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On May 5, the Trump Administration issued a pair of executive orders that could signal big changes for the drug industry and health research efforts in the United States. The orders, in part, direct federal agencies to take actions by this fall to curtail certain pharmaceutical manufacturing and health research activities performed outside the United States. The orders are among the first of many that are anticipated to initiate federal restrictions on offshore health care and life sciences activities and incentivize domestic operations in the industry.

Executive Order 14293 Regulatory Relief To Promote Domestic Production of Critical Medicines (E.O. 14293) restores an effort that was started during the first Trump administration and continued under the Biden administration to attempt to assist companies to bring pharmaceutical manufacturing capacity back to the United States. As with E.O. 14292, this order directs federal agencies to take the next 90 to 180 days to review and offer changes to regulations and subregulatory guidance to help increase American manufacturing capacity for pharmaceuticals.

Executive Order 14292, Improving the Safety and Security of Biological Research (E.O. 14292) seeks to regulate and eliminate “gain of function research” which has been identified by some as the genesis of the novel coronavirus responsible for COVID-19. On top of suspending federal funding for gain-of-function research both in and outside of the United States, the order broadly suspends funding for “other life-science research” that is occurring in countries of concern or foreign countries where there is not adequate oversight. The order also directs federal agencies to revise the framework for oversight and managing risks in biological research.

Both of these executive orders could signal massive changes to the production and importation of drugs as well as the research process behind those drugs. As a result, pharmaceutical manufacturers, research institutions, and health care institutions that dispense, distribute, or otherwise rely on these offshore activities should carefully watch upcoming actions by the various elements of the Department of Health and Human Services (HHS) as well as the Environmental Protection Agency (EPA) for guidance on how these changes will be implemented.Continue Reading Trump Executive Orders seek to encourage reshoring of pharmaceutical manufacturing and research

On September 25, 2019, the House Energy and Commerce Committee is holding a hearing entitled “Making Prescription Drugs More Affordable: Legislation to Negotiate a Better Deal for Americans.”  A background memo and text of the bills are available here.  Likewise, a second House panel – the Education and Labor Health, Employment, Labor, and Pensions…

A number of Congressional committees have recently held hearings on health policy issues, including the following:

  • House Energy and Commerce Committee hearings on “Cybersecurity in the Heath Care Sector: Strengthening Public-Private Partnerships” and Food and Drug Administration (FDA) medical device user fees.
  • A House Oversight and Government Reform Committee hearing on “Federally Funded Cancer Research:

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The Senate Health, Education, Labor and Pensions (HELP) Committee has approved the last of its biomedical innovation bills that form its counterpart to the House 21st Century Cures Act.  Together with the bills cleared by the HELP committee in February and March 2016, the panel has now passed 19 bipartisan medical innovation bills.  The five newly-approved bills are as follows:
Continue Reading Senate HELP Committee Completes Work on Bipartisan “Cures”/Medical Innovation Legislation

The Senate Health, Education, Labor and Pensions (HELP) Committee has approved several bipartisan health policy bills, including health information technology (HIT) legislation and bills aimed at spurring biomedical innovation to complement the “House 21st Century Cures” initiative. Specifically, on February 9, 2016, the Committee approved:
Continue Reading Senate HELP Committee Clears Bipartisan Biomedical Innovation, Health IT Bills

President Obama recently signed a memorandum formally establishing a White House Cancer Moonshot Task Force to coordinate and strengthen federal and private efforts to support cancer research and treatment.  The Task Force, which is chaired by Vice President Biden, is charged with developing recommendations to:

  • accelerate understanding of cancer and its prevention, early detection, treatment,

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On September 8, 2015, the House of Representatives approved the following bipartisan bills by voice vote: 

  • H.R. 1344, the Early Hearing Detection and Intervention Act of 2015 – to reauthorize a program for early detection, diagnosis and treatment regarding deaf and hard-of-hearing newborns, infants, and young children.
  • H.R. 1725, the National All Schedules

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Earlier this year, President Obama launched a high-profile “Precision Medicine Initiative” (PMI) to develop treatments, diagnostics, and prevention strategies tailored to the individual genetic characteristics of each patient.  On July 8, 2015 the White House released for public comment a draft document entitled “Precision Medicine Initiative: Proposed Privacy and Trust Principles,” which provides broad guidance…

On October 6, 2014, President Obama signed into law H.R. 4994, the Improving Medicare Post-Acute Care Transformation Act of 2014 (the “IMPACT Act”). The IMPACT Act’s provisions will affect a broad range of post-acute care (PAC) providers: home health agencies (HHAs), skilled nursing facilities (SNFs), inpatient rehabilitation facilities (IRFs), and long-term acute care hospitals…

On August 8, 2014, President Obama signed into law the following two bills approved by the Senate in July:

  • H.R. 4631, the Autism CARES Act, to continue federal research, early identification and intervention, and education related to autism; and
  • H.R. 3548, the Improving Trauma Care Act, to include in the Public Health Service Act definition of trauma injuries caused by thermal, electrical, chemical, or radioactive force.

In addition, prior to beginning the August recess, the House of Representatives approved the following bills: Continue Reading Two Health Policy Laws Enacted, Additional Bills Advance

Congressional panels have held numerous hearings on health policy issues this month, including the following:

  • The House Energy and Commerce Committee held a series of hearings on its “21st Century Cures” initiative, focusing on personalized medicine, barriers to evidence development and communication, technological innovations, the patient perspective, and modernizing clinical trials. A separate hearing focused

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Recent Congressional hearings on health policy issues include the following:

  • A House Energy and Commerce Health Subcommittee “21st Century Cures Roundtable” discussed steps Congress can take to bridge the gap between medical advances and the regulatory policies that govern them, and ultimately advance digital and personalized health care. The panel also released a related white

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The Senate Appropriations Committee has scheduled a May 7, 2014 hearing to review the Administration’s FY 2015 budget request for the Department of Health and Human Services (HHS). Also on May 7, the House Energy and Commerce Oversight Subcommittee will examine the status of health insurance enrollment under the ACA, and the Senate Aging Committee…

President Obama recently signed into law S. 330, the HIV Organ Policy Equity Act, which eliminates the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals. In addition, the President has signed S. 252, the "Prematurity Research Expansion and Education for Mothers who deliver Infants Early Reauthorization…

On November 12, 2013, the House of Representatives approved S. 330, the HIV Organ Policy Equity Act, which would eliminate the restriction on acquiring HIV-positive organs in order to permit research on transplants involving HIV-positive individuals (the Senate approved the bill in June). The House also passed S. 252, the Prematurity Research Expansion…

The full House of Representatives has passed three health policy bills recently cleared by the House Energy and Commerce Committee. On February 4, 2013, the House approved H.R. 297, the Children’s Hospital Graduate Medical Education (GME) Support Reauthorization Act of 2013 (which provides support to children’s hospitals for pediatric medical residency programs), and H.R. 225,…

House Energy and Commerce subcommittees have held hearings on “Influenza: Perspective on Current Season and Update on Preparedness” and on “SGR: Data, Measures and Models; Building a Future Medicare Physician Payment System.” On the Senate side, the Senate Health, Education, Labor, and Pensions Committee voted to approve H.R. 307, the Pandemic and All-Hazards Preparedness Reauthorization…

The House Energy and Commerce Committee approved three health policy bills on January 22, 2013, versions of which were passed by the full House during the last Congress. Specifically, the panel voted to approve: H.R. 297, the Children’s Hospital Graduate Medical Education (GME) Support Reauthorization Act of 2013 (which provides support to children’s hospitals for…