WHITE HOUSE

Drug Trafficking: Director of the White House Office of National Drug Control Policy Releases the Administration’s National Drug Control Policy

Presidential Proclamation: President Trump Proclaims February 2019 as American Heart Month


LEGISLATIVE UPDATE

Monday, January 28

Medicare: Senate Finance Committee Chairman Chuck Grassley Presses HHS and CMS for Explanation of Potential Increasing Costs to Medicare Laboratory Services

Price Increases: Committee on Oversight and Reform Hold first Hearing Examining Rising Drug Prices

Tuesday, January 29

Community Health Centers: Ranking Member Patty Murray (D-WA) Speech on Long-Term Funding for Critical Primary Care Programs

  • Senate Health Committee Chairman Lamar Alexander (R-TN) Addresses Congress’s Need to Act Soon

Drug Pricing: Senate Finance Committee Chairman Chuck Grassley’s Statement at Hearing on Drug Pricing

Pre-Existing Conditions: Ways and Means Committee Chairman Richard Neal’s Statement from Hearing on Protecting Americans with Pre-Existing Conditions

Wednesday, January 30

Veteran’s Community Care: Chairman of the Senate Committee on Veterans’ Affairs Johnny Isakson (R-GA) and Ranking Member of the House Committee on Veterans’ Affairs Dr. Phil Roe (R-TN) Issue Joint Statement on Proposed Eligibility Criteria for Veterans’ Community Care

Insulin Prices: Energy and Commerce Leaders Send Letter to Pharmaceutical Companies Requesting Information on Skyrocketing Insulin Prices

Health Subcommittee: Energy and Commerce Chairman Frank Pallone, Jr. (D-NJ) and Health Subcommittee Chairwoman Anna Eshoo (D-CA) Announce Hearing that Will Discuss the Impacts of Texas v. United States

Thursday, January 31

Geriatricians: Senator Susan Collins (R-ME) and Senator Bob Casey (D-PA) Introduce Geriatrics Workforce Improvement Act

Medicare: Energy and Commerce Committee Chairman Frank Pallone, Jr. (D-NJ) and Ways & Means Committee Chairman Richard Neal (D-MA) Release Joint Statement on Trump Administration’s Rebate Proposal

Friday, February 1

National Drug Control Strategy: Chairman of the Committee on Oversight and Reform Elijah E. Cummings Announces Director of the Office of National Drug Control Policy Will Testify at Hearing


REGULATORY UPDATE

Monday, January 28

FDA: Statement from FDA Commissioner Scott Gottlieb, M.D., and Jeff Shuren, M.D., Director of the Center for Devices and Radiological Health on Record Year for Device Innovation

NIH: Study Reveals Biomarkers Could Help Identify Those at Risk of Severe PTSD

  • NIH-funded Clinical Trial Finds evidence Linking Brain and Vascular Health

Tuesday, January 29

CDC: CDC Submits Information Collection Request to Obtain Comments From the Public and Affected Agencies

Wednesday, January 30

CMS: CMS Proposes Medicare Advantage and Part D Payment and Policy Updates to Maximize Competition and Coverage

FDA: FDA Commissioner Scott Gottlieb, M.D. Statement on Agency’s Efforts to Enhance the Utility of Orange Book to Foster Drug Competition

  • FDA Commissioner Scott Gottlieb, M.D. Statement on Improving Patient Access to Medicines

NIH: Scientists Develop Tool to Measure Success of HIV Cure Strategies

NIH: New Study Identifies Risk Factors for Neuropsychiatric Conditions After Concussion

Thursday, January 31

CMS: CMS Announces Opportunity for Public Comment on CMS’ Intention to Collect Information from the Public

HHS: New Proposed Rule Adopts Modification to the Requirements for the Use of the Telecommunication Standard Implementation Guide

Friday, February 1

FDA: FDA Announces the Availability of Draft Guidance for ANDA Submissions

  • FDA Announces Availability of Final guidance for Immunogenicity Testing of Therapeutic Protein ProdGcts
  • FDA Announces Availability of Final Guidance of Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

UPCOMING EVENTS

NIH
Meeting: National Heart, Lung, and Blood Advisory Council
February 5, 2019 8:30 AM – 12:00 PM
National Institutes of Health, Porter Neuroscience Research Center, Building 35A Convent Drive, Bethesda, MD 20892

NIH
Meeting: Surgical Sciences, Biomedical Imaging and Bioengineering Integrated Review Group; Surgery, Anesthesiology and Trauma Study Section
February 6-7, 2019 8:00 AM – 6:00 PM
Hyatt Regency Bethesda, One Bethesda Metro Center, Bethesda, MD 20814

NIH
Meeting: Integrative, Functional and Cognitive Neuroscience Integrated Review Group
February 7-8, 2019 8:00 AM – 6:00 PM
Renaissance Harborplace Hotel, 202 East Pratt Street, Baltimore, MD 21202

NIH
Meeting: National Institute of Mental Health Special Emphasis Panel; Treatment Development—Psychosocial Interventions
February 7, 2019 9:00 AM – 4:30 PM
National Institutes of Health, Neuroscience Center, 6001 Executive Boulevard, Rockville, MD 20852 (Virtual Meeting)

NIH
Meeting: National Advisory Council for Complementary and Integrative Health
February 8, 2019 8:30 AM – 9:45 AM
National Institutes of Health, Natcher Building, 45 Center Drive, Bethesda, MD 20892

NIH
Meeting: National Institute on Deafness and Other Communication Disorders Special Emphasis Panel
February 8, 2019 12:00 PM – 5:00 PM
Baltimore Marriott Waterfront, 700 Aliceanna Street, Baltimore, MD 21202

NIH
Meeting: National Institute of Neurological Disorders and Stroke Special Emphasis Panel; Brain Review Meeting
February 10-11, 2019 1:00 PM – 6:00 PM
Kimpton Hotel Monaco, 700 F. Street NW, Washington, DC 20004

NIH
Meeting: Digestive, Kidney and Urological Systems Integrated Review Group; Pathobiology of Kidney Disease Study Section
February 12-13, 2019 8:00 AM – 6:00 PM
Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814

CDC
Meeting: Community Preventive Services Task Forces (CPSTF)
February 13, 2019 8:30 AM – 6:00 PM & February 14, 2019 8:30 AM – 1:00 PM
CDC Edward R. Roybal Campus, Centers for Disease Control and Prevention Headquarters (Building 19), 1600 Clifton Road NE, Atlanta, GA 30329

NIH
Meeting: National Heart, Lung, and Blood Institute Special Emphasis Panel
February 15, 2019 8:00 AM – 4:00 PM
Sheraton Baltimore Washington Airport Hotel, 1100 Old Elkridge Landing Road, Linthicum Heights, MD 21090

National Institute of Neurological Disorders and Stroke
Meeting: National Advisory Neurological Disorders and Stroke Council.
February 14th – 15th 12:30 PM – 6:00 PM
Porter Neuroscience Research Center, Building 35A, Convent Drive, Bethesda, MD 20892

NIH
Meeting: Brain Disorders and Clinical Neuroscience Integrated Review Group; Acute Neural Injury and Epilepsy Study Section
February 21-22, 2019 8:00 AM – 5:00 PM
The Dupont Hotel, 1500 New Hampshire Avenue NW, Washington, DC 20036

SAMSA
Meeting: Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC) Meeting
February 27, 2019 9:00 AM – 5:00 PM
5600 Fishers Lane, Room 5N54, Rockville, MD

CDC
Meeting: Advisory Committee on Immunization Practices (ACIP)
February 27, 2019 8:00 AM – 5:30 PM & February 28, 2019 8:30 AM – 3:30 PM
CDC, 1600 Clifton Road, NE, Tom Harkin Global Communications Center, Building 19, Kent `Oz’ Nelson Auditorium, Atlanta, GA

CDC
Meeting: Disease, Disability, and Injury Prevention and Control Special Emphasis Panel and Occupational Safety and Health Education and Research Centers (ERC)
February 12-13, 2019 8:30 AM – 5:00 PM
Hilton Alexandria Old Town, 1767 King Street, Alexandria, Virginia 22314

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.