Feb 20, 2019

Study: FDA, drugmakers let opioid misuse slide

Oxycodone pain pills. Photo: John Moore/Getty Images

Federal regulators and fentanyl manufacturers didn't take action when it became clear that highly potent fentanyl products were being inappropriately prescribed to as many as half of the patients taking them, according to a new study in the Journal of the American Medical Association.

How it works: The type of fentanyl in question is approved by the Food and Drug Administration only for adult cancer patents who have already built up a tolerance to less potent opioids.

  • An FDA monitoring program requires that all doctors, pharmacists and patients involved in prescribing, dispensing and using these drugs certify that they understand their proper use.
  • The FDA also requires manufacturers to demonstrate that they are in compliance with the rules.
  • In surveys by drugmakers, most doctors, pharmacists and patients indicated that they understood how these fentanyl drugs were supposed to be used, but some providers were prescribing them for off-label use anyways.

The bottom line: In 2016, drugmakers found that between 34.6% and 55.4% of patients receiving this kind of fentanyl did not have opioid tolerance, meaning the drug was being misused.

  • Despite this information, neither the FDA nor drugmakers took action to end the inappropriate prescribing.

Go deeper: Opioids app aims to lower response times for overdose victims

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Coronavirus dashboard

Illustration: Sarah Grillo/Axios

  1. Global: Total confirmed cases as of 7 p.m. ET: 5,682,389 — Total deaths: 354,944 — Total recoveries — 2,337,385Map.
  2. U.S.: Total confirmed cases as of 7 p.m. ET: 1,697,459 — Total deaths: 100,271 — Total recoveries: 391,508 — Total tested: 15,192,481Map.
  3. Public health: Fauci says data is "really quite evident" against hydroxychloroquine — Nearly half of Americans say someone in their household has delayed medical care.
  4. Business: African American business owners have seen less relief from PPP, Goldman Sachs saysDisney plans phased reopening on July 11Author Ann Patchett says bookstores are innovating to stay connected with customers.
  5. Tech: AI will help in the pandemic — but it might not be in time for this one.
  6. 1 🎶 thing: Local music venues get rocked by coronavirus.
  7. 🎧 Podcast: Trump vs. Twitter ... vs. Trump.
  8. What should I do? When you can be around others after contracting the coronavirus — Traveling, asthma, dishes, disinfectants and being contagiousMasks, lending books and self-isolatingExercise, laundry, what counts as soap — Pets, moving and personal healthAnswers about the virus from Axios expertsWhat to know about social distancingHow to minimize your risk.
  9. Other resources: CDC on how to avoid the virus, what to do if you get it, the right mask to wear.

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Updated 24 mins ago - Politics & Policy

Top Senate Democrat says State Dept. is working on new Saudi arms deal

Secretary of State Mike Pompeo briefs reporters on May 20. Photo: Nicholas Kamm/pool/AFP via Getty Images

Senate Foreign Relations ranking member Bob Menendez (D-N.J.) wrote in a CNN op-ed on Wednesday that he learned that the State Department is currently working to sell thousands of additional precision-guided bombs to Saudi Arabia.

Why it matters: Democrats say that Steve Linick, the State Department inspector general who was ousted on Secretary of State Mike Pompeo's recommendation, was investigating the administration's previous effort to sell weapons to Saudi Arabia without congressional approval.

U.S. coronavirus death toll crosses 100,000

Data: Johns Hopkins University; Chart: Danielle Alberti/Axios

More than 100,000 Americans have died of the coronavirus, according to data from Johns Hopkins — a terrible milestone that puts the death toll far beyond some of the most tragic events in U.S. history.

By the numbers: The death toll from COVID-19 now stands at more than 34 times the number of people who died on 9/11.