The drug shortage in America reaches new heights

Shortages of cancer drugs and other life-saving drugs are reaching their worst point in a decade, forcing doctors to develop alternative solutions and the Biden administration to mount a government-wide response.

Because matter: Shortages are emerging deep-seated problems in the American drug supply chain, especially with regards to commonly used generic drugs. A recent House hearing looked into a price “race to the bottom” that cools manufacturing investment and can leave just one or two companies actively producing a drug in shortage.

What are they saying: “This generic business, especially for these complex drugs, these complex formulations, is not a healthy business right now,” Scott Gottlieb, a former FDA commissioner and Pfizer board member, told CBS News on Sunday.

• “There are things the government can do, but most of them will come at a cost. We will have to look at ways to provide greater reimbursements for these hard-to-manufacture drugs,” he said.

Drive the news: There are more than 300 medicines in shortages, the highest since 2014, according to the American Society for Health-System Pharmacists.

• The American Cancer Society warned earlier this month about potentially “life-threatening” supply problems with chemotherapy drugs that “have no effective alternative.”
• “As first-line treatments for a number of cancers, including triple-negative breast cancer, ovarian cancer and leukemia, often experienced by pediatric cancer patients, shortages could lead to treatment delays which could lead to worse outcomes “said chief executive officer Karen Knudsen. in a statement.
• The Society of Gynecologic Oncology this month outlined strategies for allocating low drug supplies for gynecologic cancers and warned that without planning, disparities in care could worsen.
• Heart drugs such as adenosine, which is given intravenously for emergency treatment of an irregular or rapid heartbeat, as well as cardiac stress tests, are also in short supply and may require hospitals to limit use to emergencies, they say health system pharmacists.
• IV antibiotics such as penicillin used in hospitals are also running out across the country.

Between the lines: Experts are quick to point out the challenges faced by generics makers in a low-margin business that has driven much manufacturing to consolidate into a few players or to relocate overseas.

• On Friday, Teva Pharmaceutical Industries, one of the makers of Adderall, which was in short supply, announced plans to scale back its generics business, citing low profitability, Bloomberg reported.
• Generics maker Lannett Co., which makes a number of drugs including a form of lidocaine that is in short supply, announced a financial restructuring earlier this month, saying it plans to file for Chapter 11 bankruptcy protection. .
• Akorn Pharmaceuticals, a major maker of many generic drugs, shut down earlier this year contributing to shortages of adenosine, a heart drug, as well as shortages of albuterol. The company’s products were then recalled because there were none left on hand to address potential quality issues, reported The New York Times.
• A “disastrous” FDA inspection of an Intas Pharmaceuticals manufacturing facility in India that revealed quality control issues was the root cause of the shortages of chemotherapy drugs, Gottlieb said.
• “It all boils down to how many players do we have in the manufacturing of this drug, are they able to financially support their manufacturing of these drugs?” Emmanuel Ayanjoke, an assistant professor of pain management and palliative care at Cedarville University told ABC News.

Between the lines: Gottlieb, who served as FDA commissioner during the Trump administration, has pointed to efforts to contain the cost of drugs included in the Inflation Reduction Act as contributing to underinvestment in safe and sustainable generic supplies.

• A generic drug maker could make a sterile injectable drug for $500 and lose money on it, he said. If they were to invest in upgrading their production, they might want to raise the price to $1,000.

• “At $1,000, even though it’s a lot of money, it might be cheap compared to the value the drug provides, but according to the Inflation Reduction Act, that’s an increase you may not be able to afford,” Gottlieb said.

Being smart: While many of the shortages are hitting generics, they’re also impacting some brand-name drugs like a growth hormone drug made by Novo Nordisk called Norditropin, NPR reported.

• Some shortcomings are being attributed to old-fashioned supply and demand issues, such as what was seen with Tylenol for children during the convergence of flu, RSV and COVID cases in the fall and winter months.

What to watch: While the Biden administration and Congress are both looking at ways to address what has been called a national security concern, including through a reauthorization of the Pandemics and All-Hazards Preparedness Act, or PAHPA.

• The White House has a team dedicated to addressing ongoing shortages and quality issues plaguing the drug supply chain, Bloomberg reported.
• The House Energy and Commerce Committee held a hearing to look into the root cause of the shortage problem with a promise to work to find solutions to the ongoing supply problems.

But solutions it could be costly and disruptive. The FDA can identify problems and work with manufacturers, but it lacks the experience and, in some cases, the authority to address the industry’s biggest economic problems.

• Energy and Commerce President Cathy McMorris-Rodgers (R-Wash.) addressed options such as increasing reimbursement for generic drugs and examining the business practices of pharmaceutical benefit managers.
• Rep. Frank Pallone of New Jersey, the Democratic leader on energy and commerce, last week called for more transparency on the ingredients of overseas-made drugs and expanded reporting in case of unexpected spikes in drug demand, as well make it easier for the FDA to safely extend the shelf life of critically shorted drugs.

The bottom line: America’s drug shortage problem could get worse as generic drug makers cut back, but it’s unclear whether the government is in a position to respond.