Author: Peter

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

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

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

The U.S. biopharmaceutical industry depends on predictable and reliable intellectual property protections, including patents, to maintain its role as the global leader in biopharmaceutical innovation. While these strong IP protections promote innovation and pave the way for the research and development of new medicines for patients, they also have a tremendous impact on the U.S. economy...Here is a snapshot of the industry’s significant economic footprint in the United States, by the numbers:...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.

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

Walgreens retail clinic business has been floundering. Last week, Walgreens announced that it would shut the last of its in-house retail clinics and in favor of outsourcing clinic operations to hospitals and health systems...Other retailers are investing in more expansive healthcare services to realize the promise of store-based healthcare. That’s one reason why CVS Health is rolling out its HealthHUBs, while Walmart is phasing out its traditional retail clinics in favor of a more comprehensive Walmart Health offering...Many large retail chains operate clinics, but their strategies and growth rates differ. I expect the traditional retail clinic model to fade in favor of locations with broader healthcare services. This new direction will put pharmacies in more direct competition with urgent care clinics and primary care providers...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