Tag Archives: FDA

FDA Push for MAT Means More Money for Big Pharma

Medication-Assisted Treatment (MAT), coupled with psychosocial counseling, is widely acknowledged to be the current “gold standard” of care in treating opioid addiction.

Currently, just three drugs exist to treat opioid use disorder: buprenorphine, methadone, and naltrexone. Adherence to the drugs is typically low, and addiction treatment experts have long said MAT is vastly underutilized, calling for expanded access to existing options and the development of more drugs beyond the existing three.

How effective is MAT for addiction? Here’s the science.

On Monday August 6th, the Food and Drug Administration announced a new policy in the way it evaluates drugs to treat opioid addiction that the agency says will give it more flexibility to approve new treatments.

FDA Commissioner Scott Gottlieb, since his appointment, has been a strong proponent of MAT.

Now, the agency will also consider factors like whether a drug could reduce overdose rates or the transmission of infectious diseases.

“We must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission,” FDA Commissioner Scott Gottlieb said in a statement.

The announcement is the latest in a string of efforts to improve the federal government’s response to the growing opioid crisis, which also includes legislation on Capitol Hill that aims to ensure treatment is evidence-based and, separately, to ensure more federal programs will pay for methadone treatment.

According to STAT News, the topic has also led to some controversy in Washington. The White House recently name-checked  a single drug, Vivitrol, a form of naltrexone manufactured by Alkermes, in a strategy document — preferential treatment that addiction experts said could hamstring doctors who should be able to consider all available treatment options.

The Senate is also expected to make MAT a key element of its response to the opioid crisis, but it remains unclear whether it will consider legislation on the opioid crisis prior to November’s midterm elections.

What We Are Reading This Week

Much thanks to the American Health Lawyer’s Association (AHLA), for compiling today’s news for us:

Trump Opioid Plan Explicitly Favors Alkermes’ Vivitrol Over Other Addiction Medications.

In covering the White House’s recent national strategy to address the opioid epidemic, STAT (3/26, Facher) reports that when Alkermes CEO Richard Pops testified before a White House commission on the opioid crisis in September, he “stressed the importance of increasing insurance coverage for Vivitrol [naltrexone], but added that patients should be made aware of all available treatment options.” Administration health officials “themselves expressed doubts about the approach,” but a White House spokesman later confirmed that the strategy document referred specifically to naltrexone in its injectable form, which is made only by Alkermes and marketed as Vivitrol.

Draft Legislation Would Bolster FDA’s Powers In Opioid Fight.

The Hill (3/26, Roubein) reports Senate Health Committee Chairman Lamar Alexander (R-TN) on Monday released draft legislation “aimed at bolstering the Food and Drug Administration’s (FDA) capacity to respond to the opioid crisis.” One of the draft bills “would let the FDA require drug manufacturers to package certain opioids in set doses, known as ‘blister packs,’” that would reduce the volume of opioids prescribed and be easier to dispose of. The Hill reports other draft legislation “would ensure the FDA can spend the $94 million included in the spending bill passed last week to upgrade equipment at the border, boost laboratory capacity and improve the infrastructure to better seize illegal drugs at the border,” including fentanyl.

The Washington Times (3/26, Howell) reports Alexander also said that the FDA should use the new funding to improve its coordination with US Customs and Borders Protection.

American Dental Association Backs Seven-Day Limits On Opioid Prescriptions.

CBS News (3/26, Strickler) reports on its website that according to new research (PDF) published Monday in the Journal of the American Dental Association, dental prescriptions for opioids have been rising while opioid prescriptions have been declining nationwide. The American Dental Association “has now released a new policy saying they now support statutory limits of seven days for dental opioid prescriptions,” limits not currently embraced by the American Medical Association, “which has so far resisted opioid prescription limits.”

The Hill (3/26, Roubein) reports the new research “shows that 6.4 percent of all opioid prescriptions were written by dentists in 2012, but that rates increased slightly from 2010 to 2015.” ADA president Joseph Crowley said in a press release, “This new policy demonstrates ADA’s firm commitment to help fight the country’s opioid epidemic while continuing to help patients manage dental pain.”

The AP (3/26, Tanner) reports dental opioid prescriptions grew slightly “despite evidence that ibuprofen and acetaminophen work just as well for most dental pain.” The AP reports that according to a study published in the same journal, dentists “are the leading prescribers of opioids for U.S. teens and the largest increase in dental prescriptions from 2010 to 2015 occurred in 11- to 18-year-olds.”

The Washington Examiner (3/26, Leonard) also reports.

ZOHYDROGATE: AND HERE COME THE ADDICTS

The FDA defied its own experts to approve a new prescription narcotic in a form almost certain to cause addiction and death from overdoses.

On October 26 the savvy investor’s website SeekingAlpha.com published the following remarkable comment about a new and highly addictive painkiller called Zohydro ER, which only the previous day had been approved for sale by the U.S. Food and Drug Administration despite consistent warnings – including from the FDA’s official advisory panel – that Z is potentially more addictive and dangerous than its sister opiate drug, the original and deadly OxyContin.

The full article can be read here:
http://www.thefix.com/content/zohydrogate-and-here-come-addicts?page=all