Pharmaceutical & Medical Device Regulatory Update, Vol. II, Issue 7

Pharmaceutical & Medical Device Regulatory Update, Vol. II, Issue 7

Read the Pharmaceutical & Medical Device Regulatory Update, Vol. II, Issue 7 newsletter.

Jones Day Announcements

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As we celebrate the one-year anniversary of the Jones Day Pharmaceutical & Medical Device Regulatory Update, we are hoping to get your feedback on the information you find most useful and if there is anything additional you would find helpful in our biweekly update. To that end, we would very much appreciate your participation in a short survey. We anticipate it will take you less than five minutes to complete.


April22–23, 2015: Cristiana Spontoni will speak at the 1st Annual Women Leaders in Life Sciences Law Conference program "Pharmaceutical and Medical Device Regulatory Developments, Issue Spotting: Updates on the Substantive Legal Developments Affecting Life Sciences Companies in 2015 and Beyond."

April 27, 2015: Maureen Bennett will serve as a panelist on the Boston Bar Association's Health Law Education Committee—Legal and Ethical Implications of Medical Tourism.

May 3–5, 2015: Scott Edelstein and Alexis Gilroy will speak at the American Telemedicine Association's Annual Meeting in a program titled "Telehealth Partnering in US & Abroad—A Look at Viable Strategies & Legal Considerations." Doug Pearson and Bruce Olcott will speak at a pre-conference session titled "Digital Health in Transition: Regulatory Insight for Product Developers."

Top News

Hamburg Steps Down as FDA Commissioner and Discusses Future Issues

Last week, Margaret A. Hamburg completed a nearly six-year stint as FDA Commissioner. In a departing interview with National Public Radio, Hamburg discussed her experiences promoting partnerships among FDA, the research community, and industry to streamline regulatory review systems, while balancing those efforts with the agency's commitment to public health. The interview also looked to future issues FDA may address, including the use of 3D printers for personalized medicine and the possible regulation of medical marijuana. Hamburg advised the next FDA commissioner to be prepared to tackle the unexpected, the job often entails responding to breakthrough technologies and public health crises.

CDER Finalizes Guidance on Critical Path Innovation Meetings

FDA's Center for Drug Evaluation and Research ("CDER") recently issued final guidance discussing the purpose, scope, and administrative procedures for critical path innovation meetings ("CPIMs"). CPIMs provide a venue for CDER and clinical investigators to discuss challenges in drug development as well as proposed methodologies and technologies for improving the efficiency and success of innovation. CDER intends for CPIMs to promote information sharing among regulators, industry, academia, and patient advocacy groups, although the guidance clarifies that CPIMs are not a substitute for formal meetings on pending drug applications. A request for a CPIM must describe the proposed agenda and be submitted electronically to the Office of Translational Services.

FDA Denies Petition to Require Biosimilar Applicant to Certify Information Exchange

A week after a federal court in California ruled that the patent information exchange provisions of the Biologics Price Competition and Innovation Act ("BPCIA") are not mandatory, FDA has denied the reference product manufacturer's citizen petition for FDA to require biosimilar applicants to certify they will participate in those provisions. FDA determined the certification procedures are separate from the biosimilar application review process by the agency and stated the courts should decide the scope and parameters of that process under the statute.

White House Issues Action Plan to Fight Antibiotic-Resistant Bacteria

Following a fatal bacteria outbreak at a Los Angeles hospital in February 2015, the Obama administration recently released a national action plan for halting the spread of antibiotic-resistant bacteria by the limiting overuse of antibiotics. The National Action Plan for Combating Antibiotic-Resistant Bacteria closely tracks a strategy document issued by the White House in September 2014. The action plan provides specific milestones for five strategic goals: slowing the emergence of resistant bacteria and preventing the spread of resistant infections; strengthening national "One-Health" surveillance efforts to combat resistance; advancing the development and use of rapid and innovative diagnostic tests for identification and characterization of resistant bacteria; accelerating basic and applied research and development for new antibiotics, other therapeutics, and vaccines; and improving international collaboration and capacities. As part of the action plan, the federal government intends to fund new antibiotic research and require hospitals to increase infection controls.

CMS Releases Documents on Paying for Biosimilars

The Centers for Medicare and Medicaid Services ("CMS") recently released three documents addressing payments for biosimilars under Medicare Parts B and D and Medicaid. The Part D memorandum discusses the application of formulary review policies, the low-income subsidy, catastrophic cost-sharing rules, and the coverage gap discount program for biosimilars. The Part B publication states CMS will incorporate licensed biosimilars into the average sales price payment methodology. Under the Medicaid Drug Rebate program, biosimilars are considered single-source drugs for reimbursement purposes.

Japan Launches Agency for Medical Research and Development

The Japanese government has established the Agency for Medical Research and Development ("AMED") to promote medical research and development more efficiently and comprehensively. AMED is intended as a means to overcome the shortcomings of the former system wherein three ministries were subsidizing medical research and development separately. AMED seeks to implement comprehensive change at all levels of medical research and development, from basic science to the implementation of practical applications. AMED has begun operations with approximately 300 personnel and a budget of about 125 billion yen for the 2015 fiscal year, which will be invested in creating innovative pharmaceuticals and competitive medical devices, developing regenerative products, and promoting co-research on genomic medicine to overcome diseases.

Other News

FDA Issues Guidance on Electronic Submission of Lot Distribution Reports for BLAs

FDA Issues Final Guidance on Evaluation and Labeling of Abuse-Deterrent Opioids

Public Citizen Urges FDA to Take Action to Curb Off-Label Promotion of Diabetes Drugs

Virginia Governor Signs "Right to Try" Bill for Investigational Drugs

Proposed Legislation Calls for FDA to Expedite Review of EU-Approved Drugs

Georgia Biosimilar Substitution Bill Approved by Legislature, Heads to Governor for Signature

Regulatory Notices

FDA Recommends Use of the World Health Organization Drug Dictionary

In the March 31, 2015, Federal Register, FDA announced its support for the World Health Organization ("WHO") Drug Dictionary, maintained by the Uppsala Monitoring Centre, as a resource for drug and biologics submissions. FDA encourages sponsors and applicants to use WHO Drug Dictionary codes in investigational study data and regulatory submissions to CDER and the Center for Biologics Evaluation and Research. Comments due May 5, 2015.

FDA Requests Nominations for Individuals and Consumer Organizations for Advisory Committees

In the April 3, 2015, Federal Register, FDA announced it is accepting materials from consumer organizations interested in nominating or participating in the selection of voting and nonvoting consumer representatives to serve on its advisory committees or panels. Nominations are for advisory committees and panels with current vacancies or vacancies expected to occur in the near future. Interest letters and nominations due May 4, 2015.

FDA Amends Regulations to Reflect Name Change of Anti-Infective Drugs Advisory Committee Name

In the April 6, 2015, Federal Register, FDA announced an amendment to the standing advisory committees' regulations changing the name of the Anti-Infective Drugs Advisory Committee. The committee name has been changed to the Antimicrobial Drugs Advisory Committee to better reflect the products and issues brought to the committee.

FDA Extends Comment Period for Identifying Potential Biomarkers in Drug Development

In the April 3, 2015, Federal Register, FDA announced an extension of the comment period for information regarding the development and qualification of biomarkers in areas related to human drug therapeutics. Interested parties may submit information on specific medical and biological areas where novel biomarkers can be identified that would meaningfully advance drug development. Comments now due May 15, 2015.

FDA Reclassifies Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid into Class II

In the March 27, 2015, Federal Register, FDA announced the reclassification of the brain injury adjunctive interpretive electroencephalograph assessment aid into Class II (special controls). FDA is requiring certain labeling, software verification and validation, and biocompatibility assessments to mitigate identified health risks, such as adverse tissue reaction and equipment malfunction leading to injury.

FDA Reclassifies Urethral Insert with Pump for Bladder Drainage into Class II

In the April 6, 2015, Federal Register, FDA announced the reclassification of the urethral insert with pump for bladder drainage into Class II (special controls). FDA is requiring certain labeling, sterilization validation, and biocompatibility assessments for identified health risks, such as adverse tissue reaction, infection, and reflux or renal damage.

FDA Determines Regulatory Review Period for JUXTAPID Patent

In the April 6, 2015, Federal Register, FDA published its determination regarding the regulatory review period for the drug JUXTAPID. FDA did not publish any determinations regarding the regulatory review periods for patent extensions of biologics.

FDA Issued the Following Draft and Final Guidance Documents

Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products, March 24, 2015, Federal Register.

Guidance for Industry: Critical Path Innovation Meetings, March 31, 2015, Federal Register.

Guidance for Industry: Abuse-Deterrent Opioids—Evaluation and Labeling, April 2, 2015, Federal Register.

Guidance for Industry: Residual Solvents in Animal Drug Products, April 3, 2015, Federal Register.

Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information, March 31, 2015, Federal Register. Comments due May 29, 2015.

Draft Guidance for Industry: Target Animal Safety Data Presentation and Statistical Analysis, March 31, 2015, Federal Register. Comments due June 1, 2015.

Draft Guidance for Industry: Development and Submission of Near Infrared Analytical Procedures, March 31, 2015, Federal Register. Comments due June 1, 2015.

Draft Guidance for Industry and FDA Staff: Procedures for Meetings of the Medical Devices Advisory Committee, April 1, 2015, Federal Register. Comments due June 1, 2015.

FDA Announced the Opportunity to Comment on the Following Proposed Information Collections

  • Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees
  • Request for Samples and Protocols
  • New Animal Drugs for Investigational Uses

FDA Announced the Following Collections Have Been Submitted to OMB

  • Survey of Health Care Practitioners for Device Labeling Format and Content
  • Comparative Price Information in Direct-to-Consumer and Professional Prescription Drug Advertisements

EU Regulatory Notices

European Commission Publishes New Version of Annex 15

On March 30, 2015, the European Commission published the new version of Annex 15 "Qualification and Validation" of EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use. The Annex contains qualification and validation principles applicable to the facilities, equipment, utilities, and processes used for the manufacture of medicinal products manufacturing and may also be used as supplementary optional guidance for active substances. The new version will become operational on October 1, 2015.

European Commission Issues New Guidelines on the Formalized Risk Assessment for Ascertaining the Appropriate Good Manufacturing Practice for Excipients

On March 19, 2015, the European Commission issued new guidelines on risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use. The risk assessment as set out in these guidelines should be carried out for excipients for authorized medicinal products for human use by March 21, 2016.

European Commission Issues New Guidelines on Principles of Good Distribution Practice of Active Substances for Medicinal Product

On March 19, 2015, the European Commission published guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use. The guidelines provide stand-alone guidance for importers and distributors. The guidelines will come into operation on September 21, 2015.

Commission Regulation No. 490/2015/EU

Commission Regulation No. 490/2015/EU amending Council Regulation (EC) No 297/95 regarding the inflation-rate adjustment of European Medicines Agency fees was published on March 23, 2015.

Europe Bans Chinese API Maker Following an Inspection in Late January

The European Directorate for the Quality of Medicines has suspended the marketing authorization of a Chinese manufacturer of active pharmaceutical ingredients after an inspection carried out in late January 2015 at its Zhejiang Province facilities. Inspectors documented 27 deficiencies, reporting contamination problems in the povidone iodine manufacturing that could pose risks to patients. In 2012, the company faced similar issues with European regulators after refusing to allow inspectors into its facilities.

CMDh Places New Restriction on Hydroxyzine-Containing Medicines

The CMDh (Coordination Group for Mutual Recognition and Decentralised Procedures—Human) has approved new measures on the use of hydroxyzine in patients at high risk of heart rhythm problems. These measures, which encompass restrictions in use and dose, will be directly implemented by the Member States where the medicines are authorized, according to an agreed timetable.

Upcoming Meetings, Workshops, and Conferences

Drugs and Biologics

Public Meeting on Identification of Alternative In Vitro Bioequivalence Pathways Which Can Reliably Ensure In Vivo Bioequivalence of Product Performance and Quality of Non-Systemically Absorbed Drug Products for Animals, April 16, 2015, in Rockville, MD.

Public Workshop on Advancing the Development of Pediatric Therapeutics, April 16–17, 2015, in Silver Spring, MD.

2015 Office of Regulatory Science and Innovation Science Symposium, April 17, 2015, in Silver Spring, MD.

Ninth Annual Drug Information Association/Food and Drug Administration Statistics Forum—2015, April 20, 2015, in Bethesda, MD.

Public Hearing on Homeopathic Product Regulation: Evaluating the Food and Drug Administration's Regulatory Framework After a Quarter-Century, April 20–21, 2015, in Silver Spring, MD. Comments due June 22, 2015.

Public Meeting on Chagas Disease Patient-Focused Drug Development, April 28, 2015, in Silver Spring, MD.

Public Meeting on Functional GI Disorders Patient-Focused Drug Development, May 11, 2015, in Silver Spring, MD.

Public Conference on Food and Drug Administration Clinical Trial Requirements, Regulations, Compliance, and Good Clinical Practice, May 13–14, 2015, in Cincinnati, OH.

Public Workshop on Electronic Cigarettes and Public Health, June 1–2, 2015, in Hyattsville, MD.

FDA/AFDO Conference titled In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation, June 20–24, 2015, in Indianapolis, IN.

FDA/PDA Conference titled Mission Possible: Patient-Focused Manufacturing, Quality, and Regulatory Solutions, September 28–30, 2015, in Washington, D.C.

Medical Devices

FDA Public Workshop on Clinical Considerations of Risk in the Postmarket Environment, April 21, 2015, in Silver Spring, MD.

FDA/Xavier University Global Medical Device Conference, May 6–8, 2015, in Cincinnati, OH.

FDA/Biomedical Engineering Society Public Conference on Frontiers in Medical Devices: Innovations in Modeling and Simulations, May 18–20, 2015, in Hyattsville, MD.

Public Hearing on Generic Drug User Fee Amendments of 2012—Regulatory Science Initiatives, June 5, 2015, in Silver Spring, MD.

FDA/AFDO Conference titled In Motion: Science Transforming Policy in Food, Drug, and Medical Device Regulation, June 20–24, 2015, in Indianapolis, IN.

FDA Public Workshop titled Robotically Assisted Surgical Devices: Challenges and Opportunities, July 27–28, 2015, in Silver Spring, MD.

Advisory Committees

April 14, 2015: Endocrinologic and Metabolic Drugs Advisory Committee (to discuss the results of the cardiovascular outcomes trial for certain new drug applications for anti-diabetic therapies)

April 15, 2015: Cardiovascular and Renal Drugs Advisory Committee (to discuss a new drug application for the proposed indication of reduction of thrombotic cardiovascular events in patients with coronary artery disease undergoing percutaneous coronary intervention ("PCI") who have not received an oral P2Y12 inhibitor prior to the PCI procedure and in whom oral therapy with P2Y12 inhibitors in not feasible or desirable)

April 17, 2015: Neurological Devices Panel of the Medical Devices Advisory Committee (to discuss the current knowledge regarding the conduct of clinical studies and evaluation of clinical study data for flow diverter technology)

April 29, 2015: Joint Meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee and the Oncologic Drug Advisory Committee (to discuss a biologics license application for an oncolytic immunotherapy for the treatment of patients with injectable regionally or distantly metastatic melanoma)

April 30, 2015: Ear, Nose, and Throat Devices Panel of the Medical Devices Advisory Committee (to discuss and make recommendations regarding the classification of Hearing Protectors, Circumaural Hearing Protectors, Middle Ear Inflation Devices, Tactile Hearing Aid Devices, Vestibular Analysis Apparatuses, Speech Training Aids for the Hearing Impaired (Battery Powered or Non-Patient), Speech Training Aids for the Hearing Impaired (AC-powered and Patient-Contact), and Nasal Septal Button Devices)

May 12, 2015: Pulmonary-Allergy Drugs Advisory Committee (to discuss new drug application 206038, lumacaftor/ivacaftor combination tablets for oral use, submitted by Vertex Pharmaceuticals, proposed for the treatment of cystic fibrosis in patients age 12 years and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator gene)

May 12, 2015: Vaccines and Related Biological Products Advisory Committee (to discuss the development and licensure of Ebola vaccines)

May 13, 2015: Blood Products Advisory Committee (to discuss strategies for implementation of serological and nucleic acid testing for Babesia microti in blood donors)

May 14–15, 2015: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee (to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography procedures in hospitals in the United States)

For more comprehensive listings of FDA meetings, please visit these FDA web pages:

Meetings, Conferences, and Workshops (Drugs)

Workshops, Meetings, and Conferences (Biologics)

Workshops & Conferences (Medical Devices)

FDA Advisory Committee Calendar

Recent Notable Drug and Device Approvals/Clearances

FDA approves breath test to aid in diagnosis of delayed gastric emptying (April 6, 2015)

FDA expands use of CoreValve System for aortic "valve-in-valve" replacement (March 30, 2015)

FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema (March 25, 2015)

FDA approves treatment for inhalation anthrax (March 25, 2015)

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.

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