Tag Archives: FDA

FDA seeking ‘right balance’ for opioid regulations

FDA seeking ‘right balance’ in regulating opioid prescriptions | BioPharma Dive By Rebecca Pifer Published July 10, 2018

Food and Drug Administration chief Scott Gottlieb reaffirmed in a statement Monday the agency’s commitment to finding the “right balance” between reducing the U.S. rate of opioid addiction and providing access to legitimate patients, for whom these medications can be lifesaving.

He had strong words for practitioners regarding their role in helping spur the opioid epidemic. “The roots of this crisis are embedded in the practice of medicine, and prescribing practices that were at times too cavalier,” Gottlieb said.

No, they are not. The “roots” of this crisis are the skyrocketing rates of addiction. And the problem is expanding much farther than just opioids, with use of and overdoses from drugs like meth and cocaine rising.  Continue reading

DEA Revises Opioid-Quota Rules Unchanged

DEA Revises Opioid-Quota Rules, Leaving Out Requested Change by Kerry Dooley Young – July 13, 2018

The Drug Enforcement Administration (DEA) will update its established procedures for setting production quotas for addictive drugs without heeding a recommendation from medical groups regarding shortages of injectable opioids.

The DEA on July 11 announced its final decision on changes to its regulations regarding aggregate production quotas (APQs), which it said were initially issued in 1971.

When a policy is close to 50 years old, it shouldn’t be revised or changed as much as thrown out entirely. So much more is known about medications and drugs in general than 50 years ago, it’s ludicrous that such old policies are still used at all.   Continue reading

FDA Finds Errors in Opioid Data, calls for quality review

FDA finds errors in its opioid sales data, calls for quality review – by Meg Tirrell | @megtirrell – May 16, 2018

The Food and Drug Administration says it’s found mistakes in opioid sales data provided by industry researcher Iqvia that led to an overestimation of the amount of prescription fentanyl being used in the U.S

This means that they assumed more of the fentanyl found on the streets and involved in overdoses was from prescriptions when instead it was illicit.

Because the larger number fed into the prevailing narrative that prescription opioids are fueling the “opioid crisis”, these numbers weren’t questioned closely.  Continue reading

FDA Acknowledges Suffering from Opioid Crackdown

FDA Head Acknowledges Suffering Caused by Opioid Crackdown – By Jacob Sullum|May. 15, 2018

Yesterday Scott Gottlieb, head of the Food and Drug Administration,acknowledged that the crackdown on pain pills, aimed at preventing nonmedical use, is hurting legitimate patients, some of whom have contacted his agency.

He announced a July 9 public meeting focusing on the concerns of people who use opioids to relieve chronic pain. The FDA is accepting public comments on the subject through September 10.   Continue reading

Patient-Focused Drug Development meeting with FDA

Patient-Focused Drug Development meeting with FDA – Twitter Conversation sent by Scott Gottlieb, the FDA Commissioner from:

Scott Gottlieb, M.D. @SGottliebFDA   
#FDA will be hosting a Patient-Focused Drug Development meeting July 9 to obtain patients’ perspectives on the impacts of chronic pain, views on treatment approaches and challenges or barriers to accessing treatments.

This sounds promising to me. It seems like big step forward for pain patients, for the FDA Commissioner to publicly acknowledge that we exist and that opioids are necessary for some of us… quite a daring move in today’s opiophobic political atmosphere. Continue reading

FDA, AAPM on Evidence-Based Opioid Prescribing

FDA, AAPM Open Talks on Evidence-Based Opioid Prescribing & Increased Naloxone Availability – April 13, 2018 – By Angie Drakulich

In a follow-up statement to an announcement by FDA Commissioner Scott Gottlieb, MD, the American Academy of Pain Medicine (AAPM) has issued its support for the development of evidence-based opioid prescribing guidelines.

The federal agency’s announcement seemed to mark a shift in approach from the 2017 declared opioid public health emergency and the administration’s “avoid opioids at all costs” mentality, not to mention its alleged temporary retreat from “evidence-based” medicine.

This implies a retreat from the CDC guidelines, thank goodness!   Continue reading

Request a Meeting on Drugs from FDA

I just found this interesting government web page, indicating that you can simply request a meeting with the FDA’s “Center of Medical Products and Tobacco” (an odd pairing) by filling out a short form online.

Meetings between stakeholders and the FDA’s Center for Drug Evaluation and Research (CDER) promote effective two-way communication to improve drug development and safety.

To submit your request for a meeting on drug-related topics, please click the Request a Meeting on Drugs button below and download the meeting request form to your desktop.   Continue reading

Patient Input to FDA Opioid Policy Committee

What is the Sound of One Hand Clapping? – National Pain Report – Feb 2018 – By Richard A Lawhern, Ph.D.

On January 30, 2018, I was one of ~40 speakers before an audience of over 200,  in public hearings of the US FDA Opioid Policy Steering Committee, at Silver Spring Md.  

The Committee is composed of eight FDA senior department heads and Center directors.  

For once, pain patients were allowed to participate, along with medical professional societies, healthcare technology corporations, and a few partisans intent on obstructing all access to opioid pain relievers.   Continue reading

FDA Wants Your Comments About Drugs

International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances;

Request for Comments

https://www.regulations.gov/document?D=FDA-2017-N-4515-0001

The Food and Drug Administration (FDA) is requesting interested persons to submit comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of 17 drug substances.   Continue reading

FDA sued for hiding info on expert panel members

FDA sued for hiding too much info about its expert panel members – STAT – By Ed Silverman @Pharmalot April 28, 2016

in a bid to learn more about the experts who advise the US Food and Drug Administration, a consumer advocacy group has gone to court to force the agency to disclose more information about the people whose opinions help determine the fate of numerous drugs and devices.

At issue is an agency practice to redact portions of the resumes submitted by the scientific and medical experts who serve on FDA advisory committees, according to a lawsuit filed on Wednesday by Public Citizen in a federal court in Washington.

The consumer group charged the redactions are “unlawful.”   Continue reading