FDA

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"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

Makers 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.

The deal is part of a pact between the F.D.A. and the $148 billion device industry.

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"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

A 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.

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On the general topic of regulation ...

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"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

what 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.

one in, two out rule for regulation

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"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

Promising to cut "red tape," business-friendly politicians evidently judged that cost concerns outweighed the risks of allowing flammable materials to be used in facades.

Governments 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.

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"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/

"If there's a new regulation, they have to knock out two.

Trump 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.

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"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

the 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.

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"Trump's 2-For-1 Folly"

Omri Ben-Shahar

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

Regulations 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.

Over the past 35 years, federal regulations in most areas have been issued only if their benefits were shown to exceed their costs.

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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)

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"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

In 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. 

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"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

"I consider access to medicine a matter of public health," Dr. Gottlieb declared in a blog post

The 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.

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