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Under [a bill offered by Sen. Ted Cruz,] ... the FDA would have to approve “life-saving” products for which is there an unmet medical need if those drugs or devices have already been endorsed in “trusted, developed countries,” including European Union member states, Canada, Israel, Australia, and Japan. ... To be sure, the FDA review process is not perfect. What is? But the agency is still considered the gold standard by which other regulators are measured. Rubberstamping an approval that was made in, say, Japan or Romania may speed access, but may not always ensure a medicine is safe or effective. (Ed Silverman, 12/21)

America's deadliest drug problem grew even deadlier last year, as overdose deaths from opioids hit a record 28,647, or 78 people a day. This epidemic is fueled as much by well-meaning doctors as it is by dope pushers. Overdoses of the most popularly prescribed legal painkillers, such as oxycodone and hydrocodone, accounted for more deaths last year than heroin, according to numbers released Friday by the Centers for Disease Control and Prevention. (12/21)

Prescription drug abuse and overdose is a tragic public health crisis, as is inadequately treated chronic pain. In addressing these two intertwined crises, we must avoid ameliorating one problem while worsening the other. Unfortunately, CDC’s proposed opioid prescribing guideline may not reach that goal. (Bob Twillman, 12/21)

As chair of the California State Assembly Health Committee, I believe that affordable, accessible and high-quality health care coverage is a right for everyone, not a privilege. Having true access to a doctor when you need one can improve, extend and even save one's life. California's implementation of the Affordable Care Act has brought us closer than ever to providing health care coverage to all over the past three years, but many of us still need to take the critical step and sign up for coverage through Covered California. (Rob Bonta, 12/21)

In November, Montana became the 30th state to extend healthcare coverage to low-income, working uninsured people. Last week, Michigan and the Centers for Medicare and Medicaid Services (CMS) entered into an agreement to continue its program that insures more than 600,000 people. Both states are led by Republicans. Medicaid expansion is not a partisan issue. ... Earlier this year, the debate on coverage between the Florida Senate and House of Representatives brought the 2015 legislative session to an impasse. Lawmakers have yet to agree on a solution, but Florida’s healthcare challenges aren’t going away anytime soon. (Julio Fuentes, 12/21)

I have been a pediatric neurologist for 40 years, and over the past five years, I have evaluated dozens of children for potential neurological complications of concussion. Most had no serious problems. Obviously, concussions are a real concern. But what’s also worrisome is that excessive fear of concussions may discourage parents and medical professionals from letting kids play healthy team sports. (Steven M. Rothman, 12/22)

A new survey finds that physician dissatisfaction with practice “has reached a tipping point with more than half of US physicians experiencing professional burnout.“ And this is bad news for patients: “Given the extensive evidence that burnout among physicians has effects on quality of care, patient satisfaction, turnover, and patient safety . . .There is an urgent need for systematic application of evidence-based interventions addressing the drivers of burnout among physicians. These interventions must address contributing factors in the practice environment rather than focusing exclusively on helping physicians care for themselves and training them to be more resilient.” (Bob Doherty, 12/21)

The US Congress also has expressed support for value promotion, with both the House and the Senate passing legislation requiring the Centers for Medicare & Medicaid Services to pilot test value-based insurance designs in Medicare Advantage plans (the private insurance plans that contract with Medicare to provide enrollees with health care benefits). Although advocates of value-driven health care may embrace the idea of value-based insurance designs, the proposed Medicare Advantage pilot is likely too asymmetrical to create many savings. The bills promote the use of high-value health care services without creating strategies to reduce the use of low-value ones. (Peter A. Ubel, 12/21)