US Politics

Crossie said:
For the last 30 minutes, I have been typing a long post to address your general question - then Redcafe crashed before I could hit the post button, and only few paragraphs were saved. I'll do a short version below. Don't hesitate to ask if something isn't clear: Drug registration is more complex than even health care professionals, let alone patients assume.

  • All countries have an independent agency that is legally responsible for drug registration and maintenance in that country; I mention maintenance because it is a publicly totally underestimated issue that requires a lot of staff both at agencies and companies.
  • Generally, what reviewers do when assessing an application is to draw conclusions about the benefit / risk balance of that drug (or combination of drugs). The three main review areas are efficacy, safety and pharmaceutical quality of the formulation.
  • Agencies have requirements for registration and do the assessment according to local guidelines that are designed for the specific population of their country in context of the medical landscape, climate and standard of living; in some countries also health care landscape.
  • Most agencies do an independent full assessment, including Chile's. It's not uncommon though that an agency wants to see Q&As and / or assessment reports from registration procedures of that drug at the FDA and/or EMA.
  • Some agencies refer to the assessment from bigger agencies (almost always FDA and/or EMA but possibly additional ones) - but only partially. That's what is happening i.e. in some African or Asian countries. Quality data are usually reviewed independently, sometimes combined with independent inspections of manufacturing sites of drug substance (pure pharmacologically active substance) and drug product (formulation = e.g. tablet, sterile solution, syrup, ointment). Most countries would also check if sufficient pharmacokinetics, pharmacodynamics, efficacy & safety data (PK = what's the body doing with the drug?; PD = what's the drug doing with the body?) are available to support the claimed indication and usage in the population of their country; there can be big differences between caucasians and non-caucasians, and the majority of data in pivotal trial (clinical trials designed to establish efficacy and safety) are still from caucasians.

Some background that IMO helps to get a better grasp of the complexity of the subject:
  • A drug gets registered by an agency on very specific conditions. The vast majority of these conditions are outlined in what the FDA names product information(PI), the EMA summary of product characteristics (SPC or SmPC), Health Canada product monograph (PM). The agencies decide word by word, comma by comma what gets in. Practically any changes, including fixing typos, require approval.
    PIs/SmPCs/PMs are available on the agencies' websites so everybody can read them.
    Patient leaflets / package inserts reflect what patients need to know from the PI/SmPC/PM in layman's language (ideally at least). That's where a lot of the complexity, i.e. from the indication wording of a drug, is removed from the patient's eyes but it is still relevant for regulators, prescribers and reimbursement bodies.
  • Most countries offer different types of licenses for drugs. That's a really complex world but as a rule of thumb, the main difference between them is that requirements differ in terms of robustness of evidence (and possibly obligations tied to a certain type of licence).
    Obviously, a company isn't entirely free to chose which type of licence it wants to obtain; it depends on the medical environment: A drug for a disease with no or only few insufficient treatment options in this country so far (e.g. limited efficacy, suboptimal safety profile) may qualify for a licence with fewer requirements but a drug that doesn't offer anything substantially new or better than existing treatment options qualifies only for a 'standard' licence.
Hope that helps.
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brilliant post. Thanks for taking the time.
Do biologics pose a specific challenge? I am thinking about the problem, that intellectual protection/patenting is a bit problematic around for them. It is hard to clearly define them as done with other drugs previously, because molecules might be marginally different. It is possible to design similar drugs around this IP protection. I am not entirely sure how much regulators are concerned by this, but this certainly affects them when it comes to the approval of generics (biosimilars). Due to marginal differences, you need additional clinical trials to show that these generics are really similar enough. Till 2010 there was imo not even a process for this at all and all biosimilars had to start from scratch, because they couldn't use the data of the corresponding biologic. That increased the price a lot. I know that BPCIA came into place with the ACA, but I don't really know what it changed.

Do you think that the current process is suited to deal with these drugs (also remembering, that drug development is costly and very risky) and might be too expensive?
 
PedroMendez said:
brilliant post. Thanks for taking the time.
Do biologics pose a specific challenge? I am thinking about the problem, that intellectual protection/patenting is a bit problematic around for them. It is hard to clearly define them as done with other drugs previously, because molecules might be marginally different. It is possible to design similar drugs around this IP protection. I am not entirely sure how much regulators are concerned by this, but this certainly affects them when it comes to the approval of generics (biosimilars). Due to marginal differences, you need additional clinical trials to show that these generics are really similar enough. Till 2010 there was imo not even a process for this at all and all biosimilars had to start from scratch, because they couldn't use the data of the corresponding biologic. That increased the price a lot. I know that BPCIA came into place with the ACA, but I don't really know what it changed.

Do you think that the current process is suited to deal with these drugs (also remembering, that drug development is costly and very risky) and might be too expensive?
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Very welcome. I purposefully didn't elude on the whole patent issuses and likewise not on what is known as 'data protection' or 'data exclusivity' which are entirely different animals to IP but of utmost importance to originators and generic companies likewise. I can expand if you're interested.

Biologics and their equivalent of generics, so-called biosimilars, do indeed add additional challenges, including the ones you indicated.

Three generally applicable comments before I come back to biosimilars:
  • Regulatory guidelines lag by nature always behind actual scientific development.
  • Regulatory guidelines cannot address all possible situations one encounters during drug development.
  • For the two reasons above, most agencies offer companies specific scientific advice if requested by the company. It gives companies the opportunity to ask specific questions what the agencies' view on specific challenges is. The advice is not binding though.

Back to biosimilars. Keeping the two first bullets above in mind, agencies generally require the demonstration of similarity or interchangeability, including clinical data, including efficacy and safety. However, the approach from agencies how to demonstrate the latter can vary (study design, e.g. treatment schedules, efficacy measures, statistical power = sample size, ...).
What an individual agency will require for a specific biosimilar highly depends on the nature of the specific reference drug (biologic) and biosimilar: Complexity, purity and characterization of the substance, manufacturing processes etc.

Remember that the slightest change in a manufacturing process can have impacts on safety and efficacy - even when you manufacture simple, 'traditional' 'chemical entities/molecules. That's why extensive quality data are part of every drug application dossier. In the quality module, the manufacturing (among other things) are outlined in great detail. If a company wishes to make changes to the dossier (which happens quite often during the life cylce of a drug product), approval is required for almost everything. You can imagine that this is even more applicable and important to biologics and biosimilars.
If a company is convinced that they have compelling evidence that efficacy and safety of their biosimilar can be extrapolated from existing data rather than established in a clinical trial, it's advisable to seek scientific advice from key agencies (FDA, EMA, but depending on the targeted market also others). Bear in mind though that the advice is not binding and that you can be unpleasantly surprised once you submit the application and it might not be accepted.

I am content with the general approach. Remember that agencies are responsible that only drugs enter the market that have a positive benefit / risk ratio, regardless of the accessibility of that treatment. It's very similar to the German TÜV: You won't get TÜV for a car that's considered insufficiently safe just because you can't afford one that is.
If efficacy and safety of a drug cannot be sufficiently established, a drug shouldn't be on the market, whether it's a new chemical entity, a new biologic, a generic or a biosimilar.

HTH.
 
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@Crossie

I remember vaguely about the first RNAi drug - it was approved (at an extraordinary cost) in Europe but not in the US. IIRC it was to treat some eye disease. Do you know if the manufacturers tried to get it in the US? And why the US FDA rejected?
 
Black people are snowflakes
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Black people are lazy
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Black people are dumb
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Better not be marrying a black guy/girl
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This actually isn't that bad....
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https://www.washingtonpost.com/news...-a-new-high/?tid=sm_tw&utm_term=.5b689819ec49
 
As someone who teaches, I'm giving them the benefit of the doubt until I see more evidence... they probably did send notes, and made phone calls, etc. to no avail.

I've attempted to contact parents a dozen times before about their kids grade, then when the kid fails, they act like they knew nothing was wrong.
 
Interesting Washington Post article about rural America and the rise in people drawing disability...
Between 1996 and 2015, the number of working-age adults receiving disability climbed from 7.7 million to 13 million. The federal government this year will spend an estimated $192 billion on disability payments, more than the combined total for food stamps, welfare, housing subsidies and unemployment assistance.

Across large swaths of the country, disability has become a force that has reshaped scores of mostly white, almost exclusively rural communities, where as many as one-third of working-age adults live on monthly disability checks, according to a Washington Post analysis of Social Security Administration statistics.
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Disabled or just desperate? Rural Americans turn to disability as jobs dry up - The Washington Post
https://apple.news/Aw-gFq4DITe-wFtbGZfZp8Q
 
Population has also increased by over 20% and obesity rates doubled. Obesity also more common in rural areas. It's a bit sensationalist to just compare the numbers. 700 dollars sounds meager.
 
berbatrick said:
For 18 years, I thought she was stealing my identity. Until I found her
A woman apparently using my name meant a nightmare of unpaid traffic fines and a criminal record. But when I tracked her down, a different story emerged


https://www.theguardian.com/us-news/2017/apr/03/identity-theft-racial-justice

Really good article! Reads like the premise of a novel with a socially aware theme.
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That's some crazy stuff, but unfortunately very believable. My brother recently had to go back by the local police dept because they gave him the wrong traffic incident report after he was in an auto accident. He's supposed to send the form to insurance and the DMV in 15 days or risk a fine but he wasn't even a name on the form.
 
The Fine Print On The Country's Biggest-Ever Free College Plan

New York State has passed legislation that would create the largest experiment in the country to offer free tuition at two- and four-year colleges. The Excelsior Scholarship, approved over the weekend as part of the state budget, would cover full-time students in the State University of New York system, which totals 64 campuses and 1.3 million students.

New York Gov. Andrew Cuomo, a Democrat, appeared with Sen. Bernie Sanders of Vermont and state education leaders in an event hailing the new program, which would begin this fall and is estimated to cost $163 million per year.

Students from families making up to $100,000 a year would be eligible in the program's first year, and by the third year that would increase to $125,000 a year.
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http://www.npr.org/sections/ed/2017...n-the-countrys-biggest-ever-free-college-plan



But as the headline says, the full article goes on to reveal an important catch or two. One such, is a requirement to work in the state of New York for a minimum number of years following graduation.
 
Big Pharma Funds “Independent” Advocacy Groups Attacking Drug-Price Reduction Bill

The ATR ad, which goes on to call for preserving the “free-market elements of the Medicare system,” declares, “Keep Government Bureaucrats Out of Medicare Part D!”

“I found this ad particularly strange,” Peter Maybarduk, the director of Public Citizen’s Access to Medicines program said, given the group’s ostensible devotion to tax reduction. “The problem with high drug prices is one of monopoly power. We do have government bureaucrats involved; they’re giving monopolies to the companies through patents and other exclusivities.”

It might appear odd for groups such as ATR and ACU to claim that Medicare’s prescription drug policies, which were designed by drug company lobbyists to prevent competitive bidding, reflect free-market values. And why would ATR, a group devoted to tax issues, spend a large amount of money on ads that have nothing to do with taxes?

One thing both organizations have in common is the same longtime financial sponsor. PhRMA, which is required to disclose grants to other nonprofits on its annual tax return, provided ATR with $746,000 between 2010 and 2014. The American Conservative Union has received $100,000 from PhRMA during the same period.

ATR was founded by Grover Norquist, a former corporate lobbyist with a long history of using his nonprofit group to advance the interests of donors. In 2006, a congressional report found that lobbyist Jack Abramoff coordinated closely with Norquist to arrange special policy favors for his clients. In one email, Norquist requested a $50,000 donation to ATR in exchange for his group moving to oppose taxes on Brown-Forman products. The report further found that Abramoff arranged opinion columns authored by Norquist in support of Abramoff’s client goals in exchange for cash.

Franken’s Improving Access to Affordable Prescription Drugs Act would also allow for the re-importation of FDA-approved drugs selling for less abroad. It quickly gained 15 co-sponsors, including Sens. Bernie Sanders, I-Vt., Elizabeth Warren, D-Mass., and Richard Durbin, D-Ill.
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PRIVATE PRISON CORPORATION WROTE TEXAS BILL EXTENDING HOW LONG IMMIGRANT CHILDREN CAN BE DETAINED
A BILL WRITTEN by a private prison operator to assist its immigration detention business could advance through the Texas state Senate this week, despite vocal protest from civil rights groups. The legislation would allow family detention centers to be classified as childcare facilities, enabling Immigrations and Customs Enforcement to detain women and children for longer periods.

The bill aligns with the Trump administration’s punitive immigration policies and helps it navigate a challenge to federal detention policy.

During the migrant influx of 2014, the Obama administration contracted the construction of two giant family detention centers in south Texas — one for each of America’s biggest private prison companies — to hold women and children seeking asylum. CoreCivic runs the South Texas Family Residential Center in Dilley, and the Geo Group manages the Karnes County Residential Center.

However, because of multiple judicial rulings dating back to 1997, no undocumented child can be held for over 20 days in anything but a licensed “non-secure” childcare facility.

Almost nothing about these detention centers meets that definition. Grassroots groups have given them the grim nickname “baby jails,” and a survivor of a WWII-era Japanese internment camp said the facilities “triggered distressing associations of my own experience as a child.” Reports of inadequate medical care, sexual abuse, improper solitary confinement, and permanently stunted child development proliferate. Most of all, the presence of locks on the doors contradicts the idea of a non-secure facility. “They’re not allowed to leave. That’s jail,” said Mary Small of the Detention Watch Network, a national coalition working on immigration issues.

The Texas Department of Family Protective Services granted the facilities childcare licenses, but last year a state judge blocked the designation. So Geo Group, the nation’s second-largest private prison operator, went to work assembling legislation that would countermand the judicial ruling. The bill would lower state childcare standards for family detention centers, excluding the facilities from regulations such as ones that prohibit housing children and unrelated adults in the same room.

Republican State Rep. John Raney admitted to the Associated Press that Geo Group officials wrote the legislation. “I’ve known the lady who’s their lobbyist for a long time. … That’s where the legislation came from,” said Raney. “We don’t make things up. People bring things to us and ask us to help.” There’s companion legislation in the state House and Senate.
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Geo Group has a lot riding on expanding immigration detention. It runs the federal case management system for family detention and has committed significant resources to adult detention facilities, which don’t house women or children. The Trump administration just granted Geo Group a $110 million contract to build a 1,000-bed detention facility in Conroe, a small town outside of Houston. The mayor of Conroe, already home to a 1,500-bed Geo Group facility, didn’t know about the new contract until he read about it in press reports.

Geo Group made what appears to be an illegal $225,000 donation to a Trump-supporting Super PAC during the 2016 presidential election. Government contractors are barred from political donations of this type. The company also spends heavily in Texas, including $320,000 to lobby the state legislature in the first four months of this year.
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Thoughts on the new China-USA trade deal? I'm very skeptical it will turn out to be advantageous for the American financial services industry, given how much state control China still has in that industry. Interesting to see exactly what the full details of the deal are but it is significant that China are making any of these concessions at all, though they do have a history of not living up to agreements.
 
Jeff Sessions gonna Jeff Sessions....


https://www.washingtonpost.com/world...=.fa1e408d7bcc

Attorney General Jeff Sessions overturned the sweeping criminal charging policy of former attorney general Eric H. Holder Jr. and directed his federal prosecutors Thursday to charge defendants with the most serious, provable crimes carrying the most severe penalties.

The Holder memo, issued in August 2013, instructed his prosecutors to avoid charging certain defendants with drug offenses that would trigger long mandatory minimum sentences. Defendants who met a set of criteria such as not belonging to a large-scale drug trafficking organization, gang or cartel, qualified for lesser charges — and in turn less prison time — under Holder’s policy.

But Sessions’s new charging policy, outlined in a two-page memo and sent to more than 5,000 assistant U.S. attorneys across the country and all assistant attorneys general in Washington, orders prosecutors to “charge and purse the most serious, readily provable offense” and rescinds Holder’s policy immediately.
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What an odious little shitstain he is.
 
PedroMendez said:
https://www.ronjohnson.senate.gov/p...eases?ID=5E5BE361-A538-4CD6-8E57-BEA2B03939BC


decent and pragmatic proposal to improve immigration.
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How would this work in terms of a company moving a worker across state lines? For example, could a Californian company hire someone and get them a work visa, then send them to work in Ohio? Or would you need a work permit granted by the state you are working in?

Also, how do they determine how many visas each state gets to grant? Or does the state decide that?
 
the proposal would allow states, not companies, to sponsor workers. Workers wouldn't be tied to a specific employer, but the visa is only valid for the state, that sponsored it. The bill would allow additional cooperation between individual states if they wish to do so (e.g. Texas and New Mexico could agree, that their visas also count in the other state). Being able to change job would strengthen the position of employees and reduce exploitation.

At the beginning each state would get 2500/5000 (both numbers are floating around) + there is a national pool of 125.000/250.000, that each state could additionally draw up on based on certain variables (e.g. population). The cap would also depend on compliance of the VISA holders with the law. When 97%+ of the guest workers in a state complied with everything, the cap goes up, otherwise the cap is getting reduced. That would ensure that states have a vested interest to make sure that "their" visa holders don't just run off and join the black market.
Nation wide that would add another 250.000-500.000 visas, but once established the number could be increased, if the system works.
 
Thanks for the info @PedroMendez. That does indeed then sound like a workable proposal. Presumably this might also reduce the burden of visa sponsorship on small businesses, allowing them a more equal footing with big companies when it comes to hiring foreign workers.
 
Sharp contrast from the effectiveness of the GOP at state level is the clownshow at the top

 
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