The FDA issued new generic drug guidance. Photo: Saul Loeb/AFP via Getty Images

The Food and Drug Administration is rolling out official guidance on how it expects pharmaceutical companies to behave when generic drugs are ready to enter the market — namely by all parties using a shared safety protocol.

The bottom line: The guidance is not legally enforceable. But FDA Commissioner Scott Gottlieb said the policies should discourage companies that make brand-name drugs from using a drug safety system to "block generic entry and help end some of the tactics that can delay access."

Driving the news: The FDA put out two draft documents Thursday outlining how the agency can become an arbiter in the process.

  • The first document outlines how the FDA could prod brand and generic companies to sit down and develop a shared safety system.
  • The second document explains how generic drug makers could get an FDA waiver from the shared system requirement, especially in cases where drug approval is being inappropriately delayed.

Go deeper: Earlier this month, the FDA posted a list of manufacturers that have impeded generic access to their brand-name products.

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Updated 10 mins ago - Politics & Policy

Coronavirus dashboard

Illustration: Aïda Amer/Axios

  1. Global: Total confirmed cases as of 4:30 p.m. ET: 21,295,429 — Total deaths: 767,714— Total recoveries: 13,295,750Map.
  2. U.S.: Total confirmed cases as of 4:30 p.m. ET: 5,345,610 — Total deaths: 169,146 — Total recoveries: 1,796,326 — Total tests: 65,676,624Map.
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  4. Education: "Historic" laptop demand leads to shortages ahead of remote school — Why learning pods aren't a panacea for remote learning — The COVID-19 learning cliff.
  5. States: New York to reopen gyms, bowling alleys, museums.
  6. Podcasts: The rise of learning podsSpecial ed under pressure — Not enough laptops — The loss of learning.

The COVID-19 learning cliff

Illustration: Aïda Amer/Axios

Perhaps the most jarring reality of the COVID-19 pandemic for families has been the sudden and dramatic disruption to all levels of education, which is expected to have deep social and economic repercussions for years — if not decades — to come.

Why it matters: As millions of students are about to start the school year virtually, at least in part, experts fear students may fall off an educational cliff — missing key academic milestones, falling behind grade level and in some cases dropping out of the educational system altogether.

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Why it matters: If you're the Trump administration, and you're in charge of the federal government, remember that a Pew poll published in April found the Postal Service was viewed favorably by 91% of Americans.