3/19/20 OFW Law Daily COVID-19 News Conference Summary

President Donald Trump and Vice President Mike Pence held a press conference beginning at 11:30 this morning. They were joined by FDA Commissioner Stephen Hahn, White House Coronavirus Response Coordinator Deborah Birx, and Surgeon General Jerome Adams.

Summary of the President’s remarks and questions:

  1. The President announced that he signed HR 6201, the Families First Coronavirus Response Act. He said another response bill is being worked by Secretary of the Treasury Mnuchin with Republican and Democratic Senators.
  2. He said that if people had known about the virus it could have been stopped in place in China.
  3. He repeated that the Federal Government will be invoking the Defense Production Act (https://www.fema.gov/media-library-data/20130726-1650-20490-5258/final__defense_production_act_091030.pdf) to facilitate the acquisition of personal protective equipment, ventilators, and other items deemed necessary to the nation’s response to the pandemic, but in response to later questions said he will “pull the trigger only if there is a “desperate need”.
  4. He complimented FDA progress in working with the private sector and slashing red tape. He had directed Commissioner Hahn to remove outdated rules and bureaucracy.
  5. He said they are working on antiviral therapies, clinical trials that he hopes to see scaled up for immediate delivery, and are looking at other drugs that have been approved abroad or may have been approved for other uses.
  6. He specifically identified the following drugs:
    1. Chloroquine and Hydroxychloroquine, which could be made available almost immediately, and
    2. Remdesivir, produced by Gilead.
  7. When asked if he could guarantee that federal support given to industry would not be used for executive bonuses or stock buyouts, the President said he is ok with conditions.
  8. The President said that they are specifically looking at a suggestion from the American Hospital Association that $100 billion not currently in legislation is needed to assist medical providers.
  9. When pressed about other protective gear being needed the President said governors are supposed to get it and that the federal government is doing what it can. He went on to report that Carnival Cruise line is willing to make ships available for medical use.
  10. The President was asked if there is any reason to disbelieve China’s claims of no new cases. He said he hopes it is true and it would have been much better if we knew sooner.
  11. He was asked if the Congress fails to act – or is unable to act because some members have tested positive for coronavirus, would he consider executive action. He replied he will continue to consider all options.
  12. He was also asked when can people get a test if they want one. He replied that people should not get a test if it is not needed.

Summary of the FDA Commissioner Hahn’s remarks and questions:

  1. Hahn said that FDA is working to approve drugs that are safe and effective. FDA has been working with CDC since early January.
  2. FDA is looking at everything coming across their desks, looking for the right drugs at the right dosages for the right people at the right time.
  3. FDA is looking at compassionate use, providing very speedy approvals when requested to get data that will be helpful in determining ultimate approvals.
  4. In the short-term FDA is looking at drugs approved for other indications. He cited Chloroquine as an example when the President directed him to look at drugs for expanded uses.
  5. He spoke about cross agency efforts such as convalescent plasma for potential benefits that could be brought out over the next weeks.
  6. He described these as a bridge to other therapies that will take 3 to 6 months to develop. They are looking to shrink what would otherwise take years into months.
  7. He spoke about Phase 1 vaccine tests taking 12 months, saying these other therapies bridge to that vaccine.
  8. In response to various questions from reporters, said he could not, by law, disclose when he expected FDA to approve Remdesivir, but that FDA is working with the company and he expects information will be released soon. He later said that Remdesivir is in clinical trials here and around the world, has been made available in compassionate use, and data regarding this usage and efficacy is being collected. When asked if there are any safety concerns since the drug is not going through the "normal" approval process and could cause potentially negative effects, Dr. Hahn said it is going through the normal process using FDA's internal processes to set up with the company the protocols to collect safety and efficacy data. This data will inform the decisions made about safety and efficacy.

Summary of the Vice President’s remarks and questions:

  1. The Vice President also spoke about the signing of the Family First bill and the expectation that the Senate is beginning work on an economic relief package.
  2. He said that the President and he will have a teleconference with governors later today from FEMA where they will say that FEMA will be taking the lead in the response program that will be “locally run, state managed, and federally supported.”
  3. Testing is now available in all 50 states. With the legislation signed last night States and private labs will be required to report testing and results to the CDC.
  4. We should expect an increase in the number of cases as testing comes online, but that should not be a cause for concern.
  5. Work continues to identify available supplies of needed items, including what is held in private stocks.
  6. He spoke about production of N95 masks by tens of millions. The liability protection provisions included in the Family First bill is an important achievement.
  7. Work is being done with health care providers and suppliers regarding ventilators. They have identified tens of thousands that can be converted to treat patients.
  8. Following a reporter’s question about CDC guidelines for masks including the potential use of bandanas, the Vice President said he visited 3M a few weeks ago regarding N95 masks. The company moved to full production in January, and these masks now can be sold as a result of the provisions in the Family First bill. The Administration is working with governors to have the hospitals in their states place orders. The federal stockpile will also reflect an increase.

Summary of Dr. Deborah Birx’s remarks and questions: (White House Coronavirus Response Coordinator):

  1. Birx said that they are moving through the testing backlog. Tests are being prioritized for those with symptoms. As a result, the testing positive rate is now at 10 to 11%.
  2. When looking at national data we should keep in mind that 50% of all data comes from 3 states. 50% of all data comes from 10 counties.
  3. She is grateful to the construction industry for their donation of supplies, i.e. masks.

Summary of Surgeon General Jerome Adams remarks and questions:

Dr. Adams said there is a need for blood donations, and that Millennials and Generation Z in particular should consider blood donations.

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