Comp leaders warn against misuse of drug compounding

June 6, 2017--Workers compensation leaders say the common practice of compounding medications for injured workers can be costly and dangerous if not done appropriately and is not guided by regulation, according to a paper released by CompPharma, L.L.C. 

CompPharma, a consortium of workers compensation pharmacy benefit managers, analyzed compounding for its paper “Compounds in Comp: A New Look at Patient Safety, Efficacy and Cost” to “clear up confusion surrounding compounding medications in workers’ compensation.

It clarifies research on the efficacy of compounds and explores how a pricing benchmark that was never intended to be applied to pharmaceutical grade chemicals has been manipulated to drive compounding prices and profits,” according to the text. 

In it, authors wrote they support traditional compounding, which FDA defines as “the extemporaneous combining, mixing or altering of ingredients by a pharmacist in response to a physician’s prescription to create a medication tailored to the specialized needs of an individual patient.” 

Yet much compounding in workers’ compensation involves creating a compounded product, marketing it to prescribers and billing “exorbitant prices,” according to the authors.

The paper also shows how the average wholesale price benchmark — the universal benchmark for prescription drug reimbursement in the United States today — has been manipulated to “drastically inflate compound prices and outlines state legislative and regulatory controls.” It is also a practice that can be wrought with fraud, according to the authors.

Not only is cost an issue but so is safety, according to lead author Phil Walls, Tampa, Florida-based chief clinical officer for pharmacy benefit manager Matrix Healthcare Services Inc., which does business as myMatrixx.

“Exposure to high concentrations of local anesthetics found in some compounded creams can cause seizures and irregular heartbeats, and there have been deaths associated with their use,” he said in a statement.

Klobuchar, McCain, Grassley Urge OMB Director Mulvaney to Use Existing Executive Authority to Bring Down Prescription Drug Costs

In a letter to Office of Management and Budget (OMB) Director Mulvaney, Klobuchar, McCain, and Grassley encourage executive or administrative action to reduce the ever-increasing financial burden of prescription drugs for millions of Americans

Klobuchar, McCain, and Grassley have worked together on bipartisan legislation that would address skyrocketing prescription drug prices, including bills to allow for personal importation of medications from Canada and bills that would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace

WASHINGTON, D.C. – U.S. Senators Amy Klobuchar (D-MN), John McCain (R-AZ), and Chuck Grassley (R-IA) have urged Office of Management (OMB) Director Mick Mulvaney to use existing executive authority to bring down prescription drug costs, including by certifying importation of prescription drugs from Canada. According to media reports, Mulvaney said last week that he has been actively discussing potential executive or administrative solutions with the President to address rising prescription drug costs. Additionally, Health and Human Services Secretary Tom Price has been holding “listening sessions” to discuss possible solutions.

Klobuchar, McCain, and Grassley have also worked together on bipartisan legislation that would address skyrocketing drug prices, including bills to allow for personal importation of medications from Canada, where drug prices are, on average, half the cost they are in the United States, and bills that would deter pharmaceutical companies from blocking generic alternatives from entering the marketplace. In their letter, Klobuchar, McCain, and Grassley detail how the Administration could use executive or administrative action to reduce the ever-increasing financial burden of prescription drugs for millions of Americans.

“According to media reports, you said on Thursday that you have been actively discussing potential executive or administrative solutions with the President to address rising prescription drug costs. Similarly, Secretary Price has been holding ‘listening sessions’ to discuss possible solutions. We write to express our support for such efforts that could provide immediate relief to Americans,” the senators wrote. “Consistent with your comments last week, the Administration has an opportunity to use existing statutory authority to quickly restore competition to the market with the introduction of cheaper, imported alternatives.”

The senators continued, “We urge you to seriously consider this existing statutory authority as well as explore other options for executive action. We also ask that you please provide your recommendations as to what additional authority you would require to protect American consumers. Of course, we would welcome your support of our legislation to bring down the costs of prescription drugs as well.” 

Klobuchar and McCain introduced the Safe and Affordable Drugs from Canada Act to require the Food and Drug Administration to establish a personal importation program that would allow individuals to import a 90-day supply of prescription drugs from an approved Canadian pharmacy. The bipartisan Preserve Access to Affordable Generics Act Klobuchar and Grassley introduced would crack down on anti-competitive “pay-for-delay” deals in which branded companies pay their generic competitors not to compete as part of a patent settlement. These pay-for-delay agreements delay consumer access to generic drugs, which can be as much as 90 percent cheaper than brand-name drugs. The legislation would help make sure consumers have access to the cost saving generics they need by stopping these anti-competitive pay-off agreements that keep more affordable generic equivalents off the market. In addition, Klobuchar and Grassley introduced the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act with Senators Patrick Leahy (D-VT), Dianne Feinstein (D-CA), and Mike Lee (R-UT). The CREATES Act would combat anticompetitive practices used by some brand-name pharmaceutical and biologic companies to block or delay entry of lower-cost generic drugs in the marketplace. 

The full text of the senators’ letter is below.

Dear Director Mulvaney:

According to media reports, you said on Thursday that you have been actively discussing potential executive or administrative solutions with the President to address rising prescription drug costs. Similarly, Secretary Price has been holding “listening sessions” to discuss possible solutions. We write to express our support for such efforts that could provide immediate relief to Americans. 

We have worked together on bipartisan legislation that would address skyrocketing drug prices, including bills to allow for personal importation of medications from Canada, where drug prices are, on average, half the cost they are in the United States, and bills that would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace.

While we pursue these legislative options in Congress, we strongly encourage you to take executive or administrative action to reduce the ever-increasing financial burden of prescription drugs for millions of Americans. We have previously outlined ways that the Administration could implement such strategies in a targeted manner that satisfies rigorous safety standards.

Specifically, we wrote to Secretary Price in February urging him to utilize authority the Administration already has under law. Our letter highlighted that Congress enacted legislation in 2003 that would enable importation of less costly medications from abroad. Under this law, the Food and Drug Administration (FDA) can permit pharmacists and wholesale retailers to import prescription drugs from Canada. Additionally, the FDA can issue a waiver to allow individuals to import prescription drugs for personal use. However, this law stipulates that the provisions related to importation do not become effective until the Secretary of Health and Human Services certifies that the implementation of importation would pose no additional risk to the public's health and safety and would result in a significant reduction in the cost of covered products to the American consumer.

Consistent with your comments last week, the Administration has an opportunity to use existing statutory authority to quickly restore competition to the market with the introduction of cheaper, imported alternatives. Under the statute, the Secretary has the authority to issue the certification in a targeted manner to address the current market conditions in a way that readily meets safety standards. The policy can also be expressly limited so that it does not negatively affect innovator companies that invested in the development of the drug.

We urge you to work with Secretary Price to immediately begin considering certifying importation of prescription drugs from Canada in the following circumstances:

1.               The drug is off patent or no longer marketed in the United States by the innovator company that initially developed the drug;

2.              In cases where there are significant and unexplained increases in price;

3.              No direct competitor drug is currently in the market and introduction of a competitor drug will benefit the prices paid by taxpayers and consumers; or

4.              The drug is produced in another country by the name brad manufacturer that initially developed the drug or by a well-known generic manufacturer that commonly sells pharmaceutical products in the United States.

We urge you to seriously consider this existing statutory authority as well as explore other options for executive action. We also ask that you please provide your recommendations as to what additional authority you would require to protect American consumers. Of course, we would welcome your support of our legislation to bring down the costs of prescription drugs as well. 

We look forward to your timely response to this request.

Grassley, Klobuchar, Gardner Introduce Legislation to Help Rural Hospitals Stay Open, Focus on Emergency Room Care, Outpatient Services

WASHINGTON, May 17, 2017 – Sen. Chuck Grassley of Iowa, Sen. Amy Klobuchar of Minnesota and Sen. Cory Gardner of Colorado today re-introduced legislation to help rural hospitals stay open while meeting the needs of rural residents for emergency room care and outpatient services. 

“A car accident or a heart attack is dangerous under the best of circumstances, but it’s a lot more dangerous for someone who’s far away from an emergency room,” Grassley said.  “When a rural hospital closes, its emergency room closes with it. This proposal will fill a pressing need, help keep hospital doors open, and offer hospital services where and when people need them most.”

“Our rural hospitals are essential institutions in communities across Minnesota. They don’t just provide vital health services, they employ thousands of doctors, nurses, pharmacists and other health care workers,” Klobuchar said. “Millions of people depend on keeping these hospitals open. Our bipartisan legislation will help ensure that rural Minnesotans and Americans across the country have access to medical care when and where they need it most.”

“Coloradans living in rural communities should not be denied access to healthcare simply because they do not live in a large metropolitan area,” Gardner said.  “This commonsense, bipartisan legislation provides rural hospitals an option to continue providing emergency services to rural America even if they do not meet Medicare’s criteria for inpatient beds. During an emergency, time is of the essence, and it is critical that we maintain access to life-saving treatment regardless of your zip code.”   

The senators noted that 60 percent of trauma deaths in the United States occur in rural areas, where only 15 percent of the population is represented.  The pace of rural hospital closures is accelerating, and many other hospitals that haven’t closed are struggling to keep their doors open.

Under Medicare, many rural hospitals are designated as Critical Access Hospitals, meaning they have to maintain a certain amount of inpatient beds as well as an emergency room.  Many hospitals struggle to attract enough inpatients to keep their Critical Access Hospital status.  When they close their doors, it often means a community loses its emergency services.  Studies show that proximity to an emergency room often means the difference between life and death.   

The senators’ bipartisan bill, the Rural Emergency Acute Care Hospital (REACH) Act, would create a new Rural Emergency Hospital classification under Medicare.  The hospital would have an emergency room and outpatient services.  It would not have the inpatient beds that many hospitals are struggling to maintain.  For example, a patient in a rural hospital with kidney disease might go to his community hospital for dialysis as an outpatient service.  He would go to a separate major hospital for specialized care such as a kidney operation.  He would go to his community hospital for emergency care for an acute episode, when time is of the essence.

The bill wouldn’t force any new requirements on hospitals.  It simply would offer them a new option. The hospitals would have to maintain some protocols in exchange for removing inpatient services, such as being able to rapidly move a patient to a larger hospital elsewhere that offers more services.

The bill text is available here. 

“Ryancare” Dead on Arrival: Can We Please Now Try Single Payer?

BY ELLEN BROWN/WEB OF DEBT

The Canadian plan also helps Canadians live longer and healthier than Americans. . . . We need, as a nation, to reexamine the single-payer plan, as many individual states are doing.  

— Donald Trump, The America We Deserve (2000)

The new American Health Care Act has been unveiled, and critics are calling it more flawed even than the Obamacare it was meant to replace. Dubbed “Ryancare” or “Trumpcare” (over the objection of White House staff), the Republican health care bill is under attack from left and right, with even conservative leaders calling it “Obamacare Lite”, “bad policy”, a “warmed-over substitute,” and “dead on arrival.”

The problem for both administrations is that they have been trying to fund a bloated, inefficient, and overpriced medical system with scarce taxpayer funds, without capping its costs. US healthcare costs in 2016 averaged $10,345 per person, for a total of $3.35 trillion dollars, a full 18 percent of the entire economy, twice as much as in other industrialized countries.

Ross Perot, who ran for president in 1992, had the right idea: he said all we have to do is to look at other countries that have better health care at lower cost and copy them.

So which industrialized countries do it better than the US? The answer is, all of them.

So which industrialized countries do it better than the US? The answer is, all of them.They all not only provide healthcare for the entire population at about half the cost, but they get better health outcomes than in the US. Their citizens have longer lifespans, fewer infant mortalities and less chronic disease.

President Trump, who is all about getting the most bang for the buck, should love that.

Hard to Argue with Success

The secret to the success of these more efficient systems is that they control medical costs. According to T. R. Reid in The Healing of America, they follow one of three models: the “Bismarck model” established in Germany, in which health providers and insurers are private but insurers are not allowed to make a profit; the “Beveridge model” adopted in Britain, where most healthcare providers work as government employees and the government acts as the single payer for all health services; and the Canadian model, a single-payer system in which the healthcare providers are mostly private.

A single government payer can negotiate much lower drug prices – about half what we pay in the US – and lower hospital prices. Single-payer is also much easier to administer. Cutting out the paperwork can save 30 percent on the cost of insurance.According to a May 2016 post by Physicians for a National Health Program:

Per capita, the U.S. spends three times as much for health care as the U.K., whose taxpayer-funded National Health Service provides health care to citizens without additional charges or co-pays. In 2013, U.S. taxpayers footed the bill for 64.3 percent of U.S. health care — about $1.9 trillion. Yet in the U.S. nearly 30 million of our citizens still lack any form of insurance coverage.

The for-profit U.S. health care system is corrupt, dysfunctional and deadly. In Canada, only 1.5 percent of health care costs are devoted to administration of its single-payer system. In the U.S., 31 percent of health care expenditures flow to the private insurance industry. Americans pay far more for prescription drugs. Last year, CNN reported, Americans paid nearly 10 times as much for prescription Nexium as it cost in the Netherlands.

Single payer, or Medicare for All, is the system proposed in 2016 by Democratic candidate Bernie Sanders. It is also the system endorsed by Donald Trump in his bookThe America We Deserve. Mr. Trump confirmed his admiration for that approach in January 2015, when he said on David Letterman:

A friend of mine was in Scotland recently. He got very, very sick. They took him by ambulance and he was there for four days. He was really in trouble, and they released him and he said, ‘Where do I pay?’ And they said, ‘There’s no charge.’ Not only that, he said it was like great doctors, great care. I mean we could have a great system in this country.

Contrary to the claims of its opponents, the single-payer plan of Bernie Sanders would not have been unaffordable. Rather, according to research by University of Massachusetts Amherst Professor Gerald Friedman, it would have generated substantial savings for the government:

Under the single-payer system envisioned by “The Expanded & Improved Medicare For All Act” (H.R. 676), the U.S. could save $592 billion – $476 billion by eliminating administrative waste associated with the private insurance industry and $116 billion by reducing drug prices …

According to OECD health data, in 2013 the British were getting their healthcare for $3,364 per capita annually; the Germans for $4,920; the French for $4,361; and the Japanese for $3,713. The tab for Americans was $9,086, at least double the others. With single-payer at the OECD average of $3,661 and a population of 322 million, we should be able to cover all our healthcare for under $1.2 trillion annually – well under half what we are paying now.

The Problem Is Not Just the High Cost of Insurance

That is true in theory; but governments at all levels in the US already spend $1.6 trillion for healthcare, which goes mainly to Medicare and Medicaid and covers only 17 percent of the population. Where is the discrepancy?

For one thing, Medicare and Medicaid are more expensive than they need to be, because the US government has been prevented from negotiating drug and hospital costs.

In January, a bill put forth by Sen. Sanders to allow the importation of cheaper prescription drugs from Canada was voted down. Sanders is now planning to introducea bill to allow Medicare to negotiate drug prices, for which he is hoping for the support of the president. Trump indicated throughout his presidential campaign that he would support negotiating drug prices; and in January, he said that the pharmaceutical industry is “getting away with murder” because of what it charges the government. As observed by Ronnie Cummins, International Director of the Organic Consumers Association, in February 2017:

. . . [B]ig pharmaceutical companies, for-profit hospitals and health insurers are allowed to jack up their profit margins at will. . . . Simply giving everyone access to Big Pharma’s overpriced drugs, and corporate hospitals’ profit-at-any-cost tests and treatment, will result in little more than soaring healthcare costs, with uninsured and insured alike remaining sick or becoming even sicker.

Besides the unnecessarily high cost of drugs, the US medical system is prone to over-diagnosing and over-treating. The Congressional Budget Office says that up to 30 percent of the health care in the US is unnecessary. We use more medical technologythen in other countries, including more expensive diagnostic equipment. The equipment must be used in order to recoup its costs. Unnecessary testing and treatment can create new health problems, requiring yet more treatment, further driving up medical bills.

Drug companies are driven by profit, and their market is sickness – a market they have little incentive to shrink. There is not much profit to be extracted from quick, effective cures. The money is in the drugs that have to be taken for 30 years, killing us slowly. And they are killing us. Pharmaceutical drugs taken as prescribed are the fourth leading cause of US deaths, after heart disease, cancer and stroke.  

The US is the only industrialized country besides New Zealand that allows drug companies to advertise pharmaceuticals. Big Pharma spends more on lobbying than any other US industry, and it spends more than $5 billion a year on advertising. Lured by drug advertising, Americans are popping pills they don’t need, with side effects that are creating problems where none existed before. Americans compose only 5 percent of the world’s population, yet we consume fully 50 percent of Big Pharma’s drugsand 80 percent of the world’s pain pills. We not only take more drugs (measured in grams of active ingredient) than people in most other countries, but we have the highest use of new prescription drugs, which have a 1 in 5 chance of causing serious adverse reactions after they have been approved.

The US death toll from prescription drugs taken as prescribed is now 128,000 per year.As Jon Rappaport observes, with those results Big Pharma should be under criminal investigation. But the legal drug industry has grown too powerful for that. According to Dr. Marcia Angell, former editor in chief of the New England Journal of Medicine, writing in 2002:

The combined profits for the ten drug companies in the Fortune 500 ($35.9 billion) were more than the profits for all the other 490 businesses put together ($33.7 billion). Over the past two decades the pharmaceutical industry has [become] a marketing machine to sell drugs of dubious benefit, [using] its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself.

It’s Just Good Business

US healthcare costs are projected to grow at 6 percent a year over the next decade. The result could be to bankrupt not only millions of consumers but the entire federal government.

Obamacare has not worked, and Ryancare is not likely to work. As demonstrated in many other industrialized countries, single-payer delivers better health care at half the cost that Americans are paying now.

Winston Churchill is said to have quipped, “You can always count on the Americans to do the right thing after they have tried everything else.” We need to try a thrifty version of Medicare for all, with negotiated prices for drugs, hospitals and diagnostic equipment.

Ellen Brown

Does Rep. Price support President Trump's campaign pledge for Personal Importation? An open letter to the President, Rep. Price and the U.S. Senate

The following letter was sent to members of the United States Senate and to the President at the White House and Rep. Tom Price, the designee for Secretary of Health and Human Services:

President
The White House
1600 Pennsylvania Avenue NW
 Washington, DC 20500

January 30, 2017

An Open Letter to President Trump and Health and Human Services Designee Rep. Price:

I am writing in my capacity as publisher of the TodaysSeniorsNetwork series of web blogs to respectfully request clarification on the stance of Rep. Price as regards his support—or lack thereof—of personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety of efficacy meet or exceed those of the U.S.

We applaud President Trump’s continued expressions of support for personal importation as evidenced by his campaign pledge, and more recently, his sharp criticism of the predatory pricing practices of Pharma that deny access to literally millions of Americans to vital medicines because the high prices render the medicines  unaffordable and unavailable.

During the Senate Judiciary Committee hearings for Rep. Price, he and Senator Bernie Sanders (D-VT) engaged in an exchange based upon Rep. Price’s continued references to his goal being ‘accessibility’ to health care for all Americans. Senator Sanders pointed out that accessibility is not the same as the ability to purchase or afford adequate medical care, or a ‘million dollar’ home.

No other example so vividly illustrates this point as the cost of prescription medicines. A medicine that is unaffordable is inherently unavailable, and a medicine that is unavailable and not able to be afforded is a medicine that is denied.

However, a recent article from Roll Call offers Rep. Price an opportunity to shed light on his definition of accessibility to health care, based upon a situation involving his role in seeking an FDA exemption for a specific case of personally imported denied to a constituent because the medicine in question was also available in the U.S.

Roll Call noted that “…In February 2006, Rep. Price’s office appealed to the FDA on behalf of a constituent in need of a medicine for a surgery. While both drugs were available for sale in the United States, the patient was trying to import them from Canada, where they were presumably cheaper. The drugs were being held in customs, and the FDA explained to Price that it wasn’t legal to import the drugs manufactured outside of the country, even though there are some exceptions to this policy…”

Ironically, one of the exceptions under which personal importation is allowable is if the medicine is unavailable. As explained above, this raises the question of whether or not a medicine is unavailable if it is unaffordable, or is it merely ‘accessible.’

When Rep. Price wrote the letter, the FDA and U.S. Customs were engaged in collusion for such seizures which were accompanied by a letter threatening the patient who personally imported their medicines that by signing the letter they were admitting they were guilty of violating the law, that they were pledging that they would not attempt to import medicines in the future, and, if they did, their signature on the Customs letter would constitute an admission of guilt.

For 16 years, as publisher of http:/RxforAmericanHealth.blogspot.com, http:AmericanRxBillofRights.blogspot.com. and www.TodaysSeniorsNetwork.com,  I and other advocates have worked on behalf of the rights of Americans to have access to safe, affordable prescription medicines. In this instance, we successfully worked with contacts in the Senate to have the seizures halted, and to also specifically deny funding to Customs for such seizures.

That is why we are asking Rep. Price to now explain if his definition of ‘access ’includes support of the rights of Americans to engage in personal importation as he sought—and failed in-- on behalf of his constituent.   

In a recent letter from many Democrat members of the U.S. House of Representative to President Barrack Obama, they sought to “…  encourage your administration to explore implementing drug importation rules that are already part of U.S. law. Under authority from the Medicare Prescription Drug Improvement and Modernization Act of 2003, the Secretary of Health and Human Services can certify the importation of prescription drugs from other countries under specific qualifications. This regulatory action would pose no risk to public health and safety and could result in a significant reduction in the cost of prescription drugs to American families.”

This leads to three specific questions that should be addressed by the President and Rep. Price:

1. Will he, if confirmed as HHS Secretary, continue his previously stated support of personal importation;

2. Does Rep. Price believe that a prescription medicine is in and of itself unavailable because it is unaffordable, thereby meeting the FDA’s stated and printed decision that a medicine or device that is unavailable is thereby exempt from restrictions of personal importation?

Will Rep. Price, if confirmed, follow the directive and intent of Congress as stated in the Medicare Prescription Drug Improvement and Modernization Act of 2003?

These questions are respectfully submitted.  We look forward to your response, and your stance on personal importation of safe, affordable medicines from Tier One countries—the most immediate relief from the predatory drug pricing practices of Pharma.

Daniel Hines

High prices force millions to buy medicine outside U.S.

 by Rachel Bluth, Kaiser Health News12:08 a.m. EST December 22, 2016

As drug prices have spiraled upward in the past decade, tens of millions of generally law-abiding Americans have committed an illegal act in response: They have bought prescriptions outside the U.S. and imported them.

One was Debra Miller of Collinston, Louisiana, who traveled to Mexico four times a year for 10 years to get diabetes and blood pressure medicine.

She quit in 2011 after the border patrol caught her returning to the United States with a three-month supply that had cost her $40. The former truck driver drew a stern warning not to do it again, but got to keep her pills.

“I didn’t know what I did wrong,” said Miller, 51, who now pays $120 a month at Walmart for her five medications while she waits to join Medicaid.

It’s no secret that some Americans regularly buy prescription drugs on the internet or while traveling abroad. But the popularity of the approach is underscored by the results of a Kaiser Family Foundation poll conducted in November. (Kaiser Health News is an editorially independent program of the foundation.)

Eight percent of respondents said they or someone in their household had imported a drug at some point, a figure that would translate to about 19 million adults in the U.S. based on current Census population estimates.

The proportion found in the poll may be low, said Andrew Zullo, a clinical pharmacist and a doctoral student at the Brown University School of Public Health who has researched the subject.

“People are uncomfortable talking about the cost of their own health care, and they don’t want to admit they are struggling to pay for their own meds,” he said. Some may also be reluctant to reveal they’ve broken the law.

Still, 8 percent is far higher than in surveys conducted by government interviewers, which suggested the number was about 2 percent in 2011 — though the government survey focused only on purchases in the previous 12 months. The Kaiser poll queried a nationally representative sample of 1,202 adults.

The internet has made it easier for Americans to buy prescription drugs abroad, frequently from disreputable sources, according to Jaime Ruiz, a spokesman for U.S. Customs and Border Protection.

The Food and Drug Administration has cautioned that many online pharmacies aren’t what they seem. An international crackdown in 2014 found that many packages of medicines purportedly from Australia, Canada, New Zealand and the United Kingdom contained drugs from other countries, including India, China and Laos.

Zullo acknowledged that imported medications could be inferior or expired. Some could be counterfeits. But many medicines purchased from another country are the same as the ones patients buy in the United States.

When purchased outside the country, many prescription medicines cost half or less than they do in the states.

According to the FDA’s website, it is generally illegal for Americans to import drugs into the states for personal use. The law isn’t rigorously enforced, in part because it is difficult to monitor the entry of medicine in suitcases and small packages. But in 2015 the FDA implemented a rule that would give government border inspectors expanded authority to destroy drugs imported for personal use at their point of entry.

In the poll, people who had imported medicines ranged from college students in their 20s to retirees in their 80s. They bought medications to treat chronic conditions — such as high blood pressure and thyroid problems — as well as acute problems such as sinus infections and acne.

Amanda Mazumder, a 27-year-old graphic designer in St. Paul, Minnesota, was stressed out by the murky legality of the situation when she tried buying birth control pills while in college five years ago.

“That was the most difficult part, trying to be an honest citizen but also getting an affordable prescription,” she said. She couldn’t afford to pay $150 a month for her birth control, but found an online Canadian pharmacy that sold her a three-month supply for $60.

Bobby Grant of Los Angeles has relied on foreign pharmacies for seven years to get medicine for his partner’s severe asthma. Grant, 38, travels internationally for his job producing live shows. Each time he’s in Mexico or France, he buys 10-packs of inhalers and 20-packs of nebulizer solution for a fraction of what they would cost in the United States.

His partner’s asthma would require inhalers costing $300 a month if she purchased them here. Grant estimates he saves at least $2,500 a year by buying the drugs overseas.

“I love her to death,” he said. “I’ll do whatever I can to take her stress away.”

Kaiser Health Network’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Editor’s note

Kaiser Health News is a nonprofit news service committed to in-depth coverage of health care policy and politics.

Senator Grassley: Competition is key to controlling drug costs, including a role for personal importation of prescription meds

By Senator Chuck Grassley

Top of Form

Bottom of Form

Back to school shopping this year brought sticker shock for families in Iowa and elsewhere. This wasn’t over pencils and notebooks but a life-saving device that kids with severe allergies have to have available at all times. The EpiPen cost has jumped more than 400 percent since 2007. 

Paying as much as $600 per product is a lot of money, especially considering families like one in Polk City, Iowa, with four kids who need EpiPens. 

The shelf life is about a year, so the EpiPen needs to be replaced, and parents try to stock the item in multiple places, like grandma’s house, in case of emergency.

The price increases brought scrutiny on the company, Mylan, that sells EpiPens. Iowans asked me to find out what was going on, and I started asking questions. 

Soon afterward, Mylan announced steps to help patients afford the product: more patient discount coupons and an authorized generic version. Still, the company won’t lower the price, and daily headlines tell us the EpiPen is only one of many prescription medicines busting budgets. So what can and should be done to hold down drug costs?

One of the best ways is to increase competition, where drug companies are encouraged to innovate and produce new products and the marketplace works to drive down prices. 

Driving down prices also requires making sure drug companies are playing fair and not gaming the rules. The Department of Justice and the Federal Trade Commission enforce the antitrust laws and investigate anti-competitive behavior. 

Companies aren’t allowed to engage in unfair or deceptive practices that end up harming consumers. The agencies need to be assertive in enforcing these laws.

I’m a co-sponsor of two bipartisan bills that would help address drug company practices that have delayed the availability of generic drugs and kept drug costs high for patients. One is the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act. 

This bill would deter brand name pharmaceutical companies from blocking less expensive generic alternatives from entering the market. The brand companies do this by denying access to the drug samples that generic makers need to develop their generic versions. 

The second bill is the Preserve Access to Affordable Generics Act. It would help end the practice of brand name and generic manufacturers’ using anti-competitive pay-off agreements to keep more affordable generic equivalents off the market.

Another way to lower costs is making sure drug companies aren’t gaming taxpayer-funded public health care programs. Medicare and Medicaid are big customers for prescription drugs and medical devices. 

When they overpay, the taxpayers overpay, and so do the beneficiaries who face out of pocket copayments. My office found that Mylan relies heavily on Medicare and Medicaid for its EpiPen revenue. Meanwhile, the federal agency that runs those health care programs says Mylan has been overcharging Medicaid for EpiPens. 

This might have cost the taxpayers hundreds of millions of dollars. Where was the federal agency while this was going on? 

The taxpayers are getting short shrift, and the Obama Administration has not done its job here. I’m continuing to ask questions. The Justice Department, and other agencies, now seem to be paying attention.

Yet another way to drive down drug costs is the reimportation of prescription drugs from other countries where product safety and effectiveness can be assured. 

The Food and Drug Administration already has the power to certify the safety of such drugs. The agency hasn’t wanted to use this power for reasons that are unclear.

The FDA also needs to continue to make progress on its backlog of generic drug applications. When a company has submitted an application for a generic product, consumers deserve a timely answer on whether that product is ready for the marketplace. 

And while the FDA’s no. 1 job is protecting public safety, the agency also needs to make sure not to impose unneeded regulations that prevent patients from getting new alterative or generic drugs as soon as possible.

There may be other steps that would ease the sticker shock of sky-high prescription drug prices. In the meantime, I’m working on legislation and oversight efforts that will make a big difference for consumers and the people of Iowa.

ADVOCACY GROUPS LAUNCH JOINT EFFORT TO ENSURE PRESIDENTIAL CANDIDATES ADDRESS LOWER DRUG COSTS AT NEXT DEBATE

Effort will give voice to millions of Americans who support access to personal importation of safe, affordable prescriptions

WASHINGTON, D.C., USA, October 5, 2016 /EINPresswire.com/-- A group of patient advocates and businesses representing the right of Americans to engage in the importation of prescription medications from safe, credentialed international pharmacies, today announced joint support of an unprecedented initiative to ensure presidential candidates Hillary Clinton and Donald Trump address the issue of prescription importation at the second presidential debate.
The group includes Daniel Hines, the publisher of TodaysSeniorsNetwork; RxRights.org; the Campaign for Personal Prescription Importation, PharmacyChecker.com, and the Prescription Justice Action Group. Together, these organizations represent more than four million Americans who import medication for personal use each year.

A 500 percent increase in the price of the EpiPen® has elevated the issue of high drug prices to the public’s attention and resulted in Congressional hearings on high drug costs in the U.S. The discussion surrounding unaffordable drug prices, however, has focused almost exclusively on long term solutions.

Americans cannot wait for long term solutions. The Commonwealth Fund reports at least 35 million Americans failed to adhere to their prescribed drug regimens in 2014 due to the high cost of their medications. This non-adherence is estimated to cost $100-$300 billion in avoidable healthcare costs in the U.S. annually, according to a study in Risk Management and Healthcare Policy (2014). Meanwhile, the Kaiser Family Foundation found that 71 percent of Americans support access to safe, affordable medications through prescription importation (September, 2016).

The group is asking Americans to support the issue by voting for its importation question through the Open Debate Coalition forum, at https://presidentialopenquestions.com/questions/12064/vote/. It is also encouraging supporters to share their stories on social media and let the moderators of the October 9 presidential debate, Anderson Cooper and Martha Raddatz, know that Americans want the presidential candidates to explain how they will provide immediate relief on drug prices and how they’ll fight to increase access to safe, affordable medications through prescription importation. Supporters should use the hashtags #RxAccess and #RxImportation to participate in the discussion.

About TodaysSeniorsNetwork
TodaysSeniorsNetwork , which includes RxforAmericanHealth and the AmericanRxBillofRights, is America's leading information source for seniors an issues facing an aging America. Publisher Daniel Hines, an international award-winning communicator brings his unique perspective to a host of issues based on his extensive work with policy-makers at the local, state and Federal levels, elected officials, seniors' and other advocacy groups, and who has worked extensively on behalf of personal importation of safe, affordable prescription medicines for 15 years. For the official blog, visithttp://www.todaysseniorsnetwork.com and for more information, contact Daniel Hines at 636.399.2849 or todaysseniorsnet@sbcglobal.net. 

About RxRights
RxRights is a national nonprofit coalition of individuals and organizations dedicated to raising awareness and spurring action around issues related to U.S. prescription drug pricing. We support the right of Americans to import medicine from legitimate, licensed online and mail order international pharmacies. RxRights.org serves as a forum for individuals to share experiences and voice opinions regarding Americans’ need for affordable prescription drugs. We encourage participation and discussion through our website. For more information visit www.rxrights.org or contact Lee Graczyk: lee@rxrights.org or 1-866-703-5442.

About Campaign for Personal Prescription Importation
Campaign for Personal Prescription Importation (CPPI) is a national nonprofit patient advocacy organization that advocates for Americans’ access to safe, affordable prescription medications from Canada for personal use. Tens of millions of Americans – especially the elderly and others on fixed incomes – struggle to pay the extremely high price of prescription medications in the U.S. We are here to be a voice for them. For more information visit www.personalimportation.org or contact Rebecca Kelley at info@personalimportation.org or 202.765.3290.

About PharmacyChecker.com
PharmacyChecker.com (www.pharmacychecker.com) is the only independent company that verifies U.S. and international online pharmacies and compares prescription drug prices. Our verifications and price comparisons have been referenced by AARP Magazine, the New York Times, the Wall Street Journal, and many others. We were formed in 2002 when our founder, Tod Cooperman, M.D., saw that increasing numbers of Americans were looking on the Internet to save money on medication but did not have adequate information to protect their health. We are a stakeholder in the online consumer-driven healthcare community, seeking an open Internet environment that promotes innovation and new business models, especially those that serve the public health. For more information, contact Gabriel Levitt at 718.387.4526 or Gabriel.levitt@pharmacychecker.com. 

About Prescription Justice Action Group
Prescription Justice Action Group is a not-for-profit organization that is dedicated to providing relief and protection for American patients. Prescription Justice Action Group brings together doctors, lawyers, public health advocates, and companies dedicated to helping people afford medication. For more information, contact Jodi Dart at 217.306.5823 or jodi@pjag.org.

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Daniel Hines
TodaysSeniorsNetwork
636-399-2849
email us here

Open Letter to Members of Congress.Asks: What will it take to get Congress to act to lower prescription dug prices?

 

The following letter was sent to members of the House Committee on Oversight and Government Reform by Publisher Daniel Hines

Daniel Hines, Publisher, TodaysSeniorsNetwork

Phone: 636-386-5234
Fax:  636-386-5904
Cell Phone: 636-399-2849
Email: TodaysSeniorsNet@sbcglobal.net

Dear Members of the U.S. House of Representatives Committee on Oversight and Government Reform:

I am writing in my capacity of publisher of the TodaysSeniorsNetwork series of blogs dealing with issues facing an aging America and the need for policies to lower the costs of prescription medicines in the U.S. to applaud your intensive questioning of Mylan CEO Heather Bresch during your recent hearings.

It is gratifying to see such bi-partisan consensus on the potential of the dramatic, undesirable consequences affecting the health and well-being of American citizens because of the predatory pricing practices of Pharma. The many expressions of outrage and indignation are, hopefully, welcomed preludes to Congressional action to end Pharma’s attitude of charging not just what the traffic will bear but what it determines to be necessary to inflated profits despite the consequences to patients that simply cannot afford their medicines.

But there are questions that remain unanswered, and must be directed to not Pharma but to Congress:

1.     Throughout the hearing, members of the Committee noted that ‘they had been here before’, charges were leveled against Ms. Bresch’s statements calling them ‘rope-a-dope,’ ‘a shell game,’ and suggestions that perhaps this will be the impetus that will finally lead to Congressional action.  While such comments are welcomed, question must be asked: “If this latest example of Pharma abuse does not lead to Congressional action, what will it take?  When will Congress act?  Why is there even a delay?

2.     The testimony of Douglas Throckmorton, M.D., Deputy Center Director for Regulatory Programs of the Food and Drug Administration, and his non-responsive answers to requests from the Committee, while not surprising, were appalling.  His refusal to share information with the Chair of the Committee was particularly troublesome, but is indicative of the FDA, an agency ostensibly designed to protect the health and well-being of Americans, claiming an equal status with Congress.  Another example of such a blatant rejection of Congressional oversight was its refusal to implement ‘march in’ rights for more than 35 years, even in light of a recent bi-partisan Congressional request from 51 members of Congress for such action.  A question that must be addressed is ‘Why does Congress allow the FDA to act in such an authoritative manner, and to basically refuse to acknowledge Congressional oversight?’  Also, why did the FDA reportedly deny the application of Teva for a competitive product to EpiPen on the basis of patent exclusivity of the design of the Mylan product?

3.     As I write this letter, the Wall Street Journal is reporting that Ms. Bresch “underreported” Mylan profits by 60 percent, manipulating tax payment claims that, according to the WSJ did not apply to Mylan.  This leads to two questions: Will this claim be investigated further by the Committee?  If the charge is found to be true, will that lead to the possibility of a perjury charge?

4.     It was especially gratifying to note that there was a consensus among many members of the Committee that a medicine that is unaffordable is, in and of itself, unavailable.  You can’t buy what you can’t afford.  But, millions of Americans have for years been denied the health benefits made possible by access to a regimen of their prescribed medicines.  It is virtually impossible to estimate the adverse impact to the health of individuals and society that have occurred simply because they can’t afford their medicines. This is due to Pharma and the FDA ignoring previously adopted directives to the FDA and HHS to explore and facilitate what is a readily available, affordable and safe resolution to the fact that Americans pay the highest prescription prices in the world—i.e., the personal importation of safe, affordable brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S.

5.     Ironically, for many years, Congress has introduced legislation that would allow such personal importation.  Both Presidential candidates support some form of personal importation of prescriptions from Canada and Tier One Countries as a means to lower prescription costs.  There are bi-partisan bills for personal importation that have been introduced in the current Congress.  But the FDA claims it cannot verify the safety and efficacy of drugs produced outside this country, although it works with Pharma to provide oversight of the more that 80 percent of the prescription ingredients that are produced outside the U.S., and has stated that it is seeking greater cooperation with counterpart oversight agencies outside the U.S.  Added to this is that while millions of Americans have been denied access to affordable medicine because of Pharma pricing practices, millions more have turned to personal importation of safe, affordable medicines for years, leading to the question, why does Congress fail to enact enabling legislation for personal importation?

In conclusion, it, one can only hope that the Mylan headings will lead to a consensus-building initiative that will result in comprehensive legislation as outlined in the American Rx Bill of Rights included with this letter. Thank you for your consideration of the issues presented.  We respectfully urge action to finally address the harmful impacts of the predatory pricing practices of Pharma, resulting in improved health and well-being of Americans.

Respectfully submitted,

Daniel Hines
Daniel Hines

The Articles of the American Rx Bill of Rights

It is time to call out the harmful effects of the undue influence of Pharma upon public health policy.  It is time for an Rx Bill of Rights on behalf of All Americans

Article One (A Basic Right to Good Health)

The impact of millions of Americans being denied the health benefits of access to a regimen of safe, affordable medicines because of cost is a national health issue that has yet-to-be-recognized consequences.  That is why the ability of American Citizens to make health care decisions in concert with their physicians such as the purchase of personally imported safe, affordable prescription medicines should not be hampered by any actions by government or private entities as a policy to restrict Americans' access to authentic medicines. 

Article Two (An Unaffordable Medicine is Unavailable)

A prescription medicine that is unaffordable is unavailable, thereby meeting the 'rules' of the FDA that such a medicine that is otherwise unavailable is indeed eligible to be personally imported by an American patient, Arbitrary denial by the FDA to such access is detrimental to the health of the patient  by denying him or her access to vital maintenance medicines. This is a violation of the purpose of the FDA which is ostensibly designed to protect the health and well-being of American citizens.

Article Three (Citizens as Stakeholders)

The relationship between the FDA, elected officials, and Pharma has led to numerous abuses, access by Pharma to legislators and other elected officials based on the contribution of millions of dollars, favored status for Pharma representatives and their front groups as the primary representative at public hearings to determine the health care policy for Federal, State and Local Governments, thereby skewering the decision-making process.  That why it is incumbent upon Congress that it act to ensure that ordinary American citizens whose health and finances are adversely affected by Pharma pricing practices, advocacy groups other than those of Pharma, are given a 'stakeholder' status equal to that of Pharma.

Article Four (Due Process)

Americans who purchase safe, affordable medicines from licensed, registered pharmacies in Tier One Countries whose standards meet or exceed those of the U.S., are the legitimate owners of their authentic medicines and are entitled to exercise their due process rights to have their personal property free from undue and unjustified seizure oar destruction by any governmental agency unless the seizing authority can demonstrate via established judicial processes and to courts that such seizures are of bogus, counterfeit or unsafe prescription medicines.

Article Five (Public Interest)

Americans are significant contributors to the development of research and development costs of new medicines through their tax dollars in support of grants to the National Institutes of Health (NIH), and, as such, should be protected from unfair or questionable patent protection granted to Pharma that fails to recognize the rights of American citizens. Abuses in pricing, illegal business activities, or undue influence upon policy-making by the FDA or elected officials should result in a reduction of the patent protection afforded Pharma to the detriment of untold numbers of Americans who must be able to pay what Pharma believes the traffic will bear.

 Article Six (Reciprocity)

The FDA should extend reciprocity to other Tier One countries in the interests of the health of American citizens. The majority of brand name prescription medicines sold to Americans is manufactured at plants outside the U.S., under FDA supervision, or at plants licensed by Pharma members to produce medicines under a license granted by a particular company, a validation that medicines produced outside the U.S. and sold in this country are indeed capable of being safe.  Also, the FDA has entered into agreements with regulatory agencies in many countries to assume the task of overseeing ingredients manufacture of ingredients for brand name medicines.  Added to that is that many countries (excluding the U.S and the FDA) have reciprocal agreements (Memorandums of Understanding) that one country will accept the medications produced in another country as safe and authentic.