WHITE HOUSE UPDATE

FY 2020 Proposal: White House Seeks Billions  in Record Investments to Stop Drug Epidemic


LEGISLATIVE UPDATE

Monday, March 11

Drug Pricing: Chairman of the Aging Committee Susan Collins (R-ME) Introduces the Biologic Patent Transparency Act

Tuesday, March 12

Drug Pricing: U.S. Senate Finance Committee Chairman Chuck Grassley of Iowa and Ranking Member Ron Wyden of Oregon Invite 5 Pharmacy Benefit Managers to Drug Pricing Hearing

Veterans’ Affairs: Ranking Member of the Senate Veterans’ Affairs Committee Jon Tester Asks How to Reduce the Rate of Veteran Suicide

Wednesday, March 13

Veterans’ Affairs: U.S. Senators Jon Tester (D-MT) and Jerry Moran (R-KS) Introduce Veterans Mental Health and Suicide Prevention Bill

Drug Pricing: Energy and Commerce Chairman Frank Pallone, Jr.’s (D-NJ) Remarks on Hearing on Making Prescription Drugs More affordable

Junk Plans: Energy and Commerce Committee Launches Investigation into Companies that Sell or Broker Junk Health Insurance Plans

Friday, March 15

Drug Pricing: Bipartisan Legislation Introduced to Increase Competition in the Pharmaceutical Industry and to Lower Prices for Consumers


REGULATORY UPDATE

Monday, March 11

CMS: Request for Comment on How to Eliminate Barriers to and Enhance Health Insurance Issuers’ Ability to Sell Individual Health Insurance Coverage Across State Lines

FDA: FDA Announces the Availability of a Model Drugs Facts Label for Nonprescription Naloxone

HHS: Statement on the FY 2020 Budget Proposal for Ending the HIV Epidemic in America

Tuesday, March 12

NIOSH: NIOSH, CDC, HHS Announce Availability of the Final National Occupational Research Agenda for Public Safety

FDA: FDA Announces Opportunity for Public Comment Involving Interviews of Pharmaceutical Manufacturers who Submit 351(k) Biologics License Applications

  • FDA Announces Approval of New Generic of Diovan (Valsartan)

Wednesday, March 13

NIH: Scientists Find New Approach that Shows Promise for Treating Cystic Fibrosis

Thursday, March 14

FDA: FDA Announces Opportunity for Public Comment on FDA’s Regulations on Current Good Manufacturing Practice for Positron Emission Tomography Drug

  • FDA Approves New Indication for a Heart Valve Repair Device
  • Statement from FDA Commissioner Scott Gottlieb, M.D., on New Strategies to Modernize Clinical Trials to Advance Precision Medicine

CMS: CMS Updates Drug Dashboards with Prescription Drug Pricing and Spending Data

Friday, March 15

FDA: FDA Announces Availability of a Final Guidance for “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals”

  • FDA Announces Availability of a Final Guidance for “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drags and Biological Products
  • Statement from FDA Commissioner Scott Gottlieb, M.D. and Director of the Center for Devices and Radiological Health Jeff Shuren, M.D. on Efforts to Evaluate Materials in Medical Devices

NIH: Light Physical Activity Linked to Lower Risk of Heart Disease in Older Women

  • NIH Study Suggests Tiny Electrical Brain Waves May be a Hallmark of Successful Memory Retrieval

UPCOMING EVENTS

FDA
Meeting: Neurological Devices Panel of the Medical Devices Advisory Committee
March 21,2019 8 AM – 5 PM
Hilton Washington, DC North/Gaithersburg, Salons A, B, C and D, 620 Perry Pkwy., Gaithersburg, MD 20877

NIH
Meeting: Office of AIDS Research Advisory Council
March 28, 2019 8:30 AM – 4:30 PM
National Institutes of Health, Conference Room 1D13, 5601 Fishers Lane, Rockville, MD 20892

CDC
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

CMS
Meeting: Healthcare Common Procedure Coding System
May 13, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

CMS
Meeting: Healthcare Common Procedure Coding System
May 14, 2019 9 AM – 5 PM
Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1850

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

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

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