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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: July 18, 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CDER Guidances: New/Revised/Withdrawn through 6/30/14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lead to the List of Guidance Documents (CDER) updated on July 7, 2014, and to CDER Guidances that are new, revised, or withdrawn through the second calendar quarter of 2014.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On July 15, 2014, FDA announced the availability of a draft guidance entitled “Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications [510(k)] with Different Technological Characteristics.”   A submitter of a premarket notification submission (often referred to as a 510(k)) must demonstrate to FDA in its 510(k) submission that the new device is “substantially equivalent” (SE) to a legally marketed (predicate) device.  At certain points in the substantial equivalence analysis, the probable benefits and risks of a new device as compared to a predicate device may be relevant. The benefit-risk factors discussed in this guidance may assist FDA reviewers in making substantial equivalence determinations and may help accommodate evolving technology during the 510(k) premarket process. This guidance may also help submitters of 510(k) premarket notifications demonstrate substantial equivalence in their premarket submissions.  You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. [FDA.gov]

On July 15, 2014, FDA announced the availability of a draft guidance entitled “Informed Consent Information Sheet. Guidance for IRBs, Clinical Investigators, and Sponsors.” This guidance is intended to provide information to institutional review boards (IRBs), clinical investigators, and study sponsors about FDA’s informed consent regulations. This guidance, when finalized, will supersede “A Guide to Informed Consent,” issued in September 1998, by the Office of Health Affairs, FDA. To enhance human subject protection and reduce regulatory burden, the Department of Health and Human Services, Office for Human Research Protections and FDA have been actively working to harmonize the agencies’ regulatory requirements and guidance for human subject research. This guidance document was developed as a part of these efforts.  Comments and suggestions regarding this draft document should be submitted within 60 days (September 15, 2014) of publication in the Federal Register of the notice announcing the availability of the draft guidance. [FDA.gov]

On July 18, 2014, FDA announced the availability of a draft guidance entitled “Providing Submissions in electronic Format – PostmarketingSafety Reports for Vaccines.” The draft guidance document provides information and recommendations pertaining to the electronic submission of postmarketing safety reports involving vaccine products marketed for human use with approved biologics license applications (BLAs), including individual case safety reports (ICSRs) and attachments to ICSRs (ICSR attachments), into the Vaccine Adverse Event Reporting System (VAERS).  Comments may be submitted until September 16, 2014.  [Federal Register]


SECTION 2 FDA NOTES & RELATED NEWS

Social Media Draft Guidance Webinar (July 10, 2014) Experiences Technical Difficulties
The Social Media Draft Guidance Webinar held on July 10, 2014, experienced connection issues.  FDA recognizes the considerable interest in this subject and apologizes that due to technical difficulties, many registrants were not able to access the webinar. The slides from the webinar are available on the FDA website at the link above.  FDA has also added questions and answers discussed during the webinar. You are invited to submit comments to the dockets for the draft guidances, also available at the link below. For general questions about the webinar, please send to druginfo@fda.hhs.gov. For specific questions related to the content of the social media draft guidances, please call the appropriate FDA contact as listed on the first page of each of the draft guidance documents.  (FDA.gov)

Developing new tools to support regulatory use of “Next Gen Sequencing” data
Next Generation Sequencing (NGS) technology produces sets of data that are so large and complex that they overwhelm the ability of most computer systems to store, search, and analyze it, or transfer it to other computer systems. NGS is a complicated technique, but basically it involves cutting the genome into millions of small pieces so you can use sophisticated chemical tricks and technologies to ignore the “junk” you don’t need, and then make up to hundreds of copies of each of the pieces you want to study. This enables additional techniques to identify changes in the sequence of nucleic acids that might be mutations. NGS enables scientists to fast-track this process by analyzing millions of pieces of the genome at the same time.

In order to prepare FDA to review and understand the interpretation and significance of data in regulatory submissions that include NGS, the Center for Biologics Evaluation and Research (CBER) supported the development of a powerful, data-hungry computer technology called High-Performance Integrated Virtual Environment (HIVE), which can consume, digest, analyze, manage, and share all this data. HIVE is a private cloud-based environment that comprises both a storage library of data and a powerful computing capacity.

Because CBER’s HIVE installation has been so successful CBER is now collaborating with FDA’s Center for Devices and Radiological Health (CDRH) to provide a second installation with greater capacity and computer power that takes advantage of the high-performance computing capacity there. When ready and approved by FDA for use, CBER will use this powerful, CBER-managed, inter-center resource to handle regulatory submissions. More at link above. (FDA.gov)

McClellan defends breakthrough
Former FDA Commissioner Mark McClellan defended FDA's expedited approval programs, including breakthrough therapy designation, in a letter to the New England Journal of Medicine. The letter, co-signed by Friends of Cancer Research Chairperson and Founder Ellen Sigal, rejected criticism of the agency's expedited approval pathways contained in a March NEJM commentary by Harvard Medical School researchers. In response to the researchers' assertion that FDA is using breakthrough therapy designation to apply "increasingly flexible evidentiary standards" for approval, McClellan argued the pathway "does not confer a less rigorous path to approval." He also said all four approved drugs that received the designation are "clear advances in the treatment of life-threatening diseases that previously lacked effective therapies."

In May, FDA released final guidance on the qualifying criteria and benefits for FDA's expedited approval programs.  (BioCentury)

Academic labs argue against FDA guidance on LDTs
A group of academic laboratories urged the White House Office of Management and Budget against the release of FDA draft guidance for regulating laboratory-developed diagnostic tests (LDTs). The letter, co-signed by researchers of 23 labs, said imposing the FDA approval process on LDTs would cause a "crippling domino effect" on diagnostic laboratory innovation. It said the researchers support the current regulatory structure for LDTs and noted that LDTs are already subject to CLIA requirements, state laws and accreditation by "deemed authorities" such as the College of American Pathologists. The co-signers include researchers from Harvard University, University of California at San Francisco, Stanford University and the Mayo Clinic.

The guidance has been tied up at OMB for at least 18 months. Earlier this month, a group of Democratic senators urged OMB to release the guidance, saying it is necessary in light of "more sophisticated, complex and high-risk LDTs coming to market" in the last decade.  FDA Commissioner Margaret Hamburg told BioCentury that FDA intends to regulate LDTs because patients have "been harmed" when tests have not been held to a standard of evidence that answers "the important questions of analytic and clinical validity".  More at link above. (BioCentury)

FDA's Stern Warning on Data Integrity
FDA’s laser focus on data integrity issues during pharmaceutical inspections has led to a complementary focus on the overall integrity of companies’ interactions with the agency.

Senior officials are making it crystal clear that firms that lose the agency’s trust will find it difficult to earn it back, creating problems far beyond an initial manufacturing setback.

Firms will find that complete honesty after a slip up will go a long way.  “One of my goals is to make it increasingly uncomfortable for firms to misrepresent information to the agency,” said Thomas Cosgrove, acting director of FDA’s Office of Manufacturing and Product Quality in the Office of Compliance.

FDA has ramped up its focus on data integrity breaches during inspections using a new forensic approach and it has uncovered numerous violations.  More at link above.  (The Pink Sheet  by subscription)

CDER Builds Strong Foundation Of NMEs For 2014 As Approval Total Hits 19
With 19 new molecular entity and therapeutic biologic approvals in 2014 to date, the Center for Drug Evaluation and Research is all but guaranteed a strong full-year count of novel agents: the drugs center need only approve nine NMEs or NBEs in the second half of the year to surpass 2013’s full-year novel approval count of 27.

Oncology leads the 2014 novel approvals count, as it historically does, but by a slim margin: FDA has approved three cancer therapies to date.

Infectious disease treatments had a strong showing in the approval count, with the first two antibiotic approvals under the Qualified Infectious Disease Product program. FDA also cleared an orphan leishmaniasis treatment and two topical antifungals for the crowded onychomycosis market.

The NME class of 2014 is striking for its unusually high proportion of priority review and orphan drugs, two categories with a significant degree of overlap: all nine novel orphan agents approved received priority review, and orphans constitute 75% of the 2014 priority NMEs.  More at link above. (The Pink Sheet  by subscription)


SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS

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

Webinar. Brookings Roundtable on Active Medical Product Surveillance: 
Findings from a Mini-Sentinel Medical Product Assessment: Influenza Vaccines and Risk of Febrile Seizures.  July 21, 2014.  1 – 2 PM EDT.
Mini-Sentinel Investigators have recently completed an assessment that examined a possible association between use of certain trivalent inactivated influenza vaccines and febrile seizures in children. [FDA.gov]

New:  Public Hearing. Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials. August 11, 2014. White Oak Campus, Silver Spring, MD. The agency is seeking stakeholder input on the potential effects of disclosing information or analyses from ongoing CV outcomes trials, including what interim data "represent the greatest risk to trial integrity or jeopardize trial continuation." [FDA.gov]

Public Meeting. Scientific Meeting of the National Antimicrobial Resistance Monitoring System.  August 12-13, 2014. White Oak Campus, Silver Spring, MD.  The purpose of the meeting is to discuss progress made in achieving the goals of the National Antimicrobial Resistance Monitoring System (NARMS) Strategic Plan: 2012–2016. [Federal Register]

Public Workshop. Hemostatic Medical Devices for Trauma Use. September 3-4, 2014.  White Oak Campus, Silver Spring, MD.  The purpose of this workshop is to discuss factors that contribute to hemostatic medical device performance and reliability and types of studies used to assess bleeding and validate methods to evaluate the severity of bleeding, and to define regulatory pathways for novel products. [Federal Register]

Public Meeting in Collaboration with the National Cancer Institute. Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated with Use of non-Oncological Drugs and Biological Products in the Post-approval Setting.  September 10 - 11, 2014.  Silver Spring, MD.  The purpose of the public meeting is to engage in constructive dialogue and information sharing among regulators, researchers, the pharmaceutical industry, public health agencies, health care providers, and the general public concerning challenges in designing and implementing post-approval studies to evaluate the risk of cancer associated with use of non-oncological drugs and biological products. The input from this meeting and public docket will be used to inform the Agency on best study design and methodological options to consider when evaluating cancer risk in the post-approval setting.  [Federal Register]

New:  Public Advisory Committee Meeting. Cardiovascular and Renal Drugs Advisory Committee. September 10, 2014. White Oak Campus, Silver Spring, MD.  The committee will be asked to discuss the potential clinical utility of fixed-combination prescription drugs composed of an anti-hypertensive drug, aspirin, and a statin administered to reduce the risk of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke in patients with a history of cardiovascular disease. The committee will be asked to discuss the patient population that could benefit from such a product, whether that population would be likely to take such a drug long term, and how this could be assured. [Federal Register]

New:  Meeting. Third Annual Patient Network Meeting; Under the Microscope: Pediatric Drug Development. September 10, 2014. Washington, DC.  The meeting will serve as a forum for FDA’s stakeholders (patients, caregivers, patient advocates, healthcare professional groups, the general public, academia, and industry) to learn about regulations that encourage pediatric product development; to discuss ways to advance pediatric product development, how health disparities impact pediatric product development, the importance of transparency in pediatric clinical trials, and how analysis of information from failed pediatric clinical trials might improve future designs for pediatric trials; and to identify ways patient input can benefit clinical trial design for pediatric trials. [Federal Register]

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]

New:  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. Hyattsville, 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]


SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS

Formula for Innovation: People + Ideas + Time
In these times of tight budgets and rapidly evolving science, we must consider new ways to invest biomedical research dollars to achieve maximum impact—to turn scientific discoveries into better health as swiftly as possible. We do this by thinking strategically about the areas of research that we support, as well as the process by which we fund that research.

Historically, most NIH-funded grants have been “project-based,” which means that their applications have clearly delineated aims for what will be accomplished during a defined project period. These research project grants typically last three to five years and vary in award amount.

To meet the changing needs of the biomedical workforce, NIH is piloting the concept of awarding longer grants that provide more stable support for investigators at all career stages. It is our hope that with more sustained support, investigators will have more freedom to innovate and explore new lines of inquiry.

Moving forward, several NIH Institutes and Centers (IC) will be developing new funding opportunities to offer more sustained support to investigators’ research programs. These longer term awards will not follow a one-size-fits-all approach; leaders of each NIH IC will decide if they wish to embark on these awards based on the balance of their portfolios and their strategic planning needs. In addition, each IC will decide the appropriate size and duration of their awards. More at link above. (NIH.gov)

NIH system to monitor emerging drug trends
An innovative National Drug Early Warning System (NDEWS) is being developed to monitor emerging trends that will help health experts respond quickly to potential outbreaks of illicit drugs such as heroin and to identify increased use of designer synthetic compounds. The system will scan social media and Web platforms to identify new trends as well as use conventional national- and local-level data resources.

The University of Maryland’s Center for Substance Abuse Research (CESAR) will receive five years of funding from the National Institute on Drug Abuse (NIDA), part of the National Institutes of Health, to develop NDEWS.  More at link above. (NIH.gov)

2014 Webinar Series on Alzheimer’s Disease and Related Dementias
The Administration for Community Living (ACL), Centers for Disease Control and Prevention (CDC), and the National Institute on Aging (NIA) at the National Institutes of Health (NIH) are collaborating to host a webinar series to increase knowledge about Alzheimer’s disease and related dementias, and resources that professionals in the public health, aging services and research networks can use to inform, educate and empower community members, people with dementia and their family caregivers.  The dates and topics are: 

Tuesday, July 22, 2014:  Updates on Alzheimer’s Disease and Related Dementias Resources 

Thursday, August 28, 2014:  Community Collaborations for Assisting People with Alzheimer’s and Dementias: The Steps to Success 

Thursday, September 25, 2014:  Alzheimer’s Research Updates 
More at link above. (National Institute on Aging)

PCORI Funding for PatientCrossroads Registries Fuels Development of New National Clinical Research Network
“PatientCrossroads...announced that three PatientCrossroads-based patient registries—DuchenneConnect, for Duchenne and Becker muscular dystrophies; the Phelan-McDermid Syndrome International Registry; and the NephCure Kidney Network, for primary Nephrotic Syndrome—have been awarded contracts by the Patient-Centered Outcomes Research Institute (PCORI) as part of the creation of a new health data network called PCORnet: the National Patient-Centered Clinical Research Network.”  (Press via National Pharmaceutical Council)

Moving Forward: The Next Steps for PCORI’s Methodology Standards
In their recent PCORI Blog, David Hickam, Director of PCORI’s Clinical Effectiveness Research program, and Katie Rader, Program Associate in the Office of PCORI’s Executive Director, write: “The Methodology Committee is taking three approaches to developing additional standards and endorsing standards of other organizations...The first strategy is to focus on gaps in our current set of standards...In a second strategy, the Committee is examining standards and guidelines offered by other organizations...Finally, we are asking the full range of healthcare stakeholders to suggest topics for new standards.”  (PCORI.org)

Guide on methodological standards in pharmacoepidemiology revised to include pharmacogenetic studies
The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP), coordinated by the European Medicines Agency, has revised its guide on methodological standards in pharmacoepidemiology and added a chapter on the design and analysis of pharmacogenetic studies.

These studies aim to investigate how individual genetic variations determine the response to a medicine, both in terms of therapeutic effect and adverse drug reactions. They help optimise the prediction of treatment response leading to a better use of medicines.

The new chapter on pharmacogenetic studies provides a comprehensive overview of all relevant methodological guidance for the conduct of pharmacogenetic studies, from the identification of genetic variants through to study design, data collection, analysis and reporting. More at link above.  (EMA.eu)

EMA releases final guideline on stroke prevention in AF
EMA published a final guideline on conducting trials for products to prevent stroke and systemic embolic events in patients with non-valvular atrial fibrillation (AF). The guideline, which is in line with a draft released last November, recommends that trials have a composite primary endpoint of time to first stroke, including ischemic and undefined strokes, and systemic embolic events, and that sponsors evaluate the components of the composite endpoint separately for secondary endpoints. The guideline comes into effect on Dec. 26, 2014.

EMA also published a concept paper proposing changes to guidance on the clinical investigation of drugs for the prophylaxis of venous thromboembolic (VTE) risk in non-surgical patients. The agency called for an update of several methodological issues, including an updated definition of bleeding events and its assessment, the inclusion of additional secondary safety outcomes for new antithrombotics and clarifications regarding imaging tests used in dose-finding and confirmatory trials. Comments are due Oct. 15.  (BioCentury)

Wider Use of Statins Could Cut Deaths from Heart Disease
In an update to the 2006 guideline on lipid modification, NICE (National Institute for Care and Excellence – UK) recommends that the threshold for starting preventative treatment for CVD should be halved from a 20 per cent risk of developing CVD over 10 years to a 10 per cent risk.

Up to 4.5 million people could be eligible for statins under the lower threshold. Offering statins to all eligible people could help to prevent up to 28,000 heart attacks and 16,000 strokes each year.  Currently, 1 in 3 deaths in the UK are caused by CVD, accounting for 180,000 deaths each year. CVD has a significant burden of disability and up to £8 billion of NHS resources are tied up in CVD.

NICE recommends that GPs start statin treatment for the primary prevention of CVD with atorvastatin 20 mg. Patients with established CVD, type 1 diabetes or type 2 diabetes should be offered a higher strength 80mg dose of atorvastatin.  More at link above.  (Press)

EFPIA Disapproves of French Off-Label Initiative
On July 8, 2014, the French National Assembly voted a draft law proposal that would potentially allow healthcare professionals to prescribe off-label drugs, even if there is an approved drug available for treatment.

EFPIA, the European Federation of Pharmaceutical Industries and Associations, harshly criticized the proposal. Richard Bergström, EFPIA Director General, said: "A worrying trend is growing across Europe with governments bypassing important health safeguards and making public health decisions based purely on short-term economic considerations. This move is a material breach of the regulatory framework created to preserve the highest standard of patient safety in Europe."

Bergström concluded: "If public authorities continue to promote off-label use of other, less costly, medicines that have not undergone stringent safety and efficacy assessments, pharmaceutical companies will be discouraged from undergoing the costly and time-consuming [authorization] process for new indications.  More at link above. (Policy and Medicine)

TPP talks make progress, barring thorny issues
Chief negotiators from the 12 member countries in Trans-Pacific Partnership free trade talks ended their eight-day session in Ottawa on Saturday with progress on issues other than thorny ones, such as intellectual property rights protection for drugs.

Since further working-level discussions are necessary, the 12 countries including Japan and the United States are expected to hold a session of chief negotiators again as early as in September to pave the way for an envisioned broad agreement in November.

The participants were able to reach a rough accord in the labor field; to solve thorny issues, chief negotiators need to meet again before the 12 nations hold ministerial talks.

During the just-ended session, the chief negotiators agreed that their countries will introduce a mechanism for prior consultations among relevant nations before they impose sanctions over products made in violation of rules, such as through child labor, sources said.  (The Japan News via FDLI SmartBrief)

India to Pay Whistleblowers for Info on Counterfeit Drugs
Indian officials say some quality-control problems that have tarnished the collective industry image are actually not due to lax standards or malfeasance, but may be traced to “vested interests” that are distributing “spurious,” or counterfeit, medicines near and far.

To combat the problem, the Indian Ministry of Health & Family Welfare is willing to reward “whistleblowers” that pass along information leading to a seizure. And informers stand to reap a bounty up to 20% of the value of any drugs that are seized. Government employees who similarly convey useful information may also be eligible to claim a reward.

“…Since spurious or fake drugs is a sensitive issue affecting the health of the citizens, as well as the prestige of the country’s pharmaceutical trade interests, there is a sense of urgency in taking on the menace on [a] priority basis,”  according to a none-page memo from the Ministry. More at link above.  (Pharmalot in the Wall Street Journal)


SECTION 5 SOURCES REVIEWED FOR THIS NEWSLETTER

Energy & Commerce Committee 21st Century Cures to hold personalized medicine roundtable
The House Energy and Commerce Committee's 21st Century Cures initiative will discuss genomic sequencing and diagnostic testing during a roundtable discussion on personalized medicine on July 23. The committee will explore how regulation of these areas affects innovative product development and delivery. 

Participants will include Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health (CDRH); Richard Moscicki, deputy director for science operations of the agency's Center for Drug Evaluation and Research (CDER); Sean Bohen, SVP of early development at the Genentech Inc. unit of Roche; and Patrick Groody, senior director of integrated business planning at Abbott Laboratories.

Sentinel System Discussed in Testimony at Congressional Hearings
The FDA’s active surveillance system designed to search health data to uncover adverse safety events for newly approved drugs is coming under fire from critics who say that progress is coming too slowly.

Aaron Kesselheim, M.D., a health policy researcher in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham & Women’s Hospital in Boston and an Assistant Professor of Medicine at Harvard Medical School, believes the FDA’s Sentinel system is promising, but says the jury is still out on whether the regulatory agency will in fact succeed in achieving its goal.

According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, the Mini-Sentinel system can survey more than 350 million person years of observation, 4 billion pharmaceutical dispensings, and 4.1 billion patient encounters.

However, Kesselheim warns that there is “still much, much more to be done before we can rely on the Sentinel initiative for any sort of real active surveillance and I think that that’s far in the future.”

“My understanding is that the funding of the Sentinel initiative going forward is still up in the air. So, I would encourage Congress to continue to fund it. But, I would also not get peoples’ hopes up that the Sentinel system is going to be some white knight from a post-market surveillance point of view,” he said.  More at link above.  (Health Data Management)

FDA Drug Center Chief: Legislation Not Needed For Patient-Reported Outcomes Collection
“FDA drug center chief Janet Woodcock told the House Energy and Commerce health panel Friday that legislation is not needed to help the agency better incorporate patient-reported outcomes in the drug development process. Instead, she said, FDA could engage patients and industry to develop standards for soliciting patient perspectives, and to develop validated tools to measure patients' risk tolerance.” (Inside Health Policy via National Pharmaceutical Council)

FedEx Indicted For Trafficking Drugs For Internet Pharmacies
From DIA Daily, July 18, 2014 (DIA Member benefit)

USA Today (7/18, Leger) reports that a Federal grand jury in San Francisco has indicted FedEx on charges of “conspiring to deliver prescription drugs for illegal Internet pharmacies.” According to the indictment, FedEx “knew for a decade that such pharmacies used their services,” and “took steps to protect its business by setting up special credit policies for Internet pharmacies so it wouldn’t lose money if police shut the sites down.” 
        NBC News (7/18, Blankstein) reported on its website that the indictment “alleges that FedEx illegally distributed controlled substances and pharmaceuticals – including phendimetrazine, Ambien, phentermine, diazepam (Valium) and Alprazolam (Xanax)” to “customers that prosecutors said ‘had no legitimate medical need’ for them.” 
The Wall Street Journal (7/18, Grossman, Stevens, Subscription Publication) reports that Federal prosecutors say that FedEx ignored repeated warnings from the government that it by shipping drugs ordered from online pharmacies that provided drugs to anyone who filled out an online questionnaire, it was violating the law. 
        The San Jose (CA) Mercury News (7/18, Mintz) reports that “Federal prosecutors allege that FedEx couriers in Kentucky, Tennessee and Virginia at different times expressed concern to executives, recounting instances of drivers being threatened and prescription drugs being shipped to addresses that included parking lots, schools and vacant homes.” 
        The AP (7/18, Elias) reports that the Justice Department “wants FedEx to forfeit $820 million it says the cargo company earned by assisting the illicit pharmacies.” 
        The New York Times (7/18, Subscription Publication) reports that in several corporate filings, FedEx “denied any wrongdoing.” The company said, “We believe that our employees have acted in good faith at all times. ... We do not believe that we have engaged in any illegal activities and will vigorously defend ourselves in any action that may result from the investigation.” 
        Bloomberg News (7/18, Schlangenstein, Gullo) notes that the company said last year that “an indictment or prosecution in the case would threaten a basic tenet of its shipping business – not opening packages.” 
        The Los Angeles Times (7/18, Raab) reports that the company “pushed back against the allegations, saying it would plead not guilty and accusing the Justice Department of threatening to compromise its customers’ privacy.” Patrick Fitzgerald, senior vice president of marketing and communications, said in a statement, “We have repeatedly requested that the government provide us a list of online pharmacies engaging in illegal activity. ... Whenever [the Drug Enforcement Administration] provides us a list of pharmacies engaging in illegal activity, we will turn off shipping for those companies immediately. So far the government has declined to provide such a list.” Reuters (7/18, Levine), TIME (7/18, Dockterman) also cover the story. 


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.