By Alex Pearlman Dr. Jonathan J. Darrow, an expert on FDA policy and faculty member at Harvard Medical School, spoke with Bill of Health editor Alex Pearlman this week about the new so-called “Right to Try” law, how it is different from existing regulations, and why expanded access programs will never work without thinking about resources…
By James Love The Senate HELP committee held a hearing on June 12 on “The Cost of Prescription Drugs: Examining the President’s Blueprint ‘American Patients First’ to Lower Drug Prices” where Secretary Alex Azar was the sole witness. It was a moment for the Democrats in the Senate to draw a sharp contrast with…
By Stephen P. Wood The opioid epidemic and the toll it is taking is on American lives has resulted in the declaration of a public health emergency by the Trump administration. There were 42,000 deaths from suspected opioid overdose in 2016, more than in any previous year to date. These deaths illuminate the direct impact…
By Stephen Wood Naloxone is an opioid-receptor antagonist. In other words, it has the ability to displace an opioid from the receptor site, and essentially reverse its activity to save overdose victims. However, a significant increase in the cost of naloxone has put it out of reach of the people who need it most.
By Oliver Kim Happy World Trade Month! While health policy is often seen as something particularly domestic, trade can have an impact on health policy here at home. Just a day before President Trump’s speech outlining the administration’s approach to rising drug costs, the Pharmaceutical Research and Manufacturers of America (PhRMA) declared May as a…
By Jonathan J. Darrow Brand-name pharmaceutical manufacturers have long been known to try to protect and extend their market exclusivity periods by obtaining patents on a drug’s substance (“primary patents”) and also on its peripheral features, such as formulations or methods of manufacture (“secondary patents”). A new study describes an emerging phenomenon of “tertiary patents,”…
By Brian Barnett, via the Washington Post I’m an addiction specialist, and my voice-mail inbox is always nearly full. Some messages are from desperate individuals looking for outpatient treatment or help finding a detoxification program. Others are from patients needing a letter confirming their treatment for a child-custody dispute or care providers informing me that…
By Zack Buck In a 2-1 decision, a three-judge panel of the Fourth Circuit Court of Appeals has struck down Maryland’s pharmaceutical price-gouging law. The law, which went into effect on October 1 of last year, prohibited drug manufacturers from imposing “unconscionable” price increases, empowering the state attorney general to assess civil penalties against drug…
This new post by Nicholas Bagley and Rachel Sachs appears on the Health Affairs Blog. Although drug formularies are ubiquitous in Medicare and the private insurance market, they’re absent in Medicaid. By law, state Medicaid programs that offer prescription drug coverage (as they all do) must cover all drugs approved by the U.S. Food and Drug Administration,…
By Nadia N. Sawicki Loyola University Chicago’s nationally acclaimed Beazley Institute for Health Law and Policy is pleased to invite original research submissions for the annual Wiet Life Science Law Scholars Conference to be held on Friday, September 7, 2018. The conference is designed to provide an intellectual venue for life science professors, scholars, and…
