Regulatory Issues

FDA Hearing Explores Competition & Innovation in Biosimilars

September 7, 2018

When it comes to how to increase the development and utilization of biosimilars, the Food and Drug Administration is all ears.  On Tuesday, the agency welcomed numerous physicians and experts to testify on competition and innovation in the biosimilars marketplace.  And at least one physician identified a critical component in uptake: physician confidence.

Summer 2018: A Health Policy Recap in 10 Quotes

August 30, 2018

Patient access developments didn’t stop for summer.  As we head into fall, here are 10 quotes from the news items – and new materials – that kept the health policy conversation lively during summer 2018.

Will Reforming Medicare Billing Rules Benefit Patients?

August 22, 2018

Last month, the federal government proposed changes to Medicare’s billing rules.  The net effect: Doctors will spend less time with their patients. As a physician myself, I know that’s not necessarily a good thing.

Are “Bad Drug” Ads Bad for Patients?

August 16, 2018

Some 2 million Americans take blood thinners.  Nearly 30 million have diabetes. Tens of thousands more treat heartburn or cancer with medication prescribed by their doctor.  Chances are, these patients’ attention piques when they hear the medicine they take followed by “medical alert” or “warning” blaring from their television.  Many, including senior citizens, might even abandon their prescribed medicines out of fear.

The Importation Question

July 24, 2018

To import, or not to import?  The question of whether to bring foreign, lower-priced versions of prescription drugs to the United States is back.  

The Crossroads of Clinical Trials and Social Media

July 3, 2018

What can America learn at the crossroads of social media and clinical trials? At a recent National Institutes of Health workshop, one organization had a clear answer: powerful methods for heightening clinical trials awareness.

Is Innovation the Answer to America’s Opioid Epidemic?

June 22, 2018

The Food and Drug Administration has approved two generic versions of an innovative drug to treat opioid addiction, increasing available treatment options for Americans fighting addiction.  The move underscores a growing realization among policymakers, regulators and industry: to address the opioid crisis, innovative solutions must be readily available.

What President Trump’s Drug Pricing Plan Means for Cancer Patients

June 1, 2018

As the global cancer community convenes for the annual meeting of the American Society of Clinical Oncology, one question looms large: What will President Donald Trump’s blueprint to lower drug prices mean for patient access?  Especially for cancer patients, who may take several medications or live on a fixed income?