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What We’re Reading: Lab Tests Under Federal Oversight; TB Cases Rise; Drug Manufacturers Lose Price Negotiation Challenges

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Makers of medical tests will have about 4 years to show the FDA that their new offerings deliver accurate results; after previously decreasing for 27 years, US tuberculosis (TB) cases increased every year since 2020; a US district judge rejected a challenge by Bristol Myers Squibb and Johnson & Johnson to the Medicare drug price negotiation program.

FDA Brings Lab Tests Under Federal Oversight to Improve Accuracy, Safety

Under a new government rule, makers of medical tests will have about 4 years to show the FDA that their new offerings give accurate results, according to the Associated Press. The regulation finalized Monday will gradually phase in oversight of new tests developed by laboratories; the goal is to ensure that new tests are safe, accurate, and reliable. Most newly developed tests that pose a high risk have 3.5 years to be FDA approved, while lower-risk tests will have 4 years to obtain approval. The FDA already reviews tests and kits made by medical device manufacturers, but tests developed in-house have been able to be marketed without each one undergoing agency review. Also, although the tests currently on the market do not have to undergo federal review, both old and new lab tests will be required to register with the FDA and report problems or errors; FDA officials will use this information to target problematic tests.

US TB Cases Increased Every Year Since 2020, Report Says

A new CDC report showed that, after previously decreasing for 27 years, US tuberculosis (TB) cases increased every year since 2020, according to the Washington Post. According to the report, 9615 TB cases were recorded in the US last year. The CDC noted that this reflects a 16% increase in cases from 2022 to 2023, and it is the highest number of US TB cases since 2013. Also, the tally reflects increases in all age groups and among people born both in the US and elsewhere. However, the report found a larger increase in TB cases among those born outside the US compared with US-born individuals (18% vs 9%). Despite these recent increases, the CDC noted that TB incidence in the US is among the lowest in the world as it is most common among those living in low- and middle-income countries.

Drug Manufacturers Lose US Drug Price Negotiation Program Challenges

A US district judge on Monday rejected a challenge to the Medicare drug price negotiation program by Bristol Myers Squibb and Johnson & Johnson, according to Reuters. Blood thinners apixaban (Eliquis) from Bristol Myers Squibb and rivaroxaban (Xarelto) from Johnson & Johnson were among the first 10 drugs chosen under the drug price negotiation program. US District Judge Zahid Quraishi became the fourth federal judge to uphold the program, rejecting the drug manufacturers’ arguments that the program was an illegal taking of their property; Quraishi said that Medicare is not taking drugs from the manufacturers, and the manufacturers are free to stop participating in Medicare if they did not want to negotiate. However, Bristol Myers Squibb has already filed a notice in court that it is appealing the ruling, arguing that it is not feasible for drugmakers to withdraw from Medicare as it represents nearly half the US prescription drug market.

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