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: March 20, 2015
SECTION 1 FDA GUIDANCES & MAPPS
Guidance Documents CBER is Planning to Publish in 2015
This is the list of guidance topics CBER is considering for development during Calendar Year 2015. The list includes topics that currently have no guidance associated with them, topics where updated guidance may be helpful, and topics for which CBER has already issued Level 1 drafts that may be finalized following review of public comments.
CDER 2015 Plan for New & Revised Guidances
The link above is the new CDER list of guidances planned for new issue or revision in Calendar Year 2015.
Searchable Database of All Official FDA Guidance Documents and Other Regulatory Guidance
FDA has created a database that provides a convenient way y to search for all FDA guidance documents from a single location. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period. Access the database at the link above. (FDA.gov)
CDRH FY 2015 Proposed Guidance & Focused Retrospective Finalized Guidance
The lists below include guidance documents that CDRH intends to publish this fiscal year (FY2015) as well as previously-issued final guidances for which CDRH would appreciate external feedback on whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2005, 1995, and 1985 subject to focused retrospective review. Although resource constraints and new issues that emerge over the course of the year may preclude CDRH from issuing every guidance document on the A-list and B-list and may require that CDRH issue guidance documents not on the lists, the A-list and B-list are intended to provide helpful information about CDRH’s current priorities for the upcoming fiscal year. CDRH plans to update all three lists every year. (FDA.gov)
On March 17, 2015, FDA announced the availability of a guidance for industry entitled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” This guidance provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices. The document also provides recommendations for the content and review procedures for premarket notification (510(k)) submissions, premarket approval (PMA) applications, humanitarian device exemption (HDE) applications, de novo requests, and investigational device exemption (IDE) applications, concerning the labeling instructions for reprocessing reusable medical devices. This guidance reflects the scientific advances in knowledge and technology involved in reprocessing reusable medical devices, especially more complex, reusable medical device designs that are more difficult to reprocess. [Federal Register]
On March 19, 2015, FDA announced the availability of a report entitled “‘Assessing CDER’s Drug Safety-Related Regulatory Science Needs and Identifying Priorities.” This report identifies drug safety-related regulatory science needs and priorities related to the mission of FDA’s Center for Drug Evaluation and Research (CDER) that would benefit from external collaborations and resources. FDA hopes to foster collaborations with external partners and stakeholders to help address these needs and priorities. This notice asks stakeholders conducting research related to these needs to describe that research and indicate their interest in collaborating with FDA to address safety-related research priorities. Comments should be submitted by May 18, 2015. [Federal Register]
On March 20, 2015, FDA published a rule entitled “Termination of the Antiviral Drugs Advisory Committee.” This document removes the Antiviral Drugs Advisory Committee from the Agency’s list of standing advisory committees. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of acquired immune deficiency syndrome, human immunodeficiency virus related illnesses, and other viral, fungal and mycobacterial infections. The Committee is no longer needed and was terminated on February 15, 2015; the rule is effective March 20, 2015. [Federal Register]
SECTION 2 FDA NOTES & RELATED NEWS
FDA seeks input on product-specific recommendations to assist and facilitate generic drug development
FDA has published 60 product-specific recommendations describing the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.
FDA is always seeking feedback and considers all comments to the docket before it begins work on the final version of a product-specific bioequivalence guidance.
As of 2015, the Agency provides quarterly notification of these recommendations for public consideration. More at link above. (FDA.gov)
FDA softens approach in meetings with Indian regulators
FDA is adopting a "carrot and stick" approach to the problems with India's pharmaceutical production.
Howard Sklamberg, deputy commissioner for global regulatory operations and policy, said as much on the opening day of a three-day visit with India regulators by him and two other FDA leaders in New Delhi.
Sklamberg said the new plan calls for rating India drugmakers and providing incentives for meeting good manufacturing practices along with use of its usual enforcement tools.
The official said the agency was still working on a rating system that would take into account the quality-producing procedures a company follows as well as its compliance with other drug-production and quality-control steps. He added that the rating system was not limited to India and that it would be imposed globally, even on the United States.
Sklamberg said the intent of the ratings was to enable the high achievers to stand out, possibly causing them to be inspected less often. More at link above. (Fierce PharmAsia)
SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS
Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015
Public Advisory Committee Meeting. Pediatric Ethics Advisory Committee. March 23, 2015. White Oak Campus, Silver Spring, MD. The Pediatric Ethics Subcommittee of the Pediatric Advisory Committee will meet to discuss the general topic of how procedural sedation for nontherapeutic (research) interventions or procedures in the pediatric population should be considered under the Additional Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart D. A brief summary of the subcommittee’s discussion will then be presented to the FDA Pediatric Advisory Committee on Tuesday, March 24, 2015. [Federal Register]
Public Workshop. Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies. March 24, 2015. Washington, DC. This workshop is being cosponsored by FDA with the American Association for Cancer Research (AACR) and the American Society of Clinical Oncology (ASCO), with the objective of facilitating an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. Registration is first come, first served with deadline of March 17, 2015. Streaming audiocast will also be available. [Federal Register]
Public Meeting. Pediatric Stakeholder Meeting. March 25, 2015. White Oak Campus, Silver Spring, MD. The FDA Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient groups, consumer groups, regulated industry, academia and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA). The report will address the implementation of the Best Pharmaceuticals for Children Act (BPCA) and Pediatric Research Equity Act (PREA). [Federal Register]
New Note: A corrected docket number for comments was published in the Federal Register of March 20, 2015. [Federal Register]
Public Meeting. Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products. March 27, 2015. White Oak Campus, Silver Spring, MD. The purpose of the meeting is to provide a public forum for FDA to listen to comments on the proposed rule on ‘‘changes being effected’’ supplements that was published in the Federal Register of November 13, 2013, and alternatives offered to this proposed rule. [Federal Register]
Public Workshop. Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics. March 30-31, 2015. White Oak Campus, Silver Spring, MD. The purpose of this workshop is to provide a forum to consider issues related to selection of endpoints and clinical outcome measures appropriate for drug development in the following disease areas: Inflammatory bowel diseases and celiac disease. [Federal Register]
Public Workshop. FCC/FDA Joint Workshop on Wireless Medical Device Test Beds. March 31, 2015. FCC Commission Meeting Room, Washington, DC. Federal Communications Commission (FCC) and the FDA will host a public workshop on the role of wireless medical test beds and their influence on the development of converged medical technology for clinical and non-clinical settings. A wireless test bed is an environment where devices can be evaluated across a range of interference scenarios. The FCC and FDA encourage the participation of a broad range of stakeholders, including device manufacturers, health care facilities and clinicians, test labs, standard-setting bodies, innovators, patient safety groups, researchers, and entrepreneurs, among others. [FDA.gov]
Public Workshop. Clinical Outcomes Assessment Development and Implementation: Opportunities and Challenges. April 1, 2015. White Oak Campus, Silver Spring, MD. The purpose of the public workshop is to provide updates on accomplishments, challenges, and ongoing efforts in the use of clinical outcome assessments (COAs), and plan for the future of COA development and utilization in drug development programs, including how to incorporate the patient voice in drug development using well-defined and reliable patient-centered outcome measures. [Federal Register]
Public Meeting. Patient-Focused Drug Development for Breast Cancer. April 2, 2015. White Oak Campus, Silver Spring, MD. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of breast cancer on daily life and patient views on treatment approaches. More information and materials as they become available at Breast Cancer Patient-Focused Drug Development [Federal Register]
Public Workshop. Assessment of Neurocognitive Outcomes in Inborn Errors of Metabolism and Advancing the Development of Pediatric Therapeutics: Assessment of Neurocognitive Outcomes. April 16-17, 2015. White Oak Campus, Silver Spring, MD. Day 1 of the workshop will focus on approaches for assessing the efficacy of therapeutic products based on neurocognitive outcomes in patients diagnosed with inborn errors of metabolism disorders. On Day 2 of the workshop, participants will discuss identification of signals in animal studies and clinical trials that warrant further clinical investigation and testing that may be predictive of neurocognitive outcome in children. [FDA.gov]
Public Advisory Committee Meeting. Neurological Devices Panel of the Medical Devices Advisory Committee. April 17, 2015. White Oak Campus, Silver Spring, MD. The committee will discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology. FDA is convening this committee to seek expert opinion on scientific and clinical considerations relating to the study design and existing clinical studies, for flow diverter technology indicated for the neurovasculature. [Federal Register]
New. Public Workshop. An Interactive Discussion on the Clinical Considerations of Risk in the Postmarket Environment. April 21, 2015. White Oak Campus, Silver Spring, MD. The purpose of this workshop is to provide a forum for an interactive discussion on assessing changes in medical device risk as quality and safety situations arise in the postmarket setting when a patient, operator, or member of the public uses the device. FDA has also opened a docket for comments on this topic (due May 19, 2015). [Federal Register]
Public Workshop. 2015 Office of Regulatory Science and Innovation Science Symposium. April 27, 2015. White Oak Campus, Silver Spring, MD. The purpose of the public workshop is to increase scientific collaborations with government institutions, academia, industry and other stakeholders, working to improve science, training, and networking in accordance with the FDA mission of the advancement of regulatory science. This venue will also enhance knowledge and awareness of the FDA ORSI resources and provide guidance of its available services. [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]
Public Advisory Committee Meeting. Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee. April 30 – May 1, 2015. Gaithersburg, MD. On April 30, 2015, the committee will discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, and Vestibular Analysis Apparatuses. On May 1, 2015 the committee will discuss key issues related to a potential pre- to post-market shift in clinical data requirements for modifications to cochlear implants in pediatric patients. [Federal Register]
Public Meeting. Patient-Focused Drug Development for Functional Gastrointestinal Disorders. May 11, 2015. White Oak Campus, Silver Spring, MD. FDA is holding this public meeting and an opportunity for public comment on Patient-Focused Drug Development for functional gastrointestinal (GI) disorders, including irritable bowel syndrome, gastroparesis, chronic persistent symptomatic gastroesophageal reflux despite standard therapeutic interventions, and chronic idiopathic constipation. [Federal Register]
New. Public Advisory Committee Meeting. Vaccines and Related Biological Products Advisory Committee. May 12, 2015. White Oak Campus, Silver Spring, MD. The committee will meet in open session to discuss the development and licensure of Ebola vaccines. [Federal Register]
Public Advisory Committee Meeting. Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee. May 14-15, 2015. White Oak Campus, Silver Spring, MD. FDA is convening this committee to seek expert scientific and clinical opinion related to reprocessing of duodenoscopes and other endoscopes, as well as automated endoscope reprocessors, based on available scientific information. [Federal Register]
Public Hearing. Regulatory Science Initiatives under the Generic Drug User Fee Amendments of 2012. June 5, 2015. White Oak Campus, Silver Spring, MD. This public hearing will provide an overview of the current status of regulatory science initiatives for generic drugs and an opportunity for public input on research priorities in this area. FDA is seeking this input from a variety of stakeholders—industry, academia, patient advocates, professional societies, and other interested parties—as it fulfills its commitment under the Generic Drug User Fee Amendments of 2012 (GDUFA) to develop an annual list of regulatory science initiatives specific to generic drugs. FDA will take the information it obtains from the public hearing into account in developing the fiscal year (FY) 2016 Regulatory Science Plan. [Federal Register]
Public Workshop. Robotically-Assisted Surgical Devices: Challenges and Opportunities. July 27-28, 2015. White Oak Campus, Silver Spring, MD. FDA is holding this public workshop to obtain information on the current challenges and opportunities related to robotically- assisted surgical medical devices, which are classified as Class II medical devices. The purpose of this workshop is to obtain public feedback on scientific, clinical, and regulatory considerations associated with RAS devices. [Federal Register]
SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS
Health Information Management Systems Society to Focus on Transforming Health
Chicago welcomes the 2015 HIMSS Annual Conference & Exhibition, April 12-16, 2015, at McCormick Place. More than 38,000 healthcare industry professionals are expected to attend to discuss health IT issues and view innovative solutions designed to transform healthcare.
DIA is proud to support this annual event that helps health IT professionals find the right solutions for their organizations.
Conference education sessions include preconference symposia on clinical and business analytics, HIEs, innovation, mobile health, nursing informatics, physicians’ IT and more. More than 300 peer-reviewed sessions, including workshops and roundtables, round out education offerings at HIMSS15.
George W. Bush, 43rd President of the United States, leads a strong roster of speakers that also includes Alex Gourlay, President, Walgreens; Bruce D. Broussard, President and CEO, Humana; and Jeremy Gutsche, Founder of Trendhunter.com and Author of “Exploiting Chaos.”
The HIMSS15 Exhibit Hall will feature the Connected Patient Gallery, Federal Health IT Solutions Pavilion, HIMSS First-Time Exhibitors Area, HIMSS Health IT Value Suite, HIMSS Interoperability Showcase™, Intelligent Health™ Pavilion (formerly known as Intelligent Hospital Pavilion), and three Knowledge Centers focused on clinical and business intelligence, disaster preparedness and mobile health.
As a HIMSS15 Endorser, DIA members are eligible to receive the member discount to attend the conference. To receive the discount, go to the online registration at www.himssconference.org/registration, and select DIA from the “Conference Endorsing Organizations” drop-down in the registration process. Enter Endorser Number “2015”. More information at title link above. (HIMSS.org)
CMS, ONC release proposed rules for Meaningful Use Stage 3
The Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health IT (ONC) have issued their proposed rules outlining the requirements for Stage 3 of the Meaningful Use incentive program. The proposed rules make several expected changes to Meaningful Use.
The CMS rule specifies the Meaningful Use criteria and maintains, for the most part, payment adjustments and hardship exceptions. Following a proposed "optional" year in 2017, starting in 2018 all providers would report on the same streamlined definition of Meaningful Use at the Stage 3 level, regardless of prior participation. It would also require reporting on a calendar-year basis starting in 2017.
The rule contains only eight objectives, which focus on advanced use of electronic health record (EHR) systems. The eight objectives are designed to align with national healthcare quality improvement efforts, promote interoperability and health information exchange and focus on the triple aim of reducing costs, improving access and improving quality. The objectives are meant to be flexible and pertain to health information exchange, consumer engagement and public health. (Fierce EMR)
Internet of Things: Connected devices at risk for malware, privacy violations
There must be a balance between the promise of new Internet of Things (IoT) tools and devices and the need for robust security and data privacy, according to a new report.
For the report, Intel Security and Atlantic Council's Cyber Statecraft Initiative gathered government, medical and security specialists to create guides for trust and innovation for connected medical devices.
Connected medical devices help patients and their caregivers better monitor their health. That kind of real-time monitoring lets patients receive feedback and alerts more quickly, the report says.
That report says the overall number of IoT connections is predicted to more than quadruple between 2014 and 2020 to about 5.4 billion.
However, the benefits of networked devices will mean little without putting the proper security in place, according to the Intel report. Security officials and healthcare organizations must take the correct steps to prevent future attacks. More at link above. (Fierce Health IT)
PCORnet Workshop with the Pharmaceutical and Biologics Industry
PCORI will hold two stakeholder workshops on March 30 and 31, with representatives of pharmaceutical and biologics manufacturers and with device and diagnostic manufacturers, respectively, on how PCORnet can be a useful resource to that community in its research efforts.
In-person attendance is by invitation only but the public is welcome to listen in via teleconference and webinar. (Register for webinar at link above.)
Although public questions and comments will not be taken during the live event, members of the public are encouraged to share them via email@example.com. (PCORI.org)
Global Dementia Discovery Fund Established
The world's first venture capital fund dedicated to finding new ways to prevent and treat dementia has raised more than $100 million with the backing of the British government and several of the world's leading drugmakers.
The global Dementia Discovery Fund is unique in focusing on a single difficult to treat disorder and in bringing together industry and government.
Drug companies involved include GlaxoSmithKline, Johnson & Johnson, Eli Lilly, Pfizer and Biogen Idec.
The initiative, announced by Britain's health minister Jeremy Hunt at a meeting in Geneva on Tuesday, follows a Group of Eight (G8) nations conference in London in December 2013 that set a goal of finding a cure or effective treatment for Alzheimer's and other forms of dementia by 2025.
GSK's head of research and development Patrick Vallance told Reuters the 2025 goal was "hugely ambitious" but that pooling resources through the new fund to back promising ideas from academic groups and small biotech firms would help to accelerate research.
More at link above. (Reuters)
NIH Awards Coriell Institute $14M Biobanking Grant
The Coriell Institute today (3/16/15) announced that it has received a $14 million competitive grant from the National Institutes of Health to support the National Institute of General Medical Sciences (NIGMS) Human Genetic Cell Repository.
The five year grant from NIGMS will support a biobank which includes more than 11,300 cell lines and 5,700 DNA samples representing 890 disease states and chromosomal abnormalities in several distinct human populations. It also contains healthy control samples and 40 induced pluripotent stem cell lines.
"The advent of faster, better, and cheaper DNA sequencing is ushering in an exciting genomic era in which biobanks are more essential than ever before," Coriell Institute President and CEO Michael Christman said in a statement. "Biobanks with high-quality, characterized specimens are helping scientists better understand many human diseases. This collection is a powerful resource for scientists studying rare genetic diseases, like progeria and Duchenne muscular dystrophy, as well as other disorders such as metabolic diseases and hereditary cancers."
Last year, the Camden, NJ-based biomedical research center launched a West Coast biobank in Novato, Calif. (GenomeWeb)
Celebrating 20 years: EMA launches anniversary book
An anniversary book to mark 20 years of the European Medicines Agency (EMA) has been published today.
The aim of the publication is to capture changes and progress in medicines regulatory science over the past 20 years, and to describe how EMA has addressed important challenges for public and animal health.
41 authors selected from the wide range of EMA partners and stakeholders have contributed to the book. More at link above. (EMA.eu)
Electronic common technical document v4.0 draft European Union module 1 implementation guide public consultation
The European Medicines Agency (EMA) has published a public consultation concerning the European Union (EU) module 1 implementation guide including electronic common technical document (eCTD) v4.0 module 1 requirements of the eCTD XML message, the regional administrative and product information specific for EU purposes and the set of controlled vocabularies relevant to EU module 1 in the format of genericode files. More at link above. (EMA.eu)
Innovative Medicines Initiative Alzheimer’s disease projects launch joint platform
The Innovative Medicines Initiative (IMI) and its AETIONOMY, EMIF and EPAD projects are proud to announce the creation of the IMI Alzheimer’s Disease Research Platform. The platform will facilitate collaboration between the three projects, helping them to deliver results faster. At the same time, IMI and the Global Alzheimer’s Platform (GAP) are announcing their plans to sign a Memorandum of Understanding to accelerate Alzheimer’s drug development by building a global, standing, trial-ready platform for Alzheimer’s drug development.
AETIONOMY is paving the way towards a new approach to the classification of neurodegenerative diseases, particularly Alzheimer’s and Parkinson’s diseases, thereby improving drug development and increasing patients’ chances of receiving a treatment that works for them.
EMIF is developing a common information framework of patient-level data that will link up and facilitate access to diverse medical and research data sources, opening up new avenues of research, particularly in the fields of Alzheimer’s disease and obesity.
EPAD is pioneering a new, more flexible approach to clinical trials of innovative Alzheimer’s disease treatments designed for people who have the disease but have not yet developed dementia. More at link above. (IMI.europa.eu)
China Drug Approval Backlog Jumped By A Third Last Year
China had more than 18,500 drugs waiting for approval at the end of 2014, up by a third from a year before, the official Center for Drug Evaluation said on Friday, reflecting industry concern that it is getting harder to get medicines approved in the China market.
Drug company executives say China has toughened the approval process, with companies forced to go through six to eight-year wait times in the world's second biggest pharmaceutical market, where spending is set to hit as much as $185 billion by 2018, according to IMS Health.
China's fast-growing healthcare market is a magnet for drugmakers, medical device firms and hospital operators, with a broader healthcare bill set to hit $1 trillion by 2020. However, the sector is riddled with issues from rampant bribery to huge divides between urban and rural care.
China's drug trial center received 8,868 drug applications in 2014, up from 7,610 the year before, according to the annual report Center for Drug Evaluation, overseen by the country's food and drug regulator, and released on Friday.
The organization said it had increased the number of reviews it completed last year, but it was outflanked by an increase in new drugs to review. More at link above. (Reuters)
Big Three Asia pharma markets poised to soar in 2015, reports say
The driving pharmaceutical segments of two of Asia's pharmaceutical giants, India and Japan, are expected to grow at rates of nearly 11% and 8% respectively through the year 2019, and China is expected to record a near-12% increase in this year alone.
Limited information from a series of recent reports by various research companies focused on the overall China pharma market, India's active pharmaceutical ingredients market and Japan's generics markets for clues to what lies ahead for the industry in Asia's three biggest markets.
One report pegged China's pharmaceutical market to increase to $110.26 billion this year, for a growth of 11.7% in U.S. dollar terms. The nation's overall healthcare industry was forecast to grow 13.5% this year. More at link above. (Fierce PharmAsia)
SECTION 5 LEGAL AND COMPLIANCE
FDA must make smarter use of big data
A bipartisan think tank is calling on Congress to enable the Food and Drug Administration to use hospital electronic health records and crowd-sourced patient experience data to transform the drug and medical device approval process.
On Monday, the Bipartisan Policy Center kicked off its five-point "FDA: Advancing Medical Innovation" initiative, focusing on the agency's role in biomedical research and how big data – currently soloed in healthcare IT systems and patient social networks – can improve personalized medicine, genomics, molecular pathways and other cutting-edge treatments.
"Our inefficient, less-than-modern, drug discovery and device approval process drives up cost and delays treatment," said the initiative's co-chair, former Senator Bill Frist. "We must accelerate the process of getting safe and effective drug and medical devices to patients."
At the kick-off event in Washington, D.C., panel members Marc Boutin, CEO of the National Health Council, and Mark McClellan, former administrator for CMS and commissioner of the FDA, and now a senior fellow at the Brookings Institute, agreed that the FDA's primary reliance on pre-market clinical trials to review the risks and benefits of medical innovations needed to catch up with innovations in healthcare data and systems.
Boutin, whose organization advocates for stronger patient involvement in healthcare delivery, urged Congress to create legal "guard rails" so that medical researchers working for drug and device makers could tap into crowdsourced patient views – aggregated in patient social networks – without fear of being fined for marketing unapproved products. McClellan emphasized post-market surveillance opportunities.
Janet Marchibroda, BPC's health innovation director, said the medical innovations initiative will result in concrete policy recommendations to Congress.
The recommendations will focus on five key areas:
- Improving the time and cost associated with the discovery, development, and delivery of safe and effective drugs and devices for patients;
- Reviewing the scope of activities within the FDA;
- Advancing a more efficient and effective regulatory framework for medical products;
- Strengthening FDA's ability to carry out its mission; and
- Maintaining U.S. global leadership in medical innovation.
More at link above. (HealthcareITNews)
Congress Pressures FDA to Finalize Opioid Guidance
The FDA will publish its long-awaited guidance on abuse-deterrent opioids by the end of June, in order to avoid a $20 million cut in funds to the commissioner's office threatened by Congress.
An amendment by Hal Rogers (R-Ky.) to the "Cromnibus" appropriations bill passed last December requires that the guidance be finalized by June 30, otherwise $20 million will be moved from the salaries and expenses section of the FDA Commissioner's office to its criminal investigations department to combat drug diversion.
Guidance for developing abuse-deterrent opioids has been a long time coming. It was initially released in January 2013, but the agency didn't hold a workshop on the draft document a 2-day meeting last October.
While it's unclear what the final language will be, the agency noted last fall that it plans to continue to evaluate approvals on a case-by-case basis -- citing the fact that the science of abuse-deterrence is still unsettled. More at link above. (MedPage Today)
House passes DEA scheduling bill
The U.S. House of Representatives passed H.R.639, a bipartisan bill that would require the Drug Enforcement Administration to schedule new drugs no later than 90 days after a drug is approved or when the agency receives FDA's scheduling recommendation, whichever comes later. It would also provide a timeline for DEA to register controlled substances for use in clinical trials. Reps. Joe Pitts (R-Pa.), Gene Green (D-Texas) and Frank Pallone (D-N.J.) introduced the bill, known as the Improving Regulatory Transparency for New Medical Therapies Act.
In addition, the bill would delay the start of marketing exclusivity for a new drug until the later of two events: its scheduling by DEA or its approval by FDA. Marketing exclusivity for new drugs currently begins upon FDA approval regardless of DEA actions. More at link above. (BioCentury)
FDA is Sued for Failing to Regulate the Use of Glutens in Medicines
After taking a generic drug seven years ago and developing side effects consistent with ingesting gluten, Michael Weber, who suffers from celiac disease, petitioned the FDA to either eliminate wheat gluten in medicines or require new labeling on drugs containing the protein. The agency response has been slow. In 2011, the FDA sought public comments about the issue, but otherwise has not taken action.
So Weber has now filed a lawsuit to demand the FDA do something.
After taking the drug, “I called my pharmacy and they were not able to determine that drug was gluten-free,” says Weber, a medical office assistant in Eastchester, N.Y. “So then I had to find which manufacturer produced the generic. I went to their website and then had to speak to somebody at the company. They said that was not a gluten-free batch… So I had to discontinue taking the drug. I would like to be able to take drugs and not have any fears or go through all these hoops.”
In his lawsuit, he argues the failure to address the issue is hurting millions of Americans. About 1% of the U.S. population has celiac disease, according to the National Foundation for Celiac Awareness. “The absence of rules to address wheat gluten in prescription medications has serious and ongoing public health implications,” says Katie Einspanier, an attorney at Public Citizen, which represents him.
It’s not clear exactly how many medicines contain wheat gluten. “Unfortunately, there is no clear answer to the question of the prevalence of gluten in either OTC or prescription medications,” a spokeswoman for the National Foundation for Celiac Awareness writes us. “This highlights “the need for comprehensive research to identify safe thresholds of gluten in medication, its impact on people with celiac disease, and the pervasiveness of gluten” in production.
Meanwhile, spokespeople for the Pharmaceutical Research & Manufacturers of America, which represents prescription drug makers, and the Consumer Healthcare Products Association, which represents over-the-counter medicines, declined comment regarding the lawsuit and say they are uncertain how many of their members use gluten in their products. More at link above. (WSJ Pharmalot)
Oregon Introduces Pharmaceutical Price Transparency Bill; PhRMA and BIO Outline Serious Concerns To Oregon State Legislature During Public Hearing
On March 11, the Oregon House of Representatives introduced House Bill 3486, which would require pharmaceutical manufacturers to file an annual report with the Oregon Health Authority on costs in the previous year associated with prescription drugs that cost $10,000 or more per year or per course of treatment. This bill is similar to California’s recently introduced “Pharmaceutical Cost Transparency Act of 2015,” and seems to represent a trend up the west coast. During this past week, Oregon’s House Committee on Health Care held a public meeting on HB 3486. Industry groups PhRMA and BIO urged the committee members that such a proposal would end up being harmful to patients, especially those living in Oregon. Insurance companies spoke in support of the bill as a way to reduce drug costs. More at link above. (Policy and Medicine)
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.