FDA

[LinksEtc]

Tweeted by @vmontori


"Does $760m a year of industry funding affect the FDA's drug approval process?"
http://www.bmj.com/content/349/bmj.g5012

Nineteen medical officers identified a total of 27 approved new drugs in the past three years that they reviewed that they thought should not have been approved. Most of these medical officers said that current FDA standards were "lower" or "much lower" than previous ones.

[LinksEtc]

Tweeted by @hhask


"Proposed US Food and Drug Administration Guidance for Industry on Distributing Medical Publications About the Risks of Prescription Drugs and Biological Products"

http://tinyurl.com/mywhjjs

In my view, the draft guidance, which is open for public comment until August 25, 2014, has the potential to undermine the FDA's drug safety laws and regulations and should be changed.

As written, the draft guidance would allow pharmaceutical companies who believe that the FDA-approved drug-labeling information overstates the risks of their drug to tell physicians that the risks are, in fact, lower.

Unfortunately, the draft guidance strikes the balance more toward the industry's view of its First Amendment right to commercial speech than toward the agency's mandate for patient protection.

[LinksEtc]

Tweeted by @brady_dennis


"Food additives on the rise as FDA scrutiny wanes"

http://www.washingtonpost.com/national/food-additives-on-the-rise-as-fda-scrutiny-wanes/2014/08/17/828e9bf8-1cb2-11e4-ab7b-696c295ddfd1_story.html?hpid=z2

The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration

"We simply do not have the information to vouch for the safety of many of these chemicals," said Michael Taylor, the FDA's deputy commissioner for food.

"I've given up on the FDA protecting the public; they are protecting businesses," said Grovit, who also has Crohn's disease.

[LinksEtc]

"Food Additive Safety"

https://www.cspinet.org/foodsafety/gras.html

Many people presume that some federal agency is overseeing the safety of the ingredients in our food supply. That's reasonable, because that is actually what the federal Food and Drug Administration (FDA) is supposed to be doing, and what Congress told it to do in a 1958 law.

But since 1997, FDA has punted on that core responsibility, allowing companies to make their own secret determinations of a substance's safety for use in our food.

[LinksEtc]

"TIA Supports FDA Guidance on Medical Device Data Systems"

http://www.healthdatamanagement.com/news/TIA-Supports-FDA-Guidance-on-Medical-Device-Data-Systems-48682-1.html

The Telecommunications Industry Association supports Food and Drug Administration intentions not to enforce some regulatory controls that apply to medical device data systems (MDDS), which the agency deems to be low risk to patients. 

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"FDA Issues Guidance on Medical Device Data Systems

http://www.healthdatamanagement.com/news/FDA-Issues-Guidance-on-Medical-Device-Data-Systems-48276-1.html

The Food and Drug Administration has issued draft guidance informing industry that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients.

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Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Draft Guidance for Industry and Food and Drug Administration Staff
DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM401996.pdf

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http://www.tiaonline.org/sites/default/files/pages/TIA%20Comments%20-%20FDA%20Draft%20Guidance%20re%20MDDS%20%20082514_0.pdf

Comments of the Telecommunications Industry Association concerning the Food and Drug Administration's Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices - Draft Guidance for Industry and Food and Drug Administration Staff (Docket No. FDA-2014-D-0798)

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FDA & Industry

< THE TURTLES - SO HAPPY TOGETHER!! >

[LinksEtc]

"Grocery Makers Trade Group to Share Additive Database with FDA"
https://www.cspinet.org/new/201408281.html

Today the food industry is congratulating itself for sharing a database of its food additive safety studies with regulators at the Food and Drug Administration. That this is seen as a step forward neatly illustrates the dysfunction built into the current system.

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"Big Food to divulge chemical info"
http://www.politico.com/story/2014/08/big-food-to-divulge-chemical-info-110395.html

Food companies are trying to beat the federal government's push to make chemicals in food more transparent.

Pressure has been building on FDA for years to look more closely at food chemicals, which are mostly self-approved by food companies relying on publicly available science and panels of industry-paid experts. But the agency hasn't gotten around to it.

[LinksEtc]

Tweeted by @ElaineSchattner

"In Plastics and Cans, a Threat to Women"

http://well.blogs.nytimes.com/2014/08/28/in-plastics-and-cans-a-threat-to-women/?_php=true&_type=blogs&smid=tw-share&_r=0

"I think most scientists working today agree that BPA is an ovarian toxicant," Dr. Flaws said. A review of research into BPA, published this summer in the journal Environmental Health Perspectives, noted that ovarian toxicity is among the most consistent and strongest effects found "in both animal models and in women."

[LinksEtc]

Tweeted by @joyclee

"THIS KID MADE AN APP THAT EXPOSES SELLOUT POLITICIANS"

http://www.vice.com/read/greenhouse-app-hannah-ewens-nick-rubin-201?utm_content=buffer0ce83&utm_medium=social&utm_source=twitter.com&utm_campaign=buffer

With US politics swimming in so much corporate money that it's pretty much an oligarchy

But thanks to 16-year-old Nick Rubin, keeping track of just how much politicians have sold out has become a lot easier. He created Greenhouse

Might help in understanding Congress/FDA interactions.

[LinksEtc]

"FDA to Strengthen Evaluation of Chemicals in Food and Feed"

http://www.foodsafetymagazine.com/news/fda-to-strengthen-evaluation-of-chemicals-in-food-and-feed/

The U.S. Food and Drug Administration (FDA) yesterday announced that it has completed a review of how it evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed and veterinary drugs. Based on the findings, the agency is taking steps to strengthen internal processes.

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"FDA Takes Steps to Strengthen Program to Assess the Safety of Chemicals in Foods, Other Products"

http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm411907.htm

[LinksEtc]

Tweeted by @ScottGottliebMD

"As FDA Tries to Regulate Lab-Developed Tests, Congress Signals Potential Opposition"
http://www.raps.org/Regulatory-Focus/News/2014/09/03/20203/As-FDA-Tries-to-Regulate-Lab-Developed-Tests-Congress-Signals-Potential-Opposition/

Last month, the US Food and Drug Administration (FDA) announced it would soon seek to regulate lab-developed tests more similarly to in vitro diagnostics (IVDs), citing the devices' increasing complexity and role in critical clinical decision-making.

And perhaps unfortunately for FDA, the House Energy and Commerce Committee is in the midst of its 21st Century Cures Initiative, which is tasked with determining how medical advances and cures can be brought to patients more quickly, with a specific focus on re-tailoring regulations to be more flexible.

[LinksEtc]

Tweeted by @HeartSisters

"Doctors' Magical Thinking About Conflicts of Interest"
http://www.nytimes.com/2014/09/09/upshot/doctors-magical-thinking-about-conflicts-of-interest.html?smid=tw-share&_r=0&abt=0002&abg=1

Conflicts of interest are real, and they are still influencing decisions from the level of the patient all the way up to national health policy. We will never be able to eliminate them all. But acknowledging them and talking about them openly is an important first step toward minimizing their impact.

[LinksEtc]

Taylor: Reproposed FSMA Rules Are 'Close'
http://tinyurl.com/o5e8p3b

"The court deadlines are really driving all of the timelines and planning that we're doing, necessarily," Taylor said. "My boss is potentially held in contempt if we don't get the rules out."

[LinksEtc]

Tweeted by @fdalawblog

"Public Citizen to FDA: Advisory Committee-Industry Revolving Door Should Be Closed

FDA Should Not Allow Recent Committee Members to Act as Hired Guns for Companies Angling for Votes of Approval by the Same Committees"

http://www.citizen.org/pressroom/pressroomredirect.cfm?ID=4278

Such a revolving door creates the appearance of a conflict of interest and threatens to undermine public confidence in the objectivity of FDA advisory committee members.

[LinksEtc]

"Antibiotic Resistance Is Everyone's Problem"
http://www.theatlantic.com/health/archive/2015/06/how-to-stop-prevent-antibiotic-resistance-resistant-bacteria/397058/?utm_source=SFTwitter

The overuse of antibiotics, both in human patients and, importantly, in livestock, has led to an explosion of antibiotic-resistant bacteria, both in the U.S. and around the world. Deaths from resistant infections are currently at about 700,000 per year, and estimated to rise to 10 million per year by 2050.

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Tweeted by @ProPublica

"Documents reveal how poultry firms systematically feed antibiotics to flocks"
http://www.reuters.com/investigates/special-report/farmaceuticals-the-drugs-fed-to-farm-animals-and-the-risks-posed-to-humans/

Major U.S. poultry firms are administering antibiotics to their flocks far more pervasively than regulators realize, posing a potential risk to human health.

Not until 2016 does the FDA plan to gather data about antibiotic use on farms, said Craig Lewis, a veterinary medical officer with the agency. Today, "none of us have an idea first-hand of what's going on" at the farm level, Lewis said this summer, at a public meeting on antibiotic resistance.

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Tweeted by @danmunro


"Maryn McKenna: What do we do when antibiotics don't work any more?"
Filmed March 2015 at TED2015

http://tinyurl.com/o67o2fg

Drug-resistant bacteria mean we're entering a post-antibiotic world — and it won't be pretty. There are, however, things we can do ... if we start right now.

[LinksEtc]

"FDA's Right to Take Photographs in Your Facility: Or Not"
http://www.foodsafetymagazine.com/enewsletter/fdae28099s-right-to-take-photographs-in-your-facility-or-not/

For these reasons, a company may want to attempt to prohibit an FDA investigator from taking photos inside its plant.