President Obama Signs Executive Order on Combating Antibiotic-Resistant Bacteria
Last week, President Obama signed an Executive
Order and issued a national strategy to spur action
within the federal government to address the public
health challenge of antibiotic-resistant bacteria. The
Order creates a national task force led by the
Secretaries of the Department of Health and Human
Services ("HHS"), Department of Defense, and
Department of Agriculture, charged with submitting
a five-year action plan by February 15, 2015. The
Order also directed HHS to propose regulations for
hospitals to better manage antibiotic use. President
Obama also announced a $20 million prize for a
diagnostic test that hospitals could use in identifying
resistant infections quickly. The President's Council
of Advisors on Science and Technology concurrently
issued a report warning that "this brewing problem
has become a crisis."
FDA and Tech Firms Address Regulatory
Challenges Posed by Mobile Medical Devices
Silicon Valley technology firms investing heavily in
mobile medical devices and apps are increasingly
confronting the challenges of clearing U.S. regulatory
approval processes.
CONTACTS
Mark Mansour
Washington
Laurie A. Clarke
Washington
Colleen M. Heisey
Washington
Christopher M. Mikson
Washington
Emily K. Strunk
Washington
Stephanie L. Resnik
Washington
Brigid C. DeCoursey
Washington
Matthew R. Bowles
Washington
Detailed Contact Information
RELATED PRACTICES
FDA Regulatory & Compliance Counseling
Health Care
Life Sciences
Although FDA has said it is not interested in regulating most medical apps that simply
track calories or help manage prescriptions, FDA will regulate apps that measure and
display physiological parameters, such as blood glucose, or allow active, remote
monitoring, such as the progress of labor, as medical devices, according to guidance
issued last year. Meanwhile, developers of mobile medical apps have asked forclarification of federal HIPAA rules in the context of rapidly changing health IT, arguing
"the risks of potential disclosure should be weighed again against the anticipated benefits
of wider sharing and easier access to crucial health data."
Schnedar to Lead CDER Office of Compliance
Cynthia Schnedar will serve as the new director of the Center for Drug Evaluation and
Research ("CDER") Office of Compliance. The position has been without a permanent
director since January 2014, when Howard Sklamberg was promoted to Deputy
Commissioner for Global Regulatory Operations and Policy. Schnedar has served as the
Deputy Inspector General at the Department of Justice since 2010. In an email to CDER
staff, Director Janet Woodcock said, "Her expertise in law enforcement, and extensive
experience as an attorney and leader in the federal government, enables her to bring a
valuable mix of knowledge and ability to analyze complex statutory and regulatory
issues." Schnedar assumes the position on October 6, 2014.
Bill to Fix Sunscreen Ingredient Approval Process Clears the Senate
The Senate has passed the Sunscreen Innovation Act through a unanimous consent
agreement. The bill, which passed the House of Representatives in late July 2014, aims to
streamline how new ingredients for over-the-counter sunscreen products are approved.
The sunscreen bill now returns to the House of Representatives for further action. Several
over-the-counter sunscreen ingredients have languished in the current FDA approval
process for 12 years, with the last ingredient being approved in the 1990s. Concerns that
consumers in the U.S. were not able to take advantage of new sunscreen technologies
prompted Congress to investigate and address the backlog.
FDA May Consider Heart Health Risks of Testosterone Drugs
Citing a sharp increase in the number of men using testosterone drugs in recent years,
FDA recently convened a joint advisory committee meeting on testosterone replacement
therapy ("TRT"). The committee focused on the appropriate patient population for TRT
and the potential risk for major adverse cardiovascular events, such as stroke or heart
attack, associated with TRT. The Advisory Committee voted 20–1 for FDA to impose new
labeling requirements, including providing additional risk information and to restrict TRT
to those with low testosterone due to medical conditions, which would prevent the
marketing of TRT for age-related testosterone issues. The committee also recommended
further studies to assess the risks associated with long-term use of TRT. FDA is not
required to follow advisory committee recommendations but often does so.
Other News
Canadian Clinical Trial Oversight Questioned
WHO Confirms Over 4,200 Diagnosed Ebola Infections in West Africa
FDA Issues Emergency Use Authorization for Ebola Detection Assay
Labs Must Send Test Results to Patient Consumers
Generic Injectable Medicines Still in Short Supply
Several Obesity Medications Scheduled for FDA Review
Regulatory Updates
FDA Issues Emergency Use Authorization for Ebola IVD
In the September 17, 2014, Federal Register, FDA announced it had issued an Emergency
Use Authorization for an in vitro diagnostic device to detect of the Ebola Zaire virus
(detected in the West Africa outbreak in 2014) at the request of the Department of
Defense.
FDA Withdraws Approval from Three ANDAs for Products Containing
PropoxypheneIn the September 12, 2014, Federal Register, FDA withdrew approval of three abbreviated
new drug applications ("ANDAs") for products containing propoxyphene. FDA found the
products are no longer shown to be safe due to risks of potentially serious and even fatal
heart rhythm abnormalities. The holders of these ANDAs waived their opportunity for a
hearing. Effective September 12, 2014.
FDA Proposes to Reclassify External Pacemaker Pulse Generator Through
Administrative Order
In the September 15, 2014, Federal Register, FDA withdrew a 2011 proposed rule and
associated guidance document that sought to reclassify external pacemaker pulse
generator ("EPPG") devices, a preamendments class III device, into class II (special
controls). FDA simultaneously issued a proposed administrative order that seeks the same
reclassification described in the withdrawn proposed rule. This substitution of an
administrative order in place of a proposed rule reflects FDASIA's changes to FDA's device
reclassification process, shifting it from a rulemaking process to an administrative order
process. In the proposed order, FDA also proposes to amend the device identification and
reclassify pacing system analyzers ("PSAs") into class II (special controls). Specifically,
FDA proposes to reclassify as Class II devices single- and dual-chamber PSAs, which are
currently classified with EPPG devices, and triple-chamber PSAs, which are
postamendments class III devices. FDA is proposing this reclassification based on new
information pertaining to the device. FDA states the proposed action would implement
certain statutory requirements. Comments due December 15, 2014.
FDA Issues Administrative Orders Proposing Device Classifications and
Reclassifications
FDA recently issued final orders to classify Dengue Virus Test Reagents and Tryptase Test
Systems as Class II devices with special controls. FDA additionally proposed reclassifying
the salivary stimulatory system and iontophoresis devices intended for any purposes other
than as an aid in the diagnosis of cystic fibrosis or as a combination drug/device product,
which are both Class III devices, into class II (special controls). For the salivary
stimulatory system, FDA proposes premarket notification and renaming the device
"electrical salivary stimulatory system." For iontophoresis devices, FDA proposes
amending the device identification to encompass all of those indications.
FDA Issued the Following Draft and Final Guidance Documents
Draft Guidance on Estradiol. September 22, 2014, Federal Register. Comments due
November 21, 2014.
Unique Device Identification System: Small Entity Compliance Guide. September 10,
2014, Federal Register.
Draft Guidance for Industry: ANDA Submissions—Refuse to Receive for Lack of Proper
Justification of Impurity Limits. September 17, 2014, Federal Register. Comments due
November 17, 2014.
ANDA Submissions—Refuse-to-Receive Standards. September 17, 2014, Federal Register.
Information Collection Activities
FDA Announced that OMB Has Approved the Collection of Information About the
Following
Testing Communications on Biological Products
Electronic Submission of Allegations of Regulatory Misconduct Associated with Medical
Devices
Providing Waiver-Related Materials in Accordance with Draft Guidance for Industry on
Providing Postmarket Periodic Safety Reports in the International Conference on
Harmonisation E2C(R2) FormatPrescription Drug Advertisements
Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
Medical Devices; Exception From General Requirements for Informed Consent
Exceptions or Alternatives to Labeling Requirements for Products Held by the Strategic
National Stockpile
FDA Announced the Opportunity to Comment on the Following Proposed
Information Collections
Survey of Health Care Practitioners for Device Labeling Format and Content (comments
due November 12, 2014).
Application for FDA Approval to Market a New Drug (comments due October 17, 2014).
FDA Announced the Following Collections Have Been Submitted to OMB for
Approval
Generic Clearance for the Collection of Qualitative Feedback on FDA Service Delivery
(comments due to OMB October 22, 2014).
FDA Makes Corrections to the Following Federal Register Notices
Postmarketing Safety Reports for Human Drug and Biological Products Electronic
Submission Requirements
• RIN Number on June 10, 2014, Federal Register
• RIN Number on August 14, 2014, Federal Register
Revocation of General Safety Test Regulations that are Duplicative of Requirements in
Biological License Applications on August 22, 2014, Federal Register
• The document proposed to amend the biologics regulations by removing the
general safety test requirements for biological products. The document published
with the incorrect title.
Draft Guidance for Industry: Electronic Submission of Lot Distribution Reports; Availability
• The document was published with the incorrect docket number on August 29,
2014, Federal Register.
Upcoming Meetings, Workshops, and Conferences
Drugs and Biologics
Public Meeting on Patient-Focused Drug Development for Idiopathic Pulmonary Fibrosis
will be held on September 26, 2014, in Silver Spring, MD.
Public Workshop on Innovations in Breast Cancer Drug Development—Next-Generation
Oncology Trials, Breast Cancer Workshop will be held on October 21, 2014, in Bethesda,
MD.
Training Course for Clinical Investigators on Scientific, Ethical, and Regulatory Aspects of
Clinical Trials will be held November 4–6, 2014, in College Park, MD.
Medical Devices
Public Workshop on Additive Manufacturing of Medical Devices: An Interactive Discussion
on the Technical Considerations of 3D Printing will be held October 8–9, 2014, in Silver
Spring, MD.
Public Workshop on Collaborative Approaches for Medical Device and Healthcare
Cybersecurity will be held October 21–22, 2014, in Arlington, VA.
Training Course for Clinical Investigators on Scientific, Ethical, and Regulatory Aspects of
Clinical Trials will be held November 4–6, 2014, in College Park, MD.Public Workshop on Brain-Computer Interface Devices for Patients With Paralysis and
Amputation will be held November 21, 2014, in Silver Spring, MD.
Advisory Committees
September 23, 2014: Pediatric Advisory Committee Meeting
October 1, 2014: Gastroenterology and Urology Devices Panel of the Medical Devices
Advisory Committee
October 8, 2014: Circulatory System Devices Panel of the Medical Devices Advisory
Committee
October 16, 2014: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee
and the Drug Safety and Risk Management Advisory Committee Meeting
October 20, 2014: Dermatologic and Ophthalmic Drugs Advisory Committee
October 30, 2014: Cardiovascular and Renal Drugs Advisory Committee
November 6, 2014: Cellular, Tissue and Gene Therapies Advisory Committee
December 12, 2014: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee
For more comprehensive listings of FDA meetings, please visit these FDA webpages:
Meetings, Conferences, and Workshops (Drugs)
Workshops, Meetings, and Conferences (Biologics)
Workshops and Conferences (Medical Devices)
FDA Advisory Committee Calendar
Enforcement Updates
Recent Product Recalls
Since the previous Update, three manufacturers have issued recalls for drugs or devices.
Two drug manufacturers recalled their products for mislabeled shipping cartons and
foreign particulate matter. One medical device manufacturer recalled its product for
electrical problems that posed a risk of electric shock.
Click here for a complete listing of FDA Recalls.
Recent Warning Letters
Since the previous Update, FDA has continued to cite manufacturers for failure to pay
their Generic Drug User Fees, with two more manufacturers receiving recently posted
warning letters. A compounding pharmacy was cited for producing drug products without
receiving valid prescriptions for individually identified patients as well as deficiencies in
sterile drug production. Two manufacturers were cited for current Good Manufacturing
Practices and Quality Systems Regulation violations, primarily insufficient recordkeeping
and a lack of quality controls. One of those manufacturers was also cited for failing to
fulfill its annual registration and listing requirements for the last two years.
Click here for FDA's Warning Letters Home page (scroll down for listing of recently posted
Warning Letters).
The Office of Prescription Drug Promotion (OPDP) issued one warning letter since the last
Update. One manufacturer was cited for making false and misleading claims in a
commercial email ("e-Pharm alert") containing unsubstantiated superiority claims.
Click here for a complete listing of 2014 OPDP Warning Letters.Recent Drug and Device Approvals/Clearances
FDA approves Trulicity to treat type 2 diabetes (September 18, 2014)
FDA approves Movantik for opioid-induced constipation (September 16, 2014)
FDA approves weight-management drug Contrave (September 10, 2014)
For additional information on drug and device approvals and clearances, please visit FDA's
web pages on Drug Approvals and Databases (includes biologics) and Device Approvals,
Denials, and Clearances.
Jones Day FDA Regulatory & Compliance Counseling Contacts
Mark Mansour
Washington
+1.202.879.3883
mmansour@jonesday.com
Laurie A. Clarke
Washington
+1.202.879.3498
lclarke@jonesday.com
Colleen M. Heisey
Washington
+1.202.879.3449
cmheisey@jonesday.com
Christopher M. Mikson
Washington
+1.202.879.3669
cmikson@jonesday.com
Emily K. Strunk
Washington
+1.202.879.3778
estrunk@jonesday.com
Stephanie L. Resnik
Washington
+1.202.879.5458
sresnik@jonesday.com
Brigid C. DeCoursey
Washington
+1.202.879.3651
bdecoursey@jonesday.com
Matthew R. Bowles
Washington
+1.202.879.3604
mbowles@jonesday.com
Follow us on:
Jones Day is a legal institution with 2,400 lawyers on five
continents. We are One Firm Worldwide
SM
.
Disclaimer: Jones Day publications should not be construed as legal advice on any specific facts or
circumstances. The contents are intended for general information purposes only and may not be quoted or
referred to in any other publication or proceeding without the prior written consent of the Firm, to be given or
withheld at our discretion. The electronic mailing/distribution of this publication is not intended to create, and
receipt of it does not constitute, an attorney-client relationship. The views set forth herein are the personal
views of the author and do not necessarily reflect those of the Firm.
© 2014 Jones Day. All rights reserved. 51 Louisiana Avenue, N.W., Washington, D.C. 20001-2113
www.jonesday.com
Click here to opt-out of this communication
