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Disparity found in analysis of practice data from CCGs (clinical commissioning groups) using First Databank’s prescribing decision tool...Drug and medical device knowledge company First Databank is urging GP practices to standardise their approaches to routine testing and monitoring of drugs, after its data revealed variance in compliance across key safety indicators for drug prescriptions...figures from analysis of...usage in 2018/2019 “suggest the need for prescribers to increase essential routine testing of clinical markers for patient harm from medications, and for more robust recording of test results into the primary care clinical system.”...READ MORE

Stephen Hahn, an oncologist and top official at the MD Anderson Cancer Center in Texas, is President Donald Trump’s choice to lead the Food and Drug Administration next...Hahn, who emerged in September as the frontrunner for the job, will replace acting commissioner Ned Sharpless, pending confirmation by the Senate...Trump chose a candidate whose resume differs notably from past FDA commissioners...READ MORE

Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Three members of the state’s dental occupational licensing board, plus two top staff members, have resigned from the board amid a scathing audit and sharp criticism from Gov. Steve Sisolak...Sisolak announced...during a meeting of the Executive Branch Audit Committee that three members of the board had resigned immediately, and that he had opted not to reappoint three board members whose terms ended in October...The board’s executive director and general counsel have also opted to resign their positions and will leave the board on December 5...Sisolak referenced “salacious and false accusations” made in an anonymous letter sent by dental board staff to a Las Vegas Review-Journal reporter yesterday suggesting unethical connections between Sisolak, his chief of staff and the Nevada Dental Association, a critic of the dental board...READ MORE

FDA’s Janet Woodcock testifies to Congress about the potential risks to US national security of the pharmaceutical industry’s reliance on Chinese imports...Democrats and Republicans alike have become increasingly concerned in recent years about the potential downsides of the tight integration of US and Chinese supply chains in multiple industries...in a recent Subcommittee on Health of the Committee on Energy and Commerce hearing, titled ‘Safeguarding Pharmaceutical Supply Chains in a Global Economy’...Janet Woodcock...was unable provide information to quell concerns about the negative implications of the reliance of the US pharmaceutical industry on Chinese manufacturing facilities...READ MORE

Artificial intelligence has become a crucial part of our technological infrastructure and the brain underlying many consumer devices....This progress has sparked the use of AI in drug discovery and development...Artificial intelligence can improve efficiency and outcomes in drug development across therapeutic areas...Misapplication of these technologies, however, can have unintended harmful consequences. To see how a good idea can turn bad, just look at what’s happened with social media...The FDA has already issued several proposals around the regulation of AI products, and it now has an opportunity to build on these efforts. The Center for Devices and Radiological Health has reviewed and cleared a number of devices that use AI. The center has also released a proposed framework, “Artificial Intelligence and Machine Learning in Software as a Medical Device.” These proposals, though, don’t necessarily apply to AI-based tools used as part of the drug development process. As a result, biopharmaceutical and technology companies aren’t sure how these tools fit into current regulatory frameworks..READ MORE

Gov. Steve Sisolak last week took a small step toward dealing with Nevada’s rogue dental regulatory board. Let’s hope he doesn’t stop there...He should also consider a re-evaluation of all the state’s licensing boards, which too often function as protectionist entities more concerned with shielding existing interests than with promoting competition and public health and safety. The dental board is hardly the only problem...Last week, for instance, Gov. Sisolak revealed that the state Board of Pharmacy for more than a decade has often failed to conduct the required background checks of drug wholesalers. Last year, a report presented to the state executive audit committee cited numerous oversight issues with the more than three dozen occupational regulatory boards operating at the state level...READ MORE

Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network

After more than a year of controversy, the federal government filed a lawsuit accusing Gilead Sciences of infringing patents on a pair of HIV prevention pills and unfairly reaping hundreds of millions of dollars from research funded by taxpayers...The patents are held by the Centers for Disease Control and Prevention, which helped fund academic research into HIV prevention that later formed the basis for a pair of pills — Truvada and Descovy — that are sold by the drug maker. The Department of Health and Human Services contended that Gilead refused to reach a licensing agreement despite “multiple attempts” at reaching a deal. “Gilead’s conduct was malicious, wanton, deliberate, consciously wrongful, flagrant, and in bad faith,” the suit states...READ MORE