Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Patient Participation in Medical Product Discussions: Comments Submitted to Docket

Patient Participation in Medical Product Discussions: Comments Submitted to Docket | Pharmaguy's Insights Into Drug Industry News | Scoop.it
 
  • Please see the comments of Hunter Syndrome Research Coalition and member organization Saving Case & Friends, Inc. in the attached PDF.


  • I am commenting about the impact FDA decisions make to me as a patient with type 1 diabetes and a provider of diabetes care. I am concerned about the wide range in glucose...


 
  • We thank you for the opportunity to submit these comments in response to Federal Register Notice FDA-2014-N-1698, FDA Activities for Patient Participation in Medical Product...

  • Involvement of the patient community in drug development is a worthy goal. I co-organized a Washington conference in 2013 called "Selling Sickness: People before profits" with the...

  • Dear FDA panel members, I come from the viewpoint of a Physician Assistant specializing in 11 of 14 years in OB/GYN with surgical experience. I have a very clear understanding of...

  • First off, I want to give FDA a BIG THANKS for its openness with the Diabetes Community in 2014. FDA opened a number of dockets for people with diabetes to comment on and we...

  • I attended the meetings on Female Sexual Dysfunction (October 27/28) as an observer. I was surprised to see that the majority of patient voices and the loudest expert voices all...

  • The Even the Score campaign is just propaganda. Sprout cannot try to make the case that 43% of women have a sexual dysfunction (which includes vaginal pain and vaginal dryness in...

Pharma Guy's insight:

"Have you ever wanted to be part of the food and drug regulatory process?," asks the FDA in its search for a Few Good Consumer Representatives to Serve on Advisory Committees; http://sco.lt/75ZP97. "Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data? If you answered “Yes,” here’s your opportunity to become an advocate for consumers!"


Also, read "The Power and the 'Science' of Patient Input"; http://sco.lt/5v9Q7l 

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Some Nominees for the FDA Patient Engagement Advisory Committee

Some Nominees for the FDA Patient Engagement Advisory Committee | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Food and Drug Administration has announced the development of a Patient Engagement Advisory Committee.


Although the FDA still has the final say on regulation, this committee would be beneficial in these ways:


  • to help identify the most important benefits and risks of a technology from a patient’s perspective;
  • to assess the relative importance to patients of different attributes of benefit and risk, and clarify how patients think about the trade-offs of these benefits and risks for a given technology; and
  • to help understand how patient preferences vary across a population.


The nine-member committee has not been established yet, but we thought we’d recommend our own nominees for promising contenders who have a sufficient background to represent patients.


A few of these people might be more obvious when it comes to patient input on healthcare, but that doesn’t diminish their voice on the matter of engagement. And some of the others could represent the voices that sometimes fall between the cracks.


Find out who here: http://bit.ly/1GDaJsC 

Pharma Guy's insight:

FDA is also seeking consumers to participate in drug review committees: http://sco.lt/75ZP97 

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FDA Discloses Only 1% of Advisers' Financial Ties to Medical Device Companies

FDA Discloses Only 1% of Advisers' Financial Ties to Medical Device Companies | Pharmaguy's Insights Into Drug Industry News | Scoop.it

David Kandzari, an Atlanta cardiologist, also has worked as a consultant to makers of medical devices. He received at least $100,000 from them in five years, according to corporate and government data.


Another organization he works with, the Food and Drug Administration, doesn't appear to mind. In October, the FDA put Dr. Kandzari on a panel reviewing a medical device made by Boston Scientific Corp., one of the companies he has advised.


The FDA didn't disclose the connection. It was among numerous financial ties the FDA hasn't disclosed between medical-device makers and the doctors and other experts who review devices for it, a Wall Street Journal analysis of corporate, state and federal data shows.


In panels evaluating devices involved in cardiology, orthopedics and gynecology from 2012 through 2014, a third of 122 members had received compensation--such as money, research grants or travel and food--from medical-device companies, an examination of databases shows.


Nearly 10% of the FDA advisers received something of value from the specific company whose product they were evaluating.


The FDA disclosed roughly 1% of these corporate connections.


The situation concerns critics. "Undisclosed conflicts raise questions about the decision-making capacity of the committees and whether the public can have confidence in their recommendations," said Joseph Ross, an associate professor at Yale School of Medicine.

Pharma Guy's insight:


If you have ever attended one of these Advisory Committee meetings, you would find that the majority of attendees are representatives of drug companies with perhaps a smattering of public interest groups and a large contingent of press people.

So you can expect that every vote by each panelist is noted and reported back to drug companies with an interest in the matter. This has got to put a lot of pressure on the panel members, many of whom have accepted money from the industry in the past or perhapswould like to accept money from them in the future!

This goes with the territory of open, public meetings. It certainly would not be in the public interest to have secret ballots. So there's not much we can do about that.

But, can't the FDA find panelists without any ties to the pharmaceutical industry? Apparently not. A Washington lawyer "who was until last year the agency's general counsel, said that finding knowledgeable experts without financial conflicts was difficult."

The reason is that the industry creates these "knowledgeable experts," which has as much to say about physician education in this country as it does about pharma industry influence over physicians. In short, physicians absolutely depend upon the industry to learn about new products and even the conditions they treat.

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#Pharma 'Highjacks' Public Comments at FDA Advisory Meetings

#Pharma 'Highjacks' Public Comments at FDA Advisory Meetings | Pharmaguy's Insights Into Drug Industry News | Scoop.it

About one-third of "public" speakers at US Food and Drug Administration (FDA) advisory committee meetings on yet-to-be-approved cancer drugs in recent years had financial ties to the pharmaceutical industry, according to new research.


In other words, public testimony, which is mostly from patients and the staff of nonprofits, and can be emotionally compelling, is regularly supported by private interests.


"The industry has hijacked that microphone; they're using it as their second presentation at advisory committee meetings," senior study author Vinay Prasad, MD, MPHfrom the Oregon Health Sciences University in Portland, said in a press statement about the findings, which were published onlineFebruary 1 as a research letter in JAMA Internal Medicine.


Dr Prasad's strong words are based on the study, which looked at all 103 public speakers at 28 meetings of the FDA Oncologic Drugs Advisory Committee (ODAC) from 2009 to 2014. The committee's recommendations are usually followed by the FDA.


The agenda at an ODAC meeting includes presentations from a drug company and the FDA itself, plus public comment.


Public comment at ODAC was overwhelmingly in favor of the drugs under discussion, the study indicates: 95 of the 103 (92%) speakers supported marketing approval; only six (5.8%) speakers did not (two were neutral).


This occurred even though ODAC meetings are typically reserved for drugs "where the risk–benefit [ratio] is even more questionable than usual," Dr Prasad explained.


Notably, 31 (30%) of the public speakers reported financial ties to the drug maker, including financial support for travel to the FDA meeting or broader organizational support.


This is unfair, Dr Prasad suggested. "The industry already gets a chance to make its case at ODACs. In my mind, any percentage more than 0% is too high," he told Medscape Medical News about the proportion of industry-supported public comment.

Pharma Guy's insight:

"Have you ever wanted to be part of the food and drug regulatory process?," asks the FDA in its search for a Few Good Consumer Representatives to Serve on Advisory Committees; http://sco.lt/75ZP97. "Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data? If you answered “Yes,” here’s your opportunity to become an advocate for consumers!"


FDA should add to its list of "Yes" questions: "Do you have financial ties to the drug industry?"

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Pharma Guy's curator insight, March 30, 2016 1:54 PM

"Have you ever wanted to be part of the food and drug regulatory process?," asks the FDA in its search for a Few Good Consumer Representatives to Serve on Advisory Committees; http://sco.lt/75ZP97. "Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data? If you answered “Yes,” here’s your opportunity to become an advocate for consumers!"

 

FDA should add to its list of "Yes" questions: "Do you have financial ties to the drug industry?"

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FDA Seeking a Few Good Consumer Representatives to Serve on Advisory Committees

FDA Seeking a Few Good Consumer Representatives to Serve on Advisory Committees | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Have you ever wanted to be part of the food and drug regulatory process? Do you have a history of public interest or a passion for consumer advocacy? Do you have experience analyzing scientific data?


If you answered “Yes,” here’s your opportunity to become an advocate for consumers! The Food and Drug Administration continually seeks input from consumers on scientific and medical issues by including Consumer Representatives on Agency advisory committees.


Participation as a Consumer Representative requires a modest time commitment. Travel expenses are paid and representatives receive reasonable compensation.


To apply you must:

  1. Be an active participant in independent consumer- or community-based organizations or have a history of advocating for the public’s interest; and
  2. Demonstrate an ability to analyze scientific data and critique research design.


FDA’s Consumer Representatives are grass-roots advocates, organizers, policy makers, or leaders of organizations with an interest in a specific subject matter. 


Pharma Guy's insight:

Which committees have vacancies to fill? One is the Vaccines & Related Biological Products. It would be interesting to see who applies and is accepted for that vacancy!

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