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

[rearnakedchoke]

The benefits seem to outweigh the side effects big time. Priaprism and mixing of nitrate use and pde5s seem to be the only danger but at that point how much worse is it really than other things that are already over the counter?

It would be smart business choice for Lilly to sell it over the counter for daily use. They could potentially have more customers than even before.

Think about the stuff thats otc, most of it doesnt come with a four hour boner warning. That would just be crazy. Maybe a 1mg pill, thats about it.

 

[EL CORINTHIAN]

Think about the stuff thats otc, most of it doesnt come with a four hour boner warning. That would just be crazy. Maybe a 1mg pill, thats about it.

Well yea because that's not the intended purpose and at 5mg that's probably never going to happen. 1MG isn't going to do shit.

 

[Arkain2K]

The FDA Has Approved the First Generic EpiPen Alternative
The new product will offer a more affordable alternative to a life-saving drug
By Brigit Katz | August 17, 2018​

EpiPens provide immediate, life-saving treatment to people with severe allergies, but the company that makes EpiPens has recently faced heated criticism for hiking up the price of its autoinjectors. Now, in order to introduce a more affordable alternative into the market, the Food and Drug Administration has approved a generic version of the EpiPen for the first time, report Carolyn Y. Johnson and Laurie McGinley of the Washington Post.

Teva Pharmaceuticals, an Israeli company, will manufacture the new generic version. Pharmacists will now be able to automatically swap prescriptions for EpiPen or EpiPen Jr. with Teva’s product. It is not yet clear how much the new drug will cost, or when it will become available. "We're applying our full resources to this important launch in the coming months and [are] eager to begin supplying the market," Teva spokesperson Doris Saltkill said in a statement.

The generic is, however, sure to be cheaper than the brand name EpiPen, which is owned by the company Mylan. EpiPens are injector devices that deliver doses of the hormone epinephrine that reduces swelling in the airways and increases blood flow in the veins when people experience a severe allergic reaction, or anaphylaxis, which can be triggered by things like bee stings, peanuts and medications. Epinephrine is inexpensive, and Epipens used to be fairly affordable too; when Mylan acquired the rights to sell the EpiPen in 2007, the drug cost around $100 for a two-pack.

In 2016, however, Mylan raised the price of its EpiPen two-pack to $600, according to Anna Edney of Bloomberg. After facing steep criticism from patients and lawmakers, Mylan introduced its own generic version that costs around $300.

More trouble came in May, when the FDA put the EpiPen on its list of drugs in shortage. Pfizer, which manufactures the EpiPen for Mylan, reportedly experienced disruptions in the St. Louis, Missouri, factory that makes all U.S. EpiPens, and more than 400 patients in 45 states reported difficulty in finding the drug, according to Edney.

There have been other alternatives to the EpiPen, like the Adrenaclick and the Auvi-Q, but they have by and large failed to find a foothold in the market. The Adrenaclick has faced its own manufacturing issues, while the Auvi-Q costs $4,500 for two autoinjectors, report Meg Tirrell and Leanne Miller of NBC News. Mylan also has the advantage of brand recognition; the EpiPen has been around since 1987, and has for many years been the most common method of injecting epinephrine.

Additionally, Mylan has fiercely protected its hold on the market, and has even been accused of acting illegally to shut down competition. Mylan pushed back against the advance of Teva’s new product, claiming that differences in the way the products function would be confusing to patients. For example, Mylan has a single, non-removable cap, but Teva’s generic has two, including one that is removable.

The FDA rejected Teva’s initial application in 2016, citing “major deficiencies,” according to Johnson and McGinley of the Washington Post. But in response to the Trump administration’s promises to cut drug prices, FDA Commissioner Scott Gottlieb has been working to remove barriers to the development of generic drugs.

The approval of the Teva generic is part of the FDA’s “longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” Gottlieb said in a statement. “This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages.”

https://www.smithsonianmag.com/smar...d-first-generic-epipen-alternative-180970064/

 

[Arkain2K]

Trump administration proposes Medicare Part D changes to bolster negotiating power
Plans could remove drugs from 'protected' status if prices skyrocket
By Tom Howell Jr. | November 26, 2018

Seema Verma, administrator at the Centers for Medicare and Medicaid Services, said the changes will save taxpayers $690 million over 10 years.​

The Trump administration on Monday proposed letting private plans in Medicare refuse to cover drugs in a set of “protected classes” if prices rise faster than inflation, saying it will pry deeper discounts from drug makers.

Plans operating in the Part D drug benefit must cover nearly all drugs that fall into six therapeutic classes of treatments for things like cancer or HIV.

Administration officials said that, unfortunately, that guaranteed coverage allows drug companies to charge what they want instead of offering bargains.

“The lack of any ability for Part D plans to manage drugs in the protected classes has allowed the pharmaceutical industry to command high prices on protected class drugs in Part D, without patients getting a good deal,” Health Secretary Alex Azar and Seema Verma, administrator at the Centers for Medicare and Medicaid Services (CMS), wrote in a blog post Monday. “Insurance plans in the private market do not face the same constraint.”

Drugs in protected classes are typically discounted 20 percent to 30 percent in the private insurance market, but only 6 percent under Medicare Part D, the administration said.

CMS officials said it’s only fair to make sure seniors get the same discounts. It says drug companies should be allowed to remove protected-class drugs from their formularies — the list of drugs they cover — if price increases exceed inflation, so insurers have more leverage to negotiate down costs.

A new drug that is not a “significant innovation” over an earlier version— for instance, it only has an extended release — could also be removed from protected-class protection.

Ms. Verma said the changes will save taxpayers $690 million over 10 years.

Guaranteed coverage within the protected classes was included in Part D to ensure patient access while the program was getting set up a dozen years ago. Officials said it was “never intended to be permanent.”

CMS said there are 63 percent more drugs in protected class than when the policy was created a dozen years ago, and prices for drugs that fall into the classes keep rising.

Administration officials said Part D spending on Latuda, an antipsychotic prescribed to more than 100,000 Medicare beneficiaries, increased nearly 19 percent each year from 2013 to 2017.

The Obama administration sought to remove some drugs from protected classes in 2014, but the idea was shelved amid pushback from members of Congress and patient groups.

Predicting pushback today, the Trump administration said they’ve built in enough protections to preserve patient access to drugs. For instance, plans will still be required to cover at least two drugs in each protected class.

“It’s important to remember if seniors don’t like a plan that takes advantage of their flexibilities, they’re in the driver’s seat,” Ms. Verma said. “These new tools will only become as common as beneficiaries want them to be.”

Ms. Verma said the plans could also place patients on the most cost-effective drugs in protected classes first, before turning to more costly alternatives if they don’t work — a technique known as step therapy. The administration already proposed a similar change for doctor-administered drugs under Medicare Part B.

It’s also mulling ways to ensure that rebates drugmakers give to insurers for their products are passed along to consumers at the pharmacy counter, so they pay less out of pocket.

The administration will receive comments on its proposals to implement them by 2020.

Monday’s rollout is the latest in a series of steps Mr. Trump is taking to try and slash drug prices. Soaring prescription costs are a key concern for many Americans, so the White House rolled out a pricing blueprint in May.

Earlier this year, Mr. Trump signed a bill banning “gag clauses” that had forbidden pharmacists from telling customers they could pay less for a drug by using cash instead of coughing up their copay under their insurance.

He wants to peg certain Medicare prices to an “international pricing index,” saying it will fix a “rigged” system in which Americans effectively subsidize drug innovation and lower costs in other developed nations.

And he wants Big Pharma to disclose the list prices of drugs in their TV ads.

Democrats who recaptured the House in the mid-term elections say drug pricing is an area where they could work with Mr. Trump.

They want the president to use government authority under Medicare to negotiate down prices, however — an idea Mr. Trump seemed to adopt during the 2016 campaign, before ignoring it in his sweeping drug-pricing plan.

https://www.washingtontimes.com/news/2018/nov/26/trump-administration-proposes-medicare-part-d-chan/

 

[Arkain2K]

Trump Administration Throws Down Gauntlet On Drug Prices
Joshua Cohen | Jan 16, 2019

President Donald Trump stands with Secretary of Health and Human Services Alex Azar as he arrives to talk about drug prices during a visit to HHS in Washington, Thursday, Oct. 25, 2018​

Another new year, another set of announcements by the pharmaceutical industry regarding price increases for prescription drugs. Much to the annoyance of the Trump Administration the pharmaceutical industry keeps raising list prices of drugs. At present, without the ability to institute direct price controls, there's little the Administration or Congress can do to rein in list prices. The Trump Administration has made it clear, however, that it won't tolerate business as usual. And, legislators on both sides of the aisle appear to be similarly inclined.

What may spook the pharmaceutical industry most is that in spite of being diametrically opposed on most issues, the executive branch and House and Senate Democrats (along with a number of key Senate Republicans) appear to be more or less aligned on drug prices. In particular, they seem to agree on the fact that list prices matter a lot to their constituents, patients, whose co-insurance is calculated on the basis of list prices.

The Trump Administration is challenging prescription drug policy status quo in unprecedented ways. To illustrate, the Department of Justice has expanded its investigation of possible generic drug-price fixing to 300 products. And, in 2018, the Department of Health and Human Services (HHS) - with Alex Azar, Scott Gottlieb, and Seema Verma leading the charge - released a series of memoranda, white papers, tweets, and official policy statements on numerous topics related to containment of drug prices. Several policies have been implemented per the first of January 2019. These include the authorized use of step therapy by Medicare Advantage plans and prohibition of pharmacy gag clauses which had barred pharmacies from telling patients about less-expensive treatment options.

More controversially, in 2018 the Trump Administration proposed changes to Medicare Part B prices, which would peg them to an "international pricing index" as a means to align the U.S with other countries. A proposed rule on Medicare Part B prices is expected in the spring of 2019, with the start of a pilot possible in early 2020.

Late last week Senator Bernie Sanders (I-VT) and Representative Elijah Cummings (D-MD) introduced a bill aimed at containing drug prices. This bill has a greater reach than the Trump administration's Medicare Part B pricing proposal. A much larger set of drugs would be subject to international price indexing controls under the proposed legislation. Also, the bill would allow the Secretary of HHS to negotiate Medicare Part D prices, and permit U.S. residents to purchase medicines directly from Canada and other countries. The latter initiative is gaining traction, as Senators Grassley (R-IA) and Klobuchar (D-MN) announced last week the introduction of a bill to allow importation of prescription drugs from approved pharmacies in Canada.

In 2018, the Trump Administration repeatedly threatened to remove the safe harbor exemption for rebates negotiated between pharmacy benefit managers, payers, and drug manufacturers. While it's far from certain whether the safe harbor exemption can easily be lifted in 2019, there is bipartisan political support for making substantial changes to the rebate system, in particular, in the transparency realm. In a letter sent last week to the Department of HHS criticizing the rebate system's lack of transparency, Senator Susan Collins (R-ME) wrote that the "opacity of these financial interactions” in the prescription drug supply chain “conceal incentives that distort the pharmaceutical market." Ultimately, even if the safe harbor exemption is not removed, forcing companies to reveal details concerning negotiated rebates would in effect defang the rebate system.

And, in a tweet, FDA Commissioner Scott Gottlieb says the agency is concerned with certain drugmakers' tactics designed to instill fear in patients and doctors about switching from originator biologics to biosimilars. Gottlieb has indicated that action would be taken against "bad actors." In essence, the Administration is attempting to reinvigorate the competitiveness of the biologics market. In the U.S., sales of biosimilars have been relatively modest due in part to branded drug firms' strategies, such as exclusive contracts with PBMs and insurers, and marketing campaigns aimed at diminishing trust in biosimilar safety and efficacy.

https://www.forbes.com/sites/joshua...ws-down-gauntlet-on-drug-prices/#1cab488624b3

 

[IGIT]

Trump Administration Throws Down Gauntlet On Drug Prices
Joshua Cohen | Jan 16, 2019

President Donald Trump stands with Secretary of Health and Human Services Alex Azar as he arrives to talk about drug prices during a visit to HHS in Washington, Thursday, Oct. 25, 2018​

Another new year, another set of announcements by the pharmaceutical industry regarding price increases for prescription drugs. Much to the annoyance of the Trump Administration the pharmaceutical industry keeps raising list prices of drugs. At present, without the ability to institute direct price controls, there's little the Administration or Congress can do to rein in list prices. The Trump Administration has made it clear, however, that it won't tolerate business as usual. And, legislators on both sides of the aisle appear to be similarly inclined.

What may spook the pharmaceutical industry most is that in spite of being diametrically opposed on most issues, the executive branch and House and Senate Democrats (along with a number of key Senate Republicans) appear to be more or less aligned on drug prices. In particular, they seem to agree on the fact that list prices matter a lot to their constituents, patients, whose co-insurance is calculated on the basis of list prices.

The Trump Administration is challenging prescription drug policy status quo in unprecedented ways. To illustrate, the Department of Justice has expanded its investigation of possible generic drug-price fixing to 300 products. And, in 2018, the Department of Health and Human Services (HHS) - with Alex Azar, Scott Gottlieb, and Seema Verma leading the charge - released a series of memoranda, white papers, tweets, and official policy statements on numerous topics related to containment of drug prices. Several policies have been implemented per the first of January 2019. These include the authorized use of step therapy by Medicare Advantage plans and prohibition of pharmacy gag clauses which had barred pharmacies from telling patients about less-expensive treatment options.

More controversially, in 2018 the Trump Administration proposed changes to Medicare Part B prices, which would peg them to an "international pricing index" as a means to align the U.S with other countries. A proposed rule on Medicare Part B prices is expected in the spring of 2019, with the start of a pilot possible in early 2020.

Late last week Senator Bernie Sanders (I-VT) and Representative Elijah Cummings (D-MD) introduced a bill aimed at containing drug prices. This bill has a greater reach than the Trump administration's Medicare Part B pricing proposal. A much larger set of drugs would be subject to international price indexing controls under the proposed legislation. Also, the bill would allow the Secretary of HHS to negotiate Medicare Part D prices, and permit U.S. residents to purchase medicines directly from Canada and other countries. The latter initiative is gaining traction, as Senators Grassley (R-IA) and Klobuchar (D-MN) announced last week the introduction of a bill to allow importation of prescription drugs from approved pharmacies in Canada.

In 2018, the Trump Administration repeatedly threatened to remove the safe harbor exemption for rebates negotiated between pharmacy benefit managers, payers, and drug manufacturers. While it's far from certain whether the safe harbor exemption can easily be lifted in 2019, there is bipartisan political support for making substantial changes to the rebate system, in particular, in the transparency realm. In a letter sent last week to the Department of HHS criticizing the rebate system's lack of transparency, Senator Susan Collins (R-ME) wrote that the "opacity of these financial interactions” in the prescription drug supply chain “conceal incentives that distort the pharmaceutical market." Ultimately, even if the safe harbor exemption is not removed, forcing companies to reveal details concerning negotiated rebates would in effect defang the rebate system.

And, in a tweet, FDA Commissioner Scott Gottlieb says the agency is concerned with certain drugmakers' tactics designed to instill fear in patients and doctors about switching from originator biologics to biosimilars. Gottlieb has indicated that action would be taken against "bad actors." In essence, the Administration is attempting to reinvigorate the competitiveness of the biologics market. In the U.S., sales of biosimilars have been relatively modest due in part to branded drug firms' strategies, such as exclusive contracts with PBMs and insurers, and marketing campaigns aimed at diminishing trust in biosimilar safety and efficacy.

https://www.forbes.com/sites/joshua...ws-down-gauntlet-on-drug-prices/#1cab488624b3

hi Arain2K,

profits for pharma and biotech have been surging over the last few years. they've had their biggest profits in history, lol.

a combination of the enormous sums of money bought in via the tax breaks, along with huge price hikes on medications related to diabetes, cancer, HIV, multiple sclerosis, asthma and chronic obstructive pulmonary disease, and autoimmune diseases such as rheumatoid arthritis and psoriasis - its been a joyous time for Merck shareholders like myself.

pharma and biotech are making wonderful bank, and all those chest thumping announcements from Mr. Trump about reigning in drug prices?

much ado about nothing.

The token concessions are “a calculated risk,” said one drug lobbyist. “Take these nothing-burger steps and give the administration things they can take credit for.”
https://www.politico.com/story/2018/08/03/trump-drug-prices-companies-721145

- IGIT

 

[IGIT]

Trump administration proposes Medicare Part D changes to bolster negotiating power
Plans could remove drugs from 'protected' status if prices skyrocket
By Tom Howell Jr. | November 26, 2018

Seema Verma, administrator at the Centers for Medicare and Medicaid Services, said the changes will save taxpayers $690 million over 10 years.​

https://www.washingtontimes.com/news/2018/nov/26/trump-administration-proposes-medicare-part-d-chan/

hi again Arain2K,

nothing has changed.

With his May 11 plan, Trump is, in effect, leaving the current pharmaceutical system in place. Increasingly, its most powerful shareholders are the activist managers of the hedge funds and private equity groups that own major stakes in America’s drug companies.
https://newrepublic.com/article/149438/big-pharma-captured-one-percent

Mr. Trump, like his predecessors, is completely outflanked.

over the last 20 years, pharma and healthcare have spent more money on K street than any other other sector in America. over 4 billion dollars.
two times what oil and gas spent lobbying for favors and goodies, lol.

the POTUS never had a chance, and he should let this one go, unless he wants to get involved in a public demonstration of his impotence.

- IGIT

 

[IGIT]

"rolling back"

hi hi curryjunkie,

aye, lol.

its funny. its like, a brief cessation in price hikes in 2018 constitutes "rolling back".

pharma is just taking a breather after prices were ratcheted up in 2017.

Brand-name pharmaceutical companies and health insurers increased their profits in the second quarter of this year...Drug companies continue to raise their list prices for branded drugs despite the public furor, so they naturally maintained their status as the most profitable sector in health care.
https://www.axios.com/pharma-leads-...077-5f7249a8-b607-41c3-9941-5d3fb92d667d.html

Mr. Trump....Mr. Obama...and others before them, have absolutely no chance.

Nearly 340 former congressional staffers now work for pharmaceutical companies or their lobbying firms, according to data analyzed by KHN and provided by Legistorm, a nonpartisan congressional research company. On the flip side, the analysis showed, more than a dozen former drug industry employees now have jobs on Capitol Hill—often on committees that handle health care policy.
https://www.thedailybeast.com/big-pharmas-government-revolving-door-who-do-they-really-work-for

no chance at all.

- IGIT

 

[curryjunkie]

Obesity is not the fundamental issue. The lack of humanity is. That pushes people to try to compensate in all sorts of destructive ways. Thank of yourself for example. You confuse having a piece of the truth with justification for beating someone over the head with it. As if that’s actually a solution, or there wasn’t a time where you didn’t know, and were struggling in darkness. Becoming more forgiving people is the answer to the fear that has swept us all, IMO.

do you get your overwhelming condescencion on prescription? every post you make is a variant of this bullshit, lower your dose...

 

[Arkain2K]

Here’s why many prescription drugs in the US cost so much—and it’s not innovation or improvement
Yoni Blumberg | Mon, Jan 14 2019

Americans spend about $1,200 on prescriptions drugs a year, according to the latest figures from the Organization for Economic Cooperation and Development. That’s more than people pay in any other developed country in the world.

In the past, pharmaceutical companies have attributed high prices to innovation, arguing that new and improved drugs are naturally more expensive. But a new study published in the journal Health Affairs complicates that idea.

It suggests that, largely, costs have gone up because companies are raising the price of drugs that are already available.

“We found that, in the case of brand-name drugs, rising prices were driven by manufacturers increasing prices of medications that are already in the market rather than [by] the entry of new products,” lead author Inmaculada Hernandez, an assistant professor at the University of Pittsburgh School of Pharmacy, tells CNBC Make It.

‘Out-of-pocket costs continue to soar’

Looking at wholesale data for around 27,000 prescription drugs, Hernandez and her colleagues found that, between 2008 and 2016, brand-name oral prescription drugs rose 9 percent annually, while injectable drugs increased 15 percent per year. Inflation, meanwhile, is only about 2 percent.

These percentage changes reflect list prices, which are set by manufacturers and don’t fully match what consumers pay, since they don’t account for rebates or insurance discounts.

Some increased prices, such as those for specialty and generic drugs, seem to be driven by the entry of new medications into the market, the researchers found. Otherwise, price increases don’t necessarily reflect improvement or even change.

In 2014, the list price for a Sanofi brand of insulin called Lantus increased nearly 50 percent, for example, even though it had already been on the market for more than a decade. (The average net price, or what consumers pay, for Lantus has actually decreased in recent years, though, a spokesperson for Sanofi tells CNBC Make It.)

Pharmaceutical companies kicked off the new year with significant price hikes. Dozens of drugmakers raised the list prices of hundreds of medications an average of 6.3 percent on Jan. 1, according to a recent analysis from the health software company Rx Savings Solution.

“Those increases are examples of what we mean by year-over-year inflation in existing products,” Hernandez says.

Gerard Anderson, professor of health policy and management at Johns Hopkins University, tells NPR that raising the cost of existing drugs benefits drugmakers and insurers.

“Research and development is only about 17 percent of total spending in most large drug companies,” he says. “Once a drug has been approved by the FDA, there are minimal additional research and development costs so drug companies cannot justify price increases by claiming research and development costs. ”

The study did not examine why prices of existing drugs have gone up, but the researchers say a lack of competition and the regulatory environment in the U.S. allow “for price increases much higher than in other countries.”

Critics contend that the study offers an “inaccurate portrayal of the U.S. marketplace,” and they take issue with the fact that the researchers focused so much on wholesale price numbers.

“On average, 40 percent of the list price of medicines is given as rebates or discounts to insurance companies, the government, pharmacy benefit managers and other entities in the supply chain that often require large rebates in order for a medicine to be covered,” says Holly Campbell, deputy vice president of public affairs for the Pharmaceutical Research and Manufacturers of America, which represents the drug industry.

“However,” she adds, “these savings are often not shared with patients whose out-of-pocket costs continue to soar.”

Raising drug prices affects everyone

When prices go up, it doesn’t just affect Americans without coverage. It can have much broader ramifications.

“Rising drug prices affect uninsured or underinsured patients, patients with high-deductible plans, those in the deductible or doughnut hole phase of their plans, the government as a payer, and all Americans in the form of higher premiums,” says Hernandez. The doughnut hole refers to a coverage gap where your drug spending has reached a certain limit, so you usually have to cover costs until you reach what’s called your out-of-pocket maximum.

Uninsured Americans are three times as likely as adults with private coverage to postpone or skip a prescription because they can’t afford it. And a 2016 survey found that even 14 percent of insured Americans said they didn’t fill a prescription or skipped doses of their medication because of the cost.

William Shrank, chief medical officer of the University of Pittsburgh Medical Center Health Plan, and co-author of the Pittsburgh study, says their findings call for “policy efforts designed to control health-care spending by capping price inflation to some reasonable level. ” In other words, they suggest that lawmakers impose new limits on how much pharmaceutical companies can increase list prices.

Other countries have had success holding down drug prices by employing centralized price negotiations, according to the Commonwealth Fund, and minimizing out-of-pocket expenses by offering universal coverage.

The government has recently started pressuring drugmakers to make medications more affordable. President Donald Trump reportedly met with his advisors in January to address price hikes, according to Politico.

And California Gov. Gavin Newsom signed an executive order, only hours into his new job, directing the state to set up a single-purchaser system for prescription drugs, in hopes of holding down costs.

For at least a decade, a majority of Americans have been dissatisfied with the country’s largely for-profit health-care system, according to Gallup. In one poll, 71 percent of respondents said the system is “in a state of crisis” or “has major problems.” That’s partly because costs are more expensive in the U.S. than elsewhere: Overall, the country spends twice as much as its peers, yet it gets poorer results.

https://www.cnbc.com/2019/01/10/why-prescription-drugs-in-the-us-cost-so-much.html

 

[Arkain2K]

 

[Arkain2K]

 

[Arkain2K]

Drug Makers Try to Justify Prescription Prices to Senators at Hearing
By Robert Pear | Feb. 26, 2019

​

WASHINGTON — Pharmaceutical executives, testifying before Congress, could not readily explain on Tuesday why the prices for many brand-name prescription drugs were much higher in the United States than in other developed countries.

“It is almost as if the taxpayer has ‘stupid’ written on their face,” Senator Bill Cassidy, Republican of Louisiana, told the seven executives, who faced a barrage of questions and criticism at a three-hour hearing of the Senate Finance Committee.

Mr. Cassidy joined two other Republican senators, Charles E. Grassley of Iowa and John Cornyn of Texas, and all the Democrats on the panel in expressing deep concern about constituents who could not afford the drugs they needed to survive.

Senator Robert Menendez, Democrat of New Jersey, the home to many drug and biotechnology companies, offered what he described as “a friendly warning” to the witnesses. “If you don’t take meaningful action to reduce prescription drug prices,” he said, “policymakers are going to do it for you.”

The hearing was political theater, but could also be a first step toward legislation to provide some relief to consumers, as lawmakers of both parties and President Trump have vowed to slow the relentless rise of drug prices.

It was also clear from the hearing that senators had a lot to learn about drug pricing and that pharmaceutical executives did not fully appreciate the explosive political potential of the issue.

“I feel like I need a Ph.D. in prescription drug pricing to understand how the heck this industry works,” said Senator Maggie Hassan, Democrat of New Hampshire.

Richard A. Gonzalez, the chairman and chief executive of AbbVie, the maker of the best-selling arthritis drug Humira, told the committee that his company made profits in countries like Germany and France where prices of brand-name drugs were often much lower than in the United States.

“The U.S. has some of the highest prices in the world,” Mr. Gonzalez said.

Senator Ron Wyden of Oregon, the senior Democrat on the committee, asked, “How is that not gouging American consumers with high prices?”

“You’re willing to sit by and hose the American consumer while giving price breaks to consumers overseas,” Mr. Wyden said. Drug makers’ attempts to justify their prices, when so many patients cannot afford them, are “morally repugnant,” he said.

The drug makers vehemently opposed Mr. Trump’s proposal for Medicare to pay for certain prescription drugs based on the prices paid in other developed countries.

The Trump administration has said Medicare is paying 80 percent more than the amount other advanced industrial countries do for some of the most costly physician-administered drugs. Under its proposal, Medicare would still pay 26 percent more.

But the drug company executives bristled at the idea. Under such proposals, they said, the United States would be importing price controls from other countries where coverage of costly new drugs is sometimes delayed or denied.

“American patients have access to cancer medicines about two years earlier than patients in other countries, including Germany, France and the United Kingdom,” said Pascal Soriot, the chief executive of AstraZeneca. As a result, he suggested, American patients have generally seen greater improvements in cancer survival rates.

Kenneth C. Frazier, the chief executive of Merck, said his company could not just walk away from European markets where health officials set lower drug prices. It would be “immoral to leave the patients behind,” he said.

Mr. Cornyn said AbbVie had tried to block competition for Humira by surrounding it with a thicket of patents. In response to questions, Mr. Gonzalez, the chief executive, said AbbVie had 136 patents on Humira, with different patents protecting its use to treat different conditions.

“I support drug companies’ recovering a profit based on their research and development of innovative drugs,” Mr. Cornyn said. “But at some point that patent has to end, that exclusivity has to end, so that patients get access to those drugs at a much cheaper cost.”

Mr. Cassidy expressed interest in an idea that has been embraced by many Democrats but few Republicans: that Medicare should, in some cases, be able to negotiate prices with drug manufacturers.

“Right now,” Mr. Cassidy said, “Medicare has a very limited ability to negotiate” prices based on the relative value of a therapy. Medicare’s prescription drug plans, offered by private insurers, hire pharmacy benefit managers to negotiate, but they are not always effective, he said.

Senator Sherrod Brown, Democrat of Ohio, said taxpayers subsidized pharmaceutical research, through the National Institutes of Health, and advertising, through tax deductions for business expenses. But, he noted, many drugs cost more than the median income of Medicare beneficiaries, about $26,000 a year.

“We can’t afford to gave Big Pharma the blank check that you’ve had,” Mr. Brown told the executives.

Mr. Grassley, the committee chairman, set the tone for the hearing when he said that practices of the pharmaceutical industry “thwart the laws and regulations designed to promote competition” and the use of lower-cost generic drugs.

Several themes ran through the testimony of the drug company executives, who were clearly playing defense. The main problem, they said, is not the high list prices set by drug manufacturers, but the high out-of-pocket costs paid by patients.

Several drug company executives suggested establishing a monthly or annual limit on a Medicare patient’s out-of-pocket costs for prescription drugs.

Several chief executives, including Mr. Frazier of Merck and Olivier Brandicourt of Sanofi, said they could also support legislation that speeds the development of generic medications by requiring brand-name manufacturers to provide samples to generic drug companies. Generic drug developers need samples to show that a generic copy is equivalent to the original, but they have often had difficulty getting them.

Ronny Gal, a securities analyst who follows the drug industry for Sanford C. Bernstein & Company, said he doubted that drug companies would change their pricing practices because of the hearing.

“This is a $460 billion industry,” Mr. Gal said. “You think three hours of an orchestrated show before Congress will lead to different behavior? I don’t think so.”

Pharmaceutical executives do “want to be at the table for whatever comes next,” Mr. Gal said, and that could eventually include discussions and negotiations on legislation.

Mr. Gonzalez, of AbbVie, said drug prices were a problem for some patients because their out-of-pocket costs were often a percentage of a drug’s list price.

Mr. Soriot said the list prices of drugs did not reflect the true cost because AstraZeneca and other companies provided rebates and discounts to many health insurance plans and the middlemen known as pharmacy benefit managers. On average, he said, the rebates — intended to secure a favored position on a health plan’s list of covered drugs — are “nearly 50 percent of our gross revenues in the United States.”

AbbVie, AstraZeneca and several other companies said they would reduce prices for consumers if Congress outlawed the rebates that drug makers pay to insurers and middlemen to promote the use of their drugs in Medicare and commercial insurance.

Democratic senators wanted a firmer commitment. They asked the drug company executives to put it in writing.

Albert Bourla, the chief executive of Pfizer, said he supported efforts to eliminate rebates paid to health plans and middlemen. Patients, he said, should get the benefit of such price concessions at the pharmacy counter.

“None of the close to $12 billion of rebates that Pfizer paid in 2018 found their way to American patients,” Mr. Bourla said.

He also said drug makers should be paid in proportion to the value of their medicines. Pfizer, he said, could be “paid based on the number of strokes we prevent or the number of cancer patients who go into full remission, rather than the number of pills we sell.”

With the proliferation of high-deductible health plans, Mr. Bourla said, patients are paying a larger share of prescription drug costs.

“Patients are made to pay on average 14 percent of the cost of their medicines, but only 3 percent of the costs associated with hospital stays,” he said.

Patients, doctors and members of Congress have cited rising insulin prices as an example of what is wrong with drug prices in America, and Mr. Brandicourt, the Sanofi chief executive, defended the company’s record.

“The net price of our insulin product Lantus has fallen over 30 percent since 2012,” Mr. Brandicourt said. “Yet over this same period, average out-of-pocket costs for patients with commercial insurance and Medicare — before the benefit of any Sanofi financial assistance program — has risen 60 percent.”

https://www.nytimes.com/2019/02/26/us/politics/prescription-drug-prices.html

 

[Bobby 3 Sticks]

I'd like to see generic drug producers be allowed to be sued for drugs that cause adverse side effects .

Ex: in WI a couple had two children suffer birth defects from generic Zofran but aren't allowed to sue the generic manufacturer or the name brand manufacturer because the name brand didn't make it

 

[Joe265]

Talking about drug prices is a red herring. The entire industry is under a veil of deceit and corruption. They literally just formulate drugs to create permanent revenue streams.

 

[nhbbear]

There are cancer drugs that cost 80k for one series of treatment, but it only costs the company $178 to manufacture. That is just evil shit

 

[ObamaPhoneLady]

I would be 110% in favor of a blanket law for all industries that sets a maximum profit per unit. A $1 investment should never exceed a $100 return imo. That allows for capitalism to flourish but limits abuse imo.

 

[jefferz]

What’s ironic is that you can almost guarantee every congressman “grilling” these companies have got hundred of thousands in campaign contributions from these companies.
They’ve benefited from these inflated prices as well.

 

[Arkain2K]

What’s ironic is that you can almost guarantee every congressman “grilling” these companies have got hundred of thousands in campaign contributions from these companies.
They’ve benefited from these inflated prices as well.

Ain't that the truth, and that's how managed to get away with it for so long, no matter which party is in power.

Big Pharma gotten too greedy for their own good though, there aren't many issues in America right now that transcend party lines, and drug prices is one of those rare instances where President Trump, Democrats, and Republicans are actually in complete agreement.

I've got a feeling that when those bills finally hits the voting floor, even the corrupted senators who accepted hundreds of thousands from Big Pharma will have no other choice but to vote for it.

 

[Arkain2K]

Why Big Pharma’s Case to Congress Comes Up Short
Drug CEOs still aren't willing to own up to their industry's role in keeping prescription-drug prices so high.
By Max Nisen | February 26, 2019

Seven senior executives from leading pharmaceutical companies went in front of the Senate Finance Committee Tuesday to answer for their industry's excessive drug-pricing practices. They struck a fairly conciliatory tone: The CEOs of Merck & Co., Pfizer Inc. and others all pledged to work with lawmakers on ways to keep down costs, offering several industry reforms that they support.

It marked a shift from the industry's sometimes more combative stance, and reflects mounting pressures from increasingly bipartisan scrutiny. But that softer tone is hard to trust. The group continued to rely on old arguments that support the status quo, largely favored minor and distant tweaks, and offered little in the way of concrete detail or explicit commitments. That’s insufficient in an environment where patients in the world’s richest country are rationing medicine because they can’t afford it.

There were a few memorable moments. Democratic Senator Ron Wyden compared AbbVie Inc.'s patent strategy for its best-seller Humira to Gollum's possessiveness of the One Ring in “The Lord of the Rings,” to the chagrin of AbbVie CEO Richard Gonzalez. But that might have been the high point of the hearing. The executives emerged largely unscathed.

All seven executives expressed support for the Trump administration’s plan to overhaul how drugs are paid for in Medicare Part D, which helps more than 40 million older Americans afford medicines. Currently, drugmakers pay large rebates to pharmacy benefit managers – the companies that negotiate drug costs for health plans – in order to gain market share. These PBMs derive a portion of their revenue from the rebates; under the new plan, all of those discounts would flow directly to consumers.

This shift could have real benefits. The current system incentivizes drugmakers to increase list prices – and consequently rebates – to gain PBM favor. That increases costs for people who are on high-deductible plans or have to pay co-insurance for drugs.

But the industry supports the new policy for a reason. It doesn’t harm them, and hampers their biggest drug-pricing rivals. In fact, the plan could actually increase profits at pharma firms, if they don’t reduce list prices to the currently negotiated rate. (Executives at the hearing wouldn’t explicitly commit to doing that.) Several executives said that lower list prices would have to wait on reform extending to the larger private market, something that might not happen for years or at all, because they’re reluctant to lose market share or sales. That’s an attitude that will maintain the status quo.

Multiple firms mentioned support for value-based pricing, a system under which they would pay discounts when a drug doesn’t work as expected. Such deals are relatively uncommon in the U.S., and these types of discounts tend to be quite modest. There are regulatory issues in the way of doing more, but senators should be hesitant to trust that removing those barriers is a solution to the pricing problem. Such plans often don’t address the fact that medicines are priced excessively to begin with. A discount based on an inflated price where pharma sets the terms isn’t likely to be much of a deal.

The panel universally opposed policies that would substantially curb prices and hit their bottom line, like granting broader negotiating power to Medicare, changing generous patent laws, or tying certain drug prices in Medicare to the generally lower prices charged in other countries (something the Tump administration supports). The executives trotted out their usual reasoning, claiming as they have before that such policies would stifle innovation and reduce access. Merck CEO Ken Frazier obliquely referred to some of the more aggressive proposals under consideration by the Trump administration as "outrageous," saying they would mean we would get fewer groundbreaking medicines. This contrasts with his earlier statement that the industry had a "duty to do better."

These companies do spend billions on research and have developed important medicines. But the idea that there’s not room for bigger reform is pretty silly. All but one of the seven companies represented at the hearing were among the 15 most profitable health-care companies in the world in 2018. Only two of the firms on that list, UnitedHealth Group Inc. and Medtronic Plc, don’t make drugs. The other 13 – from AbbVie to Roche Holding AG and Sanofi – generated $100 billion in net income last year at a higher margin that most other industries dream of, and sent more than $100 billion back to shareholders in the form of stock buybacks and dividends. Bottom line: The incentive to innovate isn’t going to vanish if prices come down, nor are these companies likely to remove medicines from the massive U.S. market.

The industry put on a friendly face today, which makes sense in an environment where even traditionally friendly Republican lawmakers are asking tough questions. But its unwillingness to consider real change is going to cost it in the long run.

https://www.bloomberg.com/opinion/a...timony--why-big-pharma-s-case-comes-up-short-