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Content Currents


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: December 5, 2014


CDER List of Guidance Documents (Updated)

CDER Guidances New/Revised/Withdrawn 1/1/14 - 9/30/14

The links above lead to the List of Guidance Documents (CDER) updated on October 27, 2014, and to CDER Guidances that are new, revised, or withdrawn through the third calendar quarter of 2014.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On December 5, 2014, FDA announced the availability of a draft guidance entitled “How To Obtain a Letter From the Food and Drug Administration Stating That Bioequivalence Study Protocols Contain Safety Protections Comparable to Applicable Risk Evaluation and Mitigation Strategies for Reference Listed Drugs.” This draft guidance describes how a prospective abbreviated new drug application (ANDA) applicant may request a letter stating that FDA has determined the following: The potential applicant’s bioequivalence (BE) study protocol contains safety protections comparable to those in the risk evaluation and mitigation strategy (REMS) with elements to assure safe use (ETASU) applicable to the reference listed drug (RLD) and FDA will not consider it a violation of the REMS for the RLD sponsor to provide a sufficient quantity of the RLD to the interested generic firm or its agent to allow the firm to perform the testing necessary to support its ANDA.  Comments should be submitted by February 3, 2015. [Federal Register]

On December 4, 2014, FDA announced the availability of the final rule entitled ‘‘Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling.” FDA is amending its regulations governing the content and format of the ‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and ‘‘Nursing mothers’’ subsections of the ‘‘Use in Specific Populations’’ section (under § 201.57 (21 CFR 201.57)) and the ‘‘Precautions’’ section (under § 201.80 (21 CFR 201.80)) of the labeling for human prescription drug and biological products (both referred to as ‘‘drugs’’ or ‘‘drug products’’ in this final rule). In this rulemaking, the Agency is finalizing many of the provisions in the proposed rule issued on May 29, 2008 (73 FR 30831). This rulemaking is part of a broad effort by the Agency to improve the content and format of prescription drug labeling. The final rule creates a consistent format for providing information about the risks and benefits of drug use during pregnancy and lactation and by females and males of reproductive potential. [Federal Register]

On December 4, 2014, FDA announced the availability of a draft guidance entitled ‘‘Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Prescription Drug and Biological Products—Content and Format.” This draft guidance is intended to assist applicants in complying with the new content and format requirements in the Pregnancy, Lactation, and Females and Males of Reproductive Potential subsections of labeling for human prescription drug and biological products, as described in the final rule, Content and Format of Labeling for Human Prescription Drug and Biological Products; Requirements for Pregnancy and Lactation Labeling. The rule, which is being published concurrently with this draft guidance, is referred to as the ‘‘Pregnancy and Lactation Labeling Rule’’ (PLLR). The draft guidance will assist applicants in developing labeling for new products, revising existing labeling, and implementing the content and format requirements of the PLLR for human prescription drug and biological products. Comments should be submitted by February 2, 2015. [Federal Register]

On December 2, 2014, FDA announced the availability of the guidance entitled ‘‘Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex.” The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. FDA is concerned that statements submitted for inclusion in medical product labeling, such as ‘‘latex-free,’’ ‘‘does not contain natural rubber latex,’’ or ‘‘does not contain latex’’ are not accurate because it is not possible to reliably assure that there is a complete absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product. [Federal Register]

On December 2, 2014, FDA announced the availability of a scale-up and post-approval changes guidance entitled ‘‘SUPAC: Manufacturing Equipment Addendum.” This replaces the draft guidance of the same name that combined and superseded ‘‘SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,’’ published on January 1, 1999; and ‘‘SUPAC–SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,’’ published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced. [Federal Register]

On December 1, 2014, FDA announced the submission to OMB of a proposed collection of information on a ‘‘Medical Devices; Humanitarian Use Devices.” This collection of information implements the Humanitarian Use Devices (HUD) provision of section 520(m) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(m)) and subpart H, part 814 (21 CFR part 814).  The information collected will assist FDA in making determinations on the following: (1) Whether to grant HUD designation of a medical device; (2) exempt an HUD from the effectiveness requirements under sections 514 and 515 of the FD&C Act, provided that the device meets requirements set forth under section 520(m) of the FD&C Act; and (3) whether to grant marketing approval(s) for the HUD.  Comments should be received by December 31, 2014.  [Federal Register]

On November 28, 2014, FDA announced announced the availability of a draft guidance entitled “Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions.” The draft guidance is intended to inform manufacturers, members of the medical and scientific community, and other interested persons that at this time we do not intend to object to the marketing of single- and combination-ingredient, acetaminophen-containing, nonprescription (commonly referred to as over-the-counter (OTC)) drug products bearing a warning as described in the draft guidance alerting consumers that the use of acetaminophen may cause severe skin reactions. Comments should be submitted by January 27, 2015.   [Federal Register]

On November 28, 2014, FDA announced announced the availability of a draft guidance entitled “The Drug Supply Chain Security Act Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs: How To Exchange Product Tracing Information.” The draft guidance addresses the drug supply chain security provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), which requires the Secretary of the Department of Health and Human Services to establish initial standards for the interoperable exchange of transaction information, transaction history, and transaction statements, in paper or electronic format. Specifically, the guidance establishes standards for how transaction information, transaction history, and transaction statements should be exchanged among trading partners through the extension and/or use of current systems and processes. Comments should be submitted by January 27, 2015.  [Federal Register]

On November 24, 2014, FDA announced the availability for public comment of ‘‘Demographic Subgroup Data for FDA Approved Products on FDA’s Internet Website.’’  This new posting implements Action 3.1 from Priority 3 of the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan designed to improve the availability and transparency of clinical trial demographic subgroup data. FDA is requesting comments on the format, content, and overall usability of the site to determine whether this approach is user friendly to the public. Comments should be submitted by January 23, 2015. [Federal Register]

On November 24, 2014, FDA announced announced the availability of a final guidance entitled “Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act.” The guidance is intended to assist human drug compounders that elect to register as outsourcing facilities in registering, re-registering, or de-registering with FDA. The guidance provides information on how an outsourcing facility should submit facility registration information electronically in structured product labeling (SPL) format using FDA’s electronic submission system. [Federal Register]

On November 24, 2014, FDA announced announced the availability of a final guidance entitled “Fees for Human Drug Compounding Outsourcing Facilities Under the FD&C Act.” This guidance describes the annual establishment fee, the reinspection fee, annual adjustments to fees required by law, how to submit payment, the effect of failure to pay fees, and how to qualify as a small business to obtain a reduction of the annual establishment fee. [Federal Register]

On November 24, 2014, FDA announced announced the availability of a revised draft guidance entitled “Electronic Product Reporting for Human Drug Compounding Outsourcing Facilities.” The revised draft guidance addresses provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) added by the Drug Quality and Security Act (DQSA) and updates reporting instructions for drug compounders that choose to register as outsourcing facilities. Comments should be submitted by January 23, 2015. [Federal Register]

On November 24, 2014, FDA announced announced the availability of a guidance entitled “Design Considerations for Devices Intended for Home Use.” This document supersedes “Design Considerations for Devices Intended for Home Use” issued August 5, 2014. Devices used in the home or other non-clinical environments are associated with unique risks created by the interactions among the user (often a layperson), the use environment, and the device. This guidance identifies several factors that manufacturers of home use devices should consider, especially during device design and development, and provides recommendations for minimizing these unique risks.  [Federal Register]


Updated List of CDER Key Officials Posted

FDA Accumulating Evidence Towards Standards for Breakthrough Designations
Summary:  Janet Woodcock says agency still cannot detail specific criteria for the popular incentive, but data on breakthrough requests show common characteristics.  

FDA still may not be able to clearly describe the bar for a breakthrough therapy, but an internal analysis indicates the agency is building evidence toward a more clear description of the criteria for potential sponsors.

An FDA evaluation of the first two years of the program indicates some similar characteristics of products receiving breakthrough status as compared to products that didn’t. The biggest factor in breakthrough designation decisions may be the magnitude of treatment effect.  Dr. Janet Woodcock, CDER Director, indicated that designees have clinical data showing a more than 50% risk reduction, such as in disease progression, over the comparator.  Breakthrough success did not appear affected by orphan drug status, but targeted therapies or those with a genetic component were more likely to gain the designation. More designees in the FDA analysis had alternative therapies available than denials. Breakthrough designees also tended to have evidence from more trials and a slightly higher trial enrollment.

Since the program launch in 2012, more than 240 designation requests have been received and 68 granted.  More at link above.  (Pink Sheet, paid subscription required)

FDA Quietly Consults Patients To Understand Rare Disease Trial Endpoint Significance
Summary: Meeting with Morquio A patient and caregivers appears to have helped to assuage FDA concerns about clinical relevance of rare disease trial’s primary endpoint – and illustrates FDA’s openness to patient input even during specific reviews of new product applications.

FDA consulted a Morquio A patient and several caregivers as it struggled to determine the clinical relevance of the candidate product’s effect on the six-minute walk test, apparently unbeknownst to the product’s sponsor.

The consultation during FDA’s active BLA review process shows that patient groups can engage with FDA outside the context of an advisory committee, and reinforces the agency’s interest in patient and caregiver input.

Early in the review, the agency conducted a teleconference with “patient caregivers and an adult patient” to better understand their personal experiences, according to the clinical review document. The meeting occurred less than two months after the application had been filed.  No minutes of the meeting were included in the publicly available review documents, but a footnote in advisory committee briefing documents says that patients shared the “clinical signs and symptoms that are most troublesome.”  An FDA statement indicated that “reviews often incorporate the patient perspective at varying levels of interactions and phase of drug development.”

The patient teleconference also illustrates another, lesser-known strategy patients and advocates can use to educate or potentially influence agency reviewers, especially if they are struggling with clinical meaningfulness.  FDA allows patient groups to meet with reviewers to talk about issues related to their disease.  Im this case, it appears from documents that FDA may have initiated the teleconference with patients. But in other cases, patients requesting meetings with a review division can allow them to “make a direct impact on drug development in their disease.” Patient advocacy groups typically are approached to provide recommendations for participants when FDA initiates a patient meeting.

More at link above.  (The Pink Sheet, paid subscription required)

Helping patients and health care professionals better understand the risks and benefits of medications for pregnant and breastfeeding women
In her December 3, 2014, FDA Voice blog, Dr. Sandra Kweder provided a brief summary of the provisions of the new final rule on labeling of medications for use in pregnancy and lactation.  She writes:

“Today, after years of careful consideration — and listening to public feedback — FDA has published a final rule that sets standards for providing a consistent way for drug manufacturers to provide information about the risks and benefits of prescription drug and biological products used during pregnancy and lactation.  It also includes requirements for ways of communicating relevant information for women and men of reproductive potential.

“The new rule eliminates an old and possibly confusing way of communicating risk during pregnancy and breastfeeding, which used letter categories of A, B, C, D, and X, to classify various types of risks. It may look simple, but this system was anything but. As a result, the letter categories that have been a familiar presence in drug labeling since the 1970s were often misinterpreted as a sort of grading system of risks, which gave an overly simplified view of product risks.

“Here’s a quick overview: Prescribing information for health care professionals provided by manufacturers will now contain required subheadings within the Pregnancy and Lactation subsections: risk summary, clinical considerations, and data. These subsections will provide more detailed information regarding, for example, human and animal data on the use of the drug, specific adverse reactions and information about dose adjustments needed during the pregnancy and post-partum (after giving birth) periods. It will apply not just to new drugs approved from now on, but also to older drugs approved since 2001 that have been marketed for years without their labeling being updated to incorporate important new information related to pregnancy and lactation.”

FDA also issues a draft guidance for industry on including this information in the product label.  The comment period will be open until February 3, 2015 (see Section I for links to the rule and the draft guidance.)  More at link above. (FDA.gov)


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

Meeting. Realizing the Benefits of the Unique Device Identifier in Health Care.  Office of the National Coordinator and Pew Charitable Trusts.  December 9, 2014. Washington, DC. This meeting will present discussion on the benefits and challenges of integrating the unique device identifiers (UDI) into clinical care, registries, the supply chain, and other facets of health care delivery. [FDA.gov]

Public Workshop. Developing and Using Precision Therapies in the ‘‘Omics’’ Era: Generating and Interpreting Evidence for Rare Subsets. December 12, 2014. White Oak Campus, Silver Spring, MD.  Cosponsored with the Center for Translational and Regulatory Sciences at the University of Virginia (UVA). The goals of this public workshop are to facilitate discussion on current scientific approaches using rare subsets during drug development programs and to further seek input from multiple stakeholders on approaches to obtain evidence that inform the regulatory evaluation of therapeutic products in rare subsets of patients identified through in-vitro diagnostic testing when specific, controlled trials are not feasible. [Federal Register]

Public Workshop. Immunology of Protection from Ebola Virus Infection. December 12, 2014. Rockville, MD and Webcast.  The Food and Drug Administration (FDA), the National Institutes of Allergy and Infectious Diseases (NIAID), the Department of Defense (DoD), the Centers for Disease Control and Prevention (CDC), and the Biomedical Advanced Research and Development Authority (BARDA) are co-sponsoring a workshop, entitled “Immunology of Protection from Ebola Virus Infection.” The purpose of this workshop is to discuss important aspects of Ebola virus and vaccine immunology in order to inform future clinical, scientific and regulatory decision-making related to vaccines against Ebola. [FDA.gov]

January 8-9, 2015.  Two-day public meeting on prioritization of Lab-Developted Tests (LDTs).  At this meeting, FDA will discuss its proposal for a risk-based framework to address regulatory oversight of laboratory developed tests (LDTs). The agency plans to discuss with stakeholders how to balance patient safety and access to LDTs..  (FDA.gov)

Public Policy Committee Meeting. Health Information Technology Policy Committee Advisory Meeting.  Monthly beginning January 13, 2015.  Locations to be published.  This notice announces forthcoming meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). The function of the committee is to provide recommendations to the National Coordinator on a policy framework for the development and adoption of a nationwide health information technology infrastructure that permits the electronic exchange and use of health information as is consistent with the Federal Health IT Strategic Plan and that includes recommendations on the areas in which standards, implementation specifications, and certification criteria are needed. [Federal Register]

Public Standards Committee Meeting. Health Information Technology Standards Committee Advisory Meeting.  Monthly beginning January 28, 2015.  Locations to be published.  This notice announces forthcoming meetings of a public advisory committee of the Office of the National Coordinator for Health Information Technology (ONC). The function of the committee is to provide recommendations to the National Coordinator on standards, implementation specifications, and certification criteria for the electronic exchange and use of health information for purposes of adoption, consistent with the implementation of the Federal Health IT Strategic Plan, and in accordance with policies developed by the Health IT Policy Committee. [Federal Register]

Public Workshop. Seventh Annual Sentinel Initiative. February 5, 2015.  Washington, DC.  Convened by the Engelberg Center for Health Care Reform at the Brookings Institution and supported by a cooperative agreement with FDA, this 1-day workshop will bring the stakeholder community together to discuss a variety of topics on active medical product surveillance. There will also be a live webcast for those unable to attend the meeting in person. [Federal Register]

Public Meeting. Chagas Disease Patient-Focused Drug Development. April 28, 2015.  White Oak Campus, Silver Spring, MD.  FDA is interested in obtaining patient input on the impact of chagas disease on daily life and patients’ views on currently available therapies to treat the condition. [FDA.gov]


ACOG Statement on FDA Pregnancy Labeling Final Rule
“The American College of Obstetricians and Gynecologists applauds the Food and Drug Administration (FDA) for taking needed steps to increase understanding about the effect of prescription medicines on women during pregnancy and lactation. The FDA’s updated method of presenting information about both risk and benefit will improve the ability of all physicians to treat their pregnant and breastfeeding patients, as well as women who may become pregnant. It will also help more women to understand and take part in their healthcare decision-making.

“As obstetrician-gynecologists, we understand the importance of keeping women healthy before, during, and after their pregnancies, whether they live with chronic conditions or whether they are confronting new diagnoses. And, we recognize that medications can be vital to maintaining a mother's continued good health when pregnant, a goal of central concern in obstetric care. It is essential that all providers have the information they need to safely, effectively, and reliably treat their female patients. We also want to ensure that medicines will help, and not harm, both mother and child.

“Moreover, ACOG hopes that the inclusion of more information on prescription medicine labeling will provide added incentives for clinical research as well as participation in patient registries, to better capture the impact that prescription medicines have on pregnant and breastfeeding women. It is crucial that healthcare providers have access to as much information as possible, and more research will help lead to better care for women in the future.” More at link above. (ACOG)

NIH takes step to speed the initiation of clinical research by ensuring use of single IRB
The National Institutes of Health has issued a draft policy to promote the use of single institutional review boards or IRBs, in multi-site clinical research studies. When the regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then, the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Studies that go beyond a single site are often able to recruit more individuals from diverse populations. These multi-site studies can often generate important results in less time. However, working through IRB review at each site can add delay without increasing the protections for the research participants in the study.

The draft NIH policy proposes that all NIH-funded, multi-site studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program, should use a single IRB. Exceptions to the policy would be allowed if local IRB review is necessary to meet the needs of specific populations or where it is required by federal, state or tribal laws or regulations. Wider use of single IRB review in multi-site studies will help achieve greater efficiencies in the initiation of studies across NIH’s entire clinical research portfolio.

NIH is seeking public comments on the draft policy through a 60 day comment period closing Jan. 29, 2015.  More at link above.  (NIH.gov)

PCORI's Next Steps on Hepatitis C Research Opportunities
Dr. Joseph Selby, Executive Director of PCORI (the Patient Centered Outcomes Research Institute), wrote in his recent blog about the decision to be undertaken by the PCORI Board of Governors at its December 8 meeting regarding the development of a funding announcement targeting HCV infection (Hepatitis C):

“PCORI recently convened a large stakeholder workshop to discuss whether new comparative clinical effectiveness research (CER) studies we might fund could answer key questions about how to best diagnose and treat hepatitis C (HCV) infection. It was a particularly timely event given recent regulatory approvals of groundbreaking new treatments for this serious condition. I summarized the workshop event in an earlier blog post and now want to update you on our next steps.

Based on the discussions at the workshop, our Scientific Oversight Committee will recommend to the PCORI Board of Governors at its December 8 meeting that the Board approve development of a targeted PCORI Funding Announcement (PFA) addressing key questions in detection and treatment of HCV infection. If approved, the PFA would commit up to $50 million in research funding and seek proposals to address CER questions in each of four specific areas identified by workshop attendees:
  • Best approaches to screening and diagnostic testing in various patient populations
  • Care-delivery interventions to support treatment effectiveness
  • Head-to-head clinical trials comparing the new oral therapies for a range of patient-relevant outcomes over time
  • Comparisons of immediate treatment versus monitoring for clinical progression in patients at low risk for developing serious liver disease
We believe this substantial investment of research funds will create a cluster of critical studies that will help patients, clinicians, healthcare systems, and payers develop a sound approach to identification and optimal management of this challenging chronic condition.”  More at title link above. (PCORI.org)

CMS Health Spending Growth Hit Record Low in 2013
CMS's Office of the Actuary said U.S. health spending growth hit a 54-year low of 3.6% in 2013, mirroring a pattern of slow growth in the overall economy over five years. The $2.9 trillion in total health spending represented 17.4% of GDP, which was stable compared to the previous year.

CMS attributed the slowdown partly to meager growth in Medicare and private health insurance spending. Medicare growth dipped to 3.4% in 2013 from 4% in 2012, and was affected by slower enrollment, some ACA provisions and federal budget sequestration. Out-of-pocket costs and spending on hospital, physician and clinical services also decelerated in 2013.

The slowdown was offset by faster spending growth for Medicaid and prescription drugs. Medicaid spending growth increased to 6.1% in 2013 from 4% in 2012, affected by higher provider reimbursement rates, a temporary increase in payments to primary care physicians and Medicaid expansion in some states.

Prescription drug spending grew at a rate of 2.5% in 2013, up from 0.5% in 2012, amid price increases for brand name and specialty drugs, higher spending on new drugs and more total prescriptions. Several blockbuster drugs lost patent protection in 2012.

In September, CMS said it expected prescription drug spending to grow by 6.8% in 2014, driven in part by the newly insured and people switching insurance plans under the ACA. CMS also attributed the increase in part to new HCV treatments and spending on specialty drugs. (BioCentury)

EMA Management Board discusses next steps after judgment of EU Civil Service Tribunal

The European Medicines Agency’s (EMA) Management Board held an extraordinary meeting on 27 November 2014 in Rome, Italy, to discuss the consequences of the judgment by the European Union Civil Service Tribunal that annulled the appointment of the Agency’s Executive Director Guido Rasi.

The Management Board chaired by Sir Kent Woods confirmed that Deputy Executive Director Andreas Pott will be in charge of the management and operations of the Agency until the new selection procedure suggested by the European Commission is finalised. The European Commission plans to publish a vacancy announcement for the post of Executive Director shortly.

Sir Kent Woods was asked to explore how Guido Rasi can best support the Agency in the coming months as his contract is in operation.  More at link above. (EMA.eu)

Hackers Target Top Pharmaceutical Executives to Gain Trading Advantage
Hackers have been targeting large healthcare and pharmaceutical companies with highly-targeted attacks in an attempt to play the stock market with insider information, warn security experts.

The researchers claim to have evidence of a “team of native-English speaking operators with extensive knowledge of the nuances in industries they targeted as well as financial practices”.

The group - which has been dubbed FIN4 - have been observed collecting information from nearly 100 publicly traded companies or the firms which advise them, particularly in healthcare and pharmaceuticals, all of which have access to insider information that would give a “clear trading advantage”.   More at link above. (The Telegraph via Pharmalot)

China Issues Draft Guidance on Multi-Regional Clinical Trials
On November 21, 2014, China Food and Drug Administration ("CFDA") released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) ("Guidance") for public comments through December 21. The Guidance aims to set forth clear requirements for multi-regional clinical trials ("MRCT") involving study sites in China. In the past few years, MRCT has emerged as a popular strategy for global concurrent drug development by multinational pharmaceutical companies, but its governance has not been fully addressed in the existing Drug Registration Rules ("DRR") and the Good Clinical Practices for Drugs ("GCP"). More at link above.  (Mondaq)


Energy & Commerce Committee Announces Hearing Schedule for Week of December 8
The House Energy and Commerce Committee today announced its hearing schedule for the week of December 8. As Congress prepares for the New Year, members will look into the fiscal challenges and opportunities for savings within the federal health care budget, discuss genetically modified food ingredients, and examine America’s changing energy market. On Tuesday, the Subcommittee on Health will hold a hearing to discuss fiscal priorities in federal health care spending as it prepares for the 114th Congress. Spending on Medicare, Medicaid, and the Affordable Care Act are key drivers of our nation’s fiscal challenges. Members will examine these challenges and discuss opportunities for savings within the federal health care budget. The Majority Memorandum, a witness list, and witness testimony will be available here as they are posted. More at link above. (Energy and Commerce Release)

More Committee Bills Cleared for President's Signature
The House of Representatives on Wednesday evening approved bipartisan bills that will now head to President Obama to be signed into law. H.R. 669, including the Sudden Unexpected Death and Data Enhancement Awareness Act, S. 2917, and the Adding Ebola to the FDA Priority Review Voucher Program Act.

H.R. 669, introduced by Health Subcommittee Ranking Member Frank Pallone (D-NJ) and Rep. Peter King (R-NY), provides for activities to help improve the understanding of stillbirth, sudden unexpected infant death, and sudden unexplained death in children.

S. 2917, championed by full committee Vice Chairman Marsha Blackburn (R-TN) in the House, will strengthen the Food and Drug Administration’s voucher program to include diseases like Ebola. This will help encourage more investment and innovation for the development of treatments for these diseases. Blackburn commented, “With nearly 15,000 cases and over 5,000 deaths, the 2014 Ebola epidemic is the worst since the discovery of the virus in 1976. In light of this global outbreak there should be an intensive effort to find and approve a treatment or better yet, a vaccine to prevent Ebola.”

These bills join H.R. 5728, the STELA Reauthorization Act, and H.R. 4067, an act to provide for the extension of the enforcement instruction on supervision requirements for outpatient therapeutic services in critical access and small rural hospitals through 2014, that are both awaiting the president’s signature.

A complete list of the committee’s bipartisan #RecordOfSuccess is available online here.  More at link above.  (Energy and Commerce Release)


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.