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: May 17, 2013
SECTION 1 FDA GUIDANCES
FDA has announced the availability of a final guidance document entitled, “Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data.” This guidance describes best practices pertaining to conducting and documenting pharmacoepidemiologic safety studies that use electronic healthcare data, including administrative claims and EMR data, and includes recommendations for documenting the design, analysis, and results of such studies to optimize the agency’s review of submitted protocols and final reports. The guidance was released out of CDER and CBER.
[Guidance Document] [FR Notice]
FDA Plans Study on Communicating Composite Scores in DTC Advertising
Given the lack of research on consumer understanding of composite scores and how to best present this information in DTC advertisements, the main goal of the current research is to evaluate how consumers interpret and respond to DTC prescription drug advertising that includes benefit information based on composite scores. Specifically, this research will explore:
- Whether consumers are aware of how efficacy is measured for specific drugs;
- How well consumers comprehend the concept of composite scores;
- Whether exposure to DTC advertisements with composite scores influence consumers' perceptions of a drug's efficacy and risk; and
- Different methods for presenting composite scores in DTC ads to maximize consumer comprehension and informed decision making.
On May 16, FDA posted to the Federal Register the decision to classify the ingestible event marker into Class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. The device is ssigned the generic name ingestible event marker, and it is identified as a prescription device used to record time-stamped patient-logged events. The ingestible component links wirelessly through intrabody communication to an external recorder which records the date and time of ingestion as well as the unique serial number of the ingestible device. FR Notice Ingestible Device
FDA Request for Comments on Postmarketing Surveillance
This notice solicits comments on information collection requirements for postmarket surveillance (PS) of medical devices. Regulation requires manufacturers to conduct postmarket surveillance on devices meeting criteria in the statute and establishes procedures for FDA approval. The regulation also indicates what information must be in a PS plan and in interim and final reports. Comments on the collection of this information are requested by July 15, 2013. (FDA)
Guidance on CDRH Appeals Processes
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes.” This document describes the processes available to outside stakeholders to request additional review of decisions or actions by CDRH employees which include requests for supervisory review of an action, petitions, and hearings. Of these, the most commonly used process is the request for supervisory review (a “10.75 appeal”). This document provides general information about each process as well as guidance on how to submit related requests to CDRH and FDA. [Federal Register]
Draft Guidance on CDRH Appeals Processes: Q&A About 517A
FDA is announcing the availability of the draft guidance entitled “Center for Devices and Radiological Health (CDRH) Appeals Processes: Questions and Answers About 517A.” This draft document provides CDRH's proposed interpretation of key provisions of the Federal Food Drug and Cosmetic Act (FD&C Act), which were added by FDASIA, as those provisions pertain to requests for documentation of rationales for significant decisions and requests for supervisory review of regulatory decisions and actions taken by CDRH. This draft guidance is not final nor is it in effect at this time. Comments may be made until August 15, 2013 (90 days) [Federal Register]
SECTION 2 FDA NOTES & RELATED NEWS
FDA Measure to Address Drug Shortages
Due to recent shortages of critical drugs for infants, brought on by issues with Quality Systems compliance at US manufacturers, FDA is allowing for foreign manufacturers to import these drugs into the US. By allowing for foreign manufacturers to import these drugs, FDA is not only hoping to fill the current supply gap, but to also create a back-up to prevent future supply shortages. (outsourcing-pharma)
Request for Comments: Center for Drug Evaluation and Research Medical Policy Council
FDA is requesting public suggestions, recommendations, and comments for topics (including scientific, clinical, regulatory, or other topics) on existing or novel medical policy issues that may warrant consideration by the Council. Comments should describe the following: (1) The medical policy issue recommended for discussion, (2) the rationale for doing so (e.g., clarifying previous advice or precedents, reconciling apparently differing perspectives within CDER or between CDER and regulated industry), (3) recommendations on how the medical policy issue could be addressed or implemented; and (4) existing policy documents (e.g., final guidance) relevant to the medical policy issue. Comments are due by July 16, 2013. More information
Track Our Success as We Implement New Law, by Leslie Kux, Assistant Commissioner for Policy, and Malcom Bertoni, Assistant Commissioner for Planning
As we continue to implement the exciting new tools provided by the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), we are inviting interested members of the public to use the Internet to track our progress. FDASIA gave FDA new authorities to help FDA establish improved systems for combating drug shortages, protect the drug supply chain in an increasingly global market, and get generic medicines on pharmacy shelves and available to consumers more quickly. It is also encouraging companies to invest in discovering and developing new antibiotics, accelerate patient access to new medical treatments and breakthrough therapies, and promote the development of more treatments for children.
To read the rest of this blog, see FDA Voice Blog, May 15, 2013.
SECTION 3 AGENCY AND ADVISORY COMMITTEE MEETINGS
2013 Medical Countermeasures Initiative Regulatory Science Symposium. May 29-31, 2013. The symposium is intended to provide a forum for the exchange of ideas for medical countermeasure development, highlight work on regulatory science as it applies to the development and advancement of medical countermeasures, facilitate innovative directions, and inform stakeholders on medical countermeasure-related scientific progress and accomplishments. [FR Notice]
A Scientific Roadmap for the Future of Animal-Free Systemic Toxicity Testing.
May 30-31, 2013. FDA Wiley Building in College Park, Maryland. Conveniently located near the Washington, DC-area Metro system, the workshop is free-of-charge. See information on Agenda, how to register, directions, and accommodations. Registration deadline is May 15, 2013 and preregistration is required.
The scientific roadmap was the product of an October 2011 workshop held by the transatlantic think tank for toxicology (t4). Five whitepapers on systemic toxicity were prepared for workshop, taking a broad perspective on how to make further progress. The outcome was published as “A roadmap for the development of alternative (non-animal) methods for systemic toxicity testing,” in the January 2012 issue of ALTEX. A follow-up open meeting in Brussels in March, 2012, co-organized by numerous organizations and attended by some 150 experts, favorably reviewed and discussed the roadmap. The FDA-sponsored May 30-31 workshop will provide a similar forum and ample opportunity for discussing the roadmap, as well as possible updates in light of recent developments.
Assuring Integrity while Facilitating Innovation in Medical Research: A Workshop
June 5, 2013. IOM of the National Academies. This is part of the series of Roundtables on Translating Genomic-Based Research for Health. Full information at link above.
Public Meeting. 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device. June 13, 2013. The focus of this meeting is FDA’s interpretation of its regulations concerning when a modification made to a 510(k)-cleared device requires a new 510(k) submission. [FR Notice]
Public Conference. “Redefining the ‘C’ in CGMP: Creating, Implementing and Sustaining a Culture of Quality.” June 11-13, 2013. Co-sponsored with ISPE (International Society of Pharmaceutical Engineering. Pharmaceutical Quality System (ICH Q10) Conference on teaching the principles of CGMP, reaping the benefits that come from establishing and maintaining a state of control, implementing continual improvement, enhancing regulatory compliance, and meeting quality objectives every day. [FR Notice]
Global Quality Systems—An Integrated Approach to Improving Medical Product Safety. Public Workshop. June 10-11, 2013. The FDA Cincinnati District Office and the Association of Food and Drug Officials (AFDO) are cosponsoring the workshop intended to provide information about FDA drug and device regulation to the regulated industry. [FR Notice]
Public Workshop. “FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices.” June 11-12, 2013. Present, discuss, and receive input on an FDA library of models and data relevant to medical devices and present, discuss, and receive input on a strategy to assess the credibility of computer models used to evaluate medical devices. [FR Notice]
New: Public Meeting. HIV Patient-Focused Drug Development and HIV Cure Research. June 14, 2013. FDA is interested in obtaining patient input on the impact of HIV on daily life, currently available therapies to treat the condition, and patients’ views on issues related to HIV cure research. White Oak, Silver Spring, MD. Register by June 5, 2013. [FDA PDUFA Notice]
Patient-Focused Drug Development: Disease Area Meetings Planned for FY2013-2015
Public Meeting. Generic Drug User Fee Amendments of 2012; Regulatory Science Initiatives. June 21, 2013. Provide an overview of the current status of the regulatory science initiatives for generic drugs, and provide an opportunity for public input on research priorities in this area. [FR Notice] The register notice indicates that the input will be used to help develop the 2014 Regulatory Science Plan (required by GDUFA). A transcript will be available within 30 days.
(Note: September 11-12, NCTR will have a global summit on regulatory science focusing on nanotechnology. (To be held in Little Rock, AR.)
Public Workshop. The Center for Devices and Radiological Health (CDRH) Health of Women (HoW) Program: Educate, Enable, Enlist and Explore – HoW to Improve the Health of Women. June 24-25, 2013. Explore unique issues in the regulation of medical devices related to the health of women and provide input on the priority activities. [FR Notice]
SECTION 4 OTHER REGULATORY AUTHORITIES & ORGANIZATIONS
Using the PCORI Methodology Standards - PCORI Webinar. June 4, 2013, 1 – 2:30 PM.
PCORI aims to empower patients and their caregivers by providing the evidence needed to make truly informed decisions about their health and health care. In November 2012, PCORI's Board of Governors adopted comprehensive standards for conducting patient-centered outcomes research. The purpose of this webinar is to help researchers understand how the PCORI Methodology Committee hopes the standards will be used to support high-quality, scientifically rigorous patient-centered outcomes research. The webinar is part of a PCORImini-course focusing on ways researchers can utilize methodology standards to improve patient-centered outcomes research (PCOR).
Presenters: Joe Selby, PCORI Executive Director, and Sean Tunis, Director of the Center for Medical Technology Policy.
White Paper: Reporting the Findings of Updated Systematic Reviews of Comparative Effectiveness: How Do Users Want To View New Information?
AHRQ released this white paper on May 16, 2013. A PDF version can be downloaded at the link above. Conclusion from Executive Summary: “Different users of CERs clearly have different information needs. Yet whereas policymakers need access to the entire data set and analyses that comprise a systematic review (the original and the update), all users benefit from summaries that clearly show what changed in as succinct a format as possible, preferable in graphic form.”
A schedule for the HIT Standards Committee’s assessment of policy recommendations from the Health Information Technology (HIT) Policy Committee has been published. For a listing of upcoming HIT Standards Committee meetings, please visit the ONC Web site at http://healthit.gov. The HIT Standards Committee has created six workgroups to analyze the areas of: clinical quality, clinical operations, implementation, consumer technology, nationwide health information networks, and privacy and security. Full information at: Federal Register HIT
EU Scientific Committees to Look at Synthetic Biology
The European Commission’s three Scientific Committees have been requested to provide a joint scientific opinion on the relationship of Synthetic Biology (SB) to genetic modification of organisms, its implications for human and animal health and the environment, and the major gaps in knowledge necessary for performing a reliable risk assessment.
Synthetic Biology is the term used to describe the creation of biological systems that do not exist in nature using engineering principles to better understand life processes, to generate and assemble functional modular components, and to develop novel applications or processes, such as products that produce, absorb or detect chemical substances of interest. (RegLink Associates)
EMA Calls for Comments on ICH Guideline M7: Assessment & Control of Mutagenic Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk
The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential carcinogenic risk. This guideline addresses products that are manufactured with genotoxic materials, including intermediates and reagents.
Passed by the ICH in February of this year, the guideline is now in ICH Step 3 which requires each of the ICH regions to adopt the guideline and provide for a comment period. The EU is the first region to adopt it.
China’s Food and Drug Administration (CFDA) issued instructions to its provinces regarding requirements for certifying excipient manufacturers for the right to export products to the EU. The instructions include requirements for provincial food and drug supervision and management departments to identify officials familiar with pharmaceutical good manufacturing practice (GMP) with basic command of English as well as on-site GMP inspection requirements. [Instructions] (Regulatory Focus)
China Considers Price Cuts on Essential Drug List
China’s National Development and Reform Commission is considering adjusting essential drug prices. (PharmAsia News – paid subscription only)
Health Canada has agreed to extend its GMP requirements for drug establishment licensing (EL) to all active pharmaceutical ingredients (APIs). The new regulations take effect November 2013 and are intended to solidify GMP requirements for APIs to secure supply chain and harmonize with the regulations of other countries. (in-Pharma Technologist)
Prices for Drugs on India's National Essential List could Fall by 80%
India's new Drug Price Control Order (DPCO) has now been introduced, and is expected to lead to reductions in the prices of 348 essential drugs by up to 80%. The new DPCO replaces the 1995 Order which regulated the prices of just 74 bulk drugs and their formulations, and It increases the number of medicines under government price control to 652. The ceiling prices of NELM (National Essential List of Medicines) products will be set at the simple average of all brands with a market share of at least 1%, replacing the current cost-plus basis, and this should see many prices of drugs including cancer treatments and anti-infectives decline by as much as 80%, according to observers. The new order will take effect 45 days from May 15, when it was announced by the Department of Pharmaceuticals. (PharmaTimes) (Full article at link above)
Brazil: House Holds Hearing on Anvisa Regulatory Authority
The Committee on Social Security and Family of Brazil’s House of Representatives held a hearing on May 9, 2013 on the scope of regulatory authority of Brazil’s National Health Surveillance Agency (Anvisa) with the focus, “Does Anvisa have too much regulatory authority?”
The deputy director of Anvisa, Neilton Araújo, argued that several bills introduced in the Brazilian Congress to cut back the agency’s regulatory authority would in fact be a setback for public health. The Federal Assistant Attorney, Victor Valencia, meanwhile argued that there is a need to have a public discussion about a proposed management model for regulatory agencies. (RegLink Associates)
SECTION 5 COMPLIANCE & LEGAL NEWS
Black Box Warning for Opioids Requested by States Attorney Generals
In the latest effort to mitigate side-effects associated with prescription painkillers, dozens of state attorney generals have asked FDA to issue a Black Box warning on all opioid analgesics about the possibility these drugs can cause neonatal abstinence syndrome, which is caused when infants suddenly lose their opioid drug supply at birth. (PharmaLot)
House Advances Track and Trace Bill
Yesterday, the US House Energy & Commerce Committee advanced a Track-and-Trace bill to further secure the US prescription drug supply chain. The legislation will establish a process to help the FDA and stakeholders better understand how and when to move to unit-level traceability. (InPharma Technologist)
Hatch-Waxman Act: Unintended Consequences with Antitrust Implications?
An interesting article is linked above on the Supreme Court case brought by FTC against Actavis in which FTC challenges a settlement between a brand-name drug manufacturer and generic manufacturers as a violation of antitrust laws. Though the logic is complex, the outcome of this case has potential to “shape the contours” of brand-name infringement litigation against generic manufacturers and could also alter the framework of the Hatch-Waxman Act. An opinion is expected in late June. (Becker)
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; BIOtechNow; CDISC Monthly Newsletter; CER Daily Newsfeed (NPC); Daily Dose (Becker); DIA Daily; Drug Daily Bulletin; Eye on FDA; Federal Register Table of Contents; Fierce Medical Devices; Fierce Pharma; Fierce Vaccines; FDLI Smartbrief; Medical Device Daily; Medical Device & Diagnostic Industry; NPC Bulletin; Pharmalot; PharmaTimes; PhRMA website; Policy and Medicine (newsletter); Regulatory Focus; Reg Link Associates; US FDA Daily Digest Bulletin.