LEGISLATIVE UPDATE

Monday, April 1

House Committee on Energy and Commerce: Committee Announces Full Committee Markup of Net Neutrality, Healthcare and Climate Change Bills

Tuesday, April 2

Latest Hearing: Senate Finance Committee Hearing on “Drug Pricing in America: A Prescription for Change, Part III”

PBMs: U.S. Senate Finance Committee Chairman Chuck Grassley and Ranking Member Ron Wyden Send Letter to the Three PBMs on the Skyrocketing Cost of Insulin

Medicaid: U.S. Senate Finance Committee Chairman Chuck Grassley and Ranking Member Ron Wyden Celebrate Passage of Right Rebate Act

Drug Pricing: Energy and Commerce Chairman Frank Pallone’s Opening Remarks from Hearing on Rising Insulin Prices

  • Energy and Commerce Chairman Frank Pallone Condemns Administration’s Legal Campaign Taking Away Americans’ Health Care

Wednesday, April 3

Medicaid: Bipartisan Bill to Improve Health Outcomes and Care for Children with Complex Medical Conditions in Medicaid Passes Congress

Drug Pricing:  U.S. Senate Finance Committee Chairman Chuck Grassley Releases Statement on Capping Out-of-Pocket Costs for Insulin Prescriptions

Thursday, April 4

Medicaid: U.S. Senate Finance Committee Chairman Chuck Grassley Writes Article “Stop Kicking Medicaid’s Safety Net Hospital Payments Down the Road”

Drug Pricing: House Energy and Commerce Committee Approves CREATES Act

  • Energy and Commerce Chairman Frank Pallone Remarks on the Passage of 12 Bills to Lower Health Care and Prescription Drug Costs for Consumers

REGULATORY UPDATE

Monday, April 1

CMS: Notice of Approval of the American Association for Accreditation of Ambulatory Surgery Facilities, Inc.

Medicare: CMS Finalizes Medicare Advantage and Part D Payment Policy Updates to Increase Competition and Coverage

Tuesday, April 2

CDC: CDC Announced Opportunity for Comment on “Drug Overdose Surveillance and Epidemiology”

FDA: FDA Issues Final Rule Amending the General Biologics Regulations Relating to Time of Inspection Requirements and Removing Duties of Inspector Requirements

  • FDA Announces Opportunity for Public Comment on Generic Clearance for Quick Turnaround Testing of Communication Effectiveness

Drug Pricing:  Statement from FDA Commissioner Scott Gottlieb, M.D., on Lowering the Costs of Insulin and Increasing Competition at House Energy and Commerce Committee Hearing

 Opioids: FDA Issues Two Warning Letters to Operators of Websites Illegally Marketing Unapproved, Potentially Dangerous, Misbranded Opioid Medications

Wednesday, April 3

FDA: Statement from FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on Efforts to Stop Manufacturers from Marketing Unapproved Products and the Agency’s Commitment to Advance Stem Cell Product Development

  • Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on New Efforts to Improve Quality of Compounded Drugs

NIH: Opioid Epidemic Increasing Rates of Certain Infectious Diseases Including HIV/AIDS, Hepatitis, Heart Infections, and Skin and Soft Tissue Infections

Thursday, April 4

FDA: FDA Announces Comment Period for “Providing Regulatory Submissions in Electronic and Non-Electronic Format – Promoting Labeling and Advertising Materials for Human Prescription Drugs

  • Statement from FDA Commissioner Scott Gottlieb, M.D., and Director of the Center for Drug Evaluation and Research Janet Woodcock, M.D., Regarding Ongoing Safety Issues with Nitrosamine-Free Valsartan and ARB Class medicines
  • FDA Issues Warning Letter to Genomics Lab for Illegally Marketing Genetic Test

Friday, April 5

CMS: CMS Finalizes Policies to Bring Innovative Telehealth Benefit to Medicare Advantage


UPCOMING EVENTS

Hearing
House Committee on Energy and Commerce: “Priced Out of a Lifesaving Drug: Getting Answers on the Rising Cost of Insulin”
April 10, 2019 10:30 AM
2322 Rayburn House Office Building

Hearing
Senate Veterans’ Affairs Committee: “Implementing the Veterans Community Care Program”
April 10, 2019 2:30 PM
Russell Senate Office Building SR-418

NIH
Meeting: Clinical Laboratory Improvement Advisory Committee
April 11, 2019 8:30 AM – 1:00 PM
The Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244

NIH
Meeting: NIH Clinical Center Research Hospital Board
April 12, 2019 9:00 AM – 3:00 PM
National Institutes of Health, Building 1, Wilson Hall, 1 Center Drive, Bethesda, MD 20892

CDC
Meeting: Advisory Council for the Elimination of Tuberculosis Meeting (ACET)
April 16, 2019 10:00 AM – 3:30 PM
8 Corporate Blvd., Building 8, Conference Rooms 1A and 1B, Atlanta, Georgia 30329

FDA
Meeting: Antimicrobial Drugs Advisory Committee
April 26, 2019 8:30 AM – 1:00 PM
Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903

FDA
Meeting: Reagan-Udall Foundation for the Food and Drug Administration
May 2, 2019 10:00 AM – 12:00 PM
The public meeting will be held at the PEW Charitable Trusts, 901 E St. NW, Washington, DC 20004

CMS
Meeting: Healthcare Common Procedure Coding System
May 15, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

CDC
Meeting: Healthcare Infection Control Practices Advisory Committee (HICPAC)
May 16, 2019 9:00 AM – 5:00 PM
Centers for Disease Control and Prevention, Global Communications Center, Building 19, Auditorium B, 1600 Clifton Road NE, Atlanta, Georgia 30329-4027

NIH
Meeting: National Advisory Council on Aging
May 21, 2019 3:00 PM – 5:00 PM
National Institutes of Health, Building 60, Lecture Hall, One Cloister Court, Bethesda, MD 20892

NIH
Meeting: National Advisory Mental Health Council
May 30, 2019 9:00 AM – 1:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), Conference Rooms C/D/E, 6001 Executive Boulevard, Rockville, MD 20852

NIH
Meeting: National Heart, Lung, and Blood Advisory Council
June 4, 2019 8:00 AM – 12:00 PM
National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892

HRSA
Meeting: Council on Graduate Medical Education
June 5, 2019  8:30 AM – 5:00 PM & June 6 8:30 AM – 2:00 PM
5600 Fishers Lane, Rockville, Maryland 20857

NIH
National Advisory Council on Aging
September 10-11, 2019 3:00 PM – 5:00 PM
National Institutes of Health, Neuroscience Center Building (NSC), North Bethesda, 6001 Executive Boulevard, Rockville, MD 28052

NIH
Meeting: Center for Scientific Review
September 23, 2019 8:30 AM – 3:00 PM
National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892

NIH
Meeting: Board of Scientific Counselors, NIDDK
October 10-11, 2019 8:00 AM – 6:00 PM
National Institutes of Health, Building 10, Solarium Conference Room 9S233, 10 Center Drive, Bethesda, MD 20892

FDA
Meeting: The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products
May 13, 2019 9 AM – 5 PM
FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503B), Silver Spring, MD 20993-0002.

CDC
Meeting: CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment
May 14, 2019 8:30 AM – 5:30 PM
CDC Corporate Square, Building 8, Conference Room 1-ABC, 8 Corporate Boulevard, Atlanta, Georgia 30329 and Web conference: 1-877-603-4228, Participant code: 42598858

NIH
Meeting: Board of Scientific Counselors, National Institute of Neurological Disorders and Stroke
June 23-25, 2019 6:00 PM – 12:00 PM
Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814

CMS
Meeting: Medicare Advisory Panel on Clinical Diagnostic Laboratory Tests
June 24, 2019 8:00 AM – 4:30 PM
Main auditorium of the Centers for Medicare & Medicaid Services (CMS), Central Building, 7500 Security Boulevard, Baltimore, Maryland 21244-1850