The FDA Will No Longer Require Animal Testing for New Drugs

The FDA Will No Longer Require Animal Testing for New Drugs

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The Food and Drug Administration (FDA) will no longer require all drugs to be tested on animals, thanks to the FDA Modernization Act 2.0. The new law has everyone from Sen. Rand Paul (R–Ky.) to People for the Ethical Treatment of Animals (PETA) cheering.

The FDA Modernization Act 2.0 was passed as part of the omnibus appropriations bill that Congress passed in late December. “The inclusion of this bipartisan effort is a step toward ending the needless suffering and death of animal test subjects – which I’m glad both Republicans and Democrats can agree needs to end,” said Paul, who co-sponsored the bill with Sen. Cory Booker (D–N.J.), in a statement.

In addition to reducing animal suffering, the bill “will accelerate innovation and get safer, more effective drugs to market more quickly by cutting red tape that is not supported by current science,” Paul said.

Previously, all drugs in development were required to undergo animal studies before being tested in human trials. Now, drug companies will still have the option to start testing experimental drugs on animals, but they won’t have to.

This doesn’t mean that drug companies will start going straight to testing drug toxicity on humans, but that they may rely on alternative methods to animal testing. Language in the Federal Food, Drug, and Cosmetic Act now states that tests may “include animal tests, or non-animal or human biology-based tests methods, such as cell-based assays, micro physiological systems, or bioprinted or computer models.”

These days, “there are a slew of other methods that drugmakers employ to assess new medications and treatments, such as computer modeling and ‘organs on a chip,’ thumb-sized microchips that can mimic how organs’ function are affected by pharmaceuticals,” notes NPR.

The rule change eliminates “an archaic and debilitating government mandate for animal testing of experimental drugs,” said Wayne Pacelle, president of Animal Wellness Action and the Center for a Humane Economy.

A statement from PETA said the new law “signals a radical shift in the way drugs and treatments are developed.” It’s now pushing for the National Institutes of Health (NIH) “to get with the program” and stop conducting unnecessary experiments on animals. The group’s Research Modernization Deal calls on the NIH to “stop using animals in areas of research where we know this approach isn’t leading to treatments for humans” and “redirect public funding toward sophisticated, non-animal methods,” arguing that “reliance on animal models diverts funds from more promising areas of research and delays the development of effective drugs and treatments.”


FREE MINDS

From jokes to jail. “Humorless government agents have recently inflicted unlawful retaliation against harmless pranksters, and courts have shielded those agents from accountability,” warn Thomas Berry and Nicholas DeBenedetto in USA Today. The pair summarize recent cases of people arrested and jailed for parodying police or making jokes about them. Charges in one case were dropped; the man in the other case was eventually acquitted. “Both then sued to receive compensation for their ordeals,” note Berry and DeBenedetto:

But in both cases, the police raised the defense of qualified immunity, a judge-made doctrine that insulates government officials from liability for violating constitutional rights.

Plaintiffs can overcome qualified immunity only if they can identify a case with nearly identical facts as a precedent and prove that the constitutional right in question was “clearly established” at the time it was violated. In both cases, courts found that this bar was not met and denied relief.

First Amendment rights are, of course, very well-established, and many First Amendment cases have concerned humor and parody. These cases demonstrate yet again that practical limitations on qualified immunity are a joke. The doctrine has become a catchall to shield officers from any and all wrongdoing.


FREE MARKETS

Google defends Section 230, asks judge to dismiss antitrust case. Google parent company Alphabet filed a brief yesterday in Gonzalez v. Google, the upcoming Supreme Court case concerning Section 230, sometimes known as “the internet’s First Amendment.” It provides a good overview of why Section 230 was enacted and the problems it solves, as well as the case at hand:

In this case, petitioners contend that YouTube violated the Anti-Terrorism Act (ATA) by displaying ISIS videos to users watching similar videos. YouTube abhors terrorism and over the years has taken increasingly effective actions to remove terrorist and other potentially harmful content. But Section 230(c)(1) forecloses petitioners’ claims. YouTube provides a website that publishes third-party videos using algorithms to sort and list related videos that may interest viewers so that they do not confront a morass of billions of unsorted videos.

Petitioners now concede that Section 230(c)(1) bars their primary theory below: that YouTube violated the ATA by failing to remove all ISIS videos that users posted
in violation of YouTube’s policies. Section 230(c)(1) similarly bars petitioners’ remaining theory about YouTube displaying additional videos in a box labeled “Up next.” Petitioners do not allege any link between this aspect of YouTube and the Paris attack that is the focus of their claim. That aside, the claim “treat[s]” YouTube as the “publisher” of third-party ISIS videos because it faults YouTube for allegedly amplifying ISIS’s message by making ISIS-related videos easier to locate and view.

Petitioners and the government would gerrymander YouTube’s display of additional video recommendations out of Section 230(c)(1)’s scope. But the sorting and grouping of videos is quintessential publishing. Every website that displays third-party content must select and organize that content. If Section 230(c)(1) does not apply to how YouTube organizes third-party videos, petitioners and the government have no coherent theory that would save search recommendations and other basic software tools that organize an otherwise unnavigable flood of websites, videos, comments, messages, product listings, files, and other information.

Google summarizes its arguments in this blog post. Reason has more on the upcoming Supreme Court case here.

The company is also fighting another big court case right now, this one against the federal government and multiple states, which allege Alphabet broke antitrust law to maintain a monopoly on search and search advertising. “In December, Google asked Judge Amit Mehta of the U.S. District Court for the District of Columbia to dismiss both the antitrust case that the Justice Department filed in 2020 along with 11 states as well as a related complaint brought by 35 states led by Colorado,” notes Reuters. “The motions were sealed and redacted versions were filed on Wednesday.”

You can find the redacted versions here and here.


QUICK HITS

• Some good news: The United States’ cancer death rate fell by 32 percent between 1991 and 2019.

• The Office of the Director of National Intelligence’s report on “unidentified aerial phenomena”—a.k.a. UFOs—is out.

• Attorney General Merrick Garland has appointed special counsel to investigate the classified documents found at President Joe Biden’s home and office.

• Kentucky public school advocates are trying to stop a state law that makes it easier for charter schools to open.

• High school students in Georgia are suing for the right to wear Black Lives Matter clothing to school.

• Utah Walmarts are doing some deliveries by drone now.

• Western countries including the U.S., France, and Germany have started sending more intense weapons to Ukraine. “Now it looks likely that modern Western tanks will be added to the growing list of powerful weapons being sent Ukraine’s way,” reports The New York Times. “The Biden administration, leading the coalition of allies supplying Ukraine with weapons, is still holding back American-made M1 Abrams tanks…But American officials maintain they have never stood in the way of Germany or any other nation sending Western tanks to Ukraine.”



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The FDA Will No Longer Require Animal Testing for New Drugs

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