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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.

Go deeper

Updated 19 mins ago - Politics & Policy

Harris breaks tie as Senate proceeds with lengthy debate on COVID relief bill

Photo: Caroline Brehman/CQ-Roll Call, Inc via Getty Images)

The Senate on Thursday voted 51-50 — with Vice President Kamala Harris breaking the tie — to proceed to debate on President Biden's $1.9 trillion coronavirus rescue package, likely setting up a final vote this weekend.

The state of play: Sen. Ron Johnson (R-Wis.) forced Senate clerks to read the entire 628-page bill on the floor, which took nearly 11 hours and lasted until 2:05 a.m. Friday. The Senate then adjourned and is expected to reconvene at 9 a.m. to debate the bill before considering amendments.

1 hour ago - Health

Cuomo advisers reportedly altered July COVID-19 nursing homes report

New York Gov. Andrew Cuomo. Photo: Seth Wenig/AFP via Getty Images

New York Gov. Andrew Cuomo's advisers successfully pushed state health officials to exclude certain data on the number of COVID-19 nursing home deaths from a July report, the Wall Street Journal reported late Thursday.

Why it matters: The changes resulted in a "significant undercount of the death toll attributed to the state’s most vulnerable population," the WSJ wrote.

Ro Khanna wary of Biden approach on Middle East

Rep. Ro Khanna. Photo: Cody Glenn/Sportsfile for Web Summit via Getty Images

An outspoken progressive Democrat is wary of President Biden’s approach to the Middle East, arguing it’s like “conceding defeat of the aspiration” to win a Nobel Peace Prize.

Why it matters: A number of members of Biden’s own party dislike his Middle East strategy, as his administration signals the region is no longer the priority it was for President Obama and his predecessors.