Nonprofit working to block drug imports has ties to pharma lobby

Business, Emily Kopp , Rachel Bluth · Kaiser Health News · Apr 18, 2017

A nonprofit organization that has orchestrated a wide-reaching campaign against foreign drug imports has deep ties to the Pharmaceutical Research and Manufacturers of America, or PhRMA, the powerful lobbying group that includes Eli Lilly, Pfizer and Bayer.

The nonprofit, called the Partnership for Safe Medicines, has recently emerged as a leading voice against Senate bills that would allow drugs to be imported from Canada.

Both the lobbying group and the nonprofit partnership have gone to great lengths to show that drugmakers are not driving what they describe as a grass-roots effort to fight imports, including an expensive advertising blitz and an event last week that featured high-profile former FBI officials and a former Food and Drug Administration commissioner.

However, a Kaiser Health News analysis of groups involved in the partnership shows more than one-third have received PhRMA funding or are local chapters of groups that have received PhRMA funding, according to PhRMA tax disclosures from 2013 to 2015.

Forty-seven of the organizations listed in the ads appear to be advocacy organizations that received no money from PhRMA in those years.

A PhRMA senior vice president, Scott LaGanga, previously led the Partnership for Safe Medicines for 10 years. At PhRMA, LaGanga was responsible for the lobbying group's alliances with patient advocacy groups, and he was simultaneously listed as the executive director of the Partnership for Safe Medicines on each of that group's annual tax filings since 2007, the earliest year for which they are available from ProPublica's Nonprofit Explorer.

LaGanga wrote a 2011 article about the partnership's origins. Published in the Journal of Commercial Biotechnology, it described "public-private partnerships in addressing counterfeit medicines." His PhRMA job was not disclosed in the article.

From 2010 to 2014, the organization hosted a conference called the Partnership for Safe Medicines Interchange. In a video from a 2013 event, LaGanga thanks pharmaceutical companies, most of them PhRMA members, for sponsoring the event.

In February, LaGanga moved to a senior role at PhRMA and stepped down as executive director of the Partnership for Safe Medicines, just as the group's campaign to stop import legislation was revving up.

The partnership's new executive director, Shabbir Safdar, said LaGanga resigned from the group to avoid the appearance of a conflict of interest.

"That's why Scott's not executive director anymore," he said. PhRMA declined to make LaGanga available for an interview.

Considering Legislation

The Senate push to allow Americans to buy pharmaceuticals from Canada comes as more patients balk at filling prescriptions because of soaring drug prices. Prescription medicines purchased in the U.S. can run three times what they cost in Canada, data from the company PharmacyChecker.com show.

In 2016, about 19 million Americans purchased pharmaceuticals illegally from foreign sources through online pharmacies or while traveling, according to a Kaiser Family Foundation poll. Many survey respondents cited pricing disparities as the reason.

A bill cosponsored by Sen. Bernie Sanders (I-Vt.) would provide a mechanism for Canadian drug manufacturers to sell to U.S. consumers and pharmacies. Sanders introduced the bill in February. In January, Sens. John McCain (R-Ariz.) and Amy Klobuchar (D-Minn.) also introduced a bill to allow drug imports from Canada.

In the House, Rep. Elijah Cummings (D-Md.) introduced a similar bill to Sanders', along with 23 other Democrats.

The U.S. drug industry has strongly opposed efforts to open the borders to drug imports, but the PhRMA lobbying group is not mentioned in the nonprofit partnership's recent advertising blitz against the proposed legislation. The nonprofit says its grass-roots effort is supported by 170 members, including professional organizations and trade groups.

The nonprofit describes PhRMA as a dues-paying member with no larger role in shaping the group's activities. Partnership spokeswoman Clare Krusing would not say how much each member contributes. PhRMA spokeswoman Allyson Funk declined to say whether PhRMA funds the partnership.

"PhRMA engages with stakeholders across the health care system to hear their perspectives and priorities," Funk said. "We work with many organizations with which we have both agreements and disagreements on public policy issues, and believe engagement and dialogue are critical."

Campaigning Against Drug Imports

The partnership recently launched its ad campaign, warning against the alleged dangers of legalizing Canadian drug imports. It includes television commercials, promoted search results on Google and a full-page print ad in The Washington Post and The Hill. The group's YouTube page shows recent commercials targeted to viewers in 13 states.

"We don't disclose specific ad figures, but the campaign is in the high six figures," Safdar said.

The commercials ask voters to urge their senators to "oppose dangerous drug importation legislation."

The newspaper ad reads, "Keep the nation's prescription drug supply safe. Urge the Senate to reject drug importation measures." Its headline declares that "170 healthcare advocacy groups oppose drug importation," noting a letter to Congress signed by its members. The ad lists 160 members who signed the letter, and PhRMA's name is not included.

"Having a big membership allows the coalition to present what looks like a unified show of grass-roots support ... but it does raise questions about which members of the coalition are really driving and funding the group's policy-making," said Matthew McCoy, a postdoctoral fellow at the University of Pennsylvania who studies patient advocacy groups.

The list of groups includes at least 64 trade organizations representing the biomedical industry, professional associations representing pharmacists, a private research company and two insurance companies.

One group that signed the letter, the "Citrus Council, National Kidney Foundation of Florida Inc.," represents a single volunteer, according to an email from the group. A spokesman for the National Kidney Foundation of Florida said the volunteer's views contradict the position of the umbrella group, and said the foundation supports "any sort of drug importation that allows our patients to have access to drugs at the best price."

Two of the hepatitis patients' advocacy groups that were listed, the National Association of Hepatitis Task Forces and the California Hepatitis C Task Force, are run by the same person, Bill Remak. Remak said the groups receive small amounts of PhRMA funding.

"I don't enjoy having to take this extreme position of saying we shouldn't import at all, but until we have some oversight regime, some way of protecting consumers, it's a really tough call," he said.

"Current drug importation proposals do not appear to have equal safety and chain-of-custody accountability laid out adequately for patient safety concerns," said William Arnold, president of the Community Access National Network, which is also listed in the ad and is an advocacy and support group for people living with HIV/AIDS or hepatitis in Washington, D.C. His group did not accept money from PhRMA between 2013 to 2015, the Kaiser Health News analysis found.

Concerns About Safety And Price

Last week, the partnership hosted a panel at the National Press Club featuring former FBI director Louis Freeh and former FDA commissioner Dr. Andrew von Eschenbach. The discussion focused on the alleged health and legal dangers of online pharmacies.

"You can talk about lowering prices, but if a drug comes with a high probability of toxicity and death, that comes at a high cost to the patient," von Eschenbach said. "That's what's at issue with drug importation."

Each speaker argued that the bill co-sponsored by Sanders would be harmful to patients. Around the same time that bill was introduced, the partnership also sent emails to member organizations seeking help to stop such a measure.

Speakers at the partnership event claimed importation would lead to a flood of counterfeit medicines laced with arsenic, fentanyl and lead paint.

"These drugs are manufactured in jungles, in tin drums, in basements. ... Those are the sort of sanitary conditions we're talking about here," said George Karavetsos, a former director of the FDA's Office of Criminal Investigations.

Both von Eschenbach and Karavetsos have ties to the pharmaceutical industry. Von Eschenbach left the FDA in 2009 to join Greenleaf Health, which counsels pharmaceutical clients, before starting his own consulting company, and Karavetsos counsels pharmaceutical clients at DLA Piper, a Washington, D.C., law firm.

In an interview, Josh Miller-Lewis, Sanders' deputy director of communications, refuted Karavetsos' arguments. He said Canadian drugmakers can apply for licenses, and all drugs would have to come from FDA-inspected plants.

Politico reported in October that PhRMA is bolstering its war chest by another $100 million per year, suggesting to many industry analysts that drugmakers are gearing up for a ferocious fight.

"I think it's safe to say pharmaceutical corporations are prepared to spend some fraction of their multibillion-dollar profits to fight drug importation and any other policy that might end the plague of overpriced medicine," said Rick Claypool, research director for Public Citizen, a watchdog group critical of the drug industry.

An Open Letter to President Trump: How personal importation of brand-name medicines can help lower health costs

Dear President Trump:

Recently, you have once again called for measures to lower the costs of prescription medicines for millions of Americans who continue to be denied the health benefits of access to a regime of vital medicines for one reason—they are unaffordable.

Estimates are that as many as 46 million Americans have been forced to make a decision to ‘skip ‘ their medicines because of the predatory pricing practices of Pharma.

All of this is unnecessary. 

If you act in support of a workable legislative bill to allow the personal importation of brand-name prescription medicines from licensed, registered pharmacies in Tier One Countries—including but not limited to Canada—whose standards of safety and efficacy meet or exceed those of the U.S., there could be almost immediate relief from what are the highest drug prices in the industrial world.

However, recently, a great deal of attention has been directed towards a proposal from Senator Bernie Sanders (I-VT), Senator Corey Booker (D-NJ),  Rep. Elijah Cummings (D MD 24)and others  to pass what was a failed model when it was first introduced in 2003, and then brought forth again a few years later.

The irony of Senator Booker’s sponsorship of the bill should be a red flag.  He represents New Jersey, which is nicknamed the United State of Pharma due to the presence of 46 Pharma companies, leading to Pharma’s long-standing influence upon New Jersey politics. 

Senator Booker, who before the 2016 elections had received $239,000 from Pharma-related contibutions voted against an amendment to allow personal importation offered by Senator Sanders during the recent budget reconciliation process, one of 13 Democrats to do so,  a vote which drew a great deal of criticism from media, the public and Democrat Party members.

He said he would support personal importation IF the proper safety standards were included.  Instead, he and others have come together in support  of the fatally flawed 2003 legislation.  (To review the built-in failings of the bill S. 469  click here, published in RxforAmericanHealth.)

Simply put, this is not legislation based upon the right and ability of American citizens to make independent, informed healthcare decisions.    It is not a personal importation bill.   Rather,  it is an awkwardly written set of procedures that could actually lead to higher prices as it calls for wholesaling of medicines from Canada to wholesalers in the U.S., with no guarantee that they would pass along savings to American patients.

It would also impose  U.S. oversight and approval of the safety, efficacy and validity of medicines approved by the Canadian system, which is widely recognized as being on par with the U.S. and other Tier One Countries. 

The solution is not that difficult.  There are bills offered by Senators John McCain (R-AZ) and Amy Klobuchar (D-MN), and Rep. Keith Ellision (D MN 7) that would allow American patients to personally import medicines from Canada (and/or) other countries whose standards of safety and efficacy are recognized as being equal to those of the U.S.

Recently, the FDA has announced the launch of a series of reciprocal agreements with a number of Tier One Countries so the structure for guaranteeing the safety of medicines from those countries is already in place.

So, Mr. President when supporters of S. 469 come to you, we recommend you ask some straight questions that demand straight answers:

1. Does anyone truly believe that Canadian provincial licensing authorities will cede any of that authority to allow the FDA to come into Canada to provide what is basically an oversight of the authority/ability of licensing procedures? As Senator Sanders has often said, “Show me the Dead Canadians” a reference to those who have died from non-existent  failures of the Canadian system.

2. How will personal importation into the U.S., which has been identified with Canada for more than 17 years be defensible within Canada if wholesaling is allowed, reviving an old argument about Canadian objections to the Country becoming 'America's Drugstore'? 

3.  In a related issue, there is a continuing push for Pharmacare in Canada.  Will S. 469 become the cause of what could be viewed in Canada as a threat to its ability to address its own challenges and problems of pharma costs and availability?

4.  S. 469 is not personal importation, but is instead a push for a different, unworkable, doomed-to-failure importation strategy.

5.  You have suggested that you want to renegotiate the North American Free Trade Agreement (NAFTA).  Perhaps you should consider  the recommendation from more than 14 yearsa go that personal importation should be a ‘trade issue,’  a recommendation from no less an authority than  then-Pfizer CEO Kimball.   

5.  A fatal flaw of S. 469 is that it is a mistaken claim that without FDA approval (US Approval), the regulatory agencies in Tier One countries are not capable of determining the safety and efficacy of medicines, despite their  record that proves that  the medicines from Tier One Countries are  safe,  and their regulatory agencies are capable of guaranteeing the safety, efficacy and authenticity of medicines on a par with U.S. authorities.  

6.  Some proponents of  S.  469 say or hope it is a shift of the determination of safety, efficacy and authenticity of medicines and sources from countries of origin to the dispensing entity, such as pharmacies who dispense the medicines.

7.  Perhaps you should ask the supporters of S. 469 if they will guarantee that any savings they claim from wholesale operations will be shared with American patients.

So, Mr. President, we urge you: Be alert as to what policy or combination of policies you might choose to end the predatory pricing of Pharma. 

With that, we respectfully  suggest that you consider the provisions in the AmericanRxBillof Rights.  And, as a first ‘baby’ step,  that you consider issuing an executive order for HHS Secretary Price to implement reciprocity (the framework is now in place for Memorandums of Understanding ) with Tier One countries. By allowing true personal importation for individuals, you will plant the seeds for lowering other health care costs thanks to the improved health of American patients who will thereby avoid worsening medical conditions that can be avoided by access to the benefits made possible by access to a regimen of  authentic, safe and affordable prescribed medicines.

Respectfully submitted,

Daniel Hines
Publisher
TodaysSeniorsNetwork
RxforAmericanHealth
AmericanRxBillof Rights

• Breaking News about Prescription Medicine Prices, Affordability
  

Top 15 pharma companies by 2016 revenue

by Eric Palmer | 

Mar 14, 2017 12:00pm  (From Fierce Pharma)

The biopharma industry is so dynamic and has had so many watershed moments for one reason or another that for someone to proclaim a new one is pretty pointless. And so I won’t. Still, it does feel as if something's happening here. The building tensions over pricing, and a review of the top 15 companies by 2016 revenues, suggests the relentless march forward of drug prices and profits may have slowed...(read more)

1. Johnson & Johnson Headquarters:  New Brunswick, New Jersey 2016 revenues: $71.89 billion 2015 revenues: $70.04 billion	2. Pfizer Headquarters: New York City 2016 revenues: $52.82 billion 2015 revenues: $48.85 billion		3. Roche Headquarters: Basel, Switzerland 2016 revenues: CHF 50.576 billion (about $50.11 billion) 2015 revenues: CHF 48.145 billion (about $47.70 billion)		4. Novartis Headquarters: Basel, Switzerland 2016 revenue: $48.52 billion 2015 revenue: $49.41 billion
5. Merck & Co. Headquarters: Kenilworth, NJ 2016 revenues: $39.8 billion 2015 revenues: $39.5 billion	6. Sanofi Headquarters: Paris 2016 revenue: €34.708 billion (about $36.57 billion) 2015 revenue: €34.861 billion (about $36.73 billion)		7. GlaxoSmithKline Headquarters:  Brentford, U.K. 2016 revenues: £27.889 billion (about $34.79 billion) 2015 revenues: £23.923 billion (about $29.84 billion)		8. Gilead Sciences Headquarters: Foster City, California 2016 revenues: $30.39 billion 2015 revenues: $32.15 billion
9. AbbVie Headquarters: North Chicago, Illinois 2016 revenues: $25.56 billion 2015 revenues: $22.82 billion	10. Bayer (healthcare businesses) Headquarters: Leverkusen, Germany 2016 revenues: €23.98 billion ($25.27 billion) 2015 revenues: €22.87 billion ($24.09 billion)		11. AstraZeneca Headquarters: London 2016 revenues: $23.00 billion 2015 revenues: $24.71 billion		12. Amgen Headquarters: Thousand Oaks, California 2016 revenues: $22.99 billion 2015 revenues: $21.66 billion
13. Teva Pharmaceutical Industries Headquarters: Petah Tikva, Israel 2016 revenues: $21.90 billion 2015 revenues: $20.00 billion		14. Eli Lilly & Co. Headquarters: Indianapolis, Indiana 2016 revenues: $21.22 billion 2015 revenues: $20 billion		15. Bristol-Myers Squibb Headquarters: New York City 2016 revenues: $19.427 billion 2015 revenues: $16.56 billion

“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

Personal Importation: It is time for Congress and the Administration to act

Recently, Senators Amy Klobuchar (D-MN), Charles Grassley (R-IA) and John McCain wrote a letter to Health and Human Services(HHS) Secretary Tom Price asking him to utilize legislation crafted 14 years ago to exercise his authority to ‘enable’ personal importation of prescription medicines under provisions of the Medicare Prescription Drug Improvement and Modernization Act of 2003.

That such a request to the Secretary is necessary is a reflection of the failure of Congress to overcome the opposition of Pharma, which views personal importation as a threat to its ability to impose the highest prescription drug prices in the world upon American patients.

The Senators are not alone in making such a request. A group of 33 Democrat members of the House of Representatives sent a similar appeal to President Obama, asking him to issue an executive order shortly before the end of his Presidency. 

Also, throughout the last 14 years, advocates for personal importation have challenged previous HHS Secretaries to act on specific portions of the legislation, namely, requiring that …’The Secretary, in consultation with appropriate government agencies, shall conduct a study on the importation of drugs into the United States pursuant to section 804 of the Federal Food, Drug, and Cosmetic Act (as added by section 1121 of this Act). Not later than 12 months after the date of the enactment of this Act, the Secretary shall submit to the appropriate committees of the Congress a report providing the findings of such study”; and, “…In particular, the Secretary shall by regulation grant individuals a waiver to permit individuals to import into the United States a prescription drug that— ‘‘(A) is imported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supply; ‘‘(B) is accompanied by a copy of a valid prescription; ‘‘(C) is imported from Canada, from a seller registered with the Secretary; ‘‘(D) is a prescription drug approved by the Secretary under chapter V; Regulations...”.

These provisions are an early indication of the fact that there was—and remains today—a realization by Congress that even in 2003, relief was needed for the millions of Americans who were then—and today—denied access to 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.

Significantly, although the HHS Secretaries over the years chose to not act on the legislation, American patients acted on their own initiative, and by so doing have provided a de facto validation of the authenticity and validity of personal importation of brand-name medicines from Tier One Countries of which Canada is one.

But, rather than relying upon 14-year old legislation, it is now time for Congress to act to deal with the current state of and continuing needs of American patients to incorporate personal importation into effective legislation as reflected in the AmericanRxBillofRights which was submitted to the platform committees of the Democrat and Republican Platform Committees of the 2016 conventions.

The need for a new approach is because there exists the potential for one provision of the 2003 Act to be not only unnecessary but actually harmful to personal importation.

The provision in the 2003 act would empower the HHS Secretary to establish wholesale operations within the U.S., solely for the importation of medicines from Canada to be resold in the U.S., as well as allowing specific pharmacies to engage in personal importation.

This was opposed by many proponents of personal importation when it was first presented in the 2003 legislation.

There are several reasons for concern about this segment of the 14-year-old bill:

·       One of the debates that arose about personal importation from Canada in 2003, was a reaction from some Canadian officials being fearful that Canada would become ‘America’s drugstore’ which can be directly linked to the wholesaling provision;

·       Equally pertinent, many American advocates of personal importation believed then, and continue to do so today, that to grant such blanket authority to wholesalers and individual pharmacies would defeat the very purpose of personal importation, i.e., individual American patients’ access to safe, affordable brand-name medicines;

·       That is because we must be concerned about U.S. wholesalers gaining control over large supplies or sources of lower-cost medicines, giving them a capability to control prices in a manner similar to the abusive practices of Pharma, and crippling the ability of Americans to make purchases of their meds from any source other than the wholesalers and pharmacists.

It is time, therefore, for Congress, especially those erstwhile supporters of personal importation to come together to form a consensus on comprehensive legislation for personal importation of prescription medicines as the only readily available avenue with which to ensure that no American is denied their access to vital lifeline medicines because they are unaffordable.

This calls for consensus building in which Representatives and Senators of both parties who support personal importation instruct their staffs to come together to identify what opportunities—and obstacles—face enactment of new, current legislation to lower prescription drug prices via personal importation;  address such  problems caused by the one in ten Americans not being able to afford their medicines; to restrain the Food and Drug Administration from the seizure and destruction of medicines which can easily be identified as authentic, safe medicines.

By acting in such a manner to meet their obligations to the American public, Congress can develop legislation in which personal importation will have a major role and will reflect the realities of the needs of Americans patients today, rather than simply appealing for the HHS Secretary to carry the water on this issue.

HHS Pick Price Made ‘Brazen’ Stock Trades While His Committee Was Under Scrutiny

By Marisa Taylor and Christina Jewett 

Kaiser Health News: Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation

February 7, 2017--Health and Human Services secretary nominee Tom Price showed little restraint in his personal stock trading during the three years that federal investigators were bearing down on a key House committee on which the Republican congressman served, a review of his financial disclosures shows.

Price made dozens of health industry stock trades during a three-year investigation by the Securities and Exchange Commission that focused on the Ways and Means Committee, according to financial disclosure records he filed with the House of Representatives.

The investigation was considered the first test of a law passed to ban members of Congress and their staffs from trading stock based on insider information.

Price was never a target of the federal investigation, which scrutinized a top Ways and Means staffer, and no charges were brought.

But ethics experts say Price’s personal trading, even during the thick of federal pressure on his committee, shows he was unconcerned about financial investments that could create an appearance of impropriety.

“He should have known better,” Richard Painter, former White House chief ethics attorney under President George W. Bush and a professor at the University of Minnesota Law School said of Price’s conduct during the SEC inquiry.

As Price awaits a Senate vote on his confirmation, Senate Democrats and a number of watchdog groups have asked the SEC to investigate whether Price engaged in insider trading with some of his trades in health care companies.

Price has said he abided by all ethics rules, although he acknowledged to the Senate Finance Committee that he did not consult the House Ethics Committee on trades that have now become controversial.

The SEC’s inquiry began in 2013, as it battled Ways and Means for documents to develop its case.

A few weeks ago, the day before President Donald Trump’s inauguration, the SEC quietly dropped its pursuit of committee documents without explanation, according to federal court records.

No charges were brought against the staffer, Brian Sutter, who is now a health care lobbyist. Sutter’s lawyer declined to comment.

Craig Holman, government affairs lobbyist with Public Citizen, described Price’s volume of stock trades during the SEC inquiry as “brazen,” given the congressman’s access to nonpublic information affecting the companies’ fortunes.

“The public is seeing this and they really don’t like it,” said Holman whose watchdog group recently filed complaints about Price’s stock trading with both the SEC and the Office of Congressional Ethics.

Trump administration officials and Price have dismissed questions that news reports and lawmakers have raised about stock trades coinciding with official actions to help certain companies, saying Price’s brokers chose the stocks independently and all of his conduct was transparent.

After acknowledging that he asked his broker to buy stock in an Australian drug company, he told the Senate Finance Committee that he did not direct his broker to make other trades.

“To the best of my knowledge, I have not undertaken such actions,” he wrote in response to finance committee questions. “I have abided by and adhered to all ethics and conflict of interest rules applicable to me.”

An analysis of Price’s trades shows that he bought health stocks in 2007, the first year Congress financial disclosures are posted online. In 2011, the the first year Price sat on the health subcommittee, he traded no health-related stocks, according to his financial disclosures filed with Congress.

That same year, members were facing public criticism because of a book detailing how they could use inside information and a “60 Minutes” investigation focused on how members and staff could legally use inside information to gain from their own stock trades.

In 2012, President Barack Obama signed the Stop Trading on Congressional Knowledge Act to rein in insider trading by members and require more disclosure. Public watchdog groups suggested at the time that the law would curb the practice.

That year, after his one-year break in health care trades, Price resumed investing in health care companies.

Along with investments in technology, financial services and retail stocks, he also bought and sold stock in companies that could be impacted by actions of his subcommittee, which has a role in determining rates the government pays under the Medicare program.

Health care firms spend heavily to influence members of Congress, lobbying on health matters, funding political campaigns and seeking favor with Medicare officials who decide how much the program will pay for certain drugs and devices. The Food and Drug Administration holds similar power, approving or putting conditions on drug and device use.

Beyond his personal investments in health care companies, Price has also advocated their interests in letters to officials and proposed laws, government records show.

In 2012, disclosure records show Price sold stock in several drug firms, including more than $110,000 worth of Amgen stock. Amgen’s stock price had steadily climbed out of a recession-level slump, but Price’s sale came a few weeks before the company pleaded guilty to illegally marketing an anemia drug.

By 2013, the health subcommittee was at the center of a major conflict between Medicare, which sets Medicare Advantage rates, and the insurance industry.

Medicare issued a notice early that year announcing its intention to reduce Medicare Advantage rates by 2.3 percent as part of a major cost-cutting initiative.

That prompted fierce lobbying by the health insurance industry. Members of Congress, including Price, wrote a letter to Marilyn Tavenner, then acting administrator for the Centers for Medicare & Medicaid Services, protesting the rate cut, saying the decrease would “disadvantage vulnerable beneficiaries with multiple chronic conditions.”

Ultimately, Medicare decided not to cut rates but instead, to increase them. Yet an hour before Medicare announced the change, a Height Securities analyst fired off a “flash” report to 200 clients that touched off a surge of trading.

The analyst’s report said a political deal was hatched on Capitol Hill to prevent the cuts as a condition for moving forward on Tavenner’s confirmation. Medicare officials increased rates by nearly 4 percent, a change that would positively impact the bottom lines of health insurance companies.

The SEC began looking for the leak’s source, and within weeks, FBI agents began interviewing staffers at the Ways and Means Committee, court records show.

They discovered communications between Sutter and a health care lobbyist. The HHS Inspector General also began a probe, and federal prosecutors briefly examined the matter activity as well.

As the case unfolded, Price bought more health care-related stocks, according to his financial disclosures.

He has testified that his broker directed all of the trades, except for his investments in Innate Immunotherapeutics, an Australian company partly owned by Rep. Chris Collins (R-N.Y.), according to Collins’ disclosures. An HHS spokesman said Monday that Price held three broker-directed accounts.

Ethics experts have said that Price should have further distanced himself by placing his assets in a blind trust.

On April 30, 2013, Price bought $2,093 worth of stocks in Incyte, a company that develops cancer drugs; $2,076 in Onyx Pharmaceuticals, a drugmaker that would soon merge with a larger drug firm; and $2,097 in Parexel International, a consultancy that helps drugs and devices win FDA approval, according to the financial disclosure records.

The same day, Price shed shares of Express Scripts, a drug management firm, and Danaher, which makes products hospitals and doctor’s offices using for testing and diagnostics. In August of that year, he bought a $2,429 stake in Jazz Pharmaceuticals, which makes sleep and cancer drugs.

On May 6, 2014, the SEC served its first subpoena for the Ways and Means Committee documents. The committee launched a vigorous fight, appealing a federal district judge’s ruling that it should comply with the SEC subpoena.

Price continued his health stock trades, including $1,000 to $15,000 in drug firms Amgen, Eli Lilly and Co., Pfizer, Biogen and Bristol-Myers Squibb.

He also bought stocks in Aetna, a major health insurer, and Athenahealth, which sells electronic medical record and medical billing software. In 2016, he also increased his investment in Innate Immunotherapeutics.

The purchase became controversial because both he and Collins bought stock in a private placement at a discounted price.

“You’re asking for trouble if you have access to nonpublic information about the health care industry and you’re buying and selling health care stocks,” Painter said.

Sanders: Will Trump Really Take on Pharmaceutical Industry? I Hope So

Senator Bernie Sanders

Sanders-Cummings legislation to incorporate personal importation

WASHINGTON, February 4, 2017-- Sen. Bernie Sanders (I-Vt.) says he will soon introduce legislation to lower prescription drug prices and hoped that President Donald Trump would support the effort.

Sanders and Rep. Elijah E. Cummings (D-Md.) are drafting legislation to significantly bring down drug prices in the United States.

While five major drug manufacturers made more than $50 billion in profits in 2015, nearly 1 in 5 Americans could not afford the medicine they were prescribed at a time when Americans pay, by far, the highest prices in the world for prescription medicine. 

Representative Cummings

“It is beyond comprehension that while Americans are dying because they cannot afford the medications they need, the 10 highest-paid CEOs in the pharmaceutical industry collectively made $327 million in 2015,” Sanders said.

“I look forward to working with President Trump on this issue if he is serious about standing up to the pharmaceutical industry and reducing drug prices,” Sanders said after Trump met with chief executives of several top drugmakers at the White House Tuesday.

The Sanders and Cummings proposal would allow Medicare, the health care program for seniors and people with disabilities, to negotiate with drugmakers for lower prices. “The root of this problem is that we are the only major country not to negotiate drug prices with the pharmaceutical industry. You can walk into a pharmacy today and the price could be double or even three times what you paid for the same medicine a year ago,” Sanders said.

Their legislation also would allow the importation of less expensive but safe and affordable drugs from other countries. The allergy treatment EpiPen, for example, costs $638 in the U.S. compared to $293 in Canada. A popular drug for high cholesterol, Crestor, costs $779 in the U.S. but $201 in Canada. Abilify, a depression medication, costs $2,852 for a 90-day supply in the U.S. but only $546 in Canada.