Apr 7, 2017

Gottlieb could speed up FDA drug approvals

J. Scott Applewhite / AP

Trump's nominee to head the FDA, Scott Gottlieb, has previously proposed a controversial plan: speed up the process for drug approvals under the agency and have politically appointed officials, not doctors, decide which drugs will be approved.

The inspiration: The European Medicines Agency — the European counterpart to the FDA — evaluates new drugs using "a body of politically appointed (and therefore politically accountable) officials, drawn from the European Commission." That means the FDA's European counterpart drug approval process exists outside the agency that evaluates them.

Why it matters: This plan could hurt the FDA's credibility, as drug approvals would become politically motivated by the appointed body Gottlieb proposed.

The FDA's drug approval process is already faster than the European Union's agency. Researchers found that the FDA took an average of 306 days to approve 170 drugs for marketing in the US, according to the New England Journal of Medicine. The European Medicines Agency spent an average of 383 days to approve 144 new drugs for marketing, the study found, so many are challenging the efficacy of Gottlieb's plan to change the review process in the US.

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Trump signs $2 trillion relief bill as U.S. coronavirus case count tops 100,000

Data: The Center for Systems Science and Engineering at Johns Hopkins; Map: Andrew Witherspoon/Axios

President Trump signed a $2.2 trillion coronavirus relief package on Friday, as infections in the U.S. topped 100,000 and more cities experience spikes of the novel coronavirus.

The big picture: The U.S. has the most COVID-19 cases in the world, exceeding China and Italy, per data from Johns Hopkins. A second wave of American cities, including Boston, Detroit, New Orleans and Philadelphia, are reporting influxes of cases.

Go deeperArrowUpdated 8 hours ago - Health

Coronavirus updates: Italy records deadliest day with nearly 1,000 dead

Data: The Center for Systems Science and Engineering at Johns Hopkins, the CDC, and China's Health Ministry. Note: China numbers are for the mainland only and U.S. numbers include repatriated citizens and confirmed plus presumptive cases from the CDC

Italy on Friday reported 969 COVID-19 deaths over a 24-hour period, marking the deadliest single-day for the country since the global outbreak began, according to data from the Health Ministry.

The big picture: The U.S. now leads the world in confirmed coronavirus cases, as the number of global cases nears 600,000. Governments around the world are trying to curb the medical and financial fallout of COVID-19, as infections surge across Europe and the U.S.

Go deeperArrowUpdated 8 hours ago - Health

Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 9 p.m. ET: 595,800 — Total deaths: 27,324 — Total recoveries: 131,006.
  2. U.S.: Leads the world in cases. Total confirmed cases as of 9 p.m. ET: 103,942 — Total deaths: 1,689 — Total recoveries: 870.
  3. Federal government latest: President Trump signed the $2 trillion coronavirus stimulus bill to provide businesses and U.S. workers economic relief.
  4. State updates: Nearly 92% of cities do not have adequate medical supplies — New York is trying to nearly triple its hospital capacity in less than a month.
  5. World updates: Italy reported 969 coronavirus deaths on Friday, the country's deadliest day.
  6. Business latest: President Trump authorized the use of the Defense Production Act to direct General Motors to build ventilators for those affected by COVID-19. White House trade adviser Peter Navarro has been appointed to enforce the act.
  7. 🏰 1 Disney thing: Both Disney World and Disneyland theme parks in the U.S. are closed until further notice.
  8. What should I do? Answers about the virus from Axios expertsWhat to know about social distancing.
  9. Other resources: CDC on how to avoid the virus, what to do if you get it.

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