Tag Archives: FDA

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

FDA Endorses Biased and Unscientific CDC Opioid Guidelines

FDA Endorses CDC Opioid Guidelines | February 04, 2016 | By Pat Anson, Editor

In a move that may have more to do with politics than healthcare, the U.S. Food and Drug Administration has set aside the advice of its own experts by endorsing the CDC’s controversial guidelines for opioid prescribing

The move is part of several sweeping changes the FDA is making in its opioid policies, including some that the agency has resisted in the past.

The most significant change is support for the CDC’s proposed opioid guidelines, which are designed to combat the so-called epidemic of opioid addiction and overdoses.

“We are determined to help defeat this epidemic through a science-based and continuously evolving approach,” said Dr. Robert Califf, FDA Deputy Commissioner for Medical Products and Tobacco.

This sounds silly, considering how little science has been involved comment by Zyp Czyk

In a news release issued late Thursday, Califf said FDA would

“re-examine the risk-benefit paradigm for opioids,”

Who’s risk-benefits? Mr. Califfs? Mine? That ratio is highly dependent on the individual, yet they intend to make all opioid therapy standard, even though they claim to want individualized medicine. What hypocrites!

use tougher language in warning labels on extended release opioids, and

I can’t imagine abusers and addicts reading the label, much less caring what it says.

prioritize development of non-opioid alternatives for pain.

However, until that happens we will still need opioids for pain.

The FDA also promised to convene an expert advisory committee before approving any new drug applications for opioids that do not have abuse deterrent properties, one of Manchin’s key demands.   

This statement is heavily focused on the potential harms of opioids.

Though it says they will seek to balance individual and societal risks, it seems that the need to prevent people from making poor choices will be given priority over providing care to individual pain sufferers for whom opioid therapy has proven to be an essential element of care

The FDA’s opioid policy changes are further outlined in a “special report” in the New England Journal of Medicine that was co-authored by Califf.

“Accordingly, we are supporting the CDC’s Guideline for Prescribing Opioids for Chronic Pain. The draft guideline received extensive public comment, and we look forward to participating in the process when the CDC finalizes it soon.

We are also supporting the Surgeon General’s efforts to engage the clinical community in a concerted approach to curbing inappropriate prescribing and proactively treating opioid addiction, while reinforcing evidence-based approaches to treating pain in a manner that spares the use of opioids.

Until clinicians stop prescribing opioids far in excess of clinical need, this crisis will continue unabated.”

Who’s clinical need? It doesn’t make sense to force a subjective factor into some arbitrary standard.

“I think we need to recognize that CDC wants to substantially limit opioid prescribing. Period,” said Sharon Hertz, director of the FDA’s Division of Anesthesia, Analgesia and Addiction Products, at a December meeting of a federal pain research panel.

Hertz said the evidence cited to support the guidelines was “low to very low and that’s a problem.” Other panel members said they were “appalled” by the guidelines, calling them an “embarrassment to the government.”

“I guess it shouldn’t surprise me that the FDA is selling out by endorsing the CDC guidelines,” said Kim Miller, a pain sufferer and patient activist.

“Could it be the FDA was not wanting to be made to look irrelevant in light of the CDC taking care of what many see as the FDA’s territory? Either way, it’s an extremely gloomy looking horizon if you’re a pain patient. Just when you think it can’t get any worse, it always does.”

“It is a sad day for chronic pain patients in this country. The unintended consequences of these guidelines will bring about a true epidemic; not the media manufactured so-called epidemic of overdoses from opioids,” said Chrystal Weaver, a Florida woman who suffers from Complex Regional Pain Syndrome.

“The last figure I heard quoted for veterans taking their life is around 42 per day. When you take away the only tool we have to help lessen the pain from war injuries you’ll see that number skyrocket   

FDA on Opioid Controversy – Where’s The Patient?

FDA Enters Opioid Controversy – Where’s The Patient? – National Pain Report

According to the email the FDA distributed Thursday night, “the plan will focus on policies aimed at reversing the (opioid) epidemic, while still providing patients in pain access to effective relief.”

Already, chronic pain advocates are asking one question: “What is the patient’s role in this action plan?”

Terri Lewis, Ph.D., who studies how the U.S. health care system treats chronic illness like chronic pain, was characteristically blunt.

“What’s missing? Once again, no patient voice,” she told the National Pain Report.   Continue reading

Update: Fluoroquinolones Antibiotic Alert – especially with EDS

The reports of damage from Fluoroquinolone Antibiotics keep escalating:

Some blame certain antibiotics for devastating side… | www.wsoctv.com | April 27, 2015

Some patients and doctors are blaming popular antibiotics for devastating side effects, including

  • ALS/ Lou Gehrig’s disease,
  • Alzheimer’s disease,
  • Parkinson’s disease,
  • and even death.

Fluoroquinolones

These kind of antibiotics are called “fluoroquinolones.”  They’re prescribed for a variety of serious bacterial infections.  Some of the more well-known generics include Ciprofloxacin and Levofloxacin, and the brand name examples include Cipro and Levaquin.  Continue reading

New NIDA DrugFacts: Is Marijuana Medicine?

DrugFacts: Is Marijuana Medicine? | National Institute on Drug Abuse (NIDA)  Revised April 2015

This new web page on NIDA’s website directly contradicts its previous page, DrugFacts: Marijuana.  But instead of taking the older page down, not only has it been left in place, but the articles even link to each other.

Only a schizophrenic could hold both positions simultaneously:

  • The old one says marijuana causes mental illness, the new one says it can be used to treat mental illness.
  • The old one says marijuana is addictive, the new one says it can be used to treat addiction.

The older version (updated the same time as the new one) is using words like “can” or “may” when stating outdated facts. I don’t have a copy of an earlier version of the old page, but I suspect these words were added when the new article was posted.

Below is info from this new page:  Continue reading

Pain Patients Being Denied Legitimate Prescriptions

Are Pain Patients Being Denied “Legitimate Prescriptions?” – National Pain Report

A month ago, the National Pain Report asked if the news media was missing the point on the pain medication story. We quoted two leaders, one doctor and one researcher, as saying that the chronic pain patient’s need for medication and society’s need to combat narcotic pain medicine abuse are separate, but may be conflated in a way that is hurting some people in pain.

Brett Connolly has been looking into whether legitimate pain patients are being denied prescriptions and his reporting shows how complex the problem is.

Neither the Food and Drug Administration nor the Drug Enforcement Administration took responsibility for legitimate pain patients being denied prescriptions.  Continue reading

What happened to keeping politics away from science?

Drugwonks | For an Opioid Non-Interference Clause

What happened to keeping politics away from science?

Some fine legislators in the World’s Greatest Deliberative Body — Senators Joe Manchin (D/WVA), David Vitter (R/LA), Shelly Moore Capito (R/WVA) and Tim Kaine (D/VA.) — have just introduced the so-called FDA Accountability for Public Safety Act.So-called, because these fine legislators do not seem to understand that there is no such thing as a drug that is 100% safe.

the legislation would require the FDA to hold advisory committee meetings for all opioids under review and submit a report to Congressional committees explaining why the agency approved an opioid against an advisory committee’s vote, including scientific evidence related to patient safety.   Continue reading

The FDA Process for Approving Generic Drugs

Online Training Seminar: “The FDA Process for Approving Generic Drugs” – Presentation Transcript

A generic drug has to have

  • the same active ingredient(s),
  • the same route of administration,
  • the same dosage form (tablet, capsule or injectable), and
  • the same strength, and
  • the same conditions of use when compared to its reference listed drug or corresponding brand name product.

Chemistry is an important aspect of the generic product review.  The chemist looks at the components, composition of the generic product, to make sure that the formulation is stable and in compliance with our regulations and standards.

The chemist looks at all the manufacturing and controls of the product, carefully reviews the batch formulation and records, and the description of the facilities to make sure they are in compliance with good manufacturing practices.  

However, since so many generics and their ingredients are produced overseas, it’s impossible for the FDA to conduct such a detailed inspection of all global suppliers (and at repeated intervals, to make sure that conditions haven’t deteriorated, as they so often do).  Continue reading

Risk of nerve damage from fluoroquinolone antibiotics

FDA Drug Safety Communication: FDA requires label changes to warn of risk for possibly permanent nerve damage from antibacterial fluoroquinolone drugs taken by mouth or by injection

The FDA has required the drug labels for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.This serious nerve damage potentially caused by fluoroquinolones may occur soon after these drugs are taken and may be permanent.

The risk of peripheral neuropathy occurs only with fluoroquinolones that are taken by mouth or by injection. Approved fluoroquinolone drugs include

  • levofloxacin (Levaquin),
  • ciprofloxacin (Cipro),
  • moxifloxacin (Avelox),
  • norfloxacin (Noroxin),
  • ofloxacin (Floxin), and
  • gemifloxacin (Factive).

Continue reading

Are generics really the same as branded drugs?

Are generics really the same as branded drugs?

Apparently, generics are not “bioequivalent” at all – unless an almost 50% difference is not considered “significant”.

In October [2012] the Food and Drug Administration took a highly unusual step: It declared that a generic drug it had previously approved — a version of the popular antidepressant Wellbutrin — was not in fact “bioequivalent” to the name-brand version. The FDA withdrew its approval.

The episode is bringing momentum to a movement that has been quietly building among many doctors and medical societies that are increasingly willing to ask a question that borders on heresy: Are generics really identical to the branded products they are meant to replicate? To a surprising degree, they say, the answer is no.

generic drugs diverge from the originals far more than most of us believe.

Continue reading