Category: Pharmacy & Biological Sciences

Global Pricing Plan Added To Trump’s Attack On Drug Prices, But Doubts Persist

The proposal would have Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries.

Sarah Jane Tribble, Kaiser Health News

President Donald Trump’s new pledge to crack down on “the global freeloading” in prescription drugs had a sense of déjà vu.

Five months ago, Trump unveiled a blueprint to address prohibitive drug prices, and his administration has been feverishly rolling out ideas ranging from posting drug prices on television ads to changing the rebates that flow between drugmakers and industry middlemen.

Thursday, Trump proposed having Medicare base what it pays for some expensive drugs on the average prices in other industrialized countries, such as France and Germany, where prices are much lower. The proposal is in the early stages of rule-making and awaiting public comments.

The U.S., Trump said, will “confront one of the most unfair practices, almost unimaginable that it hasn’t been taken care of long before this.”

The proposal was met with hope and skepticism, with several experts saying they were happy the administration was taking on Medicare Part B’s rising drug prices but questioning its approach.

Walid Gellad, director of the Center for Pharmaceutical Policy and Prescribing at the University of Pittsburgh, said in an online post that the administration’s proposed solutions were unclear. And, he said, they would “face insurmountable challenges.”

While some industry watchers pointed to the announcement as a political move, Wells Fargo pharmaceutical analyst David Maris said that this is a broader effort by the president and his administration to attack the root causes of high drug prices.

“The reality is he could very easily not take this on and do what other administrations have done and let the prices keep rising.”

Trump, too, promised more to come and said he will soon announce “some things that will really be tremendous.” On Friday, Health and Human Services Secretary Alex Azar said that, as promised in the blueprint, there would be more changes to Medicare Part D, which covers most prescriptions. Ian Spatz, a public policy expert and senior adviser at Manatt Health, said the overall blueprint was “unprecedented in terms of how many different ideas and areas of ideas that it contained.”

Nothing would happen overnight. The proposal to require drug prices in TV ads could be delayed by litigation and notably, if implemented, does not include any penalties for companies who fail to post their prices.

The proposed rebate rule was delivered to the Office of Management and Budget in July. Matt Brow, president of industry consulting firm Avalere Health, said he expects the administration to publish the rule for comment by year’s end.

Trump’s international pricing plan is not as far along as the rebate proposal. Rather, it is an “advanced notice of proposed rule-making.” The proposed rule could come in spring 2019, and Azar said the new model could begin in late 2019 or early 2020.

Yet, on Friday, Azar signaled the proposal could change, telling an audience at the Brookings Institution that the administration is “open to any number of alternative ideas.”

Avalere’s Brow said there is a good chance the proposal will change significantly.

“The sweeping nature of the proposal makes the stakes higher and makes it harder to implement,” Brow said.

If the administration moves forward, it would bypass Congress and implement a pilot under the Center for Medicare & Medicaid Innovation’s purview. The pilot would phase in over five years and apply to 50 percent of the country. Azar said there would be no changes to Medicare benefits and no restrictions on patient access.

The proposal focuses on drugs covered under Medicare Part B, which are administered in hospitals, clinics and doctors’ offices. It also would alter the reimbursement formula for doctors and providers and would allow private-sector vendors to purchase drugs and then sell them to doctors and hospitals. Medicare would reimburse those vendors at the international pricing level.

Currently, doctors and hospitals administering Part B drugs are reimbursed the average price of a drug plus 6 percent. President Barack Obama’s administration attempted to alter Part B as well but drew intense lobbying opposition and eventually withdrew a proposed pilot project.

Allan Coukell, senior director for health programs at Pew Charitable Trusts, said removing incentives that reward doctors for purchasing costlier drugs and bringing in a new way to control prices “makes a lot of sense.” Drug spending within Medicare Part B reached $22 billion in 2015, and drug costs have increased by an average of 8.6 percent annually since 2007.

Stephen Ubl, president of the industry trade group Pharmaceutical Research and Manufacturers of America, or PhRMA, said imposing foreign price controls from countries with socialized health care systems would harm patients and hinder drug discovery and development.

Azar, a former executive at pharmaceutical manufacturer Eli Lilly, told reporters Thursday that “you may hear the tired talking points” that this will affect innovation. He disputed that idea, concluding that “less than 1 percent of pharma [research and development] could potentially be impacted by this change.”

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

New Drug to Treat the Flu Approved by FDA

The new drug, Xofluza, is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years.

Alison Hunt, FDA.gov

Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours.

“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years. With thousands of people getting the flu every year, and many people becoming seriously ill, having safe and effective treatment alternatives is critical. This novel drug provides an important, additional treatment option,” said FDA Commissioner Scott Gottlieb, M.D. “While there are several FDA-approved antiviral drugs to treat flu, they’re not a substitute for yearly vaccination. Flu season is already well underway, and the U.S. Centers for Disease Control and Prevention recommends getting vaccinated by the end of October, as seasonal flu vaccine is one of the most effective and safest ways to protect yourself, your family and your community from the flu and serious flu-related complications, which can result in hospitalizations. Yearly vaccination is the primary means of preventing and controlling flu outbreaks.”

Flu is a contagious respiratory illness caused by influenza viruses. When patients with the flu are treated within 48 hours of becoming sick, antiviral drugs can reduce symptoms and duration of the illness.

“When treatment is started within 48 hours of becoming sick with flu symptoms, antiviral drugs can lessen symptoms and shorten the time patients feel sick,” said Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “Having more treatment options that work in different ways to attack the virus is important because flu viruses can become resistant to antiviral drugs.”

The safety and efficacy of Xofluza, an antiviral drug taken as a single oral dose, was demonstrated in two randomized controlled clinical trials of 1,832 patients where participants were assigned to receive either Xofluza, a placebo, or another antiviral flu treatment within 48 hours of experiencing flu symptoms. In both trials, patients treated with Xofluza had a shorter time to alleviation of symptoms compared with patients who took the placebo. In the second trial, there was no difference in the time to alleviation of symptoms between subjects who received Xofluza and those who received the other flu treatment.

The most common adverse reactions in patients taking Xofluza included diarrhea and bronchitis.

Xofluza was granted Priority Review under which the FDA’s goal is to take action on an application within an expedited time frame where the agency determines that the drug, if approved, would significantly improve the safety or effectiveness of treating, diagnosing or preventing a serious condition.

The FDA granted approval of Xofluza to Shionogi & Co., Ltd.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Large Number of Influencers on the “Health Care 50” are in Biopharma

Of the fifty most influential people innovating healthcare named by Time Magazine, those with ties to biopharma make up a large percentage.

Time Magazine released their inaugural list of the fifty most influential people in healthcare—dubbed the Health Care 50—and a solid portion of those recognized for transforming healthcare have ties to the biopharma space.

To select the fifty most influential people, among them physicians, scientists, and business and political leaders, Time Magazine’s health editors and reporters made nominations, which were then evaluated for their work on key factors, including originality, impact, and quality.

Notable honorees who are innovating healthcare through biopharma include:

  • Bill and Melinda Gates, Philanthropists and Founders of the Bill and Melinda Gates Foundation
  • Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration
  • James P. Allison and Tasuku Honjo, Recipients of the 2018 Nobel Prize in Medicine
  • David Sinclair, Professor of Genetics in the Department of Genetics at Harvard Medical School
  • Anne Wojcicki, CEO of 23andMe

To view the full list of influencers, please click here.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

TV Ads Must Disclose Drug Prices, Trump Administration Says

The Trump administration proposed a new rule this week which demands drug makers disclose list prices for medications in their TV commercials.

A new rule was proposed by the Trump administration on Monday that pharmaceutical companies reveal the list prices for all brand name drugs covered by Medicare and Medicaid that cost more than $35 a month in their television advertisements.

The proposed rule pushes for transparency, stating that the price should be listed at the end of the advertisement in “a legible manner” and should be presented against a contrasting background in a way that is easy to read. If approved, however, drug companies cannot be forced to comply, as there is no government-enforced penalty system in place. Instead, federal regulators would make public a list of companies violating the rule and depend on the private sector to take legal action.

This rule is being touted as part of the administration’s “American Patients First” blueprint, their initiative to bring down prescription drug prices. However, it is unclear how disclosing list prices for medications in television ads will lower drug prices, as a drug’s list price is not often closely related to what patients actually pay for their medications at the pharmacy.

As anticipated, the proposed rule is already facing backlash from the drug industry.

“We’re concerned that if you just have the list price in isolation in the ad, it may deter patients from seeking needed care,” Steve Ubl, President and CEO of the Pharmaceutical Research and Manufacturers of America, is quoted as saying.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Mysterious Polio-Like Illness Baffles Medical Experts

A spike in cases of children with a rare neurological disease that causes polio-like symptoms has health officials scrambling to understand the illness.

Carmen Heredia Rodriguez, Kaiser Health News

A spike in the number of children with a rare neurological disease that causes polio-like symptoms has health officials across the country scrambling to understand the illness. Yet, more than four years after health officials first recorded the most recent uptick in cases, much about the national outbreak remains a mystery.

Acute flaccid myelitis (AFM) affects the gray matter in the spinal cord, causing sudden muscle weakness and a loss of reflexes. The illness can lead to serious complications — including paralysis or respiratory failure — and requires immediate medical attention.

The federal Centers for Disease Control and Prevention is investigating 127 cases of possible AFM, including 62 that have been confirmed in 22 states this year. At least 90 percent of the cases are among patients 18 years old and younger. The average age of a patient is 4 years old.

AFM remains extremely rare, even with the recent increase. The CDC estimates fewer than 1 in a million Americans will get the disease. Officials advised parents not to panic, but remain vigilant for any sudden onset of symptoms. They also suggested that children stay up to date with their vaccines and practice good hand washing habits.

This year’s outbreak marks the third spike of AFM in four years. From August 2014 to September 2018, 386 cases have been confirmed. Yet, experts still do not understand crucial aspects of the disease, including its origins and who is most at risk.

“There is a lot we don’t know about AFM,” said Dr. Nancy Messonnier, director of the National Center for Immunization and Respiratory Diseases. Here’s what puzzles health officials about AFM:

The cause is still unknown.

Acute flaccid myelitis can be caused by viruses, such as polio or West Nile. But federal officials said that those viruses have not been linked to the U.S. outbreak over the past four years. They have not isolated the cause of these cases.

Despite symptoms reminiscent of polio, no AFM cases have tested positive for that virus, according to the CDC. Investigators have also ruled out a variety of germs. Environmental agents, viruses and other pathogens are still being considered.

The 2014 outbreak of AFM coincided with a surge of another virus that caused severe respiratory problems, called EV-D68, However, the CDC could not establish a causal link between AFM and the virus. Since then, no large outbreaks of virus have occurred, according to the CDC.

Carlos Pardo-Villamizar, a neurologist and director of the Johns Hopkins Transverse Myelitis Center, said that the mystery lies in whether the damage seen in AFM is caused by an external agent or the body’s own defenses.

“At this moment, we don’t know if it’s a virus that is coming and producing direct damage of the gray matter in the spinal cord,” he said, “or if a virus is triggering immunological responses that produce a secondary damage in the spinal cord.”

It’s not clear who is at risk.

Although the disease appears to target a certain age group, federal disease experts do not know who is likely to get acute flaccid myelitis.

Pardo-Villamizar said identifying vulnerable populations is “a work in progress.”

Mary Anne Jackson, a pediatric infectious disease specialist and interim dean of the school of medicine at the University of Missouri-Kansas City, said many of the patients she saw were healthy children before falling ill with the disease. She suspects that a host of factors play a role in the likelihood of getting AFM, but more cases must be reviewed in order to find an answer.

The long-term effects are unknown.

The CDC said it doesn’t know how long symptoms of the disease will last for patients. However, experts say that initial indications from a small number of cases suggest a grim outlook.

A study published last year found 6 of 8 children in Colorado with acute flaccid myelitis still struggled with motor skills one year after their diagnosis. Nonetheless, the researchers found that the patients and families “demonstrated a high degree of resilience and recovery.”

“The majority of these patients are left with extensive problems,” said Pardo-Villamizar, who was not involved in the study.

Jackson, who also saw persistent muscle weakness in her patients, said she believes the CDC may be hesitant to specify the long-term effects of disease because existing studies have included only small numbers of patients. More studies that include a larger proportion of confirmed cases are needed to better understand long-term outcomes, she said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Pharma Sales Growth Tied to Price Hikes

Of the roughly $23.3 billion in sales growth seen by 45 top pharmaceutical products, $14.3 billion of that has been tied to price increases, not demand.

61% of the pharma industry’s recent sales growth was apparently, at least in part, a byproduct of price increases on top-selling drugs, according to a new report from investment firm Leerink.

From 2014 through 2017, sales for 45 top pharmaceutical products, including AbbVie’s Humira, Amgen’s Neulasta and Enbrel, and Pfizer’s Lyrica, increased by 28% (roughly $23.3 billion) in the United States. However, more than $14.3 billion of those sales was the result of price increases.

Continued price hikes from pharma companies have faced backlash and much scrutiny in recent years, including at the government level, with the Trump Administration releasing a plan to tackle the rising costs in May.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Drugmakers Play The Patent Game To Lock In Prices, Block Competitors

Drug companies typically have less than 10 years of exclusive rights once a drug hits the marketplace. They can extend their monopolies by layering in secondary patents.

Sarah Jane Tribble, Kaiser Health News

David Herzberg was alarmed when he heard that Richard Sackler, former chairman of opioid giant Purdue Pharma, was listed as an inventor on a new patent for an opioid addiction treatment.

Patent No. 9861628 is for a fast-dissolving wafer containing buprenorphine, a generic drug that has been around since the 1970s. Herzberg, a historian who focuses on the opioid epidemic and the history of prescription drugs, said he fears the patent could keep prices high and make it more difficult for poor addicts to get treatment.

“It’s hard not to have that reaction of, like … these vultures,” said Herzberg, an associate professor at the University at Buffalo.

James Doyle, vice president and general counsel of Rhodes Pharmaceuticals, the Purdue subsidiary that holds the patent, said in an email statement that the company does not have a developed or approved product and “therefore no money has been made from this technology.”

“The invention behind the buprenorphine patent in question was developed more than a dozen years ago,” he wrote. “If a product is developed under this patent, it will not be commercialized for profit.”

Yet, the patenting of a small change in how an existing drug is made or taken by patients is part of a tried-and-true pharmaceutical industry strategy of enveloping products with a series of protective patents.

Drug companies typically have less than 10 years of exclusive rights once a drug hits the marketplace. They can extend their monopolies by layering in secondary patents, using tactics critics call “evergreening” or “product-hopping.”

Lisa Larrimore Ouellette, a patent law expert at Stanford University, said the pharmaceutical industry gets a greater financial return from its patent strategy than that of any other industry.

AztraZeneca in 2001 famously fended off generic versions of its blockbuster heartburn medicine Prilosec by patenting a tweaked version of the drug and calling it Nexium. When Abbott Laboratories faced multiple generic lawsuits over its big moneymaker Tricor, a decades-old cholesterol drug, it lowered the dosage and changed it from a tablet to a capsule to win a new patent.

And Forest Laboratories stopped selling its Alzheimer’s disease drug Namenda in 2014 after reformulating and patenting Namenda XR to be taken once a day instead of twice.

Another common strategy is to create what Food and Drug Administration Commissioner Scott Gottlieb calls “patent thickets,” claiming multiple patents for a single drug to build protection from competitors. AbbVie’s rheumatoid arthritis drug Humira has gained more than 100 patents, for example.

The U.S. Patent and Trademark Office awards patents when an innovation meets the minimum threshold of being new and non-obvious. Secondary patents are routinely granted to established drugs when an improvement is made, such as making it a once-a-day pill instead of twice a day, said Kristina Acri, an economist and international intellectual property expert at the Fraser Institute and Colorado College.

“Is there a better way? Maybe, but that’s not what we’re doing,” Acri said.

The controversial patent that Sackler and five co-inventors obtained is widely known as a “continuation patent.” (The original patent application for the wafer was filed in August 2007.)

Continuation patents do not necessarily extend the patent life of a drug, but they can have other uses. In 2016, Rhodes filed a lawsuit against Indivior alleging patent infringement.

Indivior, formerly part of Reckitt Benckiser, sells a film version of the popular addiction treatment drug Suboxone that is placed under the tongue — an oral medicine similar to what Rhodes has patented. Indivior’s comes in a lime flavor.

Indivior’s film, which federal regulators approved in 2010, dominates the market with a 54 percent average market share, according to the company’s most recent financial report. And the company has vigorously fought rivals, including filing lawsuits against firms such as Teva Pharmaceutical Industries, which sought approval to manufacture generic versions. Indivior declined to comment.

The Rhodes Pharmaceuticals version would be a wafer that melts quickly in the mouth. The inventors list potential flavors including mint, raspberry, licorice, orange and caramel, according to the patent.

For opioid historian Herzberg, the patent battles between companies like Rhodes and Indivior are “absolute madness.”

Decisions on what is available on the market to treat addicts should be based on what is the best way to treat the people who have the problem, he said.

Patent battles, Herzberg said, are “not how you want drug policy getting made.”

Attempts to change the patent system have intensified over the past decade as prices of prescription drugs continue to climb.

In 2011, President Barack Obama signed the America Invents Act, which included the creation of the Patent Trial and Appeal Board. The PTAB is an alternative to using the cumbersome U.S. court system to challenge weak patents. Generic drug manufacturers have used the board’s “inter partes review” process and overturned 43 percent of the patents they challenged, according to recent research.

Critics of the administrative process, including the pharmaceutical industry trade group PhRMA, said it creates “significant business uncertainty for biopharmaceutical companies.” Often companies have to defend their products twice — both in the courts as well as before the PTAB, said Nicole Longo, PhRMA’s director of public affairs.

Drug giant Allergan attempted to overcome the PTAB’s review process by arguing that the patent couldn’t be challenged at the review board because they sold the patent to the St. Regis Mohawk Tribe, which had sovereign immunity. A federal appeals court ruled this summer that Allergan could not shield its patents from the PTAB review this way.

This year, several members of Congress proposed bills that would unwind or limit changes made by the America Invents Act, though nothing is likely to happen before the midterm elections. The STRONGER Patents Act, introduced in both the House and Senate, would weaken the PTAB board by aligning its claims standards with what has been established by court rulings.

KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

12 Grants Awarded to Fund New Treatments of Rare Diseases

A third of the new awards aim to accelerate cancer research, and another 25% of the new awards fund studies evaluating drug products for rare endocrine disorders.

The U.S. Food and Drug Administration announced this week that it has awarded 12 new clinical trial research to enhance the development of medical products for patients with rare diseases. The grants, which total more than $18 million over the next four years, were awarded to principal investigators from academia and industry across the United States through the Orphan Products Clinical Trials Grants Program.

The awarded grants include:

  • Alkeus Pharmaceuticals, Inc. (Cambridge, Massachusetts), Leonide Saad, phase 2 study of ALK-001 for the treatment of Stargardt disease – $1.75 million over four years
  • Arizona State University-Tempe Campus (Tempe, Arizona), Keith Lindor, phase 2 study of oral vancomycin for the treatment of primary sclerosing cholangitis – $2 million over four years
  • Cedars-Sinai Medical Center (Los Angeles), Shlomo Melmed, phase 2 study of seliciclib for the treatment of Cushing disease – $2 million over four years
  • Columbia University of New York (New York), Yvonne Saenger, phase 1 study of talimogene laherparepvec for the treatment for advanced pancreatic cancer – $750,000 over three years
  • Emory University (Atlanta), Eric Sorscher, phase 1/2 study of Ad/PNP fludarabine for the treatment of head and neck squamous cell carcinoma – $1.5 million over three years
  • Fibrocell Technologies, Inc. (Exton, Pennsylvania), John Maslowski, phase 1/2 study of gene-modified ex-vivo autologous fibroblasts for the treatment of dystrophic epidermolysis bullosa – $1.5 million over four years
  • Johns Hopkins University (Baltimore), Amy Dezern, phase 1/2 study of CD8-reduced T cells for the treatment of myelodysplastic syndrome or acute myeloid leukemia – $750,000 over three years
  • Oncolmmune, Inc. (Rockville, Maryland) Yang Liu, phase 2b study of CD24Fc for the prevention of graft versus host disease – $2 million over four years
  • Patagonia Pharmaceuticals, LLC (Woodcliff Lake, New Jersey), Zachary Rome, phase 2 study of PAT-001 (isotretinoin) for the treatment of congenital ichthyosis – $1.5 million over three years
  • The General Hospital Corporation (Boston), Stephanie Seminara, phase 2 study of kisspeptin for the treatment of dopamine agonist intolerant hyperprolactinemia – $1.4 million over four years
  • University of Minnesota (Minneapolis), Kyriakie Sarafoglou, phase 2a study of subcutaneous hydrocortisone infusion pump for the treatment of congenital adrenal hyperplasia – $1.4 million over three years
  • University of North Carolina at Chapel Hill (Chapel Hill, North Carolina), Matthew Laughon, phase 2 study of sildenafil for the prevention of bronchopulmonary dysplasia – $2 million over four years

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

Insulin’s Steep Price Leads To Deadly Rationing

The price of insulin in the U.S. has more than doubled since 2012. Because of this, some diabetics have been forced to take drastic measures, like rationing their insulin.

Bram Sable-Smith, Side Effects Public Media

Diabetic ketoacidosis is a terrible way to die. It’s what happens when you don’t have enough insulin. Your blood sugar gets so high that your blood becomes highly acidic, your cells dehydrate, and your body stops functioning.

Nicole Smith-Holt lost her son to diabetic ketoacidosis, three days before his payday, because he couldn’t afford his insulin.

“It shouldn’t have happened,” Smith-Holt said, looking down at her son’s death certificate on her dining room table in Richfield, Minn. “That cause of death of diabetic ketoacidosis should have never happened.”

The price of insulin in the U.S. has more than doubled since 2012 alone. That’s put the lifesaving hormone out of reach for some people with diabetes, like Smith-Holt’s son Alec Raeshawn Smith. It has left others scrambling for solutions to afford the one thing they need to live. I’m one of those scrambling.

Not Enough Time

Most people’s bodies create insulin, which regulates the amount of sugar in the blood. The roughly 1.25 million of us in the U.S. with Type 1 diabetes have to buy insulin at a pharmacy because our pancreases stopped producing it.

My first vial of insulin cost $24.56 in 2011, after insurance. Seven years later, I pay more than $80. That’s nothing compared with what Alec was up against when he turned 26 and aged off his mother’s insurance plan.

Smith-Holt said she and Alec started reviewing his options in February 2017, three months before his birthday on May 20. Alec’s pharmacist told him his diabetes supplies would cost $1,300 a month without insurance — most of that for insulin. His options with insurance weren’t much better.

Alec’s yearly salary as a restaurant manager was about $35,000. Too high to qualify for Medicaid, and, Smith-Holt said, too high to qualify for significant subsidies in Minnesota’s Affordable Care Act insurance marketplace. The plan they found had a $450 premium each month and an annual deductible of $7,600.

“At first he didn’t realize what a deductible was,” Smith-Holt said. She said Alec figured he could pick up a part-time job to help cover the $450 per month.

Then Smith-Holt explained to her son what a deductible was.

“You have to pay the $7,600 out-of-pocket before your insurance is even going to kick in,” she recalled telling him. Alec decided going uninsured would be more manageable. Although there might have been cheaper alternatives for his insulin supply that Alec could have worked out with his doctor, he never made it that far.

He died less than one month after going off of his mother’s insurance. His family thinks he was rationing his insulin — using less than he needed — to try to make it last until he could afford to buy more. He died alone in his apartment three days before payday. The insulin pen he used to give himself shots was empty.

“It’s just not even enough time to really test whether [going without insurance] was working or not,” Smith-Holt said.

A Miracle Discovery

Insulin is an unlikely symbol of America’s problem with rising prescription costs.

Before the early 1920s, Type 1 diabetes was a death sentence for patients. Then researchers at the University of Toronto — notably Dr. Frederick Banting, Charles Best and J.J.R. Macleod — discovered a method of extracting and purifying insulin that could be used to treat the condition. Banting and Macleod were awarded a Nobel Prize for the discovery in 1923.

For patients, it was nothing short of a miracle. The patent for the discovery was sold to the University of Toronto for only $1 so that lifesaving insulin would be available to everyone who needed it.

Today, however, the list price for a single vial of insulin is more than $250. Most patients use two to four vials per month (I personally use two). Without insurance or other forms of medical assistance, those prices can get out of hand quickly, as they did for Alec.

Depending on whom you ask, you’ll get a different response for why insulin prices have risen so high. Some blame middlemen — such as pharmacy benefit managers, like Express Scripts and CVS Health — for negotiating lower prices with pharmaceutical companies without passing savings on to customers. Others say patents on incremental changes to insulin have kept cheaper generic versions out of the market.

For Nicole Smith-Holt, as well as a growing number of online activists who tweet under the hashtag #insulin4all, much of the blame should fall on the three main manufacturers of insulin today: Sanofi of France, Novo Nordisk of Denmark and Eli Lilly in the U.S.

The three companies are being sued in U.S. federal court by diabetic patients in Massachusetts who allege the prices are rising at the expense of patients’ health.

Eli Lilly and Company did not make anyone available for an interview for this story. But a company spokesman noted in an email that high-deductible health insurance plans — like the one Alec found — are exposing more patients to higher prices. In August, Eli Lilly opened a help line that patients can call for assistance in finding discounted or even free insulin.

A Dangerous Solution

Rationing insulin, as Nicole Smith-Holt’s son Alec did, is a dangerous solution. Still, 1 in 4 people with diabetes admit to having done it. I’ve done it. Actually, there’s a lot of Alec’s story that feels familiar to me.

We were both born and raised in the Midwest, just two states apart. We were both diagnosed at age 23 — pretty old to develop a condition that used to be called “juvenile diabetes.” I even used to use the same sort of insulin pens that Alec was using when he died. They’re more expensive, but they make management a lot easier.

“My story is not so different from what I hear from other families,” Smith-Holt recently told a panel of Senate Democrats in Washington, D.C., in a hearing on the high price of prescription drugs.

“Young adults are dropping out of college,” she told the lawmakers. “They’re getting married just to have insurance, or not getting married to the love of their lives because they’ll lose their state-funded insurance.”

I can relate to that too. My fiancée moved to a different state recently and soon I’ll be joining her. I’ll be freelancing, and won’t have health benefits, though she will, via her job. We got married — one year before our actual wedding — so I can get insured, too.

This story is part of a partnership that includes Side Effects Public Media, NPR and Kaiser Health News. A version of this story appears in The Workaround podcast.

Disclaimer: The viewpoint expressed in this article is the opinion of the author and is not necessarily the viewpoint of the owners or employees at Healthcare Staffing Innovations, LLC.

New Guidances Issued to Promote Generic Drug Access and Drug Price Competition

The guidances issued today by the FDA are part of a larger initiative by the administration to increase patient access to high-quality generics.

By Lyndsay Meyer

“One of the key ways the FDA can increase patient access to high-quality generics is by providing guidance to encourage and foster development of these cost-saving medicines, especially when it comes to complex drugs that can be hard to copy,” said FDA Commissioner Scott Gottlieb, M.D. “By explaining our current thinking and expectations on how to develop specific generic drug products that are therapeutically equivalent to the brand name drug products, we provide an efficient path for these products to receive regulatory approval to enter the market, especially when they don’t currently have any generic competition. Today, we’re releasing detailed guidance on recommendations regarding how to develop generic versions of 15 drugs that don’t currently face any generic competition. With this new batch of guidance documents, we’re not only providing recommendations for some new generic drugs, but the FDA is also modernizing some of its previously-issued guidance to make sure they reflect the most efficient path for developing generics.”

The U.S. Food and Drug Administration today announced a new set of product-specific guidances to support industry in identifying appropriate science-based methodologies and evidence for developing generic drugs. The batch contains 54 product-specific guidances, including 42 new guidances and 12 revised guidances that, when finalized, will describe the FDA’s current thinking and expectations on how to develop generic drugs that are therapeutically equivalent to their respective reference-listed drugs.

Of the guidances issued today, 12 are new draft guidances and six are revised guidances for complex drug products, including 14 products that, to date, do not have generic competition.

The FDA believes that increased transparency on product-specific guidances gives manufacturers seeking to develop generic copies of medicines, including complex drugs, a better opportunity to efficiently allocate drug development resources. The agency aims to make sure that its policies and regulations – and scientific standards – keep pace with the evolving science around developing generic versions of these complex products so that patients have access to affordable medicines.

Greater access to high quality generic drugs is one way the FDA is working to improve competition and promote access to important medicines and advance the public health.

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