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DIA's Content Currents provides you with new and important global regulatory developments and their impact on pharmaceutical, biotechnology, and medical product development.

EDITION PUBLISHED: September 12, 2014

SECTION 1 FDA GUIDANCES & MAPPS

CDER List of Guidance Documents

CDER Guidances: New/Revised/Withdrawn through 6/30/14

The links above lead to the List of Guidance Documents (CDER) updated on July 7, 2014, and to CDER Guidances that are new, revised, or withdrawn through the second calendar quarter of 2014.

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2014 (PDF - 31KB)

CDRH FY 2014 Proposed Guidance Development

On September 8, 2014, FDA posted corrections to the Final Rule entitled “Postmarketing Safety Reports for Human Drug and Biological Products; Electronic Submission Reports.”   The FDA is correcting the final rule that appeared in the Federal Register of June 10, 2014 (79 FR 33072). The document amended FDA’s postmarketing safety reporting regulations for human drug and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. The document was published with an incorrect RIN number. This document corrects the error.  On page 33073, in the third column, the RIN number heading is corrected to read ‘‘RIN 0910–AF96’’.

The FDA has also posted in the September 8, 2014, Federal Register a correction to the posting in the Federal Register of August 14, 2014 (79 FR 47655). The document published without the required RIN number and in the Notice category.  On page 47655, in the first column, add the heading ‘‘RIN 0910–AF96’’ between the Docket No. and the title of the document. [Federal Register]

On September 9, 2014, FDA announced the publication of the “Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.”  These lists are designed to help enable a user to see whether a particular biological product has been determined by the Food and Drug Administration (FDA) to be biosimilar to or interchangeable with a reference biological product. The lists cross-reference the names of biological products licensed under section 351(a) of the Public Health Service Act (PHS Act) with the names of biosimilar or interchangeable biological products licensed under section 351(k) of the PHS Act by the FDA (see below for an explanation of the sections 351(a) and 351(k) of the PHS Act). There will be separate lists for those biological products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).  More at link.  [FDA.gov]

On September 10, 2014, FDA released a guidance entitled “Unique Device Identification System: Small Entity Compliance Guide.” This small entity compliance guide (SECG) intends to provide, in plain language, the requirements of the regulation and to help small businesses understand and comply with the regulation. [Federal Register]

On September 10, 2014, FDA issued a final order entitled “Medical Devices; Immunology and Microbiology Devices; Classification of Dengue Virus Nucleic Acid Amplification Test Reagents.” FDA is classifying dengue virus nucleic acid amplification test reagents into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.  The order will be effective October 10, 2014. [Federal Register]

On September 10, 2014, FDA corrected a proposed rule entitled ‘‘Revocation of General Safety Test Regulations That Are Duplicative of Requirements in Biological License Applications’’ that appeared in the Federal Register of August, 22, 2014. The document proposed to amend the biologics regulations by removing the general safety test requirements for biological products. The document published with the incorrect title. This document corrects that error. [Federal Register]

On September 12, 2014, FDA announced that OMB has approved a collection of information entitled ‘‘Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing.” OMB control number 0910–0772 has been assigned, and the approval expires on August 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.  [Federal Register]


SECTION 2 FDA NOTES & RELATED NEWS

Updated List of CDER Key Officials Posted

The FDA Has Approved How Many Novel New Drugs So Far This Year?
For those who like to track the progress at FDA, here is a significant and up-to-date metric.

So far this year, the agency has approved 27 novel new medicines, a tally that includes biologics and which matches the 27 such medicines approved for all of 2013. At this rate, the FDA may come close to matching the 39 novel new medicines approved in 2012.

In general, the number of such drugs approved each year by the FDA is closely watched as a sign of agency efficiency.  Twenty-four of the 27 novel new medicines approved in 2013, or 89%, took place during the “first cycle” of review. This means the approvals occurred without requests for additional information that would delay approval and lead to another review cycle. Approvals for 74% of the new medicines first took place in the U.S., before other countries. 

More at link above.  (WSJ, Pharmalot)

FDA Reviewers ask Advisory Committee for CV 'polypill' development pathway
FDA reviewers asked the agency's Cardiovascular and Renal Drugs Advisory Committee for advice on a development pathway for fixed-dose combination therapies for hypertension. In briefing documents released ahead of a Wednesday meeting, the reviewers discussed "polypills" that could overcome poor adherence to multiple medications, an issue that reduces efficacy in preventing cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke in patients with a history of CV disease.

The advisory committee will review trial data of different polypills and discuss the clinical utility of fixed-combination products comprising one or more anti-hypertensive drugs, aspirin and a statin. The committee will be asked what patient population could benefit from a polypill and if sufficient adherence could be achieved without rigorous monitoring.  (BioCentury)

Surrogate Endpoints Are Dangerous Path for New Antibiotics - JAMA Editorial
Executive Summary: Expedited pathways for acute bacterial infection treatments may increase number of new products at expense of safety and effectiveness, University of Washington doctors warn in JAMA Internal Medicine.

Recent antibiotic approvals have come at the expense of rigorous scientific standards and FDA and industry’s current focus on creating new expedited approaches to incentivize further antibiotic development may repeat such patterns, allowing for the approval of potentially ineffective or harmful therapies, a JAMA Internal Medicine opinion piece argues.  Surrogate endpoints in particular were criticized: Surrogate endpoints “simply don’t make sense for acute bacterial infections,” because they introduce uncertainty without offering any advantage, according to the authors.

The JAMA article points to two guidances as changing the evidentiary standard for new antibacterial therapies: FDA’s May 2014 final guidance on expedited pathways, which indicates FDA is open to accelerated approval for some acute conditions, and a July 2013 draft guidance on antibacterial therapies for patients with unmet need for the treatment of serious bacterial diseases, which discusses using surrogate endpoints.

Though the need for more antibiotics is well agreed upon, the authors caution “lowering scientific standards for expedited drug approvals” – while likely to increase the number of antimicrobial drugs on market – “may have little impact on the public health burden of drug-resistant bacterial infections,” if the scientific compromises lead to ineffective or harmful products.  More at link above.  (Pink Sheet, paid subscription required)

FDA Talks Drug Safety with China, but Visas for Staff Still Elusive
FDA efforts to bolster its oversight of drug manufacturers in China remain partially hamstrung by ongoing delays in allowing permanent stations for its personnel there.

FDA has wanted more personnel in China for a number of years, especially after the heparin scandal, when a number of deaths and adverse reactions resulted from adulterated product components originating from China. FDA opened offices in Beijing, Shanghai and Guangzhou and wanted to increase the number of inspectors based there. In-country personnel allow the agency to conduct more inspections. But gaining the necessary visas from the Chinese government has not been an easy task, and FDA continues to wait for them.

In the meantime, FDA is recruiting inspectors and others interested in relocating to China. The agency also continues inspecting facilities there through other means. The agency has been working on projects in conjunction with the Massachusetts Institute of Technology and Epidemico to better detect problems in China and understand risk drivers to an unsafe supply chain.  More at link above.  (Pink Sheet, paid subscription required)

Schnedar named director of CDER's Office of Compliance
Janet Woodcock, director of FDA's Center for Drug Evaluation and Research, announced in an internal memo that the agency hired Cynthia Schnedar as director of CDER's Office of Compliance. Schnedar was deputy inspector general at the U.S. Department of Justice.

Carol Bennett, who had been serving as acting director of the Office of Compliance, returned to her role as deputy director of the Office of Regulatory Policy. Woodcock said Ilisa Bernstein, deputy director of the Office of Compliance, will serve as acting director until Schnedar takes over. (BioCentury)


SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS

Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015

Meeting. International Medical Device Regulators Forum (IMDRF), September 15-19, 2014.  Embassy Row Hilton, Washington, DC.  A week of global meetings to discuss worldwide medical device regulation and harmonization efforts.  [FDA.gov]

Public Advisory Committee Meeting. Cellular, Tissue and Gene Therapies Advisory Committee. September 17, 2014. Hyattsville, MD.  In open session, the committee will hear updates of research programs in the Laboratory of Biochemistry, Division of Therapeutic Proteins, the Laboratory of Molecular Oncology and the Laboratory of Molecular and Developmental Immunology, Division of Monoclonal Antibodies, Office of Biotechnology Products, Office of Pharmaceutical Sciences, Center for Drug Evaluation and Research, FDA. Another portion of the meeting will be closed to the public.  [Federal Register]

Public Hearing.  Generic Drug User Fee Amendments of 2012: Public Hearing on Policy Development.   September 17, 2014.  Hyattsville, MD.  FDA seeks input on the five draft guidance documents FDA has issued or will issue shortly to facilitate implementation of GDUFA. FDA also seeks input on additional policy priorities under GDUFA, such as the Agency’s consideration of generic drug exclusivity and the category of first generics. FDA will take the information from the public meeting into account in developing the fiscal year 2015 GDUFA priorities. [FDA.gov]

Public Advisory Committee Meeting. Joint Meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. September 17, 2014. White Oak Campus, Silver Spring, MD.  The committees will discuss the appropriate indicated population for testosterone replacement therapy and the potential for adverse cardiovascular outcomes associated with this use. [Federal Register]

Public Workshop. Pediatric Clinical Investigator Training Workshop. September 22, 2014.  Bethesda, MD.  The purpose of this workshop is to provide investigators with training and expertise in designing and conducting clinical trials in pediatric patients that will lead to appropriate labeling. [Federal Register]

Public Meeting. Patient-Focused Drug Development for Hemophilia A, Hemophilia B, von Willebrand Disease, and Other Heritable Bleeding Disorders. September 22, 2014. White Oak Campus, Silver Spring, MD.  The public meeting is intended to allow FDA to obtain patient perspectives on the impact of Hemophilia A, Hemophilia B, von Willebrand Disease, and other heritable bleeding disorders on daily life as well as patient perspectives on the available therapies for these disorders. [Federal Register]

Public Workshop. Next-Generation Sequencing Technology, Data Formats Standardization and Promotion of Interoperability Protocols.  September 24-25, 2014. National Institute of Health Campus, Bethesda, MD. The purpose of the workshop is to engage NGS stakeholders in a forum to discuss the current use of the technology and the development of data standards of NGS-related information. [Federal Register]

Public Meeting. Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis. September 26, 2014. White Oak Campus, Silver Spring, MD.  The public meeting is intended to allow FDA to obtain patient perspectives on the impact of idiopathic pulmonary fibrosis on daily life as well as patient views on treatment approaches for idiopathic pulmonary fibrosis. [Federal Register]

Public Workshop. Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3–D Printing. October 8-9, 2014. White Oak Campus, Silver Spring, MD.  The purpose of this workshop is to provide a forum for FDA, medical device manufactures, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3–D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions. [Federal Register]

Public Meeting.  Patient-Focused Drug Development and Scientific Workshop on Female Sexual Dysfunction.   October 27-28, 2014.  White Oak Campus, Silver Spring, MD.  FDA is conducting a Patient-Focused Drug Development public meeting and scientific workshop on Female Sexual Dysfunction (FSD).  [Federal Register]

Public Advisory Committee Meeting. Risk Communications Advisory Committee. November 3-4, 2014. White Oak Campus, Silver Spring, MD.  The Risk Communication Advisory Committee will discuss methods for effective risk communication with a focus on messages about the importance of eating adequate amounts of fish, while avoiding certain fish with higher amounts of methyl-mercury. These messages are especially important for women who are pregnant or nursing, or for anyone who prepares food for young children. [Federal Register]

Clinical Investigator Training Course. November 4-6, 2014. College Park, MD.  This training course, a co-sponsored event of FDA CDER and Duke University Office of Continuing Medical Education, is intended to provide clinical investigators with expertise in the design, conduct, and analysis of clinical trials; improve the quality of clinical trials; and enhance the safety of trial participants.  [Federal Register]

Public Advisory Committee Meeting. Cellular, Tissue and Gene Therapies Advisory Committee. November 6, 2014. White Oak Campus, Silver Spring, MD. The committee will discuss the draft guidance for industry entitled ‘‘Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products’’ and the Dear Gene Therapy IND or Master File Sponsor Letter.  [Federal Register]

Public Workshop. Brain-Computer Interface Devices for Patients With Paralysis and Amputation. November 21, 2014.  White Oak Campus, Silver Spring, MD.  The purpose of this workshop is to obtain public feedback on scientific, clinical, and regulatory considerations associated with BCI (Brain-Computer Interface) devices. Ideas and suggestions generated during this workshop may facilitate development of draft guidance to provide our initial thoughts regarding the content of premarket submissions for emerging BCI technologies to help speed development and approval of future submissions.  [Federal Register]


SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS

NIH Longitudinal Study Of Alzheimer’s Biomarkers Proposed At House Roundtable
Prospects for a very large-scale, longitudinal, NIH-led study to identify biomarkers for Alzheimer’s disease and other chronic diseases were debated at a House Energy and Commerce Committee roundtable in Lancaster, Pa., Aug. 31.

The idea for the study was proposed at the roundtable by Biotechnology Industry Organization CEO Jim Greenwood and was the focus of a good part of the day’s discussion. Roundtable participants included other high-ranking members of the committee, government officials, drug company representatives and members of academia.

Greenwood said such a study could significantly advance development of treatments for Alzheimer’s and other diseases such as Parkinson’s disease, ALS, cancer and cardiovascular disease as well. He suggested the effort could be modeled on the landmark Framingham Heart Study, launched by NIH in 1948 to identify risk factors for heart disease.

The roundtable was part of the committee’s 21st Century Cures initiative, an ongoing effort by the committee to gather ideas for legislation on ways to accelerate drug development and delivery.  More at link above. (Pink Sheet, paid subscription required)

NIA Publishes "Participating in Alzheimer's Research: For Yourself and Future Generations"
The National Institute on Aging at the National Institutes of Health estimates that at least 70,000 volunteers, including healthy volunteers, are urgently needed to participate in more than 150 active clinical trials and studies in the United States that are testing ways to understand, treat, prevent, or cure Alzheimer’s disease.  To encourage such participation, NIA has published a new booklet to explore:

  • how to find Alzheimer’s and related studies that might be right for you
  • the benefits and potential risks to consider
  • what happens when you join a trial or study
  • how safety is protected
  • questions to ask  
More at link above. (NIH.gov)

NIH awards aim to improve understanding of cell pathways, development of new therapies 
Building on a successful three-year pilot project, the National Institutes of Health has awarded more than $64 million to six research institutions to create a database of human cellular responses, the Library of Integrated Network-based Cellular Signatures (LINCS). Discovering such cell responses will improve scientists’ understanding of cell pathways and aid in the development of new therapies for many diseases.

The funding establishes six centers, collectively called the Data and Signature Generating Centers.

The LINCS program aims to catalog and analyze cellular function and molecular activity in response to perturbing agents — such as drugs and genetic factors — that are potentially disruptive to cells. LINCS researchers then will measure the cells’ tiniest molecular and biochemical responses, and use computer analyses to uncover common patterns in these responses — called “signatures.” LINCS data will be freely available to any scientist.  More at link above. (NIH.gov)

Gates Foundation Commits $50 M for Ebola
The Bill & Melinda Gates Foundation committed $50 million to support emergency efforts -- including the purchase of essential medical supplies and scale up emergency operations -- to contain the Ebola outbreak in West Africa. The amount includes $5 million going to the World Health Organization for emergency operations and R&D assessments; and $5 million going to the U.S. Fund for UNICEF to support efforts in Liberia, Sierra Leone and Guinea to purchase supplies, coordinate response activities and provide at-risk communities with health information.

The foundation said $2 million will go to the U.S. Centers for Disease Control and Prevention to support incident management and treatment, and strengthen health care systems.  More at link above. (BioCentury)

A Look at The Progress and The Hope in The Pipeline
The Pharmaceutical Research and Manufacturers of America (PhRMA) has released a new report entitled, “Value of Innovation in HIV/AIDS Therapy,” as well as a new “Medicines in Development” report focusing on progress developing treatments and preventive vaccines for HIV/AIDS.  From the Catalyst, the PhRMA blog, “Since 1995, with the development of the first protease inhibitors, the death rate in the U.S. from HIV/AIDS decreased by 83 percent. Researchers are not satisfied with this progress, however, and they continue to work hard every day to develop new medicines for patients.”

On September 10, the organization hosted a congressional briefing and panel discussion to talk about how HIV/AIDS treatment and our understanding of the disease have evolved over time and how close we are to preventing and/or curing this disease.

PhRMA also held the 3rd Annual Research and Hope Awards on the evening of the 10th to honor those who have played crucial roles in the research fight against HIV/AIDS.  Awards were presented in the categories of Academic Research, Biopharmaceutical Industry Research, Excellence in Advocacy and Activism, Community Champion, and Visibility and Progress.  More at link above. (PhRMA.org)

PCORI Board to Vote Sept. 15 on Releasing Proposal for Peer Review for Public Comment
The Patient-Centered Outcomes Research Institute (PCORI) Board of Governors will meet Monday, Sept. 15, to consider approving for public comment PCORI’s draft proposal for peer review of the primary research it funds and public release of its research findings.

The draft outlines how PCORI proposes to meet its legislative mandate to conduct peer review of the primary research it supports and make the findings available publicly within a specific timeframe. If approved during the Board meeting, the proposal will be posted on PCORI’s website for a 60-day public comment period that will run from Sept. 15 to Nov. 7. (PCORI.org)

JAMA Editorial on Open Access to Clinical Trials Data
Well-conducted randomized clinical trials (RCTs) are the gold standard for evaluating the safety and efficacy of medical therapeutics. Yet most often, a single group of individuals who conducted the trial are the only ones who have access to the raw data, conduct the analysis, and publish the study results. This limited access does not typically allow others to replicate the trial findings. Given the time and expense required to conduct an RCT, it is often unlikely that others will independently repeat a similar experiment. Thus, the scientific community and the public often accept the results produced and published by the original research team without an opportunity for reanalysis. Increasingly, however, opinions and empirical data are challenging the assumption that the analysis of a clinical trial is straightforward and that analysis by any other group would obtain the same results.

In this issue of JAMA, Ebrahim et al report their findings based on a rigorous search of previously published reanalyses of RCTs. Their first surprising and discomforting finding was just how infrequently data reanalysis has occurred in medical research. Full editorial at link above.  (JAMA)

Reanalyses of Randomized Clinical Trial Data 
An original investigation published in JAMA on September 9, 2014, by Ebrahim et al sought to identify all published studies that completed a reanalysis of individual patient data from previously published RCTs addressing the same hypothesis as the original RCT.  The authors found that: 

A small number of reanalyses of RCTs have been published to date. Only a few were conducted by entirely independent authors. Thirty-five percent of published reanalyses led to changes in findings that implied conclusions different from those of the original article about the types and number of patients who should be treated. More at link above. (JAMA)

DEA Places Heavy Restrictions on Vicodin and Other Hydrocodone Combination Drugs; Stakeholders Have 45 Days to Adjust
On Friday, August 22, the U. S. Drug Enforcement Administration (DEA) published their Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more restrictive Schedule II. The change will take effect 45-days from the Final Rule, so likely on Monday, October 6.

The DEA's decision to move HCPs from Schedule III to Schedule II will impact practitioners who can prescribe drugs, but ultimately it will affect all industries involved in the manufacture, supply, and distribution of HCPs. 

When the rule takes effect in early October:

  • Prescribers will no longer be able to authorize refills for HCPs and will be limited to prescribing a 30-day supply, although prescribers can issue multiple prescriptions for up to a 90-day supply. Before this rule, doctors could prescribe a 180-day supply.
  • Patients will have to be seen by a doctor for a new prescription. Before this change, refills for HCPs such as Vicodin could be called in to a pharmacy.
  • Rescheduling will also change the process required to order and transfer HCPs from a distributor to a pharmacy. For Schedule III drugs, DEA registrants could transfer HCPs through simple invoices. Now all orders must be submitted on the official DEA Form 222, and separately from the pharmacy's usual bulk order of CIII-V drugs. 
  • The new classification will place added burdens on manufacturers and distributors who will have to store HCPs in secure vaults (1301.72) rather than locked cages and will have to label all HCPs with a “C-II” designation. Only manufacturers and distributors, not retail pharmacies, are required to place Schedule II drugs in a locked vault. 
More at link above.  (Policy and Medicine)

Companion Diagnostics Market Set to Grow to $8.7B by 2019
A new report forecasts that the global companion diagnostics market will grow to $8.7 billion, up from $3.1 billion it is estimated to be in 2014.  That represents a compound annual growth rate of 22.7%, according to MarketsandMarkets, a market research firm, which issued the report.

A positive regulatory environment the world over, combined with the growing demand for targeted drugs for oncology, neurology, and infectious diseases, is driving the companion diagnostics market.

While the FDA and the EMA (European Medicines Agency) have encouraged the use of companion diagnostics, the global reimbursement landscape is a hindrance to the growth of this market, as is the use of nonvalidated tests to identify biomarkers, the report says.

However the global diagnostic market is expected to be boosted by NGS technologies and consequent development of companion diagnostics for different types of cancers as well as Alzheimer’s and Parkinson’s diseases. More at link above. (MDDI)

Generic Drug Savings in the US
A new report from the Generic Pharmaceutical Association, the trade group representing generic drug makers, indicates that these medicines saved Americans nearly $239 billion last year (2013), a 14% increase from the year before.

Much of those savings came from new generics – about $140 billion – while older copycat drugs helped U.S. consumers pocket $98 billion in savings. A new generic refers to a drug that recently became available after a brand-name drug lost patent protection.  Some of the largest savings were achieved by using generic drugs to treat widespread ailments such as diabetes and other metabolic disorders ($34 billion saved) and cardiovascular medicines ($58 billion saved).

The report, which was prepared by the IMS Institute for Healthcare Informatics for the Generic Pharmaceutical Association, does not factor in the rebates and discounts that brand-name drug makers offer customers and lower the net cost of brand-name drugs. Thus, the savings appear larger than they may actually be, although generic drug makers, in some cases, also offer such incentives.  More at title link above.  (WSJ Pharmalot and GPhA)

Karen DeSalvo: Everyone can weigh in on path to interoperability
The Office of the National Coordinator for Health IT is focused on gaining as much input as possible on how to make true interoperability happen, National Coordinator Karen DeSalvo said recently.

The ONC plans to release a refreshed health IT strategic plan for comment later this year, DeSalvo said, and is "looking forward to some strong feedback on the priorities we should place to move forward."

"[T]here are going to be places where it makes more sense for there to be advancement from the private sector or perhaps the solutions can come from other sources. The solutions don't all have to come from the federal government," she said. "We look forward to another chapter of the strategic process that engages and incorporates what everybody can own and how to make sure we all have a piece of this."

ONC will host a joint meeting Oct. 15 with its Federal Advisory Committees, both the standards and policy committees, and also will include feedback from its Wiki page at HealthIT.gov. She invited all Americans to weigh in. More at link above.  (Fierce Health IT)

The Influence of Global Environmental Change on Infectious Disease Dynamics
The twentieth century witnessed an era of unprecedented, large-scale, anthropogenic changes to the natural environment. Understanding how environmental factors directly and indirectly affect the emergence and spread of infectious disease has assumed global importance for life on this planet. While the causal links between environmental change and disease emergence are complex, progress in understanding these links, as well as how their impacts may vary across space and time, will require transdisciplinary, transnational, collaborative research. This research may draw upon the expertise, tools, and approaches from a variety of disciplines. Such research may inform improvements in global readiness and capacity for surveillance, detection, and response to emerging microbial threats to plant, animal, and human health.

The Influence of Global Environmental Change on Infectious Disease Dynamics is the summary of a workshop hosted by the Institute of Medicine Forum on Microbial Threats in September 2013 to explore the scientific and policy implications of the impacts of global environmental change on infectious disease emergence, establishment, and spread. More at link above. (IOM)

Government of Canada Reveals 32 New Brain Research Projects
Health Canada and Brain Canada announced 32 projects being funded under the Canada Brain Research Fund.

The projects announced today will accelerate innovative research that will fundamentally change our understanding of nervous system function and dysfunction and their impact on health. The research will advance knowledge and support the development of new ways to diagnose and treat all types of neurological and mental illnesses.

Funding for all 32 projects totals nearly $51.4 million, half provided by the Government of Canada and half provided by private donors, research institutions, provincial funding agencies, and charitable organizations partnering with the Brain Canada Foundation. More at link above. (Health Canada)

Regulatory information - Further guidance on adaptive licensing pilot project available
Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines Agency has released a document to address the most frequently asked questions from companies and to clarify the terms of engagement and expected outputs for prospective applicants.

The Agency launched its adaptive licensing pilot project in March 2014 to explore how adaptive licensing can be implemented with real medicine development programmes.

The adaptive licensing approach, sometimes called staggered approval or progressive licensing, is part of the Agency’s efforts to improve timely access for patients to new medicines that address serious conditions with unmet medical needs.  More at link above. (EMA.eu)

NICE Will Ask Regulators for Trial Data if Drug Makers Refuse
The U.K.’s National Institute for Health and Care Excellence (NICE), responsible for recommending coverage of medicines, issued a statement yesterday calling for increased transparency from the pharmaceutical industry.  NICE will ask European regulators for data if companies, some of which have resisted calls to release some data over concerns for trade secrets and breach of patient confidentiality, refuse to provide it. (It should be noted that some drug makers have recently taken steps to release data and make the information available to researchers.)

NICE has actually been in favor of full disclosure for some time and, in fact, is one of the supporters of the AllTrials campaign, which was created last year to pressure drug makers for greater disclosure. 

Whether NICE would obtain the kind of data from regulators the agency imagines is uncertain. Next month, the European Medicines Agency is expected to release a policy on trial data disclosure.  More at link above. (WSJ Pharmalot)

U.K. watchdogs hope to tap social media for drug-safety purposes 
Now, it's U.K. drug regulators who are devising plans to eavesdrop on social media. But unlike the FDA, which plans to monitor the world of online sharing to see whether its communications are hitting their targets, the Medicines and Healthcare Products Regulatory Agency plans to search for drug safety info.

The "WEB-RADR" project will start with a mobile app for healthcare professionals and the public to use to report drug side effects to European regulators. The app may also be a two-way street, used by the MHRA to roll out up-to-date info on medicines to doctors and patients.

A broader goal of the project will be to determine how--and to what end--regulators might monitor Facebook, Twitter, patient forums, and other sharing platforms for chatter about drug side effects.  More at link above. (FiercePharma)

China Readies New Biosimilar Guidelines
China FDA is working on new biosimilar guidelines as it faces increased public pressure to make innovative drugs available sooner.  (PharmAsia News, paid subscription required for access)

Taiwan-China to Collaborate on New Drug Discovery
The Mainland Affairs Council (MAC) recently announced that Taiwan and China have reached a concrete consensus in new drug research and development.

The Taiwan health minister met with Chinese agencies to advocate cooperation in clinical trials of new drugs. It is said that both Chinese and Taiwanese health officials mutually agreed to avoid duplication of tests by cooperating in clinical trials of drugs, recognition of clinical data and drug inspection. More at link above. (BioSpectrum)


SECTION 5 LEGAL AND COMPLIANCE

21st Century Cures Hearing on Antibiotic Drug Resistance
On Friday, September 19, the Subcommittee on Health will hold a hearing on 21st Century Cures: Examining Ways to Combat Antibiotic Resistance and Foster New Drug Development. As the 21st Century Cures initiative continues, subcommittee members will review the growing threat of antibiotic resistance and explore efforts to counteract this global health threat. The Majority Memorandum, witness list, and witness testimony will be available here as posted. (Energy & Commerce Committee)

Introduction of Continuing Resolution in House for Ebola Funds
Rep. Hal Rogers (R-Ky.) introduced a continuing resolution (H.J. Res. 124) in the U.S. House of Representatives that includes a provision allocating $88 million to CDC and HHS to address the Ebola outbreak. Rogers is chairman of the House Appropriations Committee.

The resolution would keep the federal government operating at FY14 levels through Dec. 11. The current CR funding government operations is set to expire Sept. 30, and should Congress not pass a new CR or full budget by then the government will shut down.  More at title link. (BioCentury)

FTC Sues Drug Makers Over Pay-to-Delay Deals
For the first time since the U.S. Supreme Court ruled last year that so-called pay-to-delay deals may be subject to greater antitrust scrutiny, the U.S. Federal Trade Commission has filed a lawsuit charging drug makers with violating anti-trust laws and hurting consumers in their collective pocketbooks. Specifically, the agency charged several drug for striking deals that delayed the availability of the widely promoted AndroGel testosterone replacement therapy, a $1 billion seller.

In these deals, a brand-name drug maker settles with a generic rival in exchange for ending patent litigation and launching a copycat medicine at a future date. The pharmaceutical industry contends the deals are not only legal, but actually allow drugs to reach consumers faster than if litigation continued.

The Supreme Court ruling was a boost to the agency, because it supported the contention that pay-to-delay deals may violate antitrust laws and, effectively, allowed the FTC to pursue lawsuits against drug makers.  The FTC had spent years trying to convince Congress and the courts that pay-to-delay deals hurt the economy.  More at link above.  (WSJ Pharmalot)


SECTION 6 SOURCES REVIEWED FOR THIS NEWSLETTER

A partial listing of sources reviewed for this newsletter:  AdvaMed Smartbrief; AHRQ Newsletter; Alzheimers Association; Alzheimers Research Forum Newsletter; BioCentury; Biopharma Reporter; BIOtechNow; CDISC Monthly Newsletter; CER Daily Newsfeed (NPC); Daily Dose (Becker); DIA Daily; Drug Daily Bulletin;  EMA website; EP Vantage; Evaluate Pharma; Eye on FDA; FDA.gov; FDA Law Blog; Federal Register Table of Contents; Fierce Medical Devices; Fierce Pharma; Fierce Vaccines; FDLI Smartbrief; Genomeweb; Health Industry Washington Watch; Government Health IT; Health IT Security; Institute of Medicine News; MedCityNews; Medical Device Daily; Medical Device & Diagnostic Industry; MedPage Today; NPC Bulletin; Nutra Ingredients USA; Pharmabiz; Pharmafile; Pharma IQ; PharmaTimes; PhRMA website; PM Live; Policy and Medicine (newsletter); Regulatory Focus; RegLink News; US FDA Daily Digest Bulletin.