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Lawmakers say multiple solutions are needed to fix drug supply chain problems



WASHINGTON. Drug shortages continue to plague the US, and a variety of solutions must be used to address the problem, witnesses here on Thursday said at a hearing by the House Energy and Commerce Subcommittee on Oversight and Investigations.

“According to the American Society of Health System Pharmacists, we currently have over 247 active drug shortages. Between 2021 and 2022, drug shortages increased by nearly 30%,” Committee Chair Rep. Morgan Griffith (R-Virginia) said in a report. introductory speech. “It is incredible that in our great country there is not enough medicine to treat childhood cancer. And that’s just one example.”

Influence of intermediaries

“It’s even more frustrating when you consider that most of the shortage is in the generic area, where there should be competition,” he continued. “The median price of a drug in short supply between 2013 and 2017 was less than $9 per treatment dose.” One part of the problem, Griffith says, is the influence of intermediaries such as group purchasing organizations (GPOs) and pharmacy benefit management (PBM) firms. “By one count, for every $100 spent on generic prescription drugs, $44 goes to the middleman, not the manufacturer.”

He noted that the top three PBMs control about 80% of commercial drug sales, while the top four GPOs “control 90% of the medical supply market and wield tremendous market power. quality. Instead, they use their bargaining power to impose a “race to the bottom” pricing with no regard for quality or affordability.”

Children and their providers could be particularly hard hit by drug shortages, said Rep. Cathy Castor (D-FL), a senior committee member. Children’s hospitals “have to allocate additional staff time and resources to find suitable replacement drugs and determine the appropriate replacement drug dosage… Children’s hospitals need 50% more time to close stockouts in other hospitals due to the time needed to formulate replacement drugs. into pediatric dosage forms. And it’s so expensive – one drug in short supply can cost a children’s hospital north of $50,000 in labor and substitute products. So we need to get ahead of this shortage before it happens.”

The value of scarcity forecasting

Better anticipation of potential shortages can help alleviate supply chain problems, said Laura Bray, founder of the Angels of Change group, which aims to increase access to life-saving medicines. Bray, whose own daughter was suffering from a shortage of a life-saving childhood leukemia drug, explained that her organization had chosen two drugs—potassium chloride and sodium chloride—that were expected to be in short supply, “and then we went to a small waterfront store. manufacturer and said, “How much will it cost you and how long will it take to provide this to the American people if it fails?”

“They surprised me by saying, ‘About 60 days and $100,000,'” she continued. “I said, ‘Everyone?’ and they said, “No, for both.” So I wrote a grant and signed an agreement with them and told them, “Be prepared to grant this if [the drugs] go downhill.” The projected shortage did occur, and the company’s drug inventory was accessed 650,000 times last year. -private partnership. I think it’s a model that can be copied over and over.”

Several members of the committee were concerned about the high percentage of drugs for the US market that are made in foreign countries. Representative Debbie Lesko (Republic of Arizona), vice chair of the committee, noted that Government Accountability Office (GAO) Report 2022 “It was found that the proportion of foreign facilities not inspected for more than 5 years increased from 30% in 2020 to almost 80% in 2022… Considering that most American drugs and APIs [active pharmaceutical ingredients] manufactured in overseas facilities, I have serious concerns about the FDA’s ability to ensure the quality and availability of medical products for people manufactured overseas.”

Witness Anthony Sardella, chairman of the API Innovation Center at Washington University in St. Louis, agreed that foreign inspections are “absolutely necessary for us to ensure the quality and safety of medicines consumed by US citizens and are extremely important to ensure market stability. In addition, such checks tell the FDA “what manufacturers comply with [with our rules]whose manufacturers ensure the quality of production processes. And then the next element is encouragement, rewarding those who don’t have warning letters for decades, as opposed to those who do. The ability to make this quality distinction lies in having a robust review and audit process that allows us to make these distinctions.”

The role of discounts

Rep. Kathy McMorris Rogers (R-Washington), chair of the full committee on energy and commerce, asked Alex Oshmiansky, MD, CEO and founder of the Mark Cuban Cost Plus Drug Company, to explain how drug rebates work and what The role of PBM in them was. “I think of PBM as payment systems like Visa or Mastercard,” said Oshmyansky. “Many years ago, they realized: “Hey, we process all payments; we can negotiate drug prices on behalf of the people we process payments for.” And the way they decided to do it was to negotiate a discount.”

Instead of charging for negotiations, “they [decided to] just subtract some of the discount from the list price,” he continued. “And it soon became apparent that the best way to make that part of the discount as big as possible was to make the discount as big as possible. . Thus, the standard discount for a generic drug is now between 80% and 85%. Where else in life will you get an 80% discount? Something is wrong… This discount increases the cost of the drug by 60-100%. But none of this really goes to the manufacturer.”

Rep. Frank Pallone (DN.J.), a senior member of the entire Committee on Energy and Trade, expressed concern that the FDA does not have adequate information about how pharmaceutical products are made. Fernando Muzzio, Ph.D., a professor of chemical and biochemical engineering at Rutgers University in New Jersey, agreed, adding that recent government reports on the topic “barely mention the chemical building blocks that are needed to manufacture drugs.” … There is very, very little information about where these parts come from, except that for many APIs made in India, in many cases the building blocks come from China. supply chains to ensure that we can actually produce something on friendly shores, including our shores.”

  • Joyce Frieden oversees coverage of MedPage Today in Washington, including coverage of Congress, the White House, the Supreme Court, health trade associations, and federal agencies. She has 35 years of experience in health policy. Follow

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Cancer drugs are among the top five hardest hit by shortages in the US




As the US faces a near-record number of drug shortages, cancer treatment is one of the hardest hit.

According to the data, there is an active shortage of about two dozen chemotherapy drugs, which is the fifth largest among all drug categories. data from the end of March from the University of Utah Drug Information Service.

“The fact that we have so many chemo drugs in short supply is really alarming,” said Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health System Pharmacists.

Unlike some other drugs that are also in the top five shortage categories, such as antimicrobials, there are often no alternatives for chemotherapy drugs, he said. And the shortage affects the treatment of a wide range of cancers.

“One of the key indicators of how well a patient will respond to treatment is getting the full dose on the right schedule,” Ganio said. “So when we can’t give a cure because we just can’t get it, it’s heartbreaking.”

Overall, Utah State University data shows that there were active shortages of more than 300 drugs in the US as of the end of March, including nearly 50 new shortages that had accumulated in the first three months of the year.

The data shows that the last time active drug shortages, including both new and ongoing ones, were this high was in 2014.

“Shortages are still happening and they are not being resolved or are not being resolved as quickly as new shortages start,” Ganio said.

On Thursday, the House Energy and Commerce Subcommittee on Oversight and Investigations held hearings examining the root causes of the shortfall.

The increase in demand is part of this. But experts say some high-profile deficiencies, such as amoxicillin during the most recent respiratory virus season and Adderall for ADHD, are the exception.

“They don’t really tell the story of drug shortages,” Ganio said.

Instead, the hearings focused more on production issues and the broader structure of the US drug market.

In particular, the US Food and Drug Administration has been criticized for lagging behind in inspections, especially of international businesses representing more than half of the manufacturers that ship products to the US.

A report of the Government Accountability Office, the federal oversight body, in January 2022 noted “longstanding challenges” facing the FDA’s Foreign Inspection Program and called for more formal steps to improve it.

Effective audits of both domestic and foreign manufacturing facilities are “absolutely essential to ensure the quality and safety of the drugs US citizens consume,” said Anthony Sardella, chairman of the API Innovation Center, a nonprofit dedicated to expanding the supply of US-made drugs. pharmaceutical preparations.

“They are also extremely important to market stability,” said Sardella, who was a witness at the hearing.

But at a hearing Thursday in the Health and Energy Trade Subcommittee, FDA Commissioner Dr. Robert Kaliff said that the economic problems underlying drug shortages “are not within the purview of the FDA.”

The FDA is “plugging holes in the dam,” he said, but it’s hard to motivate change when it doesn’t benefit drug companies.

“This drug shortage is becoming more widespread due to a distorted market,” said Rep. Kathy Castor, D-Fla., a senior member of the subcommittee.

“The current haphazard approach to crisis management, episode by episode, is not giving American families the confidence and quality of care they need and deserve.”

Hundreds of impending shortages are looming, and Kaliff has urged pharmaceutical companies to alert the FDA about them.

“Each company doesn’t know what the other company is doing because they are competing,” he said. “When one company lacks, we need to be able to coordinate those people.”

In addition to the FDA, there is a small group of officials in the White House dedicated to strengthening drug supply chains and quality, a senior administration official confirmed to CNN. It is reported by Bloomberg News.

The team, according to a senior official, has been “assembling for some time now” and consists of “several” White House offices, including the Domestic Policy Council and the National Economic Council.

“The Biden-Harris administration remains focused on strengthening the resilience of critical supply chains, including for medical products such as pharmaceuticals,” the official said, pointing to five executive orders issued by President Joe Biden since taking office aimed at “[catalyzing] whole-of-government action to achieve these goals”.

Blame aside, patients remain at the center of the problem.

“There is a major impact on patients every day,” said Laura Bray, founder of the Angels of Change, an advocacy group dedicated to ending drug shortages. “We also cannot forget the emotional trauma you are causing to a family in a health crisis.”

She experienced it first hand in 2019 when her 9-year-old daughter Abby was unable to get the medicine she needed to treat her leukemia due to a shortage.

Abby is doing well now, but 9 out of 10 oncologists say the drug shortage has led to patient harm, including death, said Bray, who was a witness at Thursday’s hearing.

“Patients deserve access to these medicines. The doctors, nurses and care team who are trying to solve these crises and save them deserve easy and equal access to these medicines.”

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Monkeypox: WHO declares global emergency over



The World Health Organization says future outbreaks remain a possibility as it lifts its highest alert level.

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Ramit Sethi’s tips on how to live a “rich life” are explained here



Finance expert Ramit Seti thinks you’re not taking your “rich life” seriously enough. The boisterous host of a new Netflix show how to get rich sat down with Men’s Health for our Men’s Wealth segment to provide concise but practical advice on how to live richly without being as expensive as you might think. And it all starts with the fact that you look at money as a tool, not a burden.

“We have to stop talking about it like there is something wrong with the money. “Oh God, I have to pay this off. It sucks,” Seti says. “How about ‘How can I use the money to get this?’ And how can I stop worrying about money and even start feeling good about myself?”

As the man who admits to accidentally spending $100,000 on useless software, Sethi encourages people to expect mistakes on their way to a rich life. But, they must first know what a rich life is for them. In the video, Seti explains that the more specific you are about your rich life goals, the closer you can get to them. This is why Sethi believes that someone who wants to have the freedom to do whatever they want doesn’t really understand what a rich life is for them compared to someone who wants to be able to pick their kids up from school every afternoon.

The Web has advice on how not to stop you from starting to invest, the dangers of ignoring money, and why making financial mistakes is not only normal, but expected. But if all else fails, remember his money mantra: “Spending money on what you love, as long as you ruthlessly cut spending on what you don’t like.

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Keith Nelson is a writer by destiny and a journalist by passion who has connected the dots to form the bigger picture for Men’s Health, Vibe Magazine, LEVEL MAG, REVOLT TV, Complex,, Red Bull, Okayplayer and Mic to name a few.

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