What We're Reading: Faulty Drugs; Biosimilar Awareness; Maine Implements Medicaid

A review of thousands of FDA inspection records, recalls, warning letters, and lawsuits showed how drugs that are poorly manufactured or contaminated can reach patients; biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice; Maine’s new Democratic Governor, Janet Mills, ordered the state to implement Medicaid expansion with an executive order, calling for state health officials to make the necessary changes and work with the Trump administration.

Review of FDA Documents Shows How Faulty Drugs Reach Patients

A review of thousands of FDA inspection records, recalls, warning letters, and lawsuits by Kaiser Health News Service showed how drugs that are poorly manufactured or contaminated can reach patients. FDA inspectors may find it easy to miss things because they’re working with confusing regulatory terms and standards that are often decades out of date, an industry consultant told Kaiser. Since 2013, drug companies have recalled about 8000 medicine. The flawed products contained everything from dangerous bacteria or tiny glass particles to mold or too much or too little of the drug’s active ingredient. Over the same period, 65 drug-making facilities recalled nearly 300 products within 12 months of passing an inspection.

Lack of Awareness of Potential of Biosimilars Hindering Adoption in US, Europe

New Maine Governor Issues Order Implementing Medicaid Expansion

Biosimilars have the potential to deliver substantial savings to the healthcare system, but only insofar as they are adopted and used in clinical practice, The Center for Biosimilars® reported. A recent review examining US and European healthcare provider knowledge, perceptions, and prescribing behaviors related to biosimilars found that providers are still taking a cautious approach, due partly to a lack of awareness. The review was conducted by researchers from the University of North Carolina at Chapel Hill and Premier, Inc, and relied on data from 20 surveys. Maine’s new Democratic Governor, Janet Mills, ordered the state to implement Medicaid expansion with an executive order, calling for state health officials to make the necessary changes and work with the Trump administration. The Hill reported that the state Department of Health and Human Services was orderred to work with lawmakers to provide "sustainable" funding for Maine's share of Medicaid expansion. Maine was the first state to approve expansion in 2017, but former GOP Governor Paul LePage blocked the ballot measure from taking effect.