Alston & Bird Healthcare Week in Review, October 6, 2017

I. Regulations, Notices, & Guidance

• On October 2, 2017, the Food and Drug Administration (FDA) issued a notice entitled, Determination that SPECTAZOLE (Econazole Nitrate) Topical Cream, 1%, Was Not Withdrawn from Sale for Reasons of Safety or Effectiveness. The notice announces that the FDA has determined that SPECTAZOLE (econazole nitrate) topical cream, 1%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that the FDA will not begin procedures to withdraw approval of an ANDA that refer to this drug product, and it will allow the FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
• On October 2, 2017, the FDA issued a draft guidance entitled, Abbreviated New Drug Applications for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of Recombinant Deoxyribonucleic Acid Origin. The draft guidance is intended to assist potential applicants in determining when an application for a synthetic peptide drug product (specifically glucagon, liraglutide, nesiritide, teriparatide, and teduglutide) that refers to a previously approved peptide drug product of recombinant deoxyribonucleic acid (rDNA) origin should be submitted as an abbreviated new drug application (ANDA) rather than as new drug application (NDA). Comments are due by December 4, 2017.
• On October 2, 2017, the FDA issued a draft guidance entitled, Abbreviated New Drug Applications Submissions--Amendments to Abbreviated New Drug Applications Under the Generic Drug User Fee Act. The draft guidance is intended to explain to applicants how the review goals established as part of the Generic Drug User Fee Amendments Reauthorization of 2017 (GDUFA II) apply to amendments to ANDAs and prior approval supplements (PASs) to the FDA under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This draft guidance describes amendment classifications and categories and explains how amendment submissions may affect an application’s review goal dates. The draft guidance also describes how the FDA will review amendments submitted to ANDAs and PASs received prior to October 1, 2017, the effective date to implement the GDUFA II review goals. Comments are due by December 4, 2017.
• On October 2, 2017, the FDA issued a draft guidance entitled, Abbreviated New Drug Applications Submissions--Refuse-to-Receive Standards: Questions and Answers. The draft guidance is intended to assist applicants preparing to submit ANDAs and certain prior approval supplements (PASs) to ANDAs. This guidance provides answers to questions we have received from applicants regarding the guidance for industry, “ANDA Submissions--Refuse-to-Receive Standards” (RTR Standards guidance). The questions and answers address general issues about the organization of an ANDA, filing decisions made by the FDA, the review of and deficiencies related to Drug Master Files (DMFs), product quality, and bioequivalence (BE) and clinical reviews, and are intended to clarify the deficiencies that may cause FDA to refuse to receive (RTR) an ANDA. Comments are due by December 4, 2017.
• On October 2, 2017, the FDA issued a draft guidance entitled, Formal Meetings Between the Food and Drug Administration and Abbreviated New Drug Application Applicants of Complex Products Under Generic Drug User Fee Act. The draft guidance describes an enhanced pathway for discussions between FDA and a prospective applicant preparing to submit (or an applicant that has submitted) to the FDA an ANDA for a complex product. Specifically, this draft guidance provides information on requesting and conducting product development meetings, pre-submission meetings, and mid-review-cycle meetings with FDA. The draft guidance will assist applicants in generating and submitting a meeting request and the associated meeting package to FDA for complex products to be submitted under the FD&C Act and as contemplated in the commitments made by FDA in connection with the reauthorization of the Generic Drug User Fee Amendments for Fiscal Years FYs 2018-2022 (GDUFA II). Comments are due by December 4, 2017.
• On October 2, 2017, the FDA issued a guidance entitled, M4 Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use; International Council for Harmonisation. The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance updates the Quality-related sections of the Granularity Document Annex, Module 2.3 Quality Overall Summary, and Module 3 Quality. The guidance is intended to provide recommendations on the organization of the common technical document (CTD)/eCTD and replaces the August 2001 FDA guidance for industry “M4: Organization of the CTD” and the October 2005 FDA guidance for industry “Granularity Document Annex to M4: Organization of the CTD.” Comments may be submitted at any time.
• On October 2, 2017, the FDA issued a notice entitled, Range of Risk Evaluation and Mitigation Strategies Platform Standards Initiative: Needs Assessment; Request for Comments. The notice announces that the FDA is seeking public input on the design of the REMS Platform Standards Initiative, as well as methods and best practices for its construction. To facilitate this, FDA is making available the “REMS Platform Standards Initiative: Needs Assessment” (needs assessment), which summarizes a range of risk evaluation and mitigation strategies (REMS) activities that could be standardized and integrated into the health care system through the use of electronic data standards. Comments may be submitted at any time.
• On October 2, 2017, the FDA issued a notice entitled, Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications. The notice announces that the FDA is withdrawing approval of 7 new drug applications (NDAs) and 71 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
• On October 3, 2017, the Centers for Medicare & Medicaid Services (CMS) withdrew a proposed rule entitled, Medicare and Medicaid Programs; Revisions to Certain Patient’s Rights Conditions for Participation and Conditions for Coverage. The proposed rule would revise the applicable conditions of participation for certain providers, conditions for coverage for certain suppliers, and requirements for long-term care facilities, to ensure that the requirements are consistent with the Supreme Court decision in United States v. Windsor (570 U.S.12, 133 S. Ct. 2675 (2013)), and HHS policy. Specifically, it proposed to revise certain definitions and patient’s rights provisions that currently defer to state law, in order to ensure that same-sex spouses are recognized and afforded equal rights in certain Medicare and Medicaid-participating facilities.
• On October 3, 2017, CMS withdrew a proposed rule entitled, Medicare Program; Establishment of Special Payment Provisions and Requirements for Qualified Practitioners and Qualified Suppliers of Prosthetics and Custom-Fabricated Orthotics. The proposed rule specified the qualifications needed for qualified practitioners to furnish and fabricate, and qualified suppliers to fabricate prosthetics and custom-fabricated orthotics; accreditation requirements that qualified suppliers must meet in order to bill for prosthetics and custom fabricated orthotics; requirements that an organization must meet in order to accredit qualified suppliers to bill for prosthetics and custom-fabricated orthotics; and a timeframe by which qualified practitioners and qualified suppliers must meet the applicable licensure, certification, and accreditation requirements. In addition, the proposed rule removed the current exemption from accreditation and quality standards for certain practitioners and suppliers.
• On October 3, 2017, CMS withdrew a proposed rule entitled, Medicare Program; Part B Drug Payment Model. The proposed rule discussed our proposal to implement a new Medicare payment model under section 1115A of the Social Security Act.
• On October 3, 2017, the Department of Health and Human Services (HHS) withdrew a proposed rule entitled, Administrative Simplification: Certification of Compliance for Health Plans. The document withdraws the January 2, 2014, proposed rule that would have required a controlling health plan (CHP) to submit information and documentation demonstrating that it is compliant with certain standards and operating rules adopted by the Secretary of Health and Human Services (the Secretary) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The proposed rule would have also established penalty fees for a CHP that failed to comply with the certification of compliance requirements.
• On October 4, 2017, HHS issued a notice entitled, Solicitation of Nominations for Appointment to the Advisory Committee on Minority Health. The notice announces that the Office of Minority Health within HHS is seeking nominations of qualified candidates to be considered for appointment as a member of the Advisory Committee on Minority Health (hereafter referred to as the “Committee or ACMH”). Nominations of qualified candidates are being sought to fill vacancies on the Committee. Nominations are due by January 3, 2018.
• On October 4, 2017, the FDA issued guidance entitled, Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products. The guidance provides information regarding regulatory oversight of mosquito-related products, defined as those articles for use in or on mosquitoes. The FDA is clarifying circumstances under which such products are regulated by the FDA as new animal drugs under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and other circumstances under which such products are regulated by the Environmental Protection Agency (EPA) as pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Comments may be submitted at any time.
• On October 4, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; IMPELLA 2.5 SYSTEM. The notice announces that the FDA has determined the regulatory review period for IMPELLA 2.5 SYSTEM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that medical device. Comments are due by December 4, 2017.
• On October 4, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; KOVALTRY. The notice announces that the FDA has determined the regulatory review period for KOVALTRY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the USPTO, Department of Commerce, for the extension of a patent which claims that human biological product. Comments are due by December 4, 2017.
• On October 4, 2017, the FDA issued a notice entitled, Determination of Regulatory Review Period for Purposes of Patent Extension; TECFIDERA. The notice announces that the FDA has determined the regulatory review period for TECFIDERA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the USPTO, Department of Commerce, for the extension of a patent which claims that human drug product. Comments are due by December 4, 2017.
• On October 6, 2017, the Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and CMS and HHS issued interim final rules with request for comments entitled, Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. According to the agencies, the interim final rules expand exemptions to protect religious beliefs for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration (HRSA), a component of HHS, to maintain the guidelines requiring contraceptive coverage where no regulatory recognized objection exists. These rules also leave the “accommodation” process in place as an optional process for certain exempt entities that wish to use it voluntarily. These rules do not alter multiple other Federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy. The interim final rules and temporary regulations are effective October 6, 2017. Comments must be received by December 5, 2017.
• On October 6, 2017, the Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; and CMS and HHS issued interim final rules with request for comments entitled, Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. According to the agencies, the interim final rules expand exemptions to protect moral convictions for certain entities and individuals whose health plans are subject to a mandate of contraceptivecoverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration, a component of the United States Department of Health and Human Services, to maintain the guidelines requiring contraceptive coverage where no regulatorily recognized objection exists. These rules also provide certain morally objecting entities access to the voluntary “accommodation” process regarding such coverage. These rules do not alter multiple other Federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy. The interim final rules and temporary regulations are effective October 6, 2017. Comments must be received by December 5, 2017.

• October 18, 2017: The FDA announced a public advisory committee meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The committee will discuss the safety and efficacy of new drug application (NDA) 209637 for semaglutide injection, submitted by Novo Nordisk, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• October 19, 2017: The FDA announced a regional public meeting entitled, Health Canada and U.S. Food and Drug Administration Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). he purpose of this public meeting is to provide information and solicit public input on the current activities of ICH as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Geneva, Switzerland, scheduled for November 11 through 16, 2017. The topics to be discussed are the topics for discussion at the forthcoming ICH Assembly Meeting in Geneva.
• October 20, 2017: The National Institutes of Health (NIH) announced a meeting of the NIH Clinical Center Research Hospital Board. The agenda includes discussion on the Patient Safety Racking and Reporting System; quality improvement assessment results, and IRB consolidation.
• October 20, 2017: The FDA announced a public workshop entitled, Topical Dermatological Generic Drug Products: Overcoming Barriers to Development and Improving Patient Access. The purpose of the public workshop is to provide an overview of current regulatory science initiatives related to generic topical dermatological drug products, solicit public input on scientific barriers that may limit patient access to such drug products, and discuss approaches to overcome/address any such barriers. FDA is seeking public input from a variety of stakeholders, including industry, academia, patient advocates, and professional associations.
• October 27, 2017: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). During the October meeting, the Advisory Council will welcome its new members and invite them to share their experiences and where they see the Council going over the length of their terms. The Advisory Council will also spend some time discussing the process of developing recommendations and how those recommendations relate to the National Plan. The Council will then spend much of the meeting discussing the National Research Summit on Care, Services, and Supports for Persons with Dementia and Their Caregivers, held on October 16-17.
• October 31, 2017: The FDA announced a public advisory committee meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss NDA 209819, buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence.
• November 1, 2017: HHS announced that the Office of Disease Prevention and Health Promotion (ODPHP) is hosting a listening session entitled, Partnering to Prevent Hypoglycemia. he purpose of this listening session is to exchange information about the public health importance of hypoglycemia, and discuss federal efforts to reduce preventable hypoglycemia from diabetes medications.
• November 6 – 7, 2017: The FDA announced a public advisory committee meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR). On November 6, 2017, the SAB Chair will welcome the participants, and the NCTR Director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. The SAB will be presented with an overview of the Division of Systems Biology Subcommittee and the Subcommittee Site Visit Report and a response to this review. There will be updates from the NCTR Research Divisions and a public comment session. On November 7, 2017, the Center for Biologics and Evaluation and Research, Center for Drug Evaluation and Research, Center for Devices and Radiological Health, Center for Tobacco Products, Center for Veterinary Medicine, and the Office of Regulatory Affairs will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.

II. Congressional Legislation & Committee Action

• On October 4, 2017, the Senate Finance Committee held a markup of S. 1827, the Keeping Kids’ Insurance Dependable and Secure (KIDS) Act. The legislation passed by a voice vote.
• On October 5, 2017, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing entitled, The Federal Response to the Opioid Crisis. The witnesses present included Elinore F. McCance-Katz, M.D., Ph.D., Assistant Secretary For Mental Health And Substance Use, Substance Abuse and Mental Health Services Administration (SAMHSA); Debra Houry, M.D., MPH, Director National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (CDC); Francis Collins, M.D., Ph.D., Director, National Institutes of Health (NIH); and Scott Gottlieb, M.D., Commissioner, FDA.

• On October 3, 2017, the House Energy and Commerce Health Subcommittee held a hearing entitled, Examining Patient Access to Investigational Drugs. There were four panels of witnesses who discussed H.R. 1020, the Compassionate Freedom of Choice Act of 2017 and S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017. The purpose of the hearing was to examine the FDA’s expanded access program, the GAO’s findings and recommendations to the FDA, as well as challenges facing patients, advocates, physicians, and manufacturers.
• On October 4, 2017, the House Ways & Means Committee held a markup of H.R. 849, the Protecting Seniors’ Access to Medicare Act of 2017. H.R. 849 is a bill to repeal the provisions of the Patient Protection and Affordable Care Act providing for the Independent Payment Advisory Board. The bills were reported favorably out of Committee.
• On October 4, 2017, the House Energy & Commerce Committee held a markup of H.R.849, the "Protecting Seniors' Access to Medicare Act of 2017"; H.R.1148, the FAST Act of 2017; H.R.2465, the Steve Gleason Enduring Voices Act of 2017; H.R.2557, the Prostate Cancer Misdiagnosis Elimination Act of 2017; H.R.3120, to amend title XVIII of the Social Security Act to reduce the volume of future electronic health record-related significant hardship requests; H.R.3245, the Medicare Civil and Criminal Penalties Update Act; H.R.3263, to amend title XVIII of the Social Security Act to extend the Medicare independence at home medical practice demonstration program; H.R.3271, the Protecting Access to Diabetes Supplies Act of 2017; the CHAMPION Act; and the Helping Ensure Access for Little Ones, Toddlers, and Hopeful Youth by Keeping Insurance Delivery Stable (HEALTHY KIDS) Act of 2017. All bills were reported favorably out of Committee.

• On October 2, 2017, the Office of Inspector General (OIG) released a report entitled, Wyoming State Medicaid Fraud Control Unit: 2016 Onsite Review. The report found that for FYs 2013 through 2015, the Wyoming Unit reported obtaining 11 criminal convictions; 25 global civil judgments and settlements; and total recoveries of over $3 million. We found that the Wyoming Unit was generally in compliance with applicable laws, regulations, and policy transmittals, and the Unit overcame training barriers by working with another Medicaid Fraud Control unit (MFCU) to train its newly hired investigator. However, the OIG identified three areas of concern: (1) the Unit did not pursue civil fraud cases other than "global" civil fraud cases (i.e., cases that involve the National Association of Medicaid Fraud Control Units and typically involve a group of MFCUs) during the review period; (2) although the Unit referred cases to its Federal and State agency partners, its written procedures for such referrals were incomplete; and (3) the Unit did not employ any investigators for a period of approximately 6 months, which appeared to have negative consequences for Unit investigations.
• On October 2, 2017, the OIG released a report entitled, Medicare Part B Drug Payments: Impact of Price Substitutions Based on 2015 Average Sales Prices. The report found that CMS lowered Part B reimbursement for 13 drugs on the basis of 2015 data. CMS’ price-substitution policy saved Medicare and its beneficiaries $5.4 million over 1 year based on 2015 data. Additionally, the report found that Medicare and its beneficiaries could have saved up to an additional $17 million over 1 year if CMS implemented a more expansive price substitution policy that, for example, allowed substitution for drugs that exceeded the 5 percent threshold in a single quarter.
• On October 3, 2017, the OIG released a report entitled, Medicare Payments for Clinical Diagnostic Laboratory Tests in 2016: Year 3 of Baseline Data. The report found that Medicare paid $6.8 billion under Part B for lab tests in 2016, a total that changed very little in the 3-year period from 2014 through 2016. Medicare payments were concentrated among a small number of tests and labs. The top 25 tests by Medicare payments totaled $4.3 billion and represented 60 percent of all Medicare payments for lab tests in 2016. The top 6 tests, which remained consistent with the top 6 from the previous 2 years, totaled $2.4 billion in 2016. More than half of payments for the top 25 tests went to 1 percent of labs. The report also found that Medicare payments for four categories of tests changed notably over time, despite little change in the total payments for all lab tests. In comparison to Medicare payments for other test categories, payments for two categories of tests-an emerging category of tests and microbiology tests-increased notably from 2015 to 2016. Drug tests and molecular pathology tests decreased notably during the same period.
• On October 3, 2017, the Government Accountability Office (GAO) released a report entitled, Investigational New Drugs: FDA’s Expanded Access Program. The report found that the FDA's expanded access program allows patients with serious or life threatening illnesses access to certain drugs before it has approved them. The FDA also requires that manufacturers submit data about adverse reactions to these drugs. The FDA recently testified that while the FDA has provided some guidance to manufacturers, it does not fully explain the few instances when it would use these data on adverse reactions.
• On October 4, 2017, the GAO released a report entitled, Newborn Health: Federal Action Needed to Address Neonatal Abstinence Syndrome. The report found that the rising opioid epidemic has contributed to an increase in the number of babies born with neonatal abstinence syndrome—a withdrawal condition with symptoms including excessive crying and difficulty breathing. HHS dentified key recommendations to help guide its efforts to prevent and treat this syndrome—such as providing medical education to healthcare providers on how to treat these infants. However, the GAO found that it is unclear how the department will implement these recommendations, if at all.
• On October 5, 2017, the OIG released a report entitled, The Food and Drug Administration Generally Spent Prescription Drug User Fee Collections Appropriately. The report found that the FDA generally spent prescription drug user fee collections appropriately. However, FDA did not have adequate supporting documentation for $6,403 in travel expenses, made a duplicate payment for airfare of $1,213, and overpaid a traveler $587. FDA recovered the duplicate payment and overpayment from the travelers during our review. The lack of supporting documentation appeared to be an oversight by FDA staff and not a systemic issue.
• On October 5, 2017, the Congressional Budget Office (CBO) released a report entitled, A Premium Support System for Medicare: Updated Analysis of Illustrative Options. The report presents new estimates of the budgetary effects of options for a premium support system for Medicare and examines the reasons for the changes in the estimates, including changes in law that have affected the Medicare program.

IV.Other Health Policy News

• On October 2, 2017, CMS announced that the National Partnership to Improve Dementia Care has met its goal of reducing the national prevalence of antipsychotic use in long-stay nursing home residents by 30 percent by the end of 2016. CMS also announced a new goal of a 15 percent reduction by the end of 2019 for long-stay residents in those homes with currently limited reduction rates, using the prior baseline rate (fourth quarter of 2011). The data below show current trends related to the prevalence of antipsychotic use.
• On October 3, 2017, the FDA issued an informational sheet entitled, Waiver of IRB Requirements for Drug and Biological Product Studies. The informational sheet provides guidance which is intended to provide information for sponsors and sponsor-investigators about requesting a waiver of Institutional Review Board (IRB) requirements for drug and biological product studies regulated by the FDA. This document supersedes Waiver of IRB Requirements (September 1998) Office of Health Affairs, Food and Drug Administration.
• On October 6, 2017, CMS issued an informational bulletin entitled, CMS Bulletin Addressing Enforcement of Section 1303 of the Patient Protection and Affordable Care Act. The bulletin provides issuers of their obligation to comply with Section 1303 of the Affordable Care Act.