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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HHS Tweet Touts the Trump Administration’s “Accomplishments” Like Its “Sham” Response to the Opioid Crisis, Withdrawing Regulations, and Cutting Open Enrollment Budget by 90%!

HHS Tweet Touts the Trump Administration’s “Accomplishments” Like Its “Sham” Response to the Opioid Crisis, Withdrawing Regulations, and Cutting Open Enrollment Budget by 90%! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

A new report released by the Department of Health and Human Services highlights the greatest hits of the Trump administration in 2017.

 

Among the highlights touted: efforts to identify federal regulatory burdens that hurt patients, as well as ways to lower high prescription drug costs. The result, the report said, was a “net decrease in the burden imposed by HHS regulations as well as positive reforms in a range of Medicare payment rules, actions from the Food and Drug Administration, and ongoing reviews of further areas for action.”

 

Regulatory rollbacks

To reduce burdensome regulations, the report notes that HHS withdrew 70 regulatory actions taken by the Obama administration, took 68 deregulatory actions and only introduced 27 regulations. In addition, CMS Administrator Seema Verma went on a listening tour to talk to providers, doctors and clinicians about regulatory burdens.

 

Open enrollment cutbacks

But many of the accomplishments listed in the report were controversial. For example, HHS says it conducted a “successful, consumer-friendly open enrollment period at significantly lower cost than in previous years, attracting similar levels of enrollment with more focused investments in marketing:” Yet the enrollment numbers are generally credited to the fact that private insurers stepped up advertising efforts to compensate for the fact that the federal government cut its ad budget by 90% and the amount of time citizens had to enroll in plans.

 

Response to opioid crisis

The report is also proud of the administration’s work to combat the opioid crisis in the U.S., citing Trump’s declaration that the epidemic was a national public health emergency and raising public awareness to the issue. But the response has been criticized by many who note that without funding, the declaration was meaningless. Last week former Democratic Rep. Patrick Kennedy, one of six members appointed to a bipartisan commission in March by President Trump to address the opioid crisis, called the work done by the task force a sham because the administration hasn’t put any money behind the actions the group suggested to combat the epidemic (http://sco.lt/6xPgUj).

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If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse

If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse | Pharmaguy's Insights Into Drug Industry News | Scoop.it

If Alex Azar Is Confirmed as HHS Secretary, Big Pharma’s Coup of Health Care Sphere Will Be Virtually Complete

Statement of Robert Weissman, President, Public Citizen

Note: Media reports indicate that President Donald Trump is likely to nominate Alex Azar, who served for five years as president of Lilly USA, LLC, the largest affiliate of global biopharmaceutical leader Eli Lilly and Company, to be the next U.S. Secretary of Health and Human Services.

Just days after denouncing “out-of-control” drug prices, President Donald Trump appears set to show he doesn’t mean it by naming a former pharmaceutical company executive to run the U.S. Department of Health and Human Services. If Alex Azar is nominated and his nomination confirmed, then Big Pharma’s coup d’etat in the health care sphere will be virtually complete.

In his public statements, Alex Azar has made clear that he is opposed to measures to restrain drug company profiteering and limit improper marketing and favors weaker drug safety approval standards.

Americans understand, passionately, that drug company price gouging leads to rationing of care. It is unethical and must end. Even President Trump says so. But it is highly unlikely that a pharmaceutical company executive who has made passionate arguments against price restraints is going to advance real reform. Much more likely is that he serves as the instrument by which Big Pharma aims to defend its monopolies and unaffordable prices.

The swamp only gets worse. Tom Price supported Big Pharma in the U.S. Congress. Now apparently Trump has decided to cut out the middleman, and let a pharmaceutical executive literally run the health department.

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K.I.R.M. God is Business " From Day One"'s curator insight, December 12, 2017 4:05 AM

How will the Health Care cuts effect the world of pharmacy drugs? Will the Drug Dealers become the new day pharmacist using their connections to keep the sick, poor and needy for medication to stay alive but without insurance assistance they can't afford. Yes they are smart beyond what some may look and think but consider who they are getting theirs from. Its going to be a new day in the drug industry because people are not going to see their own die when they can help their people out in a its about staying alive thing made personal, NOW! Will the Dug Dealers become new day Pharmacist that help keep their people alive by providing medications needed to stay alive because of health care assistance terminated therefore so is lives?

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High Prices, Not Rising # of Prescriptions Fuel Big Increases in Drug Spending Says HHS

High Prices, Not Rising # of Prescriptions Fuel Big Increases in Drug Spending Says HHS | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Big Pharma is already under scrutiny for skyrocketing drug prices, and now the industry is facing more pushback. A new report from the Department of Health and Human Services zeroes in on drug price increases as one key driver of rising drug costs.

Drug spending shot up by an estimated 12.6% to $424 billion from 2013 to 2014, the HHS report says. And the trend is likely to continue, with drug spending rising again to $457 billion in 2015.

Higher drug prices are primarily to blame. Prescription drug spending shot up 26% to $424 billion in 2014 from $356 billion in 2010, but the number of prescriptions didn't grow as quickly. "The fact that total expenditures rose more quickly than the number of prescriptions suggests that prices are growing faster than quantities," the report authors said. "Therefore, price changes are contributing more to the growth in spending than is growth in volume of prescriptions."

Pharma Guy's insight:

But HHS also says: "Factors underlying the rise in prescription drug spending from 2010 to 2014 can be roughly allocated as follows: 10 percent of that rise was due to population growth; 30 percent to an increase in prescriptions per person; 30 percent to overall, economy-wide inflation; and 30 percent to either changes in the composition of drugs prescribed toward higher price products or price increases for drugs that together drove average price increases in excess of general inflation." See http://sco.lt/7mh2Kv 

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Trump Nominates a Pharma Fox to Run the HHS Henhouse

Trump Nominates a Pharma Fox to Run the HHS Henhouse | Pharmaguy's Insights Into Drug Industry News | Scoop.it

President Trump's pick for health secretary previously served as a high-ranking executive at a pharmaceutical company that repeatedly raised the prices of its drugs, doubling the U.S. list price of its top-selling insulin over the five years he served as a company president.

 

Trump endorsed Alex Azar, a previous deputy secretary of Health and Human Services under President George W. Bush and pharmaceuticals executive at diabetes pharmaceuticals giant Eli Lilly, as “a star for better health care and lower drug prices” on Twitter.

 

Supporters said that Azar's understanding of the complicated dynamics behind pharmaceuticals pricing would give him an advantage in figuring out how to make drugs more affordable. Critics, however, noted that Azar's tenure at Lilly coincided with massive list price increases on insulin and made him particularly ill-suited to lower drug prices.

 

While Azar led Eli Lilly's largest affiliate, Lilly USA, the U.S. list price of Humalog insulin more than doubled, from $123 per vial in Jan. 2012 to $255 per vial when he left the company in early 2017, according to data from Truven Health Analytics. Lilly, along with other insulin makers, was hit by a class-action lawsuit alleging overpricing of insulin earlier this year.

 

“Alex had a successful career at Lilly, and we wish him the best in his future work,” Lilly spokesman Greg Kueterman said in an email.

 

Azar joined Lilly in 2007 as a senior vice president of global corporate affairs and communications. He rose to become president of the company's largest affiliate, Lilly USA, in 2012. Kueterman said his responsibilities included direction over the sales and marketing operations of the entire U.S. commercial business, including diabetes.

 

“This is the terrible record on price that we saw; now we’re talking about putting him in charge of the people's health agency — what reason do we have to expect any difference?” said Peter Maybarduk, director of the Access to Medicines Program at Public Citizen, a watchdog group. “It's a pharma fox to run the HHS henhouse.”

 

Further Reading:

  • “If Alex Azar Is Confirmed as HHS Secretary, the Big Pharma/Gov’t Swamp Will Get Worse”; http://sco.lt/67pLZR
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HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On!

HHS: Mylan Overcharged Medicaid $1.27B. DOJ: Nothing to See Here, Move On! | Pharmaguy's Insights Into Drug Industry News | Scoop.it

Mylan may have overcharged taxpayers as much as $1.27 billion over 10 years for its signature EpiPens, according to an analysis released Wednesday by the Department of Health and Human Services’s watchdog.

 

The pharmaceutical company has been in hot water for potentially misclassifying its signature epinephrine auto-injector in a way that enabled it to charge a higher price to Medicaid (read “Mylan ‘Gamed the System’ and Refuses to Testify at Senate Hearing About EpiPen Costs to Medicaid”; http://sco.lt/4mtPaj). Because the pens were classified as generic, rather than brand-name products, Mylan paid Medicaid a 13 percent instead of a 23 percent rebate — despite the company being told its classification was incorrect. That allegation came to light in the fall.

 

In October, it was reported that Mylan agreed to a $465 million settlement over these accusations, although the status of this settlement remains unclear.

 

The new calculation of unpaid rebates underscores earlier concerns that taxpayers may get shortchanged by the proposed settlement. As Sen. Chuck Grassley (R-Iowa) noted in a statement, the $465 million settlement is much less than the $1.27 billion Mylan allegedly overcharged.

 

Now the first hard estimate of the overcharging, from the Office of the Inspector General for HHS, reveals that taxpayers may have paid as much as $444 million from 2006 to 2014, and $826 million from 2015 and 2016 — amounting to $1.27 billion in all. Letters from the inspector general stress that these estimates are limited because they do not take into account “supplemental rebates” that individual states may have received.

 

The Department of Justice declined on comment on the settlement Wednesday, saying that “there is no settlement to report.”

 

Further Reading:

Pharma Guy's insight:

Boy! Pharma Sis is lucky Trump won and saved her ass by appointing a do-nothing Dept of Justice (DOJ) leader!

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HHS Transparency Reforms Not More Effective in Uncovering Conflicts of Interest

HHS Transparency Reforms Not More Effective in Uncovering Conflicts of Interest | Pharmaguy's Insights Into Drug Industry News | Scoop.it
Relationships between industry and researchers can be hard to define, but universities and other institutions must do more to scrutinize the work of their scientists for conflicts of interest.


In trying to navigate such complexities, the US National Institutes of Health (NIH) has been ahead of the curve — presumably because of long-standing concerns about physicians’ industry relationships and the high stakes for protecting patients. Its parent agency, the Department of Health and Human Services (HHS), was the first to establish conflict-of-interest disclosure rules in 1995 and is still beyond many of its counterparts in maintaining unified regulations that include yearly reports to the government. By contrast, as one example, the US National Science Foundation’s grants policy suggests that institutions look to scientific societies for ideas on how to manage a conflict of interest, and to report back to the foundation only if institutions cannot handle it themselves.


But even the HHS rules were not enough to guarantee full transparency. In 2009, a congressional report and subsequent media coverage found that some NIH-funded researchers had quietly accepted millions of dollars from industry. Again, the blame kept shifting: the universities said that the researchers had not reported the conflicts, the NIH received only bare-bones reports from institutions, and the researchers said that they did not know they were breaking any rules.


The HHS updated its policies in 2011, but pleased no one. The government underestimated the time and money that institutions would spend implementing new rules. And some aspects of the reforms have proved to be window dressing: a Nature investigation this week reveals that these reforms have uncovered few conflicts of interest that would have escaped the original regulations.


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Pharma Guy's insight:

You might also be interested in reading this Pharma Marketing Blog post: "In Medical Publishing, Is Disclosure Enough?"; http://bit.ly/scIp4 

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