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.

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.

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.

Blog Publisher calls for HHS Designee to state support for President Trump's campaign pledge on Personal Importation

 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”

— Daniel Hines

ST. LOUIS, MISSOURI, USA, January 30, 2017 /EINPresswire.com/ -- The Publisher of  RxforAmericanHealth, AmericanRxBillofRights and TodaysSeniorsNetwork, has sent an open letter to President Donald Trump and Health and Human Services Secretary Rep. Tom Price of Georgia seeking clarification on whether the designee supports the President’s campaign pledge of a role for personal importation of brand-name prescription medicines from Tier One countries as a way to lower prescription drug costs.

Hines also sent the letter to the members of the U.S. Senate.(To read the letter, click here).

“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,” says Publisher Daniel Hines.

But, Hines continues, 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 correctly pointed out that accessibility is not the same as the ability to purchase or afford adequate medical care,” Hines notes.

The problem, Hines explains, is that “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, “Hines says, noting that he sought an exemption from the Food and Drug Administration seizure of medicines of a constituent.

The exemption was sought because the constituent said the price of the medicine in the U.S. was unaffordable and he turned to Canada to personally import the medicine at a much lower cost.

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, Hines explains.

“This directly addresses the question of whether or not a medicine is unavailable if it is unaffordable, or is it ‘accessible’ if available in the U.S., but the patient can’t afford it.”

Hines notes: “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.”

“I and other advocates working on behalf of the rights of Americans to have true access to safe, affordable prescription medicines worked with contacts in the Senate to have the seizures halted, and to also specifically deny funding to Customs for such seizures,” Hines says.

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.

Another question arises from a recent letter from many Democrat members of the U.S. House of Representative to President Barrack Obama, in which 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 specific questions that should be addressed by the President and Rep. Price:

1. Will Rep. Price, if confirmed as HHS Secretary, continue his previously stated support of personal importation as exampled by his letter on behalf of a constituent turning to 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?
3. 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?

“The designee’s response to these questions is of prime importance,” Hines concludes. “The fact is that personal importation of safe, affordable medicines from Tier One countries is the most immediate relief from the predatory drug pricing practices of Pharma.”

Daniel Hines
TodaysSeniorsNetwork
6363992849
email us here

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.

Congressional letter to President chance for Obama, Trump to lower prescription drug prices by personal importation

An unaffordable medicine is unavailable in and of itself because of the price, and a medicine that is not taken because it is unavailable is of no value

— Daniel Hines

ST. LOUIS, MO, USA, December 20, 2016 /EINPresswire.com/ -- The publisher of Rx for American Health and the American Rx Bill of Rights says that a Congressional letter sent to President Barrack Obama from 33 Democrat Congressmen requesting him to use executive action on a number of fronts to lower prescription drug costs offers a chance at a cooperative effort by the President and President-elect Donald Trump that could provide relief for millions of Americans from the abusive pricing practices of Pharma by jointly recognizing the rights of Americans to have access to safe, affordable and authentic personally imported medicines.

Daniel Hines notes that both the President and the President-elect have expressed their support of a role for personal importation.

“In 2008, then-Candidate Obama pledged to support 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.,” Hines notes.

“Significantly, President-Elect Trump has called for ‘Removal of barriers to entry into free markets for drug providers that offer safe, reliable and cheaper products,’” Hines notes.

Also, in an interview upon his selection as TIME Magazine’s ‘Person of the Year,’ the President-elect said that his intent remains to “lower prescription drug costs” although he admitted that he still hadn’t decided upon just how to do it.

“In yet another twist in this strangest of Presidential elections, the President-Elect could actually offer President Obama a chance at establishing a favorable part of the Obama legacy—a role in which both men can exhibit the type of bi-partisanship that would reflect favorably upon them, all the while offering millions of Americans price relief from the abusive pricing practices of Pharma by recognition Executive recognition of the rights of Americans to have access to safe, affordable and authentic personally imported medicines,” Hines says.

The key, Hines says, is for President Obama to sign an executive order requested by the Congressional letter 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 should be followed by the President-elect openly declaring his support of the President’s action, accompanied by a vow to let the order stand as a part of his campaign pledge to support personal importation and to explicitly legalize the personal importation of medicine from licensed registered pharmacies in (Tier One) countries whose standards of safety and efficacy meet or exceed those of the U.S.

Hines notes that Candidate-Trump had at one time vowed to rescind every Executive Order issued by President Obama, but since then, President-Elect Trump has softened his stance, saying he would only rescind those that he considered ‘illegal.’

“A cooperative action by the President and the President-elect would enable both men to fulfill stances taken during their respective campaigns to take actions to lower prescription drug prices,’ Hines explains.

He notes that Candidate Obama openly supported establishing a role for Personal Importation of safe, affordable prescription medicines from licensed, registered pharmacies in Tier One Countries whose standards of safety and efficacy meet or exceed those of the U.S. in 2008, only to abandon his stance under pressure from Pharma to abandon his stance during behind-closed doors meetings leading to the Affordable Care Act, which itself now faces dismantling.

“By issuing the executive order requested in the Congressional letter, the President could ensure a part of his legacy by acting on behalf of millions of Americans who simply cannot afford their medicines. An unaffordable medicine is unavailable in and of itself because of the price, and a medicine that is not taken because it is unavailable is of no value,” he says.

“For the President-elect, cite your campaign pledge to support personal importation, let President Obama know of your support of his issuance of the Executive Order, and that there will be no attempts to set it aside by your Administration,” Hines says.

Hines notes that such action also gives the President-elect a unique opportunity to set a tone for his Administration ensuring that unelected bureaucrats of the Food and Drug Administration are subject to the clearly expressed intent of Congress, not the whims of a particular industry segment.

“That is why we urge the President and the President-elect to take the actions necessary to compel the Secretary of HHS to act , and to do so in a fair and partial manner that reflects that personally imported authentic medicines at potential savings of up to 60 percent are being denied to Americans, or for those who do engage in personal importation of their medicines, their medicines are subject to potential seizure and destruction only because of labeling differences that are required by the countries of origin of the imported medicine. The seizures can take place irrespective of the authenticity of the medicines,” Hines continues.

“Also, for President-Elect Trump, cooperation and support of such an Executive Order will illustrate that he is concerned about the health and well-being of Americans, and that he recognizes that lack of access to affordable medicines is the wind that reaps the whirlwind of Pharma pricing abuses, and consequences of costly, even possibly life-threatening health conditions that could have been avoided,” Hines concludes.

The full Subtitle of the Medicare Prescription Drug Improvement and Modernization Act of 2003 follows:
Subtitle C: Importation of Prescription Drugs - (Sec. 1121) Directs the Secretary to promulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States. Sets forth specified provisions respecting: (1) importer and foreign seller recordkeeping and information requirements; (2) qualified laboratory drug testing; (3) registration with the Secretary of Canadian sellers; and (4) approved labeling.

Daniel Hines
RxforAmericanHealth
636-399-2849
email us here

We Can’t Wait: Making the case for Personal importation of prescription medicines as the primary immediate health care tool to lower costs and provide benefits to the health and well-being of Americans

For more than a quarter-century, Americans have been victims of the predatory pricing practices of Pharma.

It is time for a change! American patients can’t wait any longer!  

There is an answer, a strategy that can provide the touchstone for a bi-partisan approach to comprehensive legislation to allow Americans the health benefits of access to vital maintenance medicines, access that could very well be a key to deterring the illness and physical deterioration that too often lead to more drastic devastating illness that will require specialty medicines.

That answer is personal importation of 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.

That is why AmericanRxBillofRights submitted its Articles defining the rights of Americans to enjoy the health and personal well-being benefits of access to personally imported medicines to Representatives, Senators and even the Platform Committees of the Republican and Democratic parties.

We did this because the challenge lies with our political leadership.  The Presidential candidates have offered their support of many of the provisions laid out in the AmericanRxBillofRights, so it is now the voters who must call out their Congressional candidates to demand answers about the harmful impacts of the predatory pricing practices of Pharma.

The first step is to define the results of the failure of Congress to act, and why we can’t wait any longer. Consider the results of Congress’ failure:

• Result #1—A denial for millions of Americans to be able to exercise their right to the health benefit made possible from access to a regimen of vital life-line brand-name medicines, simply because they are unaffordable;

• Result # 2—The ‘hoped-for’ answer to the scourge of unaffordable medicines—generic medicines—have seen price spikes that have made many of them equally unavailable to American patients;

• Result # 3—Literally millions of Americans suffer from diseases—many of them life-threatening—raising the question of a possible link to the cause-effect impact of the denial of vital personally imported maintenance medicines that could have benefited patients and deterred the harmful effects of their disease;

• Result # 4—Pharma raises prices on specialty medicines to thousands of dollars for treatments, even though many of the costly medicines are older, lower-cost medicines, and manufacturers are simply taking advantage of the illness of Americans;

• Result # 5—Congress becomes indignant, holds hearings, witness testify, advocacy groups coalesce to ‘address’ price challenges, but…prices remain high, Congress continues with more hearings…and Americans continue to pay the highest prices in the world…WHY?;

• Result #6--Because Pharma and its allies in the House of Representatives and the U.S. Senate who are the beneficiaries of Pharma’s extensive contributions have controlled the discussion on how to lower prescription and health care costs Pharma continues to rake in obscene profits, and American patients continue to be denied their medicines.

• Here is a series of questions to ask the candidates in your Congressional districts and U.S. Senate races:

• 1.     In light of the wide-spread bi-partisan support of personal importation for at least 16 years, sponsorship and support of legislation from the leadership of both political parties including the President, and the three major candidates of the Democratic and Republican Party this year, why has there been no adoption of personal importation;

• 2.    If the answer is the ‘certification’ of the safety of the medicines by the Secretary of Health and Human Services, could you please provide the names and responsibilities of other Cabinet members who are legislatively made personally responsible for certifying the health impact of regulations, decisions, policies of their particular departments?

• 3.    There are many groups that are being formed to ‘study’ the harmful impacts of recent price increases such as the spike in generic drug costs, and, of specialty medicines.  Unfortunately, the new groups being formed will require time—perhaps more than a year—to develop a consensus on the scope of the problems. Strategies to address the challenge of high prices will take even longer, ironically, since enactment of legislation to allow personal importation can offer immediate relief.

• 4.    And, this leads to a final set of questions:

• a.    If you are not a sponsor or co-sponsor of a bill to allow personal importation, why not?  If you are a supporter of personal importation, why do you believe your efforts have not gained traction?

• b.    Does the problem lie within Congress itself?  For years, the Democrats controlled the House and Senate. Now, the Republicans have had control of the House and Senate for six years, and have failed to even bring the issue to a vote.  Does this indicate that politics take precedence over the health of your constituents?

• c.     Irrespective of the cause, what is your strategy to advance the case for personal importation and lowering prescription drug costs?

• d.    Are there stumbling blocks that public action by advocacy groups and the millions of Americans for whom personal importation is a vital lifeline, can help remove?

Relief will come only when the American voter finally speaks up and takes the initiative to clearly demand that Congress act.  Americans pay the highest costs for prescription medicines in the world.  We truly Can’t Wait anymore.  The cost in terms of illness, costs, and denial of the rights of Americans to have access to good health is too immense for further delays especially when it is within the ability of Congress to offer a solution.

Publisher of Blog on High Drug Costs calls for adoption of American Rx Bill of Rights into party platforms

Daniel Hines, publisher of RxforAmericanHealth urges support of American Rx Bill of Rights

...rising costs of medicines will lead to unwelcome consequences in terms of increased price of medicines that will act as a major driver of medical costs overall...

— Daniel Hines

ST. LOUIS, MISSOURI, USA, September 3, 2015 /EINPresswire.com/ -- The publisher of RxforAmericanHealth has called for both the Democrats and Republicans to address the issue the impact of rising prescription drug costs by incorporating into their Party platforms an American Rx Bill of Rights.
Daniel Hines says that rising costs of medicines will lead to unwelcome consequences in terms of increased price of medicines that will act as a major driver of medical costs overall and force many Americans to forego needed medical care.
He also points to the potential for abuse of Congressional intent with the announcement schedule for September 30, 2015 of the rules regarding Section 708, that could lead to the seizure and destruction of safe, authentic personally brand-name medicines from licensed, registered pharmacies subject to oversight and regulation equal to or exceeding that of US agencies.

“We have called for a Congressional Caucus to use the reservoir of good will and support of many members of Congress to protect against such abuse,” Hines notes. 

“Now, it is also time to articulate the issues caused by the pricing practices of Pharma that can threaten the ability of Americans to enjoy the health benefits offered by access to a regimen of safe, authentic medicines.

“That is why as we listed the Articles of the Rx Bill of Rights, we included an explanation of each article,” he explains.


The Articles are: 

A basic right to good health; An unaffordable medicine is unavailable; Citizens must have rights as stakeholders in debate and discussions of health policy centered on pharmaceutical costs equal to that of Pharma; The rights of Americans to due process in the protection of their rights and ability to make valid medical decisions must be protected; It is in the public interest to recognize the 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; the FDA should enter into reciprocal agreements and Memorandums of Understanding (MOU) in recognition of its many agreements already in place with authorities in other countries to help ensure a safe and easily validate source of medications for Americans.

Hines cited the following explanations of the Articles:


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)
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.
(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.)


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

Daniel Hines
RxforAmericanHealth
636-399-2849
email us here