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.

Mylan, PhRMA 'play' Congress and the American Public

by Daniel Hines
Publisher, RxforAmericanHealth

Even before reading this article,  I suggested that perhaps Mylan was implementing a ‘play’ upon the American pubic…first with the price increases, then with the  rapid price decreases, and now the move with a ‘new generic’ ...seems to me to be actions designed to allow Mylan to take the steps necessary to enter the market with a ‘generic’ and Teva must wait until 2017 with approval and a new review,  by which time Mylan will control the generic segment of this market. While the introduction of the generic is not included in this story, the article deals with the PhRMA PR campaign and mind-set of an industry that has ‘played’ the American Public and Congress for decades...
http://www.rawstory.com/2016/08/the-epipen-scandal-runs-deeper-than-most-of-us-realize/

Missouri Congresswoman displays courage, insight, leadership in comments about onerous Section 805 ‘power grab’ by Pharma, Health Human Services and Homeland Security

 There is legislation in Congress that is considered ‘must pass.’  These are bills of such vital importance that there is virtually total agreement on their importance to protecting the safety of the American public.

That is why it was not surprising that recently first the U.S. Senate , and within a week later the House of Representatives overwhelmingly passed the Prescription Drug UserFee Act (PDUFA), which generates the vast majority of the federal government’s budget for the Food and Drug Administration’s (FDA) reviewing new medications.

This is one of the legitimate and valuable functions of the FDA.  The other is to provide the oversight to ensure a safe food supply forAmericans.

But, Washington being Washington, nothing is as simple as it seems. 

Lobbyists,staffers with a particular political agenda, and special interests of Congressional Representatives  and Senators have too often created a synergy that betrays the very purpose of agencies such asthe FDA by making it a surrogate for implementing policies that benefitthe particular and limited goals of those who would stand to profit, rather than doing what is best for Americans.

This occurs because special interests are able to co-opt the intent of the legislativeprocess by having Congressmen and Senators insert onerous elements in thebills, elements skillfully crafted to seem to be in accordance with the purposeof the legislation.

No lobby is better at this than the Pharmaceutical industry and its trade group PhRMA. 

For many years, we have published blogs detailing the network of the many front groups that PhRMA has created under the guise of ‘protecting’ the safety of prescription medicines sold in the United States, but which are actually meant to make the US a ‘safe haven’ for the highest prescription medicine prices in the world.

For more than 12 years, PhRMA and its members have used their vast army of lobbyists and their seemingly unlimited financial resources to deny the right of Americans to have access to safe,affordable brand-name medicines from licensed, registered pharmacies in Tier One countries, whose standards of safety and oversight meet or exceed those of the US.

They have had some successes, primary by inserting ‘poison pill’ amendments to legislationpassed by the Senate (many times) requiring the Secretary of Health and HumanServices (HHS)  to ‘certify’ the safety of each and every prescription medicine personally imported, effectively killing the legislation.

But, a distinguishing characteristic is that they never seem to give up.  However, even with their vast expenditures, Pharma is not invincible. But, it is persistent, as the following record of creating mischief illustrates:

Over the years, working in collusion with the supportive staff of the FDA, opponents of personally imported medicines have attempted a number of tactics:

• ·         Random and ill-founded seizures of legitimate prescription medicines by Customs Inspectors, extending even to intimidation of the Elderly persons, who were denied their vital medicines by the seizures,  by demanding that they sign letters prepared by Customs in which the Seniors purchasing the medicine  ‘admitted’ to being ‘guilty’ of importing ‘illegal’ medicines.

o   When Congress learned of the practices of Customs, it quickly passed legislationforbidding the seizures and ending the Customs involvement.

• ·         Attemptsto deter personal importation by attempting to lump prescription medicines fromoutside the US as ‘bogus’ and potentially dangerous to the health of Americans.

o   Fortunately, the common sense of the American public has prevailed, and the record is clear regarding the safety and efficacy of imported medicines from reputable sources.  This has been validated by independent studies, as well as Americans demonstrating that they do indeed have the ability to make responsible decisions and the ability to distinguish between legitimate sources for safe, affordable medicines.

o   Ironically, the case can be made that if Pharma were to expend the same amount of energy towards reciprocity with Tier One countries, as it and the FDA have now done regarding inspections of ingredients for the manufacture of pharmaceuticals,  such action could be beneficial in attacking the challenge of bogus pharmacies.

o   In what was a blatant betrayal of Candidate Obama’s pledge of support for personal importation, the Obama Administration engaged in ‘secret’ deal-making with Pharma in which the Administration pledged to drop support for personal importation in return for PhRMA’s pledge not to engage a ‘Harry and Louise’ type campaign (which deterred President Bill Clinton’s Administration in its attempts at healthcare reform) against what the President hoped to be his ‘legacy’ legislative accomplishment. Recently released emails between PhRMA and the White House should be ‘must reading’for anyone with indignation over the influence of powerful lobbying groups.  Ironically, the lack of transparency might be responsible for the many flaws in Obamacare--flaws that could have been avoided if there had been more opportunity for citizen input with open sessions, and which might be responsible for the legislation's constitutionality being decided by the US Supreme Court.  The outcome could affect a number of situations, including, if it is overturned, the possibility of PhRMA declaring that all deals are void.

o    http://rxforamericanhealth.blogspot.com/2011/11/stop-online-piracy-act-endangers-health.html  in which it attempted to use language that would have given legislative sanction to Pharma’s battle against personal importation.  The law of unintendedconsequences was exemplified by a ‘blackout’ and disruption of the Internet, the coming together of seniors’ groups with technical interest groups, resulting in more than 100,000 letters and emails sent by America’s elderly to Congress and the Senate.

However, the thrill of victory was short-lived as Pharma turned its attention to PDUFA, which because of its ‘must-pass’ quality, has problematic language in both the Senate and House bill.

The Senate bill contains a provision from Senator Tom Harkin (D-IA) that might be open to interpretation of the FDA that pharmacies in other countries involved in personal importation must register with the FDA.  

In conversations with the Senator's office and designees, we have been assured that the Senator continues to 'support' personal importation, and had worked with the FDA to assure that no action is taken against personal importation, but significantly when the contact with the Majority Office, the staff member said that the Conference Committee will not add language similar to that of previous bills to specifically exempt personally imported prescription medicines, because there is 'no intent' that pharmacies are included in the registration requirement.  We were told that the language is intended for ingredients manufacturers in other countries. 

We have, however, been told that the presumed members of the Conference Committee are reportedly meeting informally and in secret, causing us to wonder if they will ever learn,even after hobbling together the Rube Goldberg healthcare proposal now being considered by the Supreme Court.  

But, it in the House of Representatives when the most onerous language can be found.  Section 805 would authorize the Secretaries of HHS and Homeland Security to seize and immediately destroy and medicine that they deem to be potentially harmful to Americans' health OR (my emphasis) with a value of less than $2000. 

That is why it is gratifying to see the courage of Rep. Joanne Emerson (R-MO 8)in making the record on what advocates believe is the latest subterfuge of PhRMA to attempt to co-opt legislation for its own purposes and to open a new front on its continuing battle against personal importation--this time with the sanction of the legislative process.

Rep. Emerson's statement follows:

"MR. SPEAKER, I want to express my support for the reauthorization of the Food and Drug Administration (FDA) under consideration today.  The FDA provides essential safeguards for patients in America and around the world, while making possible new treatments and therapies for diseases and conditions which affect millions.  This bill supports greater speed of generic medications to market and assures much needed drugs to treat cancer will get to the patients who need them.

"However, one provision (Section 805) in this legislation causes me special concern.  The section includes the new authority for the Secretary of Health and Human Services to consult with the Department of Homeland Security to cause the destruction of any drug "that has reasonable probability of causing serious adverse health consequences or death. or that is valued at an amount that is $2,000 or less."  This section poses a serious concern to hundreds of thousands of Americans who receive their drugs by mail from licensed and regulated pharmacies in Canada and other foreign countries.

"For these patients, these American consumers, there is often only one choice beyond a Canadian pharmacy, and that is to not purchase the medicines they need at all.

Patients expecting receipt of legitimate prescriptions, written by their doctor and filled by a licensed pharmacy in Canada, could have their shipment of medication destroyed without receiving any notification either before or after the federal government takes that action.  A bus full of senior citizens which crosses the border into Canada to visit a pharmacy where they can fill their prescriptions for one-third the price of the same medications in Canada could have their pill bottles seized at the border, their meager budget for their monthly health care expenses already exhausted.  This is not good policy, nor is it what Americans expect from a free market.

"This language threatens a critical, cost-effective supply of medications and pharmaceuticals.  These drugs are exactly the same as their counterparts sold in America.  I urge further discussion of this critical issue in conference and a full examination of the consequences of passing this provision into law."

With her statement, Rep. Emerson, a long-time supporter of personal importation and the co-founder of the Affordable Medicine Caucus with Rep. Peter Welch (D-VT-At Large) has put Pharma on notice to not attempt to misinterpret the 'intent' of Section 805,  and she has made the record on behalf of and support for personal importation.

Rep. Emerson's example should be an example for other legislators.

Attempts by PhRMA to co-opt legislation in the same manner that it dealt with a White House so desperate to enact a legacy bill that it violated the positions and principles that the American public embraced in Candidate Obama in 2008, must be opposed by the American public, who hopefully  will rally in opposition to continued efforts at power grabs by unelected bureaucrats claiming the right to interpret implementation of legislation that could drastically affect the personal health and  well-being of untold numbers of Americans.

Let's hope their legislators heed the sentiments of American citizens and not those of PhRMA.  

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