State Rep. Harrison in Wall Street Journal: Fighting to Protect Texans from FDA’s Illegal Lab-Test Power Grab


Texas must stop unelected FDA bureaucrats from exercising authority over Americans, especially when their actions are illegal under Federal Law

Texas Insider Report: AUSTIN, Texas Rep. Brian Harrison filed House Bill 1023 to protect Texas laboratories from harmful and illegal regulations by the U.S. Food & Drug Administration (FDA) and make Texas the best prepared state to detect future pandemics by explicitly banning FDA from requiring premarket review of laboratory developed tests (LDTs). 

He explains the need for this bill in an OpEd published in today’s Wall Street Journal (see article in its entirety below,) that he co-authored with former HHS General Counsel Bob Charrow. 


“Constitutional limits on government power are being eroded.  Texas must stop allowing unelected FDA bureaucrats to exercise authority over us, especially when their actions are illegal under federal law.  I’m proud to file a bill that would make Texas the best – and possibly only – state prepared to detect the spread of future pandemics.

"Without this bill, Texas lives may be needlessly placed at risk,”
 says Harrison.

On January 31, 2020, the U.S. Department of Health & Human Services (HHS), which oversees the FDA, declared a Public Health Emergency for COVID-19 to maximize the Department’s flexibility in responding to the pandemic by removing as much regulatory red tape as possible. Unbeknownst to HHS leadership, the FDA went the exact opposite direction and created a new regulatory barrier by requiring laboratories – including some of the most prestigious academic medical laboratories and public health laboratories – seek FDA authorization before testing for COVID-19.

As has been well documented at this point, this illegal regulatory overreach effectively banned COVID-19 testing in the United States in the crucial early days of the pandemic. 

Key provisions:
  • FDA cannot regulate the activities of a state.  To provide maximum protection, the bill deems all Texas laboratories performing LDTs to be agencies of the state for purposes of FDA regulation during a Public Health Emergency. 
  • To protect against new state-level regulatory requirements, the bill prohibits any state agency from exercising additional authority, beyond those already in place, on the laboratories. 
  • FDA also does not have the authority to regulate activity that is purely intrastate.  The bill clarifies and deems by statute LDTs to be intrastate activities. 
Link to WSJ OpEd here.

 

The FDA’s Lab-Test Power Grab

The agency assumed the power to shut down early Covid testing. Now it wants Congress to formalize it.

Most Americans have never heard of “laboratory developed tests.” Yet they are at the center of a bureaucratic turf war that could harm millions of Americans and leave the country less prepared for future pandemics.

LDTs are medical laboratory tests made and used in a single laboratory to assess human specimens such as blood or saliva. They help answer questions such as whether a proposed course of chemotherapy will work on a specific patient’s cancer or whether someone with a cough has Covid-19. Most tests consumers are familiar with aren’t LDTs but commercial tests sold to laboratories by medical-device manufacturers.

The Food and Drug Administration has been lobbying Congress to pass the Verifying Accurate Leading-Edge IVCT Development Act, Valid for short, which would give the agency regulatory authority over LDTs. There is also an effort under way by the FDA and other special interests to sneak the legislation into an omnibus spending bill.

But Congress would be remiss if it ignores the lessons learned during the response to Covid-19, which demonstrated the harm of policies that this act would codify.

We both were involved in preparing the federal Covid-19 public-health emergency declaration. When it was signed on Jan. 31, 2020, the intent was to cut red tape and maximize regulatory flexibility to allow a nimble response to an emerging pandemic.

Unknown to us, the next day the FDA went in the opposite direction: It issued a new requirement that labs stop testing for Covid-19 and first apply for FDA authorization.

At that time, LDTs were the only Covid tests the U.S. had, and many were available and ready to be used in labs around the country. But since the process for emergency-use authorization was extremely burdensome and slow—and because, as we and others in department leadership learned, it couldn’t process applications quickly — many labs stopped trying to win authorization, and some pleaded for regulatory relief so they could test.

Through this new requirement the FDA effectively outlawed all Covid-19 testing for the first month of the pandemic when detection was most critical. One test got through—the one developed by the Centers for Disease Control and Prevention—but it proved to be one of the highest-profile testing failures in history because the entire nation was relying on the test to work as designed, and it didn’t.

When we became aware of the FDA’s action, one of us (Mr. Harrison) demanded an immediate review of the agency’s legal authority to regulate these tests, and the other (Mr. Charrow) conducted the review. Based on the assessment, a determination was made by department leadership that the FDA shouldn’t be regulating LDTs.

Congress has never expressly given the FDA authority to regulate the tests. Further, in 1992 the secretary of health and human services issued a regulation stating that these tests fell under the jurisdiction of the Centers for Medicare and Medicaid Services, not the FDA. Bureaucrats at the FDA have tried to ignore this rule even though the Supreme Court in Berkovitz v. U.S. (1988) specifically admonished the agency for ignoring federal regulations.

The Valid Act is a bureaucratic solution in search of a problem. A review of all reported cases in state and federal courts reveals no reported suits filed against a laboratory for an LDT result. The absence of any personal-injury suits is extraordinary in our highly litigious society and attests to the safety and efficacy of these tests.

The FDA’s own actions prove there is no need for additional regulation. While for decades it has claimed jurisdiction to regulate LDTs, up until we declared the public-health emergency, the FDA opted not to do so. Unfortunately for the U.S., the FDA couldn’t help itself and declared that it would begin regulating all LDTs for Covid-19 the moment a public-health emergency was declared.

While we stopped the FDA from regulating these tests in 2020, the Biden administration demonstrated its disregard for federal law and zeal for harmful federal regulations last November by allowing the FDA to resume regulation of LDTs.

FDA Commissioner Robert Califf recently threatened Congress that if it doesn’t enact the Valid Act, he will simply take the authority by regulation. Congress must not bend to this threat. There is no demonstrated need for the Valid Act other than to further enlarge the FDA’s jurisdiction. When speed and flexibility are paramount, a large bureaucracy shouldn’t be in charge.

If Congress gives the FDA authority to enforce needless regulatory hurdles for laboratory developed tests, it would make the U.S. less prepared for future pandemics by preventing America’s best laboratories from detecting the spread of new pathogens. Would you rather rely on laboratory testing from the CDC or from laboratories at Harvard, Stanford and Texas A&M University?

The Valid Act could literally cost lives, and it should be rejected.

Mr. Harrison is a Texas State Representative. He served as Chief of Staff at the U.S. Department of Health & Human Services from 2019-2021. Mr. Charrow served as HHS General Counsel from 2018-2021.














 

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