Week in Review

U.S. coronavirus response

  • President Donald Trump signed into law the $2 trillion coronavirus stimulus package, the largest in American history. The package will offer relief to workers and corporations, although some are skeptical of its effectiveness for states hit hardest by the coronavirus; Gov. Andrew Cuomo (D) of New York said the package is “reckless” and insufficient in helping the state, which has spent $1 billion dealing with the outbreak already.
  • For the first time, Trump used the Defense Production Act to require that General Motors prioritize the production of ventilators. 
  • The United States is now the global epicenter for the coronavirus, with the number of COVID-19 cases surpassing 82,000, more than the caseload in China, Italy and every other country in the world. 
  • The Trump administration is drafting guidelines for state and local officials to increase or loosen social distancing measures in individual counties, based on an assessment of their own threat level. 
  • Vice President Mike Pence shut down the possibility of a national quarantine, saying that the coronavirus task force has “at no point” discussed the possibility. However, several states, such as California, announced near-lockdown measures to curb the coronavirus.
  • At odds with health officials in his administration and across the country, Trump said he wants to have the economy up and running by Easter Sunday — April 12 — because he believes sustained social distancing measures are “worse than the problem.” 
  • A U.S. government warehouse in Indiana houses almost 1.5 million expired N95 masks, according to five people with knowledge of the matter, and officials from the Department of Homeland Security decided to use the stockpile for the Transportation Security Administration, according to three of those people. 

Supply shortages

  • The Food and Drug Administration will temporarily ease its validation process for manufacturers of medical devices such as ventilators, allowing automakers and other industrial companies to help meet growing demand for the machines.

Testing and treatment

  • After public health advocates raised the alarm on Gilead Sciences Inc.’s winning orphan drug status for its potential coronavirus drug, remdesivir, from the FDA, the drugmaker took the rare step of asking the agency to rescind its decision, which would protect Gilead from generic competition for seven years. 
  • With the exception of pregnant women and minors infected with the coronavirus, Gilead announced it is temporarily halting access to remdesivir, citing “overwhelming demand.” 
  • Mylan NV is waiving its exclusive distribution rights to Kaletra, another potential COVID-19 treatment, allowing generic drugmakers to seek FDA approval for their products.
  • In an effort to protect health care workers from becoming infected with COVID-19, UnitedHealth Group Inc. is offering a coronavirus swab test supported by the FDA that patients can use themselves. 
  • The FDA will grant approval on a case-by-case basis to doctors using blood plasma of recovered COVID-19 patients to treat new patients, an investigational therapy based on the hopes that antibodies in the blood may be successful in fighting the virus. 

Elsewhere in the industry

  • The coronavirus stimulus package includes significant reforms for the over-the-counter drug regulatory process, including a new program to aid the FDA in conducting harsher reviews of medications readily available at the pharmacy and expanded flexibility in updating product standards.
  • Federal prosecutors have opened a lawsuit against health insurer Anthem Inc., alleging the company committed Medicare fraud by requesting reimbursement for inaccurate claims in the order of millions of dollars, a claim Anthem fiercely denies. 
  • Bristol-Myers Squibb Co. won FDA approval for Zeposia, the multiple sclerosis treatment that was a major piece of the company’s purchase of Celgene, carving out space for the drugmaker in an extremely lucrative market. 

What’s Ahead

  • The House and Senate are both out of session until at least April 20.
  • On Tuesday, USC-Brookings Schaeffer Initiative for Health Policy will host the 24th Wall Street Comes to Washington Health Care Roundtable as a webinar.
  • On Tuesday afternoon, the American Bar Association will hold a webinar titled “Responding to the Global COVID-19 Pandemic: The State and Local Government Perspective.”
  • On Wednesday, STAT News will host a live chat on the coronavirus pandemic.
  • Also on Wednesday, the Carnegie Endowment for International Peace will host a webcast discussion titled “Crisis Upon Crisis: The Geopolitical and Economic Implications of COVID-19 in the MENA (Middle East and North Africa) Region.”
  • The Medicaid and CHIP Payment and Access Commission meets on Thursday. The webcast will be available online.

Events Calendar (All Times Local)

03/31/2020
USC-Brookings Schaeffer Initiative for Health Policy: Wall Street Comes to Washington Health Care Roundtable. 9:00 am
ERIC Research on Biosimilars Savings and Need for Competition webinar 10:00 am
Carnegie Endowment for International Peace webcast discussion: “Crisis Upon Crisis: The Geopolitical and Economic Implications of COVID-19 in the MENA Region.” 11:00 am
Improve Eye Health Quality While Managing Care Costs 2:00 pm
American Bar Association webinar: “Responding to the Global COVID-19 Pandemic: The State and Local Government Perspective” 2:00 pm
04/01/2020
STAT live chat: The coronavirus pandemic 11:00 am
04/02/2020
Medicaid and CHIP Payment and Access Commission virtual meeting 10:00 am
View full calendar

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