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Topic summary

Posted by LinksEtc
 - September 23, 2017, 08:18:26 AM
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Posted by LinksEtc
 - September 23, 2017, 08:18:12 AM
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Posted by LinksEtc
 - September 23, 2017, 08:08:43 AM
"The FDA's Consumer Protection Warnings Are Falling Under Trump

The number of agency warning letters is at its lowest level since 2008."

By John Tozzi

‎August‎ ‎28‎, ‎2017‎ ‎4‎:‎00‎ ‎AM

https://www.bloomberg.com/news/articles/2017-08-28/fda-warnings-meant-to-protect-consumers-fall-under-trump

QuoteIn written testimony (PDF) for his confirmation hearing, Gottlieb pledged to run the FDA "as an impartial and passionate advocate for public health" guided by science. He said the "FDA's enforcement tools are a bedrock of its mission."

These initial numbers, however, have watchdogs such as Public Citizen's Carome worried that Trump's pledge to roll back red tape has reached the FDA—potentially endangering Americans who rely on the 17,000-employee agency to protect them. 

----------------------------------------


"FDA Chief Says High Drug Prices 'Public Health Concern' Agency Should Address

Scott Gottlieb says FDA will start with focus on speeding approval of 'complex generics' "

By Thomas M. Burton

Oct. 2, 2017 11:20 a.m. ET

https://www.wsj.com/articles/fda-chief-says-high-drug-prices-public-health-concern-agency-should-address-1506957609

Quote"I consider access to medicine a matter of public health," Dr. Gottlieb declared in a blog post
QuoteThe FDA has traditionally taken the position that the agency's sole role in medical-product approval is assessing safety and effectiveness, and that pricing is generally out of its purview.








Posted by LinksEtc
 - September 18, 2017, 02:03:45 PM
On the general topic of regulation ...

---------------------------------------------


"With Grenfell Tower, we've seen what 'ripping up red tape' really looks like

George Monbiot

https://www.theguardian.com/commentisfree/2017/jun/15/grenfell-tower-red-tape-safety-deregulation?CMP=Share_iOSApp_Other


Quotewhat they call red tape often consists of essential public protections that defend our lives, our futures and the rest of the living world. The freedom they celebrate is highly selective: in many cases it means the freedom of the rich to exploit the poor, of corporations to exploit their workers, landlords to exploit their tenants and industry of all kinds to use the planet as its dustbin.
Quoteone in, two out rule for regulation

---------------------------------------------

"Why Grenfell Tower Burned: Regulators Put Cost Before Safety"

By DAVID D. KIRKPATRICK, DANNY HAKIM and JAMES GLANZ,   JUNE 24, 2017

https://www.nytimes.com/2017/06/24/world/europe/grenfell-tower-london-fire.html?smprod=nytcore-iphone&smid=nytcore-iphone-share&_r=0

QuotePromising to cut "red tape," business-friendly politicians evidently judged that cost concerns outweighed the risks of allowing flammable materials to be used in facades.
QuoteGovernments adopted slogans calling for the elimination of at least one regulation for each new one that was imposed, and the authorities in charge of fire safety took this to heart.

---------------------------------------------


"Trump's 'Two-for-One' Regulation Executive Order"

Bourree Lam,  Jan 30, 2017

https://www.theatlantic.com/business/archive/2017/01/trumps-regulation-eo/515007/

Quote"If there's a new regulation, they have to knock out two.
QuoteTrump met with business executives from some of America's largest companies and promised to cut regulation by 75 percent. He also ordered a freeze on all new and pending regulation at the federal level via a memorandum—save for emergencies relating to "health, safety, financial, or national security matters,"—until a Trump-appointed department head could review prospective regulations.

---------------------------------------------


"Under Trump, regulation slows to a crawl"

By DANNY VINIK
06/07/2017 05:06 AM EDT

http://www.politico.com/agenda/story/2017/06/07/trump-regulation-slowdown-000446

Quotethe economic costs of the two so-called deregulatory actions must equal or exceed the economic cost of the new regulation.

The "two-for-one" order, signed January 30, applies only to "significant" regulations with an economic impact exceeding $100 million or meeting other specified criteria, and it may be working in a counterintuitive way: Although it was touted as a way to roll back old rules, its main impact appears to be simply erecting obstacles to new regulations.

---------------------------------------------


"Trump's 2-For-1 Folly"

Omri Ben-Shahar

https://www.forbes.com/sites/omribenshahar/2017/02/17/trumps-2-for-1-folly/#1d970b1d3bea

QuoteRegulations have costs, but they also have benefits. The smoke scrubbers in our example reduce toxic emissions and the resulting illnesses. Lives are saved, health care expenses are reduced, and some jobs are created in the manufacture of the scrubbers.
QuoteOver the past 35 years, federal regulations in most areas have been issued only if their benefits were shown to exceed their costs.

---------------------------------------------


ok ... part of the reason that I bring up this "Two-for-One" regulation stuff is that I see it as being relevant to the current sesame labeling efforts.  I don't want to go too deep into politics in the on-topic section of FAS because this is a food allergy support board and it should be welcoming to all (& politics can be divisive) ... however, I wanted to share a few of the articles that have helped to shape my opinions regarding where things might be headed with the sesame ... and also to encourage people in the food allergy community to reflect on societal values, priorities, and tradeoffs regarding things like safety and cost.  The regulatory environment changes and it's important to be aware of how this can affect us - medicine safety, food recall procedures, allergen labeling, etc.


I guess that I will link to the sesame thread from here:
Re: sesame seeds labeling: US specific (laws, loopholes)






Posted by LinksEtc
 - September 18, 2017, 10:11:57 AM
"F.D.A. Deal Would Relax Rules on Reporting Medical Device Problems"

By SHEILA KAPLAN,  JULY 11, 2017

https://www.nytimes.com/2017/07/11/health/fda-medical-device-problems-rules.html?smid=tw-share

QuoteMakers of cardiac defibrillators, insulin pumps, breast implants and other medical devices might be able to delay reporting dangerous malfunctions to the Food and Drug Administration under an agreement heading for a vote in Congress.
QuoteThe deal is part of a pact between the F.D.A. and the $148 billion device industry.

------------------------------------


"Maryland Sued by Generic-Drug Trade Group Over New Pricing Law

The law, enacted in May and set to take effect in October, bars "unconscionable" price increases for generic drugs"

https://www.wsj.com/articles/maryland-sued-by-generic-drug-trade-group-over-new-pricing-law-1499370135

QuoteA trade group for the generic-drug industry filed a lawsuit Thursday seeking to block Maryland's new state law aimed at curbing steep price increases for generic drugs, the first law of its kind in the U.S.

------------------------------------




Posted by LinksEtc
 - September 18, 2017, 08:39:04 AM
I'd also recommend that patients/consumers who want health care to better address our needs read:

"An American Sickness: How Healthcare Became Big Business and How You Can Take it Back" by

Elisabeth Rosenthal

-----------------------

It has chapters such as the following:

"The Age of Pharmaceuticals"

"The Age of Medical Devices"

"The Age of Research and Good Works for Profit: The Perversion of a Noble Enterprise"

-----------------------


My opinion ... so much of health "care" is just not about patient well-being ...

ok ... not going to post emotionally ...

because what I am thinking should probably not be said now ...


-----------------------

Instead, here is another "Pride and Prejudice" quote, this time from the 2005 movie:

Quote
Mrs. Gardiner:  Take care my love.  That savors strongly of bitterness.




Posted by LinksEtc
 - September 18, 2017, 08:04:54 AM
"Industry is counting on Trump to back off rules that tell you what's in your food"

By Caitlin Dewey 

https://www.washingtonpost.com/news/wonk/wp/2017/04/27/industry-is-counting-on-trump-to-back-off-rules-that-tell-you-whats-in-your-food/?utm_term=.7bba28f6bf54

Quote
The food industry is moving to capitalize on the Trump administration's anti-regulation agenda by seeking to delay or do away with Obama-era rules governing the disclosure of calories, sugar, fiber and serving size, according to petitions filed with the Food and Drug Administration.

---------------------------------


"Trump's FDA Commissioner on Drug Prices, Regulations, Science"

By Anna Edney and Justin Mattingly

‎July‎ ‎24‎, ‎2017‎ ‎1‎:‎06‎ ‎PM

https://www.bloomberg.com/news/articles/2017-07-24/trump-s-fda-commissioner-on-drug-prices-regulations-science

QuoteBloomberg: What about drugs like EpiPen, would you come out with new rules there to create more competition? [EpiPen, made by Mylan NV, is what's known as a drug-device combination, where both the medicine and the device that administers it can have patent protections.]




Posted by LinksEtc
 - September 17, 2017, 06:47:34 PM
"Donald Trump and Peter Thiel vs. the FDA: Be afraid. Be very afraid."
https://sciencebasedmedicine.org/donald-trump-vs-the-fda-be-afraid-be-very-afraid-of-the-loosening-of-drug-approval-standards/

David Gorski  on January 16, 2017

QuoteDonald Trump's three most likely picks for FDA Commissioner all favor loosening drug approval standards. Two are cronies of Peter Thiel, of which one believes that the FDA shouldn't require evidence of efficacy, only safety, and the other believes that a "Yelp for drugs" would do a better job than the FDA. The third candidate is a bona fide, honest-to-goodness pharma shill. If any of them becomes FDA Commissioner, drug safety standards will take a nosedive.

----------------------------------

"Here's What We Know about Trump's FDA Head Nominee

Early tests for Scott Gottlieb, who was named to the post on Friday, will include a pair of bills immediately slated for congressional review"

By Dina Fine Maron on March 10, 2017

https://www.scientificamerican.com/article/heres-what-we-know-about-trumps-fda-head-nominee/

QuoteHe is currently a resident fellow at the conservative American Enterprise Institute, where he analyzes health policy, regulation and public health. He is on the Federal Health IT Policy Committee, a group that advises the Department of Health and Human Services on health care IT issues. His resume also boasts stints as the FDA's deputy commissioner, and at the Centers for Medicare and Medicaid Services as a senior official focused on new medical technologies.

----------------------------------


"Senate Confirms Scott Gottlieb to Head F.D.A."

By KATIE THOMAS, MAY 9, 2017

https://www.nytimes.com/2017/05/09/health/scott-gottlieb-senate-fda-commissioner.html?mcubz=0&_r=0

QuoteAt his confirmation hearing in April, Dr. Gottlieb told senators that he believed in upholding the F.D.A.'s reputation as the world's "gold standard" for drug approval. If confirmed, he said then, he would be "an absolutely objective regulatory watchdog" and would not do anything that could "besmirch the agency" or undermine public confidence in its work.

----------------------------------


"Trump's new FDA commissioner has a huge decision to make"

By William B. Schultz 


https://www.washingtonpost.com/opinions/trumps-new-fda-commissioner-has-a-huge-decision-to-make/2017/05/16/4ee187f8-3667-11e7-b412-62beef8121f7_story.html?utm_term=.818c2824acc6

Quoteearly tests on a small number of patients can suggest great promise, but subsequent, more robust studies often disappoint

----------------------------------


"Trump's proposed budget would cripple the NIH and FDA"

By Ellen V. Sigal

May 24, 2017

https://www.statnews.com/2017/05/24/trump-budget-nih-fda/


QuoteAt best, the proposed budget suggests that the White House doesn't understand how the NIH and the FDA function. At worst, it suggests a disregard for the millions of patients who are desperate for the scientific innovations, lifesaving therapies, and safeguards that emerge from these agencies. Cutting the NIH by the magnitude currently proposed — a staggering $6 billion — would cripple the incredible scientific momentum the health care community has been enjoying.




Posted by LinksEtc
 - September 17, 2017, 06:26:29 PM
"Released FDA docs reveal details of agency's (failed) attempt to retract paper"
http://retractionwatch.com/2017/08/21/released-fda-docs-reveal-details-agencys-failed-attempt-retract-paper/

QuoteEarlier this year, a raging controversy regarding a new drug spilled into the pages of a leading medical journal: the head of the U.S. Food and Drug Administration and another official publicly called for the retraction or correction of a peer-reviewed article about the drug. They didn't get their wish. Now, documents released by the FDA via a lawsuit shed light on the attempt — and show how tricky it can be to correct the official record.

----------------------------------------------------------------


"Auditors slam FDA for dragging its feet on food recalls"

By Coral Beach | June 9, 2016

http://www.foodsafetynews.com/2016/06/127380/#.Wb8CuU0m7IU

---------


Dept of Health & Human Services

Office of Inspector General

June 8, 2016

https://oig.hhs.gov/oas/reports/region1/11501500.pdf

Quote
TO: Robert M. Califf, M.D.
Commissioner of Food and Drugs
Food and Drug Administration

FROM: /Daniel R. Levinson/
Inspector Genera
l
SUBJECT: Early Alert: The Food and Drug Administration Does Not Have an Efficient and Effective Food Recall Initiation Process (A-01-15-01500)
QuoteWe found that FDA did not have an efficient and effective food recall initiation process that helps ensure the safety of the Nation's food supply. Specifically, FDA did not have policies and procedures to ensure that firms1 or responsible parties2 (collectively referred to in this document as "firms") initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA's immediate attention.
QuoteTo help ensure the safety of the Nation's food supply, we recommended that FDA consider our findings when implementing the FDA Food Safety Modernization Act (FSMA) and follow its own procedures for monitoring recalls.
QuoteFDA generally relies on firms to voluntarily recall harmful articles of food.3 Before 2011, FDA did not have the authority to require a firm to recall certain articles of food. However, the FSMA added section 423 to the FD&C Act,4 which gives FDA the authority to order a firm to recall certain articles of food after FDA determines that there is a reasonable probability that the food is adulterated or misbranded and that it will cause serious adverse health consequences or death to humans or animals (this is commonly referred to as SAHCODHA). FDA has used its authority under FSMA twice.5




Posted by LinksEtc
 - September 17, 2017, 05:16:05 PM
"FDA warns Chinese drug maker over lying"

By Ed Silverman @Pharmalot

August 4, 2016

https://www.statnews.com/pharmalot/2016/08/04/china-drug-safety-fda-heparin/

QuotePharmaceutical and ingredients manufacturers in China and India have come under intense scrutiny in recent years due to a series of disturbing events. In 2008, for instance, 246 deaths in the United States were linked to a fake ingredient from China that was found in the blood thinner heparin. China is now the world's largest supplier of active pharmaceutical ingredients.

--------------------------


"FDA: We won't regulate fitness trackers, wellness apps"
07.29.16
https://www.fastcompany.com/4015512/fda-we-wont-regulate-fitness-trackers-wellness-apps

--------------------------


"Six former commissioners say FDA should be independent agency"

By Helen Branswell @HelenBranswell

June 25, 2016

https://www.statnews.com/2016/06/25/six-former-commissioners-say-fda-get-cabinet-status/

QuoteThe FDA is currently part of the Department of Health and Human Services (HHS). Making it a Cabinet-level organization or finding another way to give it more autonomy would be a step in the right direction for public health, the former commissioners argued.

--------------------------

   
Medical Product Oversight:

FDA Needs More Strategic Planning to Guide Its Scientific Initiatives

GAO-16-432: Published: May 16, 2016. Publicly Released: Jun 15, 2016.

http://www.gao.gov/products/GAO-16-432

---


Food and Drug Administration:

Comprehensive Strategic Planning Needed to Enhance Coordination between Medical Product Centers

GAO-16-500: Published: May 16, 2016. Publicly Released: Jun 15, 2016.

http://www.gao.gov/products/GAO-16-500





Posted by LinksEtc
 - September 17, 2017, 04:45:46 PM
"Could the FDA be dismantled under Trump?"

By Sheila Kaplan

November 22, 2016

https://www.statnews.com/2016/11/22/fda-donald-trump/

Quote"Between a Trump presidency and a radically pro-business Congress, the next few years may see a removal of numerous consumer protections," said Michael Jacobson, cofounder and president of the Center for Science in the Public Interest.
QuoteOne former FDA official, who spoke on condition of anonymity to speak candidly, said support for the "Right to Try" movement signals a broader disapproval of regulation.

--------------------


"FDA emails show how upset some officials were over the Sarepta approval"

By Ed Silverman @Pharmalot

November 4, 2016

https://www.statnews.com/pharmalot/2016/11/04/fda-emails-sarepta-duchenne/

QuoteUnger then got even more pointed: "Perhaps granting accelerated approval to drugs that show a mere scintilla of an effect on a surrogate endpoint represents a stroke of brilliance – one that will stimulate investment in the development of drugs for these disorders. But in my opinion, this approach should receive broader public (and FDA) input before being implemented."

--------------------


"Sarepta, eteplirsen: anecdote, data, surrogate outcomes, and the FDA"

September 30th, 2016 by Ben Goldacre in bad science

http://www.badscience.net/2016/09/eteplirsen-anecdote-data-surrogate-outcomes-and-the-fda/

QuoteThe Lancet's press release on this trial was very sensible; but the press release from UCL Institute for Child Health / Great Ormond Street Hospital made misleading allusions to benefit on real-world outcomes which never appeared anywhere in the academic paper.

--------------------   


"How the FDA Manipulates the Media

The U.S. Food and Drug Administration has been arm-twisting journalists into relinquishing their reportorial independence, our investigation reveals. Other institutions are following suit"

By Charles Seife on October 1, 2016

https://www.scientificamerican.com/article/how-the-fda-manipulates-the-media/


Quote"I think embargoes that attempt to control sourcing are dangerous because they limit the role of the reporter whose job it is to do a full look at a subject," says New York Times former public editor Margaret Sullivan. "It's really inappropriate for a source to be telling a journalist whom he or she can and can't talk to."
QuoteFor example, the FDA assures the public that it is committed to transparency, but the documents show that, privately, the agency denies many reporters access—including ones from major outlets such as Fox News—and even deceives them with half-truths to handicap them in their pursuit of a story.




   
Posted by LinksEtc
 - September 17, 2017, 04:04:27 PM
"Patients' Right To Try Should Not Be A License To Fleece Them"

Bernard Munos

https://www.forbes.com/sites/bernardmunos/2016/12/08/patients-right-to-try-should-not-be-a-license-to-fleece-them/#55f2320a44ff

QuoteThere is an unlimited supply of safe but ineffective molecules that can be applied to just about any condition. If we allow them to be sold because they do no harm, and perhaps might help someone, that's what we are going to get—placebo-like drugs that are exorbitantly priced, and masquerade as the real thing.

--------------------------------------------


"Richard Lehman's journal review—5 December 2016"

http://blogs.bmj.com/bmj/2016/12/05/richard-lehmans-journal-review-5-december-2016/

QuoteHere is a short study of 18 new oncology drugs already given expedited approval by the US Food and Drug Administration (FDA). Of these, 13 were priced above $100K annually, and the most expensive, cabozantinib, did not improve overall survival and reduced quality of life compared to placebo. Thank goodness that we have Vinay Prasad and Bishal Gyawali blazing away at this, because it looks as if we can forget about any kind of regulation by the FDA.

--------------------------------------------


"FDA Targets 15 Hospitals Over Significant Deviations from Medical Device Reporting Regulation"

Posted 24 October 2016
By Zachary Brennan

http://raps.org/Regulatory-Focus/News/2016/10/24/26053/FDA-Targets-15-Hospitals-Over-Significant-Deviations-from-Medical-Device-Reporting-Regulation/

QuoteSeveral high-profile hospitals were included in the list, including Los Angeles-based Cedars-Sinai Medical Center and Boston-based Brigham and Women's Hospital, for their failure to keep written medical device reporting procedures and to report adverse events.






Posted by LinksEtc
 - September 16, 2017, 04:25:15 PM
"Why the FDA Wants More Control over Some Lab Tests

The FDA finds that many so-called laboratory-derived tests may actually harm patients"

By Charles Schmidt on December 1, 2016

https://www.scientificamerican.com/article/why-the-fda-wants-more-control-over-some-lab-tests/

QuoteEvery year in the U.S., doctor's offices and hospitals order billions of laboratory tests to measure everything from cholesterol levels in the blood to the presence of a gene thought to increase the risk of developing Alzheimer's disease. Physicians and patients typically assume that they can trust the results of these tests.
QuoteThrough a quirk of regulatory history, many such tests are not subject to the same medical standards as other tools used to identify risk for disease or to definitively diagnose a condition.

--------------------------------------------

"Audit: FDA Recall Process Puts Lives at Risk"
June 9, 2016
by Katie Worth

http://www.pbs.org/wgbh/frontline/article/audit-fda-recall-process-puts-lives-at-risk/

QuoteThe federal Food & Drug Administration puts lives at risk by not moving swiftly enough on food recalls, according to an ongoing audit of the recall program by the Office of Inspector General for the Department of Health and Human Services.
QuoteSpecifically, the audit found that the agency would negotiate voluntary recalls, but then fail to either prescribe or enforce any timeline, leaving it up to companies to decide the pace at which they would proceed.

--------------------------------------------


"The biggest health reform bill since Obamacare, explained in 600 words"

Updated by Julia Belluz  @juliaoftoronto  julia.belluz@voxmedia.com   Dec 13, 2016, 2:44pm EST

https://www.vox.com/2016/12/2/13809984/what-is-21st-cures-act

QuoteBut health researchers have called the Cures Act "lipstick on a pig" and the "19th Century Fraud Act" for good reason. The bill offsets research spending by cutting public health spending. And critics worry the bill could seriously damage the regulatory authority of the Food and Drug Administration.

--------------------------------------------


"21st Century Cures Act will distort the meaning of 'FDA approved'"

By Reshma Ramachandran and Zackary Berger

December 1, 2016

https://www.statnews.com/2016/12/01/21st-century-cures-act-fda-approval/

QuoteAs members of the National Physicians Alliance (NPA), we have been closely following the 21st Century Cures Act legislation and its potential impact on what "FDA approved" would mean for new drugs and devices. Our interest in the 21st Century Cures Act emerged from overarching concerns among ourselves and other alliance members that the FDA's mission to protect public health by "assuring the safety, efficacy, and security" of new treatments was being hijacked by the pharmaceutical and medical device industries.

--------------------------------------------


"With media watchdogs on the sidelines, pharma-funded advocacy groups pushed Cures Act to the finish line"

Trudy Lieberman

http://www.healthnewsreview.org/2016/12/with-media-watchdogs-sidelined-pharma-funded-advocacy-groups-pushed-cures-act-to-the-finish-line/

Quote
The passage of the 21st Century Cures Act, which sailed through the House of Representatives last week on its way to a future White House signing ceremony, is due in no small measure to the activities of hundreds of patient advocacy groups and assorted other stakeholders that worked in overdrive the past two years pushing the bill to the finish line. Their lobbying and advocacy paid off with a 996-page bill that according to the Energy and Commerce Committee (whose slick lobbying campaign was also crucial) would "modernize" the FDA and its approval process while speeding the delivery of cutting-edge, lifesaving medicines to patients.
QuoteWhere was the dot connection between the 200 or so patient advocacy groups and their links to PhRMA?






Posted by LinksEtc
 - September 16, 2017, 03:03:48 PM
The 21st Century Cures Act — A View from the NIH

Kathy L. Hudson, Ph.D., and Francis S. Collins, M.D., Ph.D.

N Engl J Med 2017; 376:111-113January 12, 2017DOI: 10.1056/NEJMp1615745

http://www.nejm.org/doi/full/10.1056/NEJMp1615745#t=article

QuoteThe Cures Act, formally known as H.R. 34 or the 21st Century Cures Act,1 passed overwhelmingly in the U.S. House of Representatives and Senate in the waning days of the 114th Congress and was signed into law by President Barack Obama on December 13, 2016.
Quotethe final provisions are well worth heralding, including increased support for state efforts to combat opioid abuse, new steps aimed at improving mental health services, and important changes affecting the Food and Drug Administration and the National Institutes of Health (NIH)

--------------------------------------------


"The 21st Century Cures Act passes, potentially turning the FDA into a puppet of the pharmaceutical industry"

Posted by Orac on December 8, 2016

http://scienceblogs.com/insolence/2016/12/08/the-21st-century-cures-act-passes-turning-the-fda-into-a-puppet-of-the-pharmaceutical-industry/

QuoteBasically, the pharmaceutical industry and its lackeys in Congress bought off biomedical research advocates with the promise of more funding to the NIH and to efforts to combat the opioid crisis in the US. The price was a hole host of industry-friendly provisions weakening the FDA and producing new expedited pathways for drug approval, as well as permission to promote off-label drug use.
QuoteExpect more Vioxx disasters, now that the 21st Century Cures Act threatens to turn the FDA into a puppet of the pharmaceutical and medical device industry

--------------------------------------------


"Why Patients Support The 21st Century Cures Act"

Nov 30, 2016 @ 09:54 AM

Elaine Schattner

https://www.forbes.com/sites/elaineschattner/2016/11/30/why-patients-support-the-21st-century-cures-act/#603acec44dd3

QuoteI've seen stories suggesting that "Cures" is all about perks for pharmaceutical companies, and that industry-funded advocacy groups are parading patients, like puppets, before legislators to promote the bill.
QuoteI support most of the "Cures" provisions, for three big-picture reasons.


--------------------------------------------


"Winners and losers of the 21st Century Cures Act"

By Sheila Kaplan

December 5, 2016

https://www.statnews.com/2016/12/05/21st-century-cures-act-winners-losers/

Quote
More than 1,300 lobbyists roamed the halls of Congress on the Cures Act, and disclosure reports show most of them were working for pharmaceutical companies.
Quote
The $500 million designated for the FDA is meant to pay for the agency's new responsibilities under the Cures Act. There is virtually nothing in it to improve some of FDA's longtime problems.

The Government Accountability Office considers two of the FDA's areas of focus especially "high-risk": food safety and post-approval oversight of medical products that went through the fast track.



Posted by LinksEtc
 - September 16, 2017, 02:28:25 PM
"Trump wants to blow up the FDA. The drug industry? Not so much"

By Damian Garde  @damiangarde

February 1, 2017

https://www.statnews.com/2017/02/01/trump-blow-up-fda/

QuotePresident Donald Trump wants to remake the Food and Drug Administration. And he happens to have a "fantastic person" in mind to do it, he said Tuesday — someone who will turn the agency into an industry-friendly shop that cranks out new cures on the double.

---------------------------------------


"Peter Thiel vs. the FDA

Trump has tapped Thiel to help unleash the Silicon Valley mindset on the agency. Will it work?"

Updated by Julia Belluz@juliaoftorontojulia.belluz@voxmedia.com   Jan 31, 2017, 7:54am EST

https://www.vox.com/science-and-health/2017/1/31/14364090/peter-thiel-fda-trump-silicon-valley-oneill-gulfo-srinivasan-gottlieb

QuoteThiel, a libertarian iconoclast, has repeatedly made the case that the FDA gets in the way of drug innovation by making it too difficult for new medicines to get to the market. Some of the FDA candidates he's identified — including Silicon Valley's Jim O'Neill and Balaji Srinivasan — have similarly argued that the agency should dump its requirement that drugs be proven effective before reaching the market, and that we'd be better off if the FDA operated more like a "Yelp for drugs."
QuoteIt took the infamous scandal around thalidomide, a morning-sickness medication that caused severe birth defects, to strengthen the FDA

---------------------------------------


"The FDA is slowly getting weaker. Here's why that's dangerous."

Updated by Julia Belluz@juliaoftorontojulia.belluz@voxmedia.com   Dec 13, 2016, 3:10pm EST

https://www.vox.com/science-and-health/2016/12/12/13914068/fda-future-trump-jim-oneill

QuoteThe regulations that oversee the prescription drug industry and protect consumers from dangerous products are surprisingly fragile and young.
QuoteResearchers who study the agency say the agency's standards are slowly and methodically being eroded — particularly with the forthcoming implementation of the 21st Century Cures Act.