Economy U.S Government vs. Big Pharma: Drug industry poised for rare political loss on prices

[Thunderflash500]

HAHAHAA. At every turn we're seeing the benefits of electing someone who didn't take money from big lobbyists.

To Democrats not taking money = politically inexperienced and bad. Therefore Clinton was the most experienced candidate in history.

 

[Thunderflash500]

I think if foreign drugs (much of which are really American patented pharmaceutical innovations, produced by a third party under license for localized regional consumption) be allowed to be exported to the U.S market, both governments will have to come to an agreement as to who would be held responsible (i.e, sued up the ass) if something go south.

If Mexico is to export those generic brands that are "cheaper than junkfood", whose bank account is going cover the lawsuits from the American consumers if some batches are tainted? Is it the Indian companies that built and owns the drug factories in Mexico? or is it the Mexican government agencies that regulate, overseen, and approve their production quality for export?

That's certainly something that should be addressed when NAFTA is being overhauled.

This is a minor issue most likely.

 

[Arkain2K]

This is a minor issue most likely.

Legal liability always seems like a minor issue, until that first multi-million dollars class-action lawsuit.

It would actually be a non-issue if an exporter with deep pockets and a foreign government entity steps up and say "We have thoroughly tested and hereby guarantee that our inexpensive locally-produced generic pharmaceutical products are up to the same quality and safety standard as the expensive FDA-approved brand-name drugs produced in the U.S."

Strangely enough, no foreign drug manufacturers (and their government regulators) are willing to provide quality assurance to the American consumers for the drugs rolling off their own production lines, and that reluctant to guarantee safety is a sticking point that provides ammunitions to those who are against imported drugs, businessmen and politicians alike.

So yeah, something has got to change. Bernie's proposal is for SAFE and AFFORDABLE imported drugs, afterall.

 

[Sir Galahad]

Thread Index:

• Why Big Pharma should be afraid. Very afraid (Jan 13, 2017)
• Huffington Post Editorial: Cory Booker And A Bunch Of Democrats Prove Trump Right On Big Pharma (Jan 12, 2017)
  
• Trump's Drug-Price Stance Puts Pharma on Notice (Jan 12, 2017)
• Drug Stocks Plunge as Trump Threatens to Force Price Bidding (Jan 12, 2017)
• Trump pharma bomb has industry leaders hunkered down in shock (Jan 12, 2017)
  
• Trump on drug prices: Pharma companies are ‘getting away with murder’ (Jan 11, 2017)

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Trump on drug prices: Pharma companies are ‘getting away with murder’
By Carolyn Y. Johnson
January 11, 2017

​

SAN FRANCISCO -- At his first news conference as president-elect on Wednesday, Donald Trump accused the pharmaceutical industry of “getting away with murder” and said that he would change the way the country bids on drugs to bring prices and spending down.

“Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs,” Trump said during the event at Trump Tower in New York. “We’re the largest buyer of drugs in the world, and yet we don’t bid properly.”

Federal law forbids the government from negotiating with drug companies to bring down the price of drugs for seniors using Medicare. While Trump did not announce a specific plan to address the issue, he has in the past called for ending the policy -- a proposal that Democratic lawmakers have repeatedly put forward.

The comment dropped a bomb into the middle of the drug industry’s major annual investor conference underway in San Francisco this week, sending pharmaceutical and biotech stocks plunging. The iShares NASDAQ Biotechnology Index closed down 3 percent Wednesday.

Speaking at the JP Morgan Healthcare Conference, Mylan Pharmaceuticals chief executive Heather Bresch, who has been under scrutiny for her company’s repeated list price increases on the lifesaving allergy drug EpiPen, said that it would be “premature” to respond to the president-elect’s comments because his specific plans are unknown. But she said the growing public outcry over the cost of drugs has convinced her that the system must change.

“If anybody is walking away from this conference thinking ‘business as usual,’ I think that’s a mistake,” Bresch said. “The pricing model has got to change. It’s not incremental change; I don’t think that’s what this country needs. I think it’s truly rethinking the business model.”

Pharmaceutical company AbbVie announced during the conference that it would temper its drug prices to single-digit increases annually, following similar announcements from Allergan and Novo Nordisk in recent months.

The announcement was unrelated to Trump’s comments, which came as the company was giving a presentation at the conference. Chief executive Richard Gonzalez said he had little insight into what Trump’s criticism would mean for the industry.

“I don’t have a crystal ball as to what changes the president has in mind,” he said.

In a phone interview, Allergan chief executive Brent Saunders pointed out that, in many respects, the expected pro-business agenda under Trump and a Republican Congress — such as corporate tax reform — will benefit the industry. But public anger about drug prices remains a vulnerability, he added.

Saunders has been outspoken that drug companies should show restraint in pricing to avoid a government intervention that could stifle the industry.

“Unfortunately, this is what I was worried about,” Saunders said. “It’s a complete contradiction to say the industry is getting away with murder when the industry is committed to saving and improving lives.”

He said Trump’s comments could have far-reaching implications, scaring investors away from the health care space.

“It goes to show the sentiment, and that causes investors that aren’t health-care specialists pause, in terms of investing in health care,” Saunders said. “It could cause investors in venture capital to have pause in putting money long term into health care, and it could stifle innovation.”

Rep. Peter Welch (D-Vt.) introduced a bill last week that would allow for Medicare negotiation. A 2007 Congressional Budget Office analysis found that the ability to negotiate alone for Medicare’s prescription drug benefit could be fairly toothless, having a “negligible effect on Medicare drug spending” without the ability to set prices or exclude drugs from coverage altogether by creating a formulary.

Trump also criticized drug companies for “leaving left and right,” potentially a reference to “tax inversions,” in which companies merge with foreign companies to relocate their headquarters in countries with more favorable tax rates. And he denounced the companies for manufacturing their products abroad.

Ronny Gal, an analyst with Sanford C. Bernstein and Co., said that many drug manufacturers have been gradually moving manufacturing overseas, particularly generic manufacturing.

Several chief executives said they would welcome the chance to increase manufacturing in the United States, if the business and tax climate were more favorable -- something that many hope will change under Trump.

Regeneron chief executive Leonard Schleifer said its largest manufacturing capacity is in the U.S., though the company also has a plant in Ireland.

“There’s plenty of manufacturing that does go offshore, but drugs are also sold offshore,” Schleifer said. “The fiscal and tax policies are going to make a difference here.”

https://www.washingtonpost.com/news...ting-away-with-murder/?utm_term=.c7af794890e6

Booker took too many shots to the head playing football. He's just a dumb motherfucking has been now.

 

[RockstarChris]

pills are like cigarettes. they cost 1 cent to produce but after all the government taxes, regulation, and profit you are paying like 5 bucks a pack (7 in cali)

 

[Arkain2K]

Booker took too many shots to the head playing football. He's just a dumb motherfucking has been now.

Or a simpler explaination would be that Big Pharma has a large presence in his home state, contributed a large amount of lobbying dollars, and now he's voting in their interests.

 

[Rod1]

I think if foreign drugs (much of which are really American patented pharmaceutical innovations, produced by a third party under license for localized regional consumption) be allowed to be exported to the U.S market, both governments will have to come to an agreement as to who would be held responsible (i.e, sued up the ass) if something go south.

If Mexico is to export those generic brands that are "cheaper than junkfood", whose bank account is going cover the lawsuits from the American consumers if some batches are tainted? Is it the Indian companies that built and owns the drug factories in Mexico? or is it the Mexican government agencies that regulate, overseen, and approve their production quality for export?

That's certainly something that should be addressed when NAFTA is being overhauled.

1.- Most drugs are already off-patent, i think you missed the article i pointed out that drug companies are more and more investing into "me too" drugs or changing a molecule in a drug so that they can patent it again and then spending millions on advertising telling you how this new medicine (that turns into a medicine that has been in the market for 30+ years once it hits the bloodstream) is magical, while doctors receive kickbacks for promoting an specific brand (something illegal in Mexico and i would assume most quasi-developed countries out there).


2.- You do realize that the manufacturing of medicines is not rocket science right? i would assume that companies would be overseen by the country regulatory body to ensure that the product itself contains what its actually printed on the label.


3.- What does India has anything to do here? Mexico has a long history of manufacturing its own medicine, its not central Africa down here.


4.- I certainly hope that NAFTA doesnt addressed medication, it does address IP protection and thus here in Mexico we respect patent medicine until it expires, but then again 95% of the medicine you actually need is already off-patent, its a nice little racket that big Pharma has going on in America.

 

[Rod1]

Legal liability always seems like a minor issue, until that first multi-million dollars class-action lawsuit.

It would actually be a non-issue if an exporter with deep pockets and a foreign government entity steps up and say "We have thoroughly tested and hereby guarantee that our inexpensive locally-produced generic pharmaceutical products are up to the same quality and safety standard as the expensive FDA-approved brand-name drugs produced in the U.S."

Strangely enough, no foreign drug manufacturers (and their government regulators) are willing to provide quality assurance to the American consumers for the drugs rolling off their own production lines, and that reluctant to guarantee safety is a sticking point that provides ammunitions to those who are against imported drugs, businessmen and politicians alike.

So yeah, something has got to change. Bernie's proposal is for SAFE and AFFORDABLE imported drugs, afterall.

You think drugs in Europe, Canada and other first world countries arent safe? Its not that hard really to make a drug that has been in the market for decades and not that hard to test them to a good standard of safety.

Most foreign companies ill assume dont want to risk being liable in the American market and a regulatory agency that its outright being controlled by corporate interests.

Or being held to ridiculous class action lawsuits that may or may not be won because random dudes picked from the street are capable of understanding scientific evidence (in a country where a lot of people think vaccines cause autism). Ex. Johnson and Johnson talc lawsuit.

 

[Sir Galahad]

Or a simpler explaination would be that Big Pharma has a large presence in his home state, contributed a large amount of lobbying dollars, and now he's voting in their interests.

He was a can at Stanford.

 

[Deleted member 457759]

Donald Trump didn't offer a single free phone to black people during the campaign.

Racist.

 

[Arkain2K]

USA Today: Trump's right about drug prices
USA TODAY
Jan. 16, 2017​

Donald Trump has certainly gotten the pharmaceutical industry's attention with his ruminations about drug prices. Within 20 minutes of last Wednesday's news conference, in which the president-elect called for the government to negotiate directly with pharmaceutical companies, the industry shed roughly $25 billion in stock value.

Trump is nothing if not blunt, and in this case, he happens to be right. Drug companies are, he says, “getting away with murder. We’re the largest buyer of drugs in the world, and yet we don’t bid properly, and we’re going to save billions of dollars.”

As with many of Trump's proposals, exactly what he has in mind is somewhat murky. But he has hinted at two things: jawboning the drug industry, much as he has done with defense contractors and manufacturers, and allowing the government to bargain directly with drug companies.

Medicare's inability to negotiate over prices is one of the biggest tragicomedies in all of government. The situation stems from the 2003 law that created Medicare's "Part D" drug benefit but mandated that the job of negotiating would be farmed out to myriad insurance companies that don't have government's pricing power to buy in bulk.

The argument used by Big Pharma and its congressional allies to sell this unusual procedure was — and we’re not making this up — that negotiating directly to save taxpayer money constituted Big Government.

It is time to drop this ridiculous pretense, and it can be done entirely separately from the GOP's poorly conceived effort to "repeal and replace" the Affordable Care Act, also known as Obamacare.

Government wouldn’t refuse to negotiate directly over a new aircraft carrier or an interstate highway bridge. Why should it over drugs? When spending taxpayer money, government should not spend more than it has to.

This is especially true for Medicare, which is expected to spend more than $1 trillion over the next decade on prescription drugs. Government should not pick winners and losers among individual drug companies. But it can and should use its leverage as the world's largest purchaser of prescription drugs.

Estimates on how much money could be saved through direct negotiation vary, depending on how the negotiating would take place and who is doing the estimate.

The best estimate is from the non-partisan Congressional Budget Office, which said a plan by President Obama could save $121.3 billion over 10 years just from low-income beneficiaries.

Trump might be the one person who can challenge the powerful drug lobby and finally talk some sense into Republicans on this matter. He has changed the party’s doctrine for the worse on many issues, including trade and deficit spending. Now is a chance for him to change doctrine for the better.

http://www.usatoday.com/story/opini...amacare-medicare-editorials-debates/96638534/

 

[Arkain2K]

hi Arkain2k,

it's interesting seeing President elect Trump go after various US businesses and costing investors money.

very Presidential.

i'm assuming if he can sink the stock valuation of US pharma and biotech corporations low enough, that'll really bring down the cost of their medications.

- IGIT

Ridiculous.

Your silly game of Mental Gymnastics is not something I want to participate in, so I'll allow the business analysts at CNBC to take you to school.

CNBC: There's only one way Big Pharma can survive Trump
By Jake Novak
Wednesday, 11 Jan 2017

He talked about the Russia scandal. He talked about divesting from his businesses. But the one thing that came out of President-elect Donald Trump's long-awaited news conference Wednesday that could affect the most Americans in the most vital way was his unexpected targeting of the drug industry. Trump wants drug prices down and it's past time for that industry to get serious about making a deal.

Trump's words had an immediate impact on pharma and biotech stock prices. They tanked. But the longer term impact could be much more profound. He has pointed out the problem of higher drug prices before, but the way he defined the drug industry Wednesday was something new.

First, he talked about the drug industry a manufacturing industry. And just like the way he's singled out car companies, he talked about how the drug companies are leaving the U.S., but still selling their products here. This important definition/characterization opens the door to a whole new way of negotiating with the drug companies.

All of sudden, it's possible for them to be like Carrier or Ford or Fiat Chrysler and try to curry favor with the new president by promising to bring back or save U.S. jobs in its remaining drug manufacturing plants. If the Big Pharma CEOs are smart, they should start thinking about doing that right away.

But unfortunately for them, Trump didn't stop there. He reminded the audience that the U.S. is the biggest buyer of drugs in the world and he went on to promise a better bidding procedure to get prices down. The most memorable moment may have been when he described the drug industry with the loaded and powerful term: "they're getting away with murder." Now you know why those drug stocks tanked so fast.

Of course Trump is right, the U.S. government alone is the biggest buyer of drugs in the world through Medicare and Medicaid. Those two programs for older and poorer Americans, respectively, actually make us the biggest single payer health care system on Earth even though we also have a private insurance system for everyone else.

It's always been puzzling to businessmen and businesswomen in America why our government doesn't use that leverage to negotiate lower prices on all prescription drugs. But they're forgetting the great wisdom of Nobel Prize winning economist Milton Friedman, who always taught that the worst price inflation comes when someone in the government is in charge of using someone else's money to provide goods and services to yet another party. Trump is essentially promising to change all that and he seems poised to hire just enough non-government bureaucrat types in his cabinet to actually make it happen.

But speaking of politics, the political support for this kind of "get tough" policy with the drug companies is very high. Just imagine if President Obama or Senator Elizabeth Warren had used those exact, "they're getting away with murder," words about Big Pharma. The entire liberal and a great deal of the moderate voter bases would be cheering loudly. Trump has the added burden of actually having to deliver on reducing drug prices before he gets those kinds of cheers, but at least he can count on his efforts to do so being very popular along the way.

And that's not only bad news for the drug companies, but all the other countries in the developed world who benefit from the fact that we pay more for the same drugs. In other words, Canada, Britain, France, etc. only pay less because the drug companies make up those losses or lower profits by charging America more. Their party could soon be over. But that's a big part of the new definition of "America first."

So, should everyone start to expect lower prices and potentially significantly lower profits for drug companies? Should investors take their money out of the entire pharma sector? Worse yet, will the long-held conservative belief that essentially enforcing price controls on these products lead to drug shortages and stunted medical innovation? There's a very good chance both of those ill effects could result based on what we've seen before with even essential drug treatments like the flu vaccine. Is there a way out of all of that?

The answer could be yes if Trump and his team follow through on their promise to be real, non-political deal makers. Trump loves that image of being a businessman and not a politician and a politician would be more than happy to see prices go down no matter what the longer term effects would be.

But if the drug companies do have a sympathetic ear of a fellow business leader at the table, they could get somewhere by describing their liabilities and other costs that they say force them to charge so much for certain drugs. If they're smart enough to ask for some government relief in that area, from drug tort reform to bigger tax breaks for costly research and development, some kind of price relief just might happen without those worst case scenario side effects.

And finally, there's a chance the two sides could meet in the middle when it comes to regulatory relief. Helping the industry get more new drugs to market quickly is something a Trump administration could do with everything from relaxing the FDA approval process to allowing terminally ill patients easier access to experimental drugs.

The bottom line is that after Wednesday's news conference, Big Pharma better be ready to deal with the Trump team for real. And "ready to deal," does not mean hiring more or better lobbyists like it has in the past. The drug industry definitely has some things to offer the new administration to soften the blow, but Trump wants drug prices to go down and he has the power to make life very unpleasant for the companies that don't comply.

http://www.cnbc.com/2017/01/11/how-big-pharma-can-survive-trump-commentary.html

 

[lifelessheap]

As a father of a six year old asthmatic I've got plenty of direct insight into this and yes, it sucks. A lot of these inhalers used to be generic but the CFC ban allowed pharma to patent a new delivery system. There was a push to exempt asthma medication from the ban but pharma lobbied the govt not to allow the exemption. Here you see the confluence of govt, the environmental lobby and big pharma. This is why anti establishment voices and personalities are so important to us.

Sick children that can't breathe cause GLOBAL CLIMATE CHANGE. You filthy father, you should pay 10000x if you think your children should freely suck the air after using a decades old technology that literally shoots lazer beams through the ozone layer.

But really, how fucking retarded is our government. Banning CFC in inhalers. They have zero impact on anything in the environment.

Marx said one of the best ways to control and manipulate an economy was to control the "environment."

argh

 

[Arkain2K]

The Future Of Pharma In The Age Of Trump
Patrick Cox
Jan 19, 2017

Last week, Donald Trump complained about drug prices in a press conference. Drug companies, he said, are “getting away with murder.” During that presser, pharma and biotech stocks lost over $20 billion in value.

Investors should have learned an important lesson. They probably didn’t.

Trump’s targeting of drug sellers was not a fluke. Hillary Clinton's "price gouging" tweet last September had the same type of impact on markets.

For those who understand the big picture, these two events offer clues about the future of the drug business.

The real problem isn’t drug pricing

The big picture is pretty simple. Healthcare costs will continue to rise even if drug prices go down. At most, medicines account for about 15% of the national medical bill. They’re not the reason that costs are rising. But, they are easier to attack than hospitals and doctors.

Here’s the real problem: America is broke. Worse than broke, actually. This is because of healthcare costs. These costs are the number one driver of federal spending (as well as the deficit and debt). As President Obama learned, those costs are hardcoded into the system.

Healthcare costs are rising not because of greed or inefficiency (though there are plenty of both). They're rising for demographic reasons. And they’re rising faster than we can repay the trillions we’ve already borrowed. The unfunded liabilities for future healthcare are even more of a problem.

As a result, our fiscal policy choices will be increasingly limited and ineffectual. Politicians and the public will demand that “something be done.” And that “something” will mean greater government involvement in drug pricing.

Let me explain why this is inevitable. As the Congressional Budget Office has pointed out, age-related healthcare costs and the associated debt service are the only part of the federal budget that’s growing in proportion to the whole. (Increases of approximately 9% in these programs are mandatory and automatic.)

Source: CBO

The graph above is quite sobering, but you should read the CBO’s statement below it. Note that “growth in the major health care programs… and Social Security is projected to exceed the decline in other noninterest spending relative to GDP.”

Here’s why healthcare costs are rising

The CBO clearly points to age-related disease as the culprit. Simply put, we are living longer. Healthcare costs rise exponentially with age, and the percentage of the population that is older is growing. This is simple math, but our leaders seem to be in denial over this macroeconomic reality.

This graph, based on data from the HHS Administration on Aging, makes the trend clear.

Source: CBO

This aging of the population is only one half of a bigger change… often called the flipping of the demographic pyramid. It’s taking place throughout the world. But the trend is growing fastest in the West.

The effect of the baby bust

In the past, when birthrates were higher, longer life spans and a larger aged population wouldn’t have been a problem. Today though, birthrates are too low to provide the younger workers that we need to pay for our increased medical costs.

In fact, CDC data show that the US fertility rate fell last year to its lowest since 1909 (when tracking began). This puts our fertility rate at about 1.8 births per woman. At least 2.1 births are required to replace the existing population and maintain the old-age dependency ratio (OADR).

In other words, the pool of younger workers (contributors) is shrinking… while the aged population (dependents) is growing. Our already untenable OADR is getting worse.

Optimists say that the birthrate will rise when the economy improves. It may to some degree, but US birthrates have been well below replacement rate since 1972. This is true even among immigrants. This interactive chart by the WHO shows just how dire the picture is.

Even if by some miracle, we could return to 1950s birthrates, it wouldn’t help. Why not? Babies born now won’t become working contributors for decades. Likewise, most immigrants don’t become net contributors for decades either.

The issue is that we don’t have that long to fix the problem.

The politics of the demographic shift

The political consequences of this change are huge and are not widely recognized. We can’t afford to pay the rising cost of healthcare for the aged. Nor is it possible (politically) to reduce their level of care.

In the news, we’ve heard a lot of talk about the changes in political demographics. But most reports make the mistake of focusing on ethnicities. As such, they ignore the biggest demographic change in history—the growth of the most powerful of all political blocs… the aged.

This proverbial third rail will not go quietly into the night. So politicians will try anything to put off the day of reckoning.

Most investors and politicians don’t get it. Many are in full denial. But it’s time to face facts; we're entering the Trumpian age of the deal. Big pharma’s ability to set prices will give way to political pressures.

The future outlook for pharma

There are ways to deal with this situation… and even profit from it.

One is to shift from big pharma, ETFs, and companies that sell older existing drugs and invest in biotech startups. Big pharma will claim that reduced profits on widely used drugs will limit their ability to acquire new drugs. But it may, in fact, incentivize drug discovery.

Pharma tends to be slow to replace very profitable drugs with something newer and better. The Trump Administration could make new drug development more attractive by following through on its promise to reduce regulatory hurdles.

New and better drugs can reduce total healthcare spending, not just drug costs. A significantly superior cancer drug, for example, would cut hospital and physician costs.

Even more exciting is the work in geroprotectors. These are drugs that could prevent (rather than treat) cancers and other age-related diseases. But these drugs are difficult to approve because prevention may take decades to prove with finality.

If I were Trump, I would reach out directly to the aged community. He could enlist their help to move the most promising and safest geroprotectors into the market. There are compounds, currently stalled by regulators, that have shown tremendous efficacy in animals. I think they could effectively rejuvenate older individuals and return some degree of health and vigor. Since most people are forced to retire due to their or their spouse’s health, this could repair the dependency ratio.

A more immediate solution has ironically come from the company that inspired the fateful Clinton tweet, Turing Pharmaceuticals. You may recall that “pharma bro” Martin Shkreli founded the company and then increased the price of Turing Pharmaceutical’s older antibiotic Daraprim by more than 5,000%. (Daraprim is a life saver for a few thousand Americans who suffer from the parasitic disease toxoplasmosis.)

Shkreli then targeted another company, KaloBios, for the same strategy. Shkreli's brief involvement nearly destroyed the company and investors looked for help. They chose industry veteran Cameron Durrant PhD, a well-known critic of big pharma. Despite his initial hesitance, Durrant has since turned the company around via regulatory jiu-jitsu.

Exploiting the bad press surrounding KaloBios and the biotech industry, he announced a bold new approach to drug pricing. Called the Responsible Pricing Model, it is a transparent process that involves the help and advice of those who want affordable drugs. This includes regulators, insurers, researchers, and patients. In return, KaloBios gets lower costs and risks.

This approach can shift traditionally risky biotech stocks into more bond-like instruments that could outperform ETFs. Bigger pharma players, like Allergan, are now emulating Durrant's model.

Clearly, the industry is starting to see the writing on the wall. Investors should as well.

http://www.forbes.com/sites/patrick...of-pharma-in-the-age-of-trump/2/#6c7afe33b7c5

 

[Arkain2K]

Trump tells drugmakers he'll tackle prices
By SARAH KARLIN-SMITH and NOLAN D. MCCASKILL
01/31/17

President Donald Trump vowed today to speed up drug approvals while reiterating his pledge to bring down drug costs.

"For Medicare, for Medicaid, we have to get the prices way down," Trump said during a White House meeting with pharmaceutical executives and the industry's top lobbyist.

Story Continued Below

During the campaign and since his election, Trump has often talked of pharma in tough terms. Just earlier this month, he accused the industry of "getting away with murder" and said he wanted to competitively bid drug purchases. But in public remarks on Tuesday, he took a conciliatory tone, pledging to reduce regulations and lower the bar for drug approvals.

"We're also gonna be streamlining the process so that from your standpoint, when you have a drug, you can actually get it approved if it works instead of waiting for many, many years," Trump said. "The U.S. drug companies have produced extraordinary results for our country, but the pricing has been astronomical for our country."

Trump, who's pledged to unwind the nation's regulatory regime, signaled a potentially radical approach to overhauling the Food and Drug Administration. He expressed a willingness to approve some drugs before they have been proven safe, which would be a big departure from the FDA's current practices. And he said he would soon name an FDA commissioner who will be "streamlining" the agency.

One of Trump's lead candidates for FDA commissioner, Jim O'Neill, has favored approving drugs once they have been proven safe, but before they've been determined effective. His position, which is less radical than Trump's statement, is not supported by most large drug companies, who fear such rapid approvals could ultimately undermine industry's credibility and hurt their pricing power.

"We're gonna be getting rid of regulations that are unnecessary, big league," Trump said. "Somebody said the other day, what's the percentage of regulation? I said maybe 75 percent. It could even be up to 80 percent, which is what you need because you can't even function."

Trump also appeared to reiterate his support for drug negotiations. He contended that drugmakers need to face increased competition and bidding. Yet he appeared to suggest that Medicare, which is banned from negotiating with drugmakers, is hurting competition.

"I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing a product to a vibrantly competitive market," he said. "That includes price-fixing by the biggest dog in the market, Medicare, which is what's happening. But we can increase competition and bidding wars big time — we have to — into that program."

Trump also said he plans to work on global trade and tax policy that could benefit U.S. drugmakers.

“We’re gonna be changing a lot of the rules. We’re going to be ending global freeloading,” Trump said. “Foreign price controls reduce the resources of American drug companies to finance drug and R&D innovation," he said, also encouraging drugmakers to bring more of their manufacturing back to the United States.

Executives from Merck, Amgen, Johnson & Johnson, Celgene, Novartis and Eli Lilly attended the White House meeting, along with PhRMA CEO Stephen Ubl. House Energy and Commerce Chairman Greg Walden (R-Ore.) , whose panel would oversee potential drug-pricing reforms, also was there.

Ubl, whose industry is facing heightened pressure to keep prices in check, said he's concerned about affordability and would work with the Trump administration to advance "market-based reforms."

"We discussed many areas of common ground including: advancing stronger trade agreements to level the playing field with countries around the world; reforming our tax code to spur investment and job creation here in the United States; and removing outdated regulations that drive up costs and slow innovation," Ubl said in a statement.

http://www.politico.com/story/2017/01/trump-drug-pharmaceutical-manufacturing-234423

 

[panamaican]

I'd like some information on the drug approval process and the extent to which it is actually over burdened with regulation.

I fully grasp that faster approvals are important but does anyone have actual insight on the approval process problems that aren't tied to safety? I don't.

 

[Arkain2K]

Why Drug Companies Don’t Want President Trump to Deregulate the FDA
By Sy Mukherjee
Feb 15, 2017

When President Donald Trump met with big pharma CEOs at the White House last month, he offered a combination of demands and olive branches. But the biopharma industry isn't particularly thrilled over one of his proposed gifts: a deregulated Food and Drug Administration (FDA) that speeds drug approvals past the regulatory finish line.

You'd think that the sector would champ at the bit for a stripped down FDA. But a first-to-market advantage doesn't mean much if there's not enough of a market to capitalize on. And that's exactly what's raising concerns among a number of prominent drug company executives who fear that insurance companies would be loathe to cover an unproven treatment.

"People often argue that the FDA is too restrictive," Roger Perlmutter, who heads up research and development at pharma giant Merck, told Reuters. "We have the sense that the balance is pretty right ... you have to have a well-characterized risk/benefit profile."

That sentiment was echoed by a number of other executives. Alnylam Pharma CEO John Maragarone (who hasn't been shy about wading into hot button political fights under the Trump administration) said that, while deregulation is fine and dandy, "payers are looking for evidence of value." The CEOs of numerous other biotechs shared similar thoughts with Reuters.

The consternation is understandable considering some of the names Trump is reportedly considering for the critical FDA commissioner job. One potential candidate, Peter Thiel associate Jim O'Neill, has advocated a system where drugs can be approved the minute they're shown to be safe, rather than the dual safety and effectiveness standards which the agency must now consider.

But that radical approach has already shown poor results in the marketplace. Sarepta Therapeutics, which won a controversial but pioneering approval to treat the rare disease Duchenne muscular dystrophy, has been shunned by a number of insurance companies because (as the FDA admitted in its own approval) the treatment doesn't have proven efficacy.

Besides, there's already recent, new legislation out there to speed drug approvals. President Barack Obama signed the pharma-backed 21st Century Cures Act, which itself overhauls FDA regulatory procedures, shortly before leaving office.

http://fortune.com/2017/02/15/trump-fda-deregulation-biopharma/

 

[touchedbyjab]

Big pharma had been buying off politicians for decades... you can't pull that shit on Trump.

 

[panamaican]

Interesting read. I hadn't thought about the insurance companies perspective on this.

 

[Arkain2K]