FDA approves

By Geoff Mulvihill Associated Press

The U.S. Food and Drug Administration on Wednesday approved selling the leading version of naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.

It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.

Here’s a look at the issues involved.

IS NARCAN?

WHAT

The approved nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the bestknown form of naloxone. It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.

Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.

The drug has been distrusted to police and other first responders nationwide.

Car son Carson

From 3 question who gets to determine who and what are dope and whether any university can produce expertise on the people who created hip-hop.

While I was initially met with considerable resistance for my work at Clemson, the university eventually became supportive and touted “a dissertation with a beat.”

Clemson is not the only school to recognize hip-hop as dope.

In the 50 years since its start at a back-to-school party in the South Bronx, hiphop, the culture and its art forms have come a long way to a place of relative prominence in educational institutions.

Since 2013, Harvard University has housed the Hiphop Archive & Research Institute and the Nasir Jones Hiphop Fellowship that funds scholars and artists who demonstrate “exceptional scholarship and creativity in the arts in connection with Hiphop.”

UCLA announced an ambitious Hip Hop

Advocates believe it’s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.

The decision “represents a decisive, practical and humane approach to help people and flatten the curve of overdose deaths,” said Chuck Ingoglia of the National Council for Mental Wellbeing, in a statement.

WHAT DOES THE FDA APPROVAL MEAN?

Narcan will become available over-the-counter by late summer, the company said.

Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.

Several manufacturers of generic naloxone that’s made similarly to Narcan will now be required to file applications to switch their drugs over the counter as part of a requirement by the FDA.

The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, already has an application before the FDA to distribute its version of spray naloxone without a prescription.

HOW IS NALOXONE DISTRIBUTED NOW?

Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it.

But not every

Initiative to kick off the golden anniversary. The initiative includes artist residencies, community engagement programs, a book series and a digital archive project.

Perhaps my receiving tenure and promotion at the University of Virginia is part of the school’s attempt to help codify the existence of hip-hop scholarship.

When I write about “dope,” I’m thinking of Black people like drugs to which the U.S. is addicted.

Dope is a frame to help clarify the attempts, throughout American history, at outlawing and legalizing the presence of Black people and Black culture. As dope, Black people are America’s constant ailment and cure.

To me, dope is an aspiration and a methodology to acknowledge and resist America’s steady surveillance, scrutiny and criminalization of Blackness.

By this definition, dope is not only what we are, it’s also who we want to be and how we demonstrate our being.

Dope is about what we can make with what we are given.

Dope is a product of conditions created by list price, so they make more money by forcing consumers to buy higher-priced drugs. And because they control the drug formularies, they can restrict access to lower-priced generics and have, in fact, done so.

Let’s say the Minnesota legislature passes legislation that creates a prescription drug affordability board with the power to impose state price controls on prescription drugs. What they don’t tell you is that they can’t guarantee those lower prices will mean improved affordability for the consumer because we don’t buy medicines directly from the drug manufacturers. The insurance companies and the PBMs will reap those savings and there is no requirement that they pass them on to the consumer at the pharmacy counter. What the legislature is doing can’t be called a prescription drug affordability bill or a bill to address health disparities in our state. It’s simply a bill that will further enrich health insurers and PBMs.

If state lawmakers are serious about reducing our glaring health disparities and making quality care more accessible for all Minnesotans, then they should pursue actions that will make an actual difference: Force PBMs and insurers to share the savings they negotiate with consumers. Prevent them from using their formularies to restrict access to affordable generics and biosimilars. And stop the pernicious practice of some insurers that don’t allow lowincome people to apply thirdparty patient assistance payments toward their out-of-pocket cost sharing requirements. Minnesota can boast that it has some of the best health care and healthiest citizens in the United States. Beneath those simple headlines, though, is complex reality in which some of our citizens are living sicker lives and dying too early. We can fix this, but it’s going to require our lawmakers to pursue more realistic, impactful solutions than the ones that are currently being deliberated.