Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever! PhRMA & BIO Set a New Record in 2017

The D.C. Pharma Lobbying Swamp is Bigger & More Slimy Than Ever! PhRMA & BIO Set a New Record in 2017 | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The two big groups that lobby on behalf of drug companies set a new record for their collective spending in the first year of the Trump administration.

Shelling out a combined sum of nearly $35 million to lobby the federal government in 2017, the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization upped their expenditures at a time when the sweeping tax overhaul was on the line and fears of a crackdown on drug pricing were top of mind. Remarkably, however, the record-setting spending push came in spite of the fact that neither group took a position on the biggest health policy story of the year, the long and steady Republican quest to repeal and replace the Affordable Care Act.

PhRMA came just short of breaking its own record. The group spent more than $25 million — just about $700,000 shy of its spending total in 2009, at the height of the debate over the ACA in the first year of the Obama administration. BIO spent more than $9 million, the most since at least 1999, the earliest year quarterly lobbying spending is available online for the two organizations.

The groups spent their lobbying dollars on some of the issues that generated big headlines of 2017: the new law that rewrote the tax code. Legislation concerning drug pricing. Right-to-try. Drug importation. Accelerated pathways for drug approvals. Policy issues around incentives to encourage development of drugs for rare diseases. And the confirmation of Alex Azar, President Trump’s pick to lead the Health and Human Services Department. 

 

Click here (subscription required) to see the TOP 15 Pharma company lobbyists!

Pharma Guy's insight:

This swamp will never be drained! The "PharmaGovernment Complex" is alive and well!

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Grading FDA Commissioner Gottlieb & PhRMA's "Go Boldly" Campaign

Grading FDA Commissioner Gottlieb & PhRMA's "Go Boldly" Campaign | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Food and Drug Administration Commissioner Scott Gottlieb earned high marks from [a STAT Plus] survey respondents.

 

One respondent explained why Gottlieb deserved an F: “I see no vision or mission except keep Trump happy. Good luck.”

 

But the vast majority sang his praises.

 

  • “He’s shown an independence from the pharmaceutical industry that I was not expecting and seems dedicated to balancing safety with efficiency.”

 

  • “He’s a moderate! Speeding things along but not foolishly.”

 

  • “Dr. Gottlieb seems interested in getting other agencies to do their jobs. He seems interested in improving competition and drug shortage to the best of FDA’s ability — although these problems are pharma’s to fix — not FDA’s.”

 

Further Reading:

  • “Dr. Scott Gottlieb’s Plan to ‘Get Things Done’ at #FDA is Approved by #Pharma”; http://sco.lt/7iW5TN
  • “Does Pharma Really Want to Abandon the ‘Gold Standard’ of the FDA Approval Process?”; http://sco.lt/74r19d
  • “Pharma Scientists Concerned About Gottlieb’s Industry Ties”; http://sco.lt/8jOq0n

 

The trade group PhRMA has tried to reframe the drug price debate with its “Go Boldly” campaign, paid for by a hike in membership fees. In decidedly lukewarm reviews, more than a third of respondents gave that initiative a modest 2 on a scale of 1 to 5 (with 5 being a rave). Roughly a quarter split between 1 (the worst) and 3 (meh), though one respondent noted that “featuring industry scientists was a great choice, from a PR standpoint.”

 

Among the other comments:

 

  • “All the ‘bold’ in the world doesn’t matter when people can’t afford treatments.”

 

  • “The ads are good. … People like pharma for the drugs it produces. Its R&D is not what galls people. It’s pricing and business practices.”

 

  • “There’s a ‘Go Boldly’ campaign?”

 

Further Reading:

  • “He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent”; http://sco.lt/5BIFgP
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He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent

He Boldly Stars in @PhRMA's Multi-Million $ Ad Campaign, But Has No Money to Pay His Rent | Pharmaguy's Insights Into Drug Industry News | Scoop.it

His face is everywhere: in TV commercials during late-night comedy shows, in the pages of Wired and Politico, on a billboard at the airport near Washington, D.C.

 

Brian Kursonis, who was diagnosed last year with early-onset Alzheimer’s at age 55, is a star of the drug industry’s “Go Boldly” campaign — a sophisticated PR push, costing tens of millions a year, to highlight pharma’s commitment to develop cures for dreaded diseases.

 

The ads might improve pharma’s battered reputation. But behind the soft lighting and inspiring music, the patient who’s helping anchor the campaign says his life is falling apart.

 

He is living alone, after a nine-year relationship broke up as his memory deteriorated. He had to give away his beloved dogs. He loves fly-fishing, but forgets how.

 

And he is fast running out of money.

 

Kursonis hopes he can find a way to earn a living as an advocate, but if money doesn’t come in soon, he won’t be able to make the December rent on his spartan apartment in a suburb outside Charlotte, N.C. He fears he will soon be homeless, his best option the men’s shelter in downtown Charlotte.

 

Kursonis’s story highlights the complicated, often heartbreaking realities that compound the challenges of living with a disease like Alzheimer’s.

 

In the “Go Boldly” ads — which were funded by the drug industry lobbying group PhRMA — he’s paired with a scientist who promises to bring an Alzheimer’s drug to patients in her lifetime. Even if she succeeds, a long shot in a field that has been marked by failure after failure, Kursonis knows it will likely be too late to help him and millions of other patients in the grip of the degenerative disease.

 

Now, he’s begun speaking candidly about his challenges — both on his blog and in interviews with STAT — in hopes of raising awareness and building a new career as a patient advocate.

 

“I want people to know, if I disappear, that at least I tried,” Kursonis said.

 

Further Reading:

Pharma Guy's insight:

The only option is for him to become a paid Alzheimer's patient advocate. Good luck with that! There will be many more patients vying for that opportunity.

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Trump Is Letting Pharma Continue to "Get Away With Murder!"

Trump Is Letting Pharma Continue to "Get Away With Murder!" | Pharmaguy's Insights Into Drug Industry News | Scoop.it

In the early days of his administration, President Trump did not hesitate to bash the drug industry. But a draft of an executive order on drug prices appears to give the pharmaceutical industry much of what it has asked for — and no guarantee that costs to consumers will drop.

 

The draft, which The New York Times obtained on Tuesday, is light on specifics but clear on philosophy: Easing regulatory hurdles for the drug industry is the best way to get prices down.

 

The proposals identify some issues that have stoked public outrage — such as the high out-of-pocket costs for medicines — but it largely leaves the drug industry unscathed. In fact, the four-page document contains several proposals that have long been championed by the industry, including strengthening drugmakers’ monopoly power overseas and scaling back a federal program that requires pharmaceutical companies to give discounts to hospitals and clinics that serve low-income patients.

 

Mr. Trump has often excoriated the drug industry for high prices, seizing on an issue that stirs the anger of Republicans and Democrats alike. He has accused the industry of “getting away with murder,”[http://sco.lt/6W2Ly5] and said that he wanted to allow the federal government to negotiate directly with drug companies over the price of drugs covered by Medicare (but read “Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices?”; http://sco.lt/8CcWbB).

 

But the proposed order does little to specifically call out the drug industry and instead focuses on rolling back regulations, a favorite target of the administration across many federal agencies.

 

“I do believe that the president wants to do something to lower drug prices for people, but this is a far cry from what he said on the campaign trail,” said David Mitchell, the founder of Patients for Affordable Drugs, a nonprofit that does not take money from the industry. “I don’t see anything there that addresses the drug companies getting away with murder, and it appears that is because Pharma has captured the process.”

 

Several of the proposals appear to reflect that industry influence. For example, the document directs the United States trade representative to conduct a study of price differences between the United States and other countries, and to review trade agreements that may need to be revised “to promote greater intellectual property protection and competition in the global market” (read I”an Read, CEO of Pfizer, aka the ‘Donald Trump of Pharma,’ Bashes Global ‘Freeloading’ Off U.S.”; http://sco.lt/7TRiDZ).

 

The draft order targets a program, 340B, that requires the drug industry to give discounts to hospitals and clinics that serve large numbers of low-income patients. The industry has complained that the program is being abused, while hospitals say they would have to cut services without it.

 

“That’s one that sticks out as a bit of a head scratcher,” said Dr. Joshua M. Sharfstein, a professor at Johns Hopkins Bloomberg School of Public Health who was a top F.D.A. official under President Barack Obama. “This is the executive order to lower drug prices — why would you put in a provision that would raise drug prices?”

 

In recent weeks, the industry has shown signs it believes it is getting a fairer shake.

 

In May, Joseph Jimenez, the chief executive of Novartis, told investors that he believed the administration would offer a solution that “will preserve the business model of how we innovate and discover and develop and launch in the U.S., as opposed to some of the bigger and more draconian elements that were discussed earlier,” according to Bloomberg.

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Some PhRMA Board Member Opioid-Producing Companies are NOT Signatories to Its Marketing Principles. Why Not?

In December 2008, the PhRMA Board of Directors unanimously adopted measures to enhance the PhRMA Guiding Principles on Direct to Consumer Advertisements about PrescriptionMedicines. The revised Principles took effect March 2, 2009.

Despite the thundering unanimity of the PhRMA Board, several current board members are NOT signatories to the principles. Specifically, Allergan, Alexion, Alkermes, Teva, and UCB are not signatories even though the CEOs of these companies are current PhRMA board members!

Most disturbing to me is that opioid manufacturers and marketers Allergan, UCB, and Alkermes have not agreed to obey the DTC guidelines. In addition, Alkermes, which sells Zohydro, a powerful opioid (see here), is not a signatory to PhRMA's Code on Interactions with Healthcare Professionals

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@PhRMA Goes Even More BOLDLY in a New Ad Campaign

The Pharmaceutical Research and Manufacturers of America (PhRMA) today unveiled its latest advertisement as part of its groundbreaking GOBOLDLY campaign, titled New World, featuring some of the most extraordinary breakthroughs in science being discovered by biopharmaceutical researchers.

 

“Biopharmaceutical researchers are driving unimaginable innovation in science, which is revolutionizing how the most complex diseases are treated,” said Stephen J. Ubl, president and chief executive officer of PhRMA. “We truly are in a new world of medicine and on the verge of something even greater and more impactful. This promises a future with endless potential of scientific advances.”

 

The TV, print and digital advertisement highlights the new world of science where immunotherapy is replacing chemotherapy, where researchers attack the causes of disease, not just the symptoms and where medicines can now be tailored for the individual patient.

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@PhRMA Mulls Limiting Members to Appease Trump Amid Drug Price Scandal

@PhRMA Mulls Limiting Members to Appease Trump Amid Drug Price Scandal | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry’s Washington lobbying group will likely adopt new membership rules this week that will oust many smaller companies that don’t spend heavily on research, people familiar with the matter said, amid increasing scrutiny of prescription drug prices.

 

The lobby group, Pharmaceutical Research and Manufacturers of America, or PhRMA, is proposing that to remain a member, companies will have to spend $200 million a year on research and development, based on a three-year average. They’ll also have to have to show that their research spending amounts to at least 10 percent of their global sales, according to the people, who asked not to be identified because the matter is still private.

 

PhRMA’s membership includes industry giants such as Eli Lilly & Co. and Pfizer Inc., as well as smaller companies that don’t have the same research pedigree. The thresholds are a high bar for some companies whose businesses have focused more on buying older drugs and raising their prices, and for smaller companies that don’t yet have drugs on the market.

 

The review began earlier this year after one of PhRMA’s then members, Marathon Pharmaceuticals LLC, said it would charge $89,000 a year for a drug that was being imported from overseas for about $1,000. The company had done limited new research to get the drug approved in the U.S. The drug is used to treat a rare and deadly pediatric condition.

 

Soon after Marathon announced the price for its drug, Steve Ubl, chief executive officer of PhRMA, said Marathon’s “recent actions are not consistent with the mission of our organization” (read “PhRMA Offers Up Marathon Pharmaceuticals as “Sacrificial Lamb” to Trump?”; http://sco.lt/5uZwMD and “PhRMA Embarrassed by Marathon is Forced to “Review” Membership Criteria – Is a Purge in the Cards?”; http://sco.lt/5XUvqL). Marathon left PhRMA last month ahead of the review, which the lobbying group’s board is scheduled to vote on Tuesday, according to the people familiar with the matter. The changes would be immediate, according to a third person familiar with the matter.

 

Further Reading:

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Nonprofit Working To Block Drug Imports Has Ties To Pharma Lobby

Nonprofit Working To Block Drug Imports Has Ties To Pharma Lobby | Pharmaguy's Insights Into Drug Industry News | Scoop.it

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.

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PhRMA Lacks the Guts to “Go Boldly” & Speak Out Against Trump’s Proposed Cuts to NIH Funding

PhRMA Lacks the Guts to “Go Boldly” & Speak Out Against Trump’s Proposed Cuts to NIH Funding | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The National Institutes of Health is staring down a proposed $6 billion budget cut that could slash funding for biomedical research. The response from the drug industry’s largest lobbying group?

 

Let’s call it tepid.

 

“As we review the president’s budget proposal, we look forward to continuing to work with President Trump and Congress to improve American competitiveness and protect American jobs,” PhRMA spokeswoman Nicole Longo said in a statement. She added that the organization remains “committed to ensuring that policies support innovation and value to deliver this new era of medicines to patients.”

 

Biotech — to the extent it can be surveyed on Twitter — was not impressed.

 

“Those people are truly useless,” opined Michael Gilman, a serial entrepreneur now leading Arrakis Therapeutics.

 

“This is pathetic,” added John LaMattina, former head of R&D at Pfizer. “The new PhRMA head continues to be unimpressive.”

 

“Too bad PhRMA cannot muster the guts necessary to speak out,” tweeted Dr. Samuel Blackman, an oncologist and cancer researcher.

 

PhRMA’s bland response comes in stark contrast to statements from the Bill and Melinda Gates Foundation and the American Society of Clinical Oncology, which contained terms like “deeply troubled” and “devastate our nation’s research infrastructure.”

 

Further Reading:

Pharma Guy's insight:

I called PhRMA cowards. They certainly aren't going "boldly" into the dying of the light.

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PhRMA Offers Up Marathon Pharmaceuticals as “Sacrificial Lamb” to Trump?

PhRMA Offers Up Marathon Pharmaceuticals as “Sacrificial Lamb” to Trump? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The pharmaceutical industry trade group hopes to convince you that it is not all bark and no bite.

 

In response to the outcry over Marathon Pharmaceuticals, which plans to sell a decades-old drug for $89,000 and also maintain a monopoly, the Pharmaceutical Research and Manufacturers of America slammed the company for “actions [that] are not consistent with the mission of our organization.” And the group promised a “comprehensive review” of its membership criteria (read “PhRMA Embarrassed by Marathon is Forced to ‘Review’ Membership Criteria – Is a Purge in the Cards?”; http://sco.lt/5XUvqL).

 

The goal is to “ensure we are focused on representing research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients,” according to a statement from the trade group. PhRMA, by the way, has not bothered to publicly post this declaration of intent on its web site, but instead, only distributed it to those who asked for its official views on Marathon.

 

It is not clear what is meant by a comprehensive review, though. A spokeswoman declined to provide further details or describe further steps that may be taken, such as ejecting Marathon from its ranks.

 

In fact, it is not entirely clear what, if anything, might change.

 

One thing is certain: The statement reflects increasing heat on the pharmaceutical industry, which is under escalating attack over the cost of medicines, an issue that President Trump has vowed to address. Although Trump has accused drug makers of “getting away with murder” and otherwise made vague noises about drug prices, he has yet to suggest any concrete steps.

 

Nonetheless, the industry is anxious. Hence, PhRMA lobs this statement.

 

In effect, the trade group is trying to get ahead of the proverbial curve by intimating that Marathon might just become a sacrificial lamb. And the trade group is also hoping to create the impression that its members want to put some heft behind the regular claim that price-gouging drug makers are outliers, a mantra that has been regularly repeated over the past two years.

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Generic Drug Industry Trumps PhRMA’s PR By Re-Branding Itself. Should PhRMA Follow Its Lead?

Generic Drug Industry Trumps PhRMA’s PR By Re-Branding Itself. Should PhRMA Follow Its Lead? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The Generic Pharmaceutical Association is no more. Meet the Association for Accessible Medicines.

 

Every industry group invested in the drug-pricing debate is gearing up and burnishing its brand. PhRMA, the brand-name pharmaceuticals lobby, has its “Go Boldly” campaign (read “PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: Less Hoodies, More White Coats”; http://sco.lt/4xLMLR). Now the generics lobby is launching its own “education campaign” under a whole new name.

 

“The Association’s new identity will improve recognition that the generic and biosimilar medicines industry is one of the nation’s great health care success stories, and that competition from generics and biosimilars lowers the cost of medicine,” Chip Davis, its president and CEO, said in a statement. “Our medicines drive savings, not costs, and we stand ready to work with the President, Congress, patient groups and others to create real and lasting health cost solutions.”

 

Generics figure to be major players in any resolutions that Congress or the Trump administration come up with for the drug-pricing debate. On the one hand, many lawmakers and groups, even PhRMA, talk about speeding generics to the market as a way to encourage competition and organically drive down prices. Some of the recent pricing controversies, such as Turing’s roughly 5,000 percent increase in the price of a life-saving drug, have centered on drugs that have long ago lost their patent protection, but never saw a generic competitor introduced.

 

But on the other hand, there are also incidences of extraordinary price increases for generic drugs. And some policy proposals make generic drug makers nervous, too. Senator Chuck Grassley’s bid to crack down on so-called pay-for-delay deals — litigation settlements between brand-name and generic drug makers that delay the introduction of a generic drug — are one item in particular that, according to people who work with generics, make those companies uneasy.

Pharma Guy's insight:

It has been recommended that “Big #Pharma Should Secede From PhRMA” in order to differentiate itself from price gougers (http://sco.lt/8UQ2vh). But maybe a name change would be better to wow & bamboozle the public.

 

What name should replace Pharmaceutical Research and Manufacturers of America? How about Association for Serious Science & Medicine (ASS&M)?

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Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices?

Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Today, after a meeting with pharmaceutical industry lobbyists and executives, he abandoned that pledge, referring to an idea he supported as recently as three weeks ago as a form of “price fixing” that would hurt “smaller, younger companies.” Instead of getting tough, Trump’s new plan is that he’s “going to be lowering taxes” and “getting rid of regulations.”

 

New drugs are generally covered by patent monopolies, so drug companies have a lot of pricing power; other companies can’t produce the same drug without paying royalties, so there’s little competition. But most countries use their nationalized health care systems to negotiate a good deal on drug prices. Manufacturing pills is cheap, so it’s usually still profitable for a company to sell medicine at a pretty steep discount.

 

The United States doesn’t have a nationalized health care system, but we do have Medicare for senior citizens, and since the USA is a very large country, that’s still a huge potential bulk purchaser. But a 2003 law written by congressional Republicans and signed by George W. Bush prohibits the federal government from using that negotiating power.

 

As recently as January 11, President-elect Trump was promising to revisit this policy.

 

“Pharma has a lot of lobbies, a lot of lobbyists and a lot of power. And there’s very little bidding on drugs,” he said at a press conference at Trump Tower in Manhattan. “We’re the largest buyer of drugs in the world, and yet we don’t bid properly.”

 

Today he apparently changed his mind. According to Herb Jackson, the designated pool reporter for the day, Trump’s new policy on prescription drugs is that drug companies should get tax cuts and deregulation (emphasis added):

 

I'll oppose anything that makes it harder for smaller, younger companies to take the risk of bringing their product to a vibrantly competitive market. That includes price-fixing by the biggest dog in the market, Medicare, which is what's happening. But we can increase competition and bidding wars, big time.

 

So what I want, we have to get lower prices, we have to get even better innovation and I want you to move your companies back into the United States. And I want you to manufacture in the United States. We're going to be lowering taxes, we're going to be getting rid of regulations that are unnecessary.

Pharma Guy's insight:

But read “Big Pharma (@PhRMA) Stands Behind Trump Even As He Vows to Lower Prices to Medicare”; http://sco.lt/5461NB 

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The Silence of the #Pharma Lambs on Trump's Immigration Policy

The Silence of the #Pharma Lambs on Trump's Immigration Policy | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Titans of the automotive, banking, and technology industries have spoken out in recent days against President Donald Trump’s move to block arrivals from seven Muslim-majority nations.

But the pharmaceutical sector, which relies disproportionately on immigrant labor, has been almost universally silent — perhaps in a bid to avoid rousing Trump’s ire before a crucial meeting Tuesday morning at the White House.

STAT reached out to the 15 biggest drug companies about the immigration ban; only Johnson & Johnson, Merck, and Novartis responded with statements — and they simply expressed support for affected employees, without taking a stance on Trump’s action.

The industry’s biggest lobbying group, PhRMA, has also remained mum. Trump is scheduled to meet with PhRMA executives on Tuesday morning.

“My guess is pharma is waiting to see how it plays out and which side the public opinion goes,” said Hank Greely, director of the Center for Law and the Biosciences at Stanford Law School. “I think that’s prudent — but another word for prudent, of course, is ‘cowardly.’”

Pharma Guy's insight:

Further Reading: “Pharma's Top Execs React to Trump Immigration Ban With Near Universal Silence”; http://sco.lt/8fzALh

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PhRMA Dumps Lots More Money Into Coffers of Pols & Patients

PhRMA Dumps Lots More Money Into Coffers of Pols & Patients | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Facing bipartisan hostility over high drug prices in an election year, the pharma industry’s biggest trade group boosted revenue by nearly a fourth last year and spread the millions collected among hundreds of lobbyists, politicians and patient groups, new filings show.

 

It was the biggest surge for the Pharmaceutical Research and Manufacturers of America, known as PhRMA, since the group took battle stations to advance its interests in 2009 during the run-up to the Affordable Care Act.

 

“Does that surprise you?” said Billy Tauzin, the former PhRMA CEO who ran the organization a decade ago as Obamacare loomed. Whenever Washington seems interested in limiting drug prices, he said, “PhRMA has always responded by increasing its resources.”

 

The group, already one of the most powerful trade organizations in any industry, collected $271 million in member dues and other income in 2016. That was up from $220 million the year before, according to its latest disclosure with the Internal Revenue Service.

 

PhRMA spent $7 million last year to prepare its ubiquitous “Go Boldly” ad campaign and gave millions to politicians who were up for election in both parties in dozens of states. It lavished more than $2 million on scores of groups representing patients with various diseases — many of them dealing with high drug costs.

 

Some of the biggest patient-group checks went to the American Autoimmune Related Disease Association, for $260,000; the American Lung Association, for $110,000; the Juvenile Diabetes Research Foundation, for $136,150; and the Lupus Foundation of America, for $253,500.

 

PhRMA also gave big money to national political groups financing congressional, presidential and state candidates. The conservative-leaning American Action Network got $6.1 million. The Republican Governors Association got $301,375. Its Democratic counterpart got $350,000.

 

 

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Very Few Patient Groups Don’t Take Pharma Money

Very Few Patient Groups Don’t Take Pharma Money | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Most patient and consumer advocacy groups receive funds from the pharmaceutical industry, according to a new study released by the group PharmedOut.

 

Only a handful out of 7,685 health advocacy groups in the U.S. are completely independent of pharmaceutical industry money, according to a list the group released Oct. 13. PharmedOut is a Georgetown University Medical Center project that advances evidence-based prescribing and educates health-care professionals about pharmaceutical marketing practices.

 

And industry funding of patient groups, including websites and informational materials, is often not apparent to the average consumer, which could mislead consumers into believing they’re getting unbiased health advice.

 

“Industry funding is often not disclosed on websites or informational materials or is hidden,” PharmedOut Director Adriane Fugh-Berman told me in an Oct. 16 phone call. Funding and sponsorship is often very subtle and difficult to identify, she said.

 

In addition, she said, industry sponsorship can affect the stands patient and consumer groups are willing to take, she said.

 

Groups that accept industry funding are affected by that money, regardless of whether they think they are, she said.

 

"Look at the stands taken and not taken,” she said. “For example, where is the anger and outrage about drug costs?”

 

Fugh-Berman is an associate professor in the Department of Pharmacology and Physiology and in the Department of Family Medicine at Georgetown University Medical Center.

 

Further Reading:

  • “Pharma 'Patient Centricity' Aids & Abets the Opioid Epidemic”; http://sco.lt/5RJse1

  •  “93% of Patient Advocacy Groups Included in FDA Funding Discussions Receive $ from Pharma”; http://sco.lt/8jkvFh

  • “Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation”; http://sco.lt/6QlP9N
  • “More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding”; http://sco.lt/6Ftgzh
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@PhRMA Employs a "Dark Money" Shell Game to Oppose OH Drug Price Relief Act

@PhRMA Employs a "Dark Money" Shell Game to Oppose OH Drug Price Relief Act | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The skirmish in Ohio over a ballot measure for lowering drug prices took a twist as a consumer advocate filed a complaint with state authorities alleging the pharmaceutical industry is illegally masking “dark money” from individual drug makers that oppose the initiative.

 

Known as the Ohio Drug Price Relief Act, the ballot measure would require state agencies to pay no more for medicines than the Department of Veterans Affairs. The agency currently gets a 24 percent federally mandated discount off average manufacturer prices. Supporters say the measure would save state residents $400 million annually.

 

In her complaint, Tracy Jones, a former executive director of the AIDS Taskforce of Greater Cleveland, charges that a limited liability company established by the pharmaceutical industry trade group failed to comply with state campaign finance disclosure laws, such as not providing a list of donors.

 

About $15.8 million was donated in recent weeks by the Ohioans against the Deceptive Rx Ballot Issue LLC, to a political action committee with the same name, and which was created at the same time as the LLC. In effect, the LLC is allegedly functioning as a political action committee and, therefore, is obligated to disclose contributors, according to the complaint filed on Wednesday with the Ohio Elections Commission.

 

The LLC was registered last May with state officials and the form was signed by Scott LaGanga, a senior vice president in charge of state advocacy at the Pharmaceutical Research & Manufacturers of America, the industry trade group. Another form lists the LLC as a wholly owned subsidiary of PhRMA.

 

One campaign financing expert had this to say:

 

“Circumventing disclosure of individual donors is certainly nothing new. But it’s somewhat difficult to understand why a trade group that represents the pharmaceutical industry thinks that hiding company names will achieve anything,” Edwin Bender, executive director, National Institute on Money in State Politics, a non-profit, told us. “Everyone knows who they represent.

 

“It appears they’re forming a shell company to move money around so they’re not held accountable, but corporations aren’t people — they don’t have feeling, morals, or civic courage. They’re protecting bottom lines. But in the age of the Internet, it’s an old strategy that’s getting a little tired. It’s also bad policy.”

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In a Blow to PhRMA, Only 9% of People in U.S. Rank Pharma as the Most Innovative Industry

In a Blow to PhRMA, Only 9% of People in U.S. Rank Pharma as the Most Innovative Industry | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Only 17% of consumers polled in the 2017 Klick Health Consumer Survey on Healthcare Innovation currently perceive health-related industries as being the most innovative, out of 18 industries examined. Specifically, pharmaceuticals & biotech, health & wellness, and hospital sectors lagged considerably in perceived innovation behind consumer electronics, telecommunications, and media & entertainment.

However, respondents ranked health & wellness first in terms of the industry that should be the most innovative, quickly followed by pharmaceuticals & biotech, and hospitals in the top five industries. These results suggest a desire by consumers for innovation in healthcare, even though they do not believe that healthcare-related industries are particularly innovative today.
Pharma Guy's insight:

On the bright side, Pharma does rank #4 in a list of 19 industries, most of which no one considers most innovative.

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@PhRMA Does Not Gold Boldly Enough to Address Real Issue, Says Law Professor

@PhRMA Does Not Gold Boldly Enough to Address Real Issue, Says Law Professor | Pharmaguy's Insights Into Drug Industry News | Scoop.it

[Opinion of Rachel Sachs is an associate professor of law at Washington University in St. Louis] Earlier this month, PhRMA — the trade group representing innovator pharmaceutical companies — announced a set of new membership criteria. Going forward, PhRMA members will need to meet certain standards regarding their investment in R&D (read “@PhRMA Ousts Marathon #pharma et al”; http://sco.lt/8Zj01B).

 

PhRMA may have felt it needed to take action to restore public confidence in the industry and to constrain the bad press its members have been receiving on the drug pricing front. In my view, the new rules miss the mark.

 

Under the new criteria, member companies must invest at least 10 percent of global sales into R&D and pour at least $200 million annually into R&D, both measured on a three-year average.

 

I would argue these new criteria are not narrowly tailored to the matter at hand. There is a mismatch between the goals seemingly behind these new criteria and the specific tools they have chosen to bring them about.

 

First, consider the substance of the criteria in context. Many PhRMA members are directly under fire for some of their pricing practices, and we have seen pledges in recent months by individual companies to publicly restrain themselves from some of the industry’s price-hiking behavior.

 

Why, then, tie the new criteria to the amount spent on R&D, rather than to pledges not to engage in some of the more overt bad acts of these companies? The disconnect is particularly strange when you consider that a common argument companies make when confronted with price hikes is that the increased revenue is needed to fund additional R&D.

 

A likely explanation can be found in PhRMA’s attempt to rebrand itself under the auspices of its big new advertising campaign, “Go Boldly.” The industry is seeking to remind customers that it is responsible for the innovative medical breakthroughs that have saved so many lives, and that so many people rely on each day (read “@PhRMA Goes Even More BOLDLY in a New Ad Campaign”; http://sco.lt/5xvWTp).

 

Publicly tying membership in the organization to R&D expenditures allows PhRMA to say that each of its members shares in the “Go Boldly” vision and is committed to the mission of innovation in new medical breakthroughs. However, it does so at the cost of ignoring the particular actions that have created much of the public outrage on the subject of drug pricing.

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@PhRMA Ousts Marathon #pharma et al to Appease Trump & His Campaign Promises

@PhRMA Ousts Marathon #pharma et al to Appease Trump & His Campaign Promises | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Confirming yesterday's buzz, PhRMA, the pharmaceutical industry's primary lobbying group, announced changes to its membership structure today that include stricter membership requirements and the elimination of its "associate" category (read “@PhRMA Mulls Limiting Members to Appease Trump Amid Drug Price Scandal”; http://sco.lt/52B8BV). As a result, 22 companies lost their membership or associate membership status. The new requirements, based on a three-year average:

 

At least $200 million per year spent on research

Research expenditures equal to at least 10% of global sales

 

Former members, per PhRMA:

 

  • AMAG Pharmaceuticals, Inc.
  • Horizon Pharma plc
  • Jazz Pharmaceuticals plc
  • Leadiant Biosciences
  • Mallinckrodt Pharmaceuticals
  • Orexigen Therapeutics, Inc.
  • The Medicines Company

 

Former associate members, per PhRMA:

 

  • ACADIA Pharmaceuticals Inc.
  • Aerie Pharmaceuticals, Inc.
  • Avanir Pharmaceuticals, Inc.
  • BioMarin Pharmaceutical Inc.
  • CSL Behring, LLC
  • Esperion Therapeutics, Inc.
  • Ferring Pharmaceuticals Inc.
  • Grifols USA, LLC
  • Ipsen Biopharmaceuticals, Inc.
  • Marathon Pharmaceuticals, LLC
  • Shionogi Inc.
  • Sucampo Pharmaceuticals, Inc.
  • Theravance Biopharma
  • Vifor Pharma
  • VIVUS, Inc.
Pharma Guy's insight:

This is supposed to be “PhRMA's way of trying to get rid of smaller companies that engage in the controversial practice of buying older drugs and jacking up the prices.” But PhRMA knew that some of these companies gouged prices when they accepted them as members (read, for example, “PhRMA Accepts Price Gouging #Pharma Companies Into Its Tent”; http://sco.lt/5a8tNJ and “Big #Pharma Should Secede From PhRMA, Says @John_LaMattina”; http://sco.lt/8UQ2vh).

 

It was only after meeting with Trump that PhRMA got religion and started to reconsider who it should accept as members (read “PhRMA Embarrassed by Marathon is Forced to ‘Review’ Membership Criteria – Is a Purge in the Cards?”; http://sco.lt/5XUvqL and “PhRMA Offers Up Marathon Pharmaceuticals as “Sacrificial Lamb” to Trump?”; http://sco.lt/5uZwMD).

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The Who's Who of "Health Care" (i.e., Pharma) Lobbyists, 2017 vs 2016 Budgets

The Who's Who of "Health Care" (i.e., Pharma) Lobbyists, 2017 vs 2016 Budgets | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Drug companies dug deep into their lobbying piggy banks in President Trump's first quarter, but they weren't the only health care companies or trade groups that increased their budgets in Washington. Here's a list of the top 25 spenders and how much they budgeted for health care lobbying, based on an Axios review of the Senate lobbying database.

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Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation

Patient Advocacy Groups with Funding & Form Letter from @PhRMA Oppose Nevada Legislation | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Health care nonprofits backed by the pharmaceutical industry have inundated Democratic Sen. Yvanna Cancela’s inbox over the last couple of days as discussions on a major piece of legislation she sponsored continue behind the scenes.

 

Since Friday, seven groups have sent similar letters addressed generally to Nevada state senators asking them to oppose a polarizing pharmaceutical bill, SB265. All of the groups have taken money from either PhRMA, the trade association representing pharmaceutical companies in the United States and the driving force behind the opposition to the bill, or directly from pharmaceutical companies themselves.

 

Four of the seven organizations received grant funding directly from PhRMA in recent years including:

 

  • RetireSafe, a nationwide senior advocacy organization, received a $25,000 grant in 2014
  • The Epilepsy Foundation received a $25,000 grant in 2014
  • Caregivers Voices United’s affiliate Caregivers Action Network, a family caregiver organization, received $315,000 from PhRMA as a general contribution and funding to help with an event in 2014
  • National Council of Asian Pacific Islander Physicians received two $10,000 grants in 2013 and 2014

 

Many of the organizations also took money from pharmaceutical companies in 2016, including Pfizer and Sanofi, both which have registered lobbyists this session. The local nonprofit Lupus of Nevada, Inc. has also been encouraging people on Facebook to contact their legislators about the bill and provides them with a form letter, of which Cancela says she has received many copies.

 

The legislation, which Cancela introduced in February, would put price controls on diabetes medication, require pharmaceutical sales representatives to be licensed and annually report their activities and mandate disclosure of any pharmaceutical-related contributions by nonprofits in the healthcare sector.

 

The letters, which in some portions use nearly identical language, argue that SB265 could threaten access to medications by causing stockpiling in response to the required 90-day notice ahead of certain price increases, will help pharmacy benefit managers (PBMs) and insurance companies instead of patients and require nonprofits to disclose certain information about contributions they receive from pharmaceutical companies that is already publicly available — similar arguments proffered by the pharmaceutical industry in opposition to the bill.

 

Further Reading:

  • “Pharma Turning Patients With Rare Diseases Into D.C. Lobbyists”; http://sco.lt/6wBAp7 
  • “93% of Patient Advocacy Groups Included in FDA Funding Discussions Receive $ from Pharma”; http://sco.lt/8jkvFh 
  • “The Yin Yang of Patient Advocate Groups and the Pharma Industry”; http://sco.lt/6400R7 
  • “More Than Two-thirds of Patient Advocacy Groups Receive Industry Funding”; http://sco.lt/6Ftgzh 
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Study Refutes PhRMA Claim That High Drug Prices in U.S. Funds R&D

Study Refutes PhRMA Claim That High Drug Prices in U.S. Funds R&D | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A blog posted on Health Affairs on March 7, 2017 presents a study that tested PhRMA’s long-standing argument that high prices for drugs fund research and development in the pharmaceutical industry.

 

The point of the research was to illustrate that in the US, premium prices for drugs produce billions of dollars more in revenue than is necessary to fund R&D operations at pharma companies. If premium prices were lowered to just meet R&D expenditures, the researchers pointed out, patients, business, and taxpayers could have saved $40 billion in 2015. The conclusions are in direct opposition with PhRMA’s explanation that drugs are priced to allow for innovation in the industry and are required to fund R&D operations. At the time of publication, PhRMA had not responded to requests for comment on the Health Affairs study.

 

In essence—as President Trump has implied in his comments on pharma—the US funds a chunk of the world’s pharmaceutical research. Meanwhile, other countries pay lower prices for drugs that come out of this research. According to Brian Henry, a spokesperson for pharmacy benefit manager Express Scripts, the findings of the study are not surprising. “The takeaways are consistent with what we have been saying: drug makers set drug prices, and, more and more, those prices are set higher and higher—basically orphan drug pricing for non-orphan drugs.”

 

Further Reading:

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PhRMA Embarrassed by Marathon is Forced to “Review” Membership Criteria – Is a Purge in the Cards?

PhRMA Embarrassed by Marathon is Forced to “Review” Membership Criteria – Is a Purge in the Cards? | Pharmaguy's Insights Into Drug Industry News | Scoop.it

After maintaining a steadfast silence for the past 5 days, PhRMA is cutting Jeff Aronin loose.

 

The Marathon CEO and PhRMA board member triggered a tempest over his announcement last Thursday evening that he would price his newly approved steroid — a cheap, generic offering sold in many countries around the world as deflazacort — for $89,000 a year after landing an approval to market it for Duchenne muscular dystrophy. According to a number of patient advocates, they’ve been buying the drug from overseas for about $1,000 a year.

 

On Monday Senator Bernie Sanders and Congressman Elijah Cummings accused Aronin and Marathon of ripping off the system in the latest example of a drug executive looking to cash in after gaming the FDA’s approval process (read “Senators Launch Probe into Marathon's $89K Price Tag for ‘Cheap Steroid’ - Company Retreats”; http://sco.lt/7dIrHV). Now PhRMA says Marathon is guilty of conduct unbecoming to the industry, launching a review on membership criteria that would likely leave Aronin in the cold.

 

Their statement tonight:

 

We are pleased Marathon decided to pause the launch of their medicine to solicit additional input from patients and other stakeholders. Their recent actions are not consistent with the mission of our organization. In addition, the leadership of the PhRMA Board of Directors has begun a comprehensive review of our membership criteria to ensure we are focused on representing research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients.

 

This is just the latest in a series of embarrassing controversies centered on charges of price gouging. Turing CEO Martin Shkreli got it started. Valeant was quickly swept up. And then Mylan took a turn in the public stocks. Now it’s Marathon’s time to stand in the spotlight.

 

By Wednesday night Aronin was more of a liability to PhRMA than a benefit. Just weeks ago the trade group began an ambitious marketing campaign aimed at highlighting the contributions of medical research. It was time, said PhRMA CEO Stephen Ubl in a thinly veiled jab at Shkreli, for more lab coats and fewer hoodies (“PhRMA's Dark Inspirational Video Starts a 6-Month Offensive: ‘Less Hoodies, More White Coats’"; http://sco.lt/4xLMLR).

 

At the time, Shkreli fired back that he had learned everything about raising prices from Marathon (read “’I Literally Learned from This Guy,’ Says Martin Shkreli of Marathon CEO Jeff Aronin”; http://sco.lt/5B6b2X).

 

For now, Aronin remains on the board at PhRMA. But his odds of making it much longer aren’t good.

Pharma Guy's insight:

Meanwhile, some in the industry are urging Big Pharma to Secede from PhRMA: http://sco.lt/8UQ2vh 

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Big Pharma (@PhRMA) Stands Behind Trump Even As He Vows to Lower Prices to Medicare

Big Pharma (@PhRMA) Stands Behind Trump Even As He Vows to Lower Prices to Medicare | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump promised some of the nation’s top drug company executives in a meeting at the White House on Tuesday that he would slash regulations at the Food and Drug Administration and make it easier for them to manufacture products in the United States.

 

He also described as “fantastic” the person he planned to nominate for commissioner of the Food and Drug Administration, someone he said would streamline the agency and get drug approval decisions faster.

 

“You can’t get approval for the plant, and you can’t get approval for the drug; other than that, you’re doing fantastic,” Mr. Trump said at the meeting, to laughter from top executives of companies like Merck, Johnson & Johnson, Eli Lilly and Novartis.

 

But even as he struck a cordial tone with them, he said that lowering drug costs would remain a focus and that he would discuss the issue further during the nonpublic portion of the meeting, away from the news media. “The U.S. drug companies have produced extraordinary results for our country, but the pricing has been astronomical,” Mr. Trump said. “We have to get prices down for a lot of reasons.”

 

Battered by public outrage over the rising costs of drugs in recent years, the drug industry has regarded Mr. Trump warily in recent weeks. Pharmaceutical and biotechnology stocks rallied after his election as investors bet that Mr. Trump would reduce corporate taxes and adopt more industry-friendly policies than his Democratic opponent, Hillary Clinton, who had made reducing drug prices a campaign issue.

 

But that optimism gave way to unease after Mr. Trump pledged to tackle the drug pricing issue himself, including raising the possibility of allowing Medicare to negotiate the prices of drugs directly, something the industry has long opposed.

 

Just a few weeks ago, Mr. Trump singled out the pharmaceutical industry for its high prices, accusing it of “getting away with murder.”

 

At the meeting Tuesday, Mr. Trump again referred to Medicare’s role, saying he would oppose anything that prevented competition, including “price fixing by the biggest dog in the market, Medicare, which is what’s happening.”

 

A White House spokesman later clarified that his remarks meant that the president “supports increasing bidding and competition for all drugs in Medicare.”

 

[Some other news sources think otherwise. Read, for example, “Did Big Pharma Just Convince Trump to Abandon His Push to Let Medicare Negotiate Drug Prices?”; http://sco.lt/8CcWbB]

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PhRMA CEO et al Go to Washington to Make “Peace in Our Time” with Trump

PhRMA CEO et al Go to Washington to Make “Peace in Our Time” with Trump | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Representatives from the drug industry’s top lobbying group will head to the White House Tuesday morning for a rendezvous with President Trump.

 

Steve Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, and several of PhRMA’s board members will meet with Trump and Vice President Mike Pence at 9 a.m. in the Oval Office.

 

The meeting follows Trump’s incendiary comments about drug makers before and after his election. In a recent press conference, he accused the industry of “getting away with murder” and pledged to change the way the federal government pays for prescription drugs.

 

From cancer vaccines to why we feel pain, scientists are tackling some of biology’s biggest challenges. Subscribe to “Two Scientists Walk Into a Bar” to learn more.

 

Trump promises reforms on drug prices, saying companies ‘getting away with murder’

 

A top industry official, who spoke on condition of anonymity, told STAT the drug industry viewed Tuesday’s meeting as a chance to engage the White House after the president’s fiery rhetoric and to start a dialogue on the issue.

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