for greater clarification of the single, shared REMS process is the concern over antitrust risk. Antitrust issues associated with REMS and the benefits and challenges of a collaboration in a single shared REMS are two hot topics on the agenda of the

6th Risk Evaluation and Mitigation Strategies Summit
at the Westin Alexandria, January 28-29th 2014 in Alexandria, VA

RESERVE YOUR SEAT TODAY and save up to $300
EARLYBIRD EXPIRES DECEMBER 13th 2013
Please Use Priority Code: C453MP1

This event features a cross section of small to large pharmaceutical companies, pharmacy organizations, hospitals, academia and solution providers and provides a platform to share best practices and leverage fruitful discussion with regards to:

C453-photostrip.jpg
DOWNLOAD THE COMPLETE BROCHURE HERE

Hot topics include:

  • Get an update on the FDA's report
  • Highlight Antitrust issues raised by REMS programs
  • Address challenges and opportunities in a single shared REMS and REMS that involve CME
  • 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

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October 29, 2013

FLH Partner Brian Malkin Quoted in Inside Health Policy on FDA's Response to Prometheus's Citizen Petition

duelingsquirrels.jpgOn October 24, 2013, FLH Partner Brian J. Malkin was quoted on an Inside Health Policy article "FDA Denies Shared REMS Petition; But Guidance, Rulemaking A Possibility". Some background on this topics may be found in a previous blog here.

Building upon a recent presentation made at the 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, Mr. Malkin suggested another way that FDA could find the resources to assist in the collaboration between innovator and generic companies to develop shared REMS programs: user fees from generic drug companies to help fund the process and development of guidance and initiate a notice-and-comment rulemaking.

FDA's decision to the Prometheus Citizen Petition said FDA may consider regulation or guidance as it gains more experience with the development of shared REMS, particularly in an environment where there is only the innovator's product prior to generic entry. FDA's response, however, denied the request for rulemaking at the present moment. FDA's response suggested that FDA thought a shared REMS was possible because it has been accomplished before, despite the innovator's concerns for resource commitments and potential risks arising from antitrust law and product liability. To the extent that FDA listed examples where a shared REMS worked, however, there were few contentious issues concerning patents such as patents on the REMS itself or complexities involved in obtaining the innovator's product without circumventing or avoiding the REMS for bioequivalence testing purposes. FDA also denied Prometheus with an opportunity to directly participate in the process to determine whether FDA would waive the requirement for ANDA applicants to agree to a single, shared REMS with the innovator for a product with a REMS with elements to assure safe use. In this regard, FDA said that it would invite comments, however, from both innovator and generic companies on the process to develop a single, shared REMS. FDA reserved the right to determine by specific request or on its own whether a waiver should be granted based on its evaluation of the burdens and benefits to create a single, shared REMS.

Continue reading "FLH Partner Brian Malkin Quoted in Inside Health Policy on FDA's Response to Prometheus's Citizen Petition" »

October 25, 2013

Shared REMS Editorial Published in Financier Worldwide by FLH Partner Brian J. Malkin

stepontoes.jpgFinancier Worldwide published an editorial by FLH Partner Brian J. Malkin on shared REMS in its October 2013 edition entitled, "Will the FDA provide more guidance or manage the process to share risk evaluation and mitigation strategies (REMS)?". Prior to FDA's response to the Prometheus Citizen Petition reported in our blog here, Mr. Malkin discussed his opinion whether FDA would undertake a more proactive process to manage shared risk evaluation and mitigation strategies ("REMS"). Mr. Malkin's analysis includes an overview discussion of the issue, namely negotiating the process whereby innovator and generic companies can work together to implement a shared REMS program. In the past, such negotiations have been particularly problematic when elements of the REMS were protected by patents or the negotiating parties were involved in a Hatch-Waxman litigation scenario.

In various citizen petitions and at FDA's Public Meeting Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS) on July 25-26, it has been suggested that FDA take a more proactive role to bring innovator and generic companies together to form a new shared REMS. The shared REMS would provide a platform for all parties to work toward a common goal for effective patient risk management. In addition, FDA could take a more proactive role as part of its REMS standardization process to provide more open information concerning REMS assessments for the industry to better understand what REMS elements work best. Presently, FDA has provided little guidance how the parties are expected to negotiate a shared REMS when there are outstanding issues of compensation, liability, and control under the backdrop of patents or proprietary information.

FDA Lawyers Blog and FLH would like to make sure that you have a chance to read Mr. Malkin's editorial, so we are providing a copy for download here. We hope that this helps to stimulate some additional thought and discussion about the topic.

October 18, 2013

Prometheus Shared REMS Petition Denied for Now But FDA Leaves Door Open

duelingsquirrels.jpgOn October 7, 2013, in the midst of the government shutdown, FDA responded to a Citizen Petition filed by Prometheus Laboratories, Inc. ("Prometheus") concerning shared risk evaluation and mitigation strategies ("REMS"), FDA Docket No. FDA-2013-P-0572. In its Petition, Prometheus requested "complete notice and comment rulemaking establishing the standards and processes for a single, shared REMS [Risk Evaluation and Mitigation Strategies]" and waivers for the requirement for a single, shared REMS. Prometheus also requested that it be given notice and the opportunity to engage in any process used by FDA to determine whether to grant a waiver from the requirement for a single, shared REMS for Lotronex® (alosetron hydrochloride). Additional details concerning their Petition may be found in a previous blog here.

As with many citizen petition responses these days, FDA granted the Petition in part and denied it in part, but for now the requests were essentially denied. First, FDA said that it was still deciding whether to initiate notice-and-comment rulemaking or issue guidance for single, shared REMS system development and denied this request at this time. Instead, FDA described how it has handled other single, shared REMS with elements to assure safe use ("ETASU") where the statute mandates innovator and generic companies to work together to implement a single, shared REMS rather than having multiple programs that create an additional healthcare burden. First, FDA said that it notifies both the innovator and generic companies of the single, shared REMS requirement. The Petition states that then:

FDA has expected that negotiation of the single, shared REMS would begin promptly thereafter, and would proceed concurrently with the review of the ANDA [abbreviated new drug application] application. . . .


In addition to monitoring the IWG's [industry working group's"] progress on developing a REMS, FDA has acted to help ensure that sponsors were cooperating and that there were no obstacles to developing a single, shared system. When a company indicated to the Agency that another company (brand or generic) was not receptive or responsive to such efforts, the Agency has held teleconferences, individually or jointly, with firms involved, and/or has asked them to come to FDA for face-to-face discussions to help facilitate resolution of any issues that were preventing moving forward on a single, shared
system. . . .

Unlike the elements of the REMS, which are reviewed and approved by FDA, cost-sharing, governance, and other business issues relating to the implementation of single, shared REMS are left to the discretion of the sponsors.

Continue reading "Prometheus Shared REMS Petition Denied for Now But FDA Leaves Door Open" »

September 20, 2013

HHS Adverse Event Plan Mentions FDA but Focuses on CMS as a Central Actor

HHSOn September 4, 2013, the Department of Health and Human Services ("HHS") released a report entitled "National Action Plan for Adverse Event Prevention" ("Plan"). The 176-page report purports to "engage all stakeholders in a coordinated, aligned, multi-sector, and health literate effort to reduce ADEs [adverse drug events] that are most common, clinically significant, preventable, and measurable." For this effort, the Plan focused on the intended end-users, "policymakers, health care professionals, public and private sector organizations, and communities who can organize and take action toward preventing high-priority ADEs." The high priority targets identified to prevent ADEs are the drug classes of anticoagulants, diabetes agents, and opioids. The four-pronged approach includes: surveillance, prevention, incentives and oversight, and research.

ADEs may occur in both inpatient (hospital) and outpatient and long-term settings. According to statistics cited in the Plan, ADEs account for about two million hospital stays annually and prolong hospital stays by about 1.7 to 4.6 days. ADEs in outpatient settings account for reportedly over 3.5 million emergency department visits, resulting in 125,000 hospital admissions each year.

The Plan acknowledges that a certain amount of passive (voluntary) reporting of ADEs comes via FDA's Adverse Event Reporting System ("FAERS") as well as FDA's Sentinel Initiative that monitors over 125 million lives but, the Plan says, "which do[es] not constitute a nationally representative sample, but for specific studies, FDA's Sentinel Initiative has the potential to access health records to confirm coded data or provide additional data." FDA's Sentinel Initiative was established in response to the FDA Amendments Act ("FDAAA") passed in 2007, which mandated that FDA establish an active surveillance system for monitoring drugs, using electronic data from healthcare information holders. The goal of the Sentinel Initiative is a new active surveillance system that could be used to monitor all FDA-regulated products. In particular, the Sentinel System draws on existing automated healthcare data from multiple sources to actively monitor the safety of medical products continuously and in real time.

Continue reading "HHS Adverse Event Plan Mentions FDA but Focuses on CMS as a Central Actor" »

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
.

Continue reading "FLH's Brian Malkin Quoted in InsideHealthPolicy Article on Call for Shared REMS Rulemaking" »

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®.

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

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.

Continue reading "FDA REMS Public Meeting Highlights from the Bench--Part 2 of 2" »

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.

Continue reading "FDA REMS Public Meeting Highlights from the Bench--Part 1 of 2" »

July 25, 2013

REMS Public Meeting at FDA White Oak Campus - FLH Partner Brian J. Malkin to Present on Shared REMS and Attend

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.

The docket for written comments will remain open indefinitely. However, submit comments no later than September 16th to be considered for FDA's report of its findings on standardization and identification of priority projects.

Update:

Background materials are now available on FDA's website here.

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.

Continue reading "Q1 Global Risk Management Conference Provides Insight for Upcoming FDA Public REMS Meeting" »

July 11, 2013

FLH Partner Brian J. Malkin Speaks on Shared REMS at Q1 Productions' Risk Management Conference in Alexandria, VA

On July 11, FLH Partner Brian J. Malkin will speak at Q1 Productions' Global Clinical Risk Management & Regulatory Policy Conference in Alexandria, VA on the topic "Developing a Single, Shared REMS in a Collaborative Setting". The session description reads:

The FDA approves single, shared REMS for product categories with similar risk management programs to help relieve some of the burden on healthcare providers and pharmacies. The development of shared REMS requires that multiple companies and the FDA work in tandem to unify data and risk minimization systems, a model which some companies have also used to help organize risk management plans internationally. By ensuring a strong cross-corporate collaboration, internal regulatory policies, data analysis and communication systems can be synchronized internationally for advanced risk management programs.
  • Structuring lines of communication within shared REMS network
  • Establishing similar regulatory policies
  • Utilizing data from all companies for international RMP development.

The Conference will be held on July 11-12, 2013. Throughout this two-day program, executive from industry will have an opportunity to discuss and debate the many challenges associated with profiling the risk of products as well as minimizing these risks and meeting regulatory expectations. As with all Q1 programs, the focus of the event will not only lie upon the educational content, but also providing attendees with an opportunity to network and build relationships across this highly dynamic and evolving market.

July 8, 2013

Q1 Productions' REMS Session Features FLH Partner Brian J. Malkin

Q1 ProductionisOn July 11-12, Q1 Productions ("Dedicated to Quality First®) will be hosting in Alexandria, Virginia, its Global Clinical Risk Management & Regulatory Policy Program: Implementation of Advanced Risk Management Plans that Increase the Effectiveness of Risk Assessment and Mitigation, while Increasing Drug Safety and Meeting Regulatory Policy & Guidance on a Global Level. FLH Partner Brian J. Malkin is featured to speak on July 11 with the topic: "Developing a Single, Shared REMS in a Collaborative Setting". The session description for Mr. Malkin's presentation states:

The FDA approves single, shared REMS for product categories with similar risk management programs to help relieve some of the burden on healthcare providers and pharmacies. The development of shared REMS requires that multiple companies and the FDA work in tandem to unify data and risk minimization systems, a model which some companies have also used to help organize risk management plans internationally. By ensuring a strong cross-corporate collaboration, internal regulatory policies, data analysis and communication systems can be synchronized internationally for advanced risk management programs.


  • Structuring lines of communication within shared REMS network

  • Establishing similar regulatory policies

  • Utilizing data from all companies for international RMP development.

Q1 Productions' program will provide executives from industry with the opportunity to discuss and debate the many challenges associated with profiling the risk of products, as well as ways to minimize these risks and meet regulatory expectations globally. All Q1 programs not only provide valuable educational content but also include attendees with opportunities to network and build relationships across highly dynamic and evolving markets.

Mr. Malkin hopes to see you there and welcomes individuals to contact him with related questions in this rapidly evolving field.