Alston & Bird Healthcare Week in Review, March 4, 2017

I. Regulations, Notices, & Guidance

• On February 28, 2017, the Food and Drug Administration (FDA) issued a final rule entitled, Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories. The final rule amends the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh, specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures (“specialized surgical instrumentation for use with urogynecologic surgical mesh”). The rule is effective on March 1, 2017.
• On February 28, 2017, the Drug Enforcement Administration (DEA) issued a final rule entitled, Schedules of Controlled Substances: Placement of 10 Synthetic Cathinones into Schedule I. The final rule places 10 synthetic cathinones: 4-methyl-N-ethylcathinone (4-MEC); 4-methyl-alphapyrrolidinopropiophenone (4-MePPP); alpha-pyrrolidinopentiophenone (α-PVP); 1-(1,3- benzodioxol-5-yl)-2-(methylamino)butan-1-one (butylone, bk-MBDB e); 2- (methylamino)-1-phenylpentan-1-one (pentedrone); 1-(1,3-benzodioxol-5-yl)-2- (methylamino)pentan-1-one (pentylone, bk-MBDP); 4-fluoro-N-methylcathinone (4- FMC, flephedrone); 3-fluoro-N-methylcathinone (3-FMC); 1-(naphthalen-2-yl)-2- (pyrrolidin-1-yl) pentan-1-one (naphyrone); alpha-pyrrolidinobutiophenone (α-PBP) and their optical, positional, and geometric isomers, salts and salts of isomers, whenever the existence of such salts, isomers, and salts of isomers is possible, into schedule I of the Controlled Substances Act. The rule is effective on March 1, 2017.
• On March 3, 2017, the FDA issued a notice entitled, Issuance of Priority Review Voucher; Rare Pediatric Disease Product. The notice announces the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application.
• On March 2, 2017, the Department of Health and Human Services (HHS) issued a final rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties; Delay of Effective Date. The final rule, in accordance with the memorandum of January 20, 2017, from the Assistant to the President and Chief of Staff, entitled, Regulatory Freeze Pending Review, is delaying for 60 days from the date of the memorandum the effective date of the final rule entitled, 340B Drug Pricing Program Ceiling Price and Manufacturer Civil Monetary Penalties Regulation, published in the January 5, 2017, Federal Register. The effective date is delayed until March 21, 2017.
• On March 2, 2017, the Centers for Disease Control and Prevention (CDC) issued a notice entitled, Request for Nominations of Candidates to Serve on the Clinical Laboratory Improvement Advisory Committee (CLIAC). The notice announces that the CDC is soliciting nominations for membership on CLIAC. Submissions are due by May 1, 2017.

• March 15 – 16, 2017: HHS announced a meeting of the Advisory Committee on Human Research Protections (SACHRP). On March 15, 2017, there will be a discussion focusing on selected sections of the new Common Rule, which was published January 19, 2017, with an effective date of January 19, 2018. The Subcommittee on Harmonization (SOH). The SOH will present their recommendations for considerations of the new Common Rule’s compliance dates and transition provisions, as well as for the interpretation and implementation of the new broad consent provision. The Subpart A Subcommittee (SAS) will discuss their report on the interpretation of the new exemption involving benign behavioral interventions. On March 16, 2017, the SOH will provide recommendations on the FDA Draft Guidance entitled, Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, issued July 27, 2016. SOH will also present recommendations on the return of incidental findings to research subjects. The SAS will present recommendations surrounding the new Common Rule’s expedited review requirements.
• April 4, 2017: The FDA announced a public advisory committee meeting of the Nonprescription Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss safety issues associated with over-the-counter analgesic combination products used for upset stomach (i.e., heartburn, nausea, fullness, belching, gas, acid indigestion, and/or sour stomach) and hangover indications under the Internal Analgesic and Antacid monographs in 21 CFR part 343 and 21 CFR part 331, respectively. The committees will also be asked to discuss the hangover indication under the Overindulgence, Internal Analgesic, and Stimulant monographs in 21 CFR part 357 subpart J, 21 CFR part 343, and 21 CFR part 340, respectively.
• April 4 -5, 2017: The FDA announced a public advisory committee of the Blood Products Advisory Committee. On April 4, 2017, in open session, the Committee will discuss Recombinant Human Coagulation Factor IX, GlycoPEGylated. In the afternoon, in open session, the Committee will hear an update presentation on a summary of responses to Docket FDA-2016-N- 1502: Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products. On April 5, 2017, in open session, the committee will hear overview presentations on the research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases, Office of Blood Research and Review, Center for Biologics Evaluation and Research, FDA. At the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). During the closed session, the 3 Committee will discuss the research progress made by staff involved in the intramural research programs and make recommendations regarding their personnel actions and staffing decisions.
• May 4, 2017: The FDA announced a meeting and an opportunity for public comment on Patient-Focused Drug Development for autism. The public meeting is intended to allow FDA to obtain patient perspectives on the impact of autism on daily life as well as patient views on treatment approaches for autism. Registration to attend must be received by April 24, 2017.

II. Congressional Legislation & Committee Action

• There were no healthcare-related hearings the week of February 27, 2017.

• On March 1, 2017, the House Education and the Workforce Committee will hold a hearing on entitled, Legislative Proposals to Improve Health Care Coverage and Provide Lower Costs for Families, including H.R.1101, the Small Business Health Fairness Act; the "Self-Insurance Protection Act"; and the "Preserving Employee Wellness Programs Act." The witnesses present included Mr. Jon B. Hurst, President, Retailers Association of Massachusetts who testified on behalf of the National Retail Federation (NRF); Ms. Allison R. Klausner, Principal, Government Relations Leader, Conduent Human Resource Services who testified on behalf of the American Benefits Council (ABC); Ms. Lydia Mitts, Associate Director of Affordability Initiatives, Families USA; and Mr. Jay Ritchie, Executive Vice President Tokio Marine HHC testifying on behalf of the Self-Insurance Institute of America (SIIA).
• On March 2, 2017, the House Energy and Commerce Health Subcommittee held a hearing entitled, FDA Generic Drug/Biosimilar User Fee Programs. The witnesses present included Mr. Allan Coukell, Senior Director, The Pew Charitable Trusts, Health Programs; Mr. David Gaugh, Senior Vice President of Sciences and Regulatory Sciences, Association for Accessible Medicines (AAM); Ms. Kay Holcombe, Senior Vice President of Science Policy, Biotechnology Industry Organization (BIO); Mr. Bruce A. Leicher, Chair, a Division of the AAM, the Biosimilars Council; Ms. Juliana Reed, Vice President of Government Affairs, Coherus BioSciences, Immediate Past President, The Bisosimilars Forum; and Dr. Janet Woodcock, Director, Food and Drug Administration (FDA), Center for Drug Evaluation and Research.

• On March 8, 2017, the Senate Appropriations – Subcommittee on Labor, Health and Human Services, Education and Related Agencies will hold a hearing entitled, Medical Research. The hearing will take place at 10:30 a.m. in 138 Dirksen. The witness are Timothy Eberlein, Director of the Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine; Thomas Grabowski Jr., Director of the Memory and Brain Wellness Center, Alzheimer’s Disease Research Center, Integrated Brain Imaging Center at the University of Washington; Stacey Schultz-Cherry, Member of the Department of Infectious Diseases at the St. Jude Children’s Research Hospital; and Jennifer Sasser, Assistant Professor at the University of Mississippi Medical Center.

• There are currently no healthcare-related hearings scheduled for the week of March 6, 2017.

• On February 27, 2017, the Government Accountability Office (GAO) released a report entitled, Electronic Health Records: HHS Needs to Improve Planning and Evaluation of Its Efforts to Increase Information Exchange in Post-Acute Care Settings. The report found that issues like increased costs and a lack of access to technology deter the use of electronic health records in rehab facilities. The GAO recommends that HHS comprehensively plan its efforts to increase the electronic exchange of health information in post-acute care settings.
• On March 1, 2017, the Office of Inspector General (OIG) released a report entitled, Review of the Department of Health and Human Services’ Compliance with the Federal Information Security Modernization Act of 2014 for Fiscal Year 2016. The report found that in comparison to the prior year's FISMA review, HHS has made improvements. Specifically, the number of findings have decreased from year to year. In addition, HHS and its operating divisions have implemented continuous monitoring tools that have allowed them to gain more insight to the security compliance of their assets. However, despite the progress made to improve its information security program, opportunities to strengthen the overall information security program exist. The OIG continued to identify weaknesses in the following areas: continuous monitoring, configuration management, identity and access management, risk management, incident response, security training, contingency planning, and contractor systems.
• On March 2, 2017, the GAO released a report entitled, Antibiotics: FDA Has FDA Has Encouraged Development, but Needs to Clarify the Role of Draft Guidance and Develop Qualified Infectious Disease Product Guidance. The report found that the FDA coordinated the release of 14 updated or new guidance documents on antibiotic development, in compliance with Generating Antibiotic Incentives Now (GAIN) provisions of the Food and Drug Administration Safety and Innovation Act of 2012. The GAO found that while these draft guidance documents can include updated information, it is unclear if the new information represents the FDA’s current thinking on a topic or if the purpose of the draft guidance is limited to generating public comment.

IV. Other Health Policy News

• On February 28, 2017, Senators Bernie Sanders (I-VT), Cory Booker (D-NJ) and Bob Casey (D-PA) introduced legislation to lower the cost of prescription drugs by allowing Americans to import medicine from Canada.

V. ACA Repeal News

• On February 28, 2017, National Governors Association (NGA) Vice Chair, Brian Sandoval (R-NV) said governors are working on their own plan to replace the Affordable Care Act (ACA) following their annual meeting over the weekend. Sandoval and NGA Chair Terry McAuliffe (D-VA) stressed that any replacement to the ACA must not bump anyone off coverage and McAuliffe said coverage opportunities should be expanded under a replacement plan.
• On March 1, 2017, House Ways and Means Committee Chairman Kevin Brady (R-TX) told reporters that leadership is trying to build consensus and he is aware that conservatives and moderates are offering their input. He said Trump’s speech to Congress Tuesday night indicated that he is in step with House Republicans on health savings accounts, Medicaid and tax credits.
• On March 2, 2017 House Energy and Commerce member Representative Chris Collins (R-NY) said a tax credit is worthless if it is not refundable and suggested the upcoming ACA replacement package could provide the credits directly to consumers rather than having them flow through insurance companies as they currently do.