By Lauren Clason, CQ-Roll Call

WASHINGTON — The Food and Drug Administration on Monday finalized a rule to regulate most tests developed in a lab, in a move that observers expect will face legal challenges and prompt intervention from Congress.

The rule effectively reclassifies tests developed and performed in a lab as medical devices for the purposes of FDA regulation. It’s a controversial strategy, but in the wake of the testing debacle during the COVID-19 pandemic, the FDA is clearly done waiting for Congress to act.

FDA Commissioner Robert Califf has repeatedly made comments to that effect, saying in February, “I wish Congress had, I don’t know how to say it, done its job, whatever.”

“Rulemaking is — I’m sure you know — is limited in what we can do,” he said. “But it’s a start.”

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The rule aims to help verify the accuracy of various clinical tests that doctors develop and use in labs. Califf pointed to the variations he saw while helping relatives with cancer.

“It just really disturbs me that you can go to different cancer centers and get entirely different answers based on which version of the test they happened to use,” he said.

Under the rule, lab test developers would be required to apply for FDA approval, beginning with higher-risk tests and phasing in over four years.

Some types of tests would be exempt, and the agency opted to roll back the initial proposal in several ways. Tests currently on the market would be grandfathered in, for example, and tests used within an integrated health system, the Department of Veterans Affairs or the Department of Defense would also be exempt. The FDA would also exempt tests verified through New York’s validation program.

The agency noted that it could revisit the exemptions in the future.

Currently, lab procedures are mostly regulated by the Centers for Medicare and Medicaid Services, but CMS does not validate the accuracy of the tests themselves. The FDA typically regulates testing devices like those used at home for pregnancy or COVID-19.

The agency issued the final rule seven months after releasing the proposal in September.

Industry observers expect the rule to spur Congress to finally act. Capital Alpha Partners managing director Rob Smith wrote in a client note that the FDA’s wager “isn’t a bad bet.” Key lawmakers, such as House Energy and Commerce Chair Cathy McMorris Rodgers, R-Wash., and Senate Health, Education, Labor and Pensions Committee ranking member Bill Cassidy, R-La., indicated as much after the FDA made its proposal in September, releasing statements condemning the FDA’s move.

But the congressional outlook is increasingly uncertain as lawmakers who championed a legislative solution continue to retire. Richard M. Burr of North Carolina, the former top Republican on the Senate HELP Committee, who led a Senate bill that would have created a tailored, risk-based regulatory framework, retired from the Senate at the end of 2022.

And Rep. Larry Bucshon, R-Ind., who leads the current House version, is retiring at the end of this year, along with Rodgers.

The influx of tests is also certain to strain the FDA’s resources, though grandfathering in existing tests will help relieve that burden. The agency is receiving around $70 million less in appropriations for fiscal 2024 than fiscal 2023 amid record inflation. The agency initially expected to receive around 40,000 applications under the proposed rule, which some think is a low estimate.

Perhaps in preparation for the influx in applications, the FDA recently reclassified most tests previously considered to be high-risk, which would enable those developers to go through the 510(k) premarket notification pathway rather than the more stringent premarket approval pathway.

With all those changes, the FDA now expects to receive fewer than 3,000 test applications per year.

The FDA is also certain to face legal challenges from industry groups like the American Clinical Laboratory Association, which has been vocal in its belief that the agency lacks the authority to regulate them.

“FDA’s claim that it has authority to regulate laboratories in this way rests on an implausible assumption that the entire laboratory industry has been operating in violation of the FDCA [Federal Food, Drug and Cosmetic Act] for decades,” ACLA president Susan Van Meter said in written testimony to the Energy and Commerce Health Subcommittee in March, “and only now has FDA decided to act.”

©2024 CQ-Roll Call, Inc., All Rights Reserved. Visit cqrollcall.com. Distributed by Tribune Content Agency, LLC.

By ZEKE MILLER, JOSHUA GOODMAN, JIM MUSTIAN and LINDSAY WHITEHURST (Associated Press)

WASHINGTON (AP) — The U.S. Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug, The Associated Press has learned, a historic shift to generations of American drug policy that could have wide ripple effects across the country.

The DEA’s proposal, which still must be reviewed by the White House Office of Management and Budget, would recognize the medical uses of cannabis and acknowledge it has less potential for abuse than some of the nation’s most dangerous drugs. However, it would not legalize marijuana outright for recreational use.

The agency’s move, confirmed to the AP on Tuesday by five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review, clears the last significant regulatory hurdle before the agency’s biggest policy change in more than 50 years can take effect.

Once OMB signs off, the DEA will take public comment on the plan to move marijuana from its current classification as a Schedule I drug, alongside heroin and LSD. It moves pot to Schedule III, alongside ketamine and some anabolic steroids, following a recommendation from the federal Health and Human Services Department. After the public comment period and a review by an administrative judge, the agency would eventually publish the final rule.

It comes after President Joe Biden called for a review of federal marijuana law in October 2022 and moved to pardon thousands of Americans convicted federally of simple possession of the drug. He has also called on governors and local leaders to take similar steps to erase marijuana convictions.

“Criminal records for marijuana use and possession have imposed needless barriers to employment, housing, and educational opportunities,” Biden said in December. “Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs.”

The election year announcement could help Biden, a Democrat, boost flagging support, particularly among younger voters.

Biden and a growing number of lawmakers from both major political parties have been pushing for the DEA decision as marijuana has become increasingly decriminalized and accepted, particularly by younger people. A Gallup poll last fall found 70% of adults support legalization, the highest level yet recorded by the polling firm and more than double the roughly 30% who backed it in 2000.

The DEA didn’t respond to repeated requests for comment.

Schedule III drugs are still controlled substances and subject to rules and regulations, and people who traffic in them without permission could still face federal criminal prosecution.

Some critics argue the DEA shouldn’t change course on marijuana, saying rescheduling isn’t necessary and could lead to harmful side effects.

Jack Riley, a former deputy administrator of the DEA, said he had concerns about the proposed change because he thinks marijuana remains a possible “gateway drug,” one that may lead to the use of other drugs.

“But in terms of us getting clear to use our resources to combat other major drugs, that’s a positive,” Riley said, noting that fentanyl alone accounts for more than 100,000 deaths in the U.S. a year.

On the other end of the spectrum, others argue marijuana should be treated the way alcohol is.

Last week, 21 Democrats led by Senate Majority Leader Sen. Chuck Schumer of New York sent a letter to DEA Administrator Anne Milgram and Attorney General Merrick Garland arguing marijuana should be dropped from the controlled-substances list and instead regulated like alcohol.

“It is time for the DEA to act,” the lawmakers wrote. “Right now, the Administration has the opportunity to resolve more than 50 years of failed, racially discriminatory marijuana policy.”

Federal drug policy has lagged behind many states in recent years, with 38 having already legalized medical marijuana and 24 legalizing its recreational use.

That’s helped fuel fast growth in the marijuana industry, with an estimated worth of nearly $30 billion. Easing federal regulations could reduce the tax burden that can be 70% or more for businesses, according to industry groups. It could also make it easier to research marijuana, since it’s very difficult to conduct authorized clinical studies on Schedule I substances.

The immediate effect of rescheduling on the nation’s criminal justice system would likely be more muted, since federal prosecutions for simple possession have been fairly rare in recent years.

But loosening restrictions could carry a host of unintended consequences in the drug war and beyond.

Critics point out that as a Schedule III drug, marijuana would remain regulated by the DEA. That means the roughly 15,000 cannabis dispensaries in the U.S. would have to register with the DEA like regular pharmacies and fulfill strict reporting requirements, something that they are loath to do and that the DEA is ill equipped to handle

Then there’s the United States’ international treaty obligations, chief among them the 1961 Single Convention on Narcotic Drugs, which requires the criminalization of cannabis. In 2016, during the Obama administration, the DEA cited the U.S.’ international obligations and the findings of a federal court of appeals in Washington in denying a similar request to reschedule marijuana.

___

Goodman reported from Miami, Mustian from New Orleans. AP writer Colleen Long contributed.

Gov. Tim Walz announced the appointment of Elizabeth Bentley to an at-large seat on the Minnesota Court of Appeals on April 30, 2024. (Courtesy of the Office of Gov. Tim Walz and Lt. Gov. Peggy Flanagan)

Gov. Tim Walz named Elizabeth Bentley to an at-large seat on the Minnesota Court of Appeals in an announcement Tuesday.

Bentley fills a vacancy that will occur when Theodora Gaïtas takes a seat on the Minnesota Supreme Court.

“It is my honor to appoint Elizabeth Bentley to the Minnesota Court of Appeals,” said Walz in a statement. “Her appellate experience at all levels of our state and federal courts will make her a valuable asset to the judiciary. Her work in advancing and promoting Minnesotans’ civil rights through appellate advocacy demonstrates her deep understanding of the law and commitment to improving the common good.”

Bentley is the founder and director of the Civil Rights Appellate Clinic and a visiting assistant professor at the University of Minnesota Law School. She previously served as special counsel to U.S. Sen. Amy Klobuchar during the confirmation of Justice Ketanji Brown Jackson and as an attorney in the appellate practice group at Jones Day.

Bentley also served as law clerk to Sonia Sotomayor on the U.S. Supreme Court, the Honorable Robert A. Katzmann on the U.S. Court of Appeals for the Second Circuit, and the Honorable Jed S. Rakoff on the U.S. District Court for the Southern District of New York.

Bentley received her B.A. from Northwestern University and her J.D. from Harvard Law School.

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