Amid a global shortage of key drugs, Big Pharma is coming under pressure in the US where the CEOs of two major firms have been threatened with summons to answer for their high cost of prescription medicines, notes MedicalBrief.
In a highly unusual move, United States Senate Health Committee chair Bernie Sanders has taken a step towards issuing subpoenas to the CEOs of Johnson & Johnson and Merck, linked to an investigation into high drug prices in the country.
The committee hasn’t issued a subpoena in more than 40 years, reports STAT News.
Sanders had invited J&J CEO Joaquin Duato, Merck CEO Robert Davis and Bristol Myers Squibb CEO Chris Boerner to testify at a hearing on the high costs of prescription drugs for patients in the US compared with other countries.
The hearing, titled, “Why does the US pay, by far, the highest prices in the world for prescription drugs?” was supposed to be held on 25 January, but only Boerner agreed to testify, and only if at least one other CEO participated.
Now, instead, Sanders will hold a committee vote on whether to issue the two subpoenas, and whether to authorise an investigation into high drug costs, on 31 January.
He called it “absolutely unacceptable” that the two CEOs had refused the invitation to the hearing.
“These CEOs may make tens of millions of dollars in compensation. The pharmaceutical companies they run may make billions in profits. But that does not give them a right to evade congressional oversight,” he said.
J&J said the company has “deep respect” for the committee’s work, and has continued to engage about the hearing. In a letter to the committee, the company said it had offered an executive other than the CEO to testify.
“As part of this engagement, we have expressed our concerns with the hearing as it is currently planned,” the company said in a written statement.
Merck did not immediately respond to a request for comment.
All three companies have sued the federal government alleging that the Medicare drug price negotiation programme – enacted in 2022 – is unconstitutional. Bristol Myers Squibb’s blood thinner Eliquis; J&J’s blood thinner Xarelto; anti-inflammatory medicine Stelara; and blood cancer treatment Imbruvica; and Merck’s diabetes drug Januvia were selected among the first 10 drugs to go through the negotiation process.
In a letter to the committee, J&J said the “hearing is intended as retribution for the companies’ decisions to exercise their rights to challenge a statute that inappropriately infringes on constitutionally protected freedoms”.
Other drug company executives, including the CEO of Moderna and the CEOs of insulin manufacturers, have testified before the Senate Health Committee this Congress.
Across the pond, in the UK, there have been strong calls for changes to medicines supply-chains as a result of the global shortage of key drugs. An editorial in The Guardian says the global issue has been moving up the agenda of EU states and the US as well. 'Rich western countries, along with much of the rest of the world, are heavily reliant on the pharmaceuticals manufacturing capacity of India and China for sufficient quantities of generic, off-patent drugs.
During the pandemic the risks of this model became obvious when countries were forced to compete for vaccines, and India placed export restrictions on many items, including paracetamol.'
The editorial notes that both the EU and US have responded with significant moves towards reshoring. 'France is building a paracetamol factory large enough to meet half of all European demand. Belgium has made the issue a theme of its EU presidency.
'Rules about state aid are on the cards to be altered, and pharmaceuticals recategorised as a strategic industry, like semiconductors.
While European manufacturing will make supplies more secure, it is also expected to make drugs more expensive and reduce carbon emissions and other environmental damage associated with them.'
Most recently in the UK, the alarm has been raised in relation to riluzole, a medicine used by sufferers from motor neurone disease to delay ventilator dependence and prolong life.
'Worryingly, the Motor Neurone Disease Association claims that concerns raised with the Health Secretary, Victoria Atkins, and her department, have not been properly dealt with.
'Riluzole’s manufacturer, Glenmark, has pointed to competing demands for limited stock of its active ingredient. That sufferers of such serious illnesses are facing these problems is obviously concerning. With around 100 medicines on a shortages list, the government appears under‑prepared and slow to act.'
Current shortages suggest that the current system isn’t working well, the editorial says.
'As well as day-to-day management, the UK needs a strategy. . It should include plans for spikes in demand such as that seen for HRT, after a campaign around menopause symptoms and a shift in prescribing patterns.
'Shortages such as that affecting the type 2 diabetes drug Ozempic – after it began to be prescribed for weight loss – should be anticipated, even if they cannot be avoided. '
Pharmacists have also expressed concern, saying the unprecedented shortages are endangering lives, with the number of products in short supply having doubled in two years.
Last week, a drug for controlling epileptic seizures was added to the shortages list that includes treatments for conditions ranging from cancer to schizophrenia and type 2 diabetes.
The British Generic Manufacturers Association said 111 drugs were on a shortages list by 30 October last year, and 96 on 18 December, with supply notifications issued for a further 10 treatments to NHS providers since then.
An analysis suggests a 100% increase in shortages compared with January 2022, with pharmacists and health charities claiming the conditions of some patients were deteriorating as a result.
Delyth Morgan, chief executive of Breast Cancer Now, said that during the past year, her organisation had been contacted by several patients unable to source the medicines they needed to control the spread of their disease.
“Last year many people told us, via Breast Cancer Now’s helpline, that they’d been facing difficulties accessing their hormone treatment, including letrozole, anastrozole and tamoxifen, causing them huge worry and anxiety. Travelling to a number of different pharmacies trying to get medicine is an added burden for patients at an already difficult time.”
Douglas Twenefour, head of care at Diabetes UK, said: “The ongoing shortages of many GLP-1 medications have serious implications for type 2 diabetics. With these shortages likely to last for at least the rest of this year, this will have a significant impact on many people.”
There have also been well-documented shortages in hormone replacement therapy and attention deficit hyperactivity disorder products due, in part, to higher demand.
Janet Morrison, chief executive of Community Pharmacy England, said the shortages were unprecedented and were beginning to hit patients hard. “Pharmacy teams have been struggling to get hold of prescription medicines for many months but the problem is worse than ever.
“It has become worryingly normal to see hundreds of medicines affected by pricing and other issues every month. Pharmacies spend hours – on average an extra 11 hours a week – tracking down the medicines their patients need.
“Last year we surveyed people working in pharmacies and 87% told us that their patients’ health was being put at risk due to medicine supply issues.”
The NHS is increasingly having to issue price concessions on products under which it agrees to increase its level of reimbursement to pharmacists due to spikes in demand and market prices.
There were 152 such concessions in December 2023 compared with 20 in June 2016, the month of the Brexit referendum, when the UK’s stated intention to leave the EU hit the value of sterling.
Five new shortages in 2024
Across the pond, meanwhile, as the US Food & Drug administration (FDA) imports a syphilis drug from France that’s been in short supply since spring 2023, the FDA and American Society of Health-System Pharmacists have reported five new drug supply issues in 2024, reports Becker’s Medicine Review. They are, in alphabetical order:
1. Diazepam injection is used for anxiety, muscle spasms, seizures and alcohol withdrawal. Three solutions are on back order without resupply dates and two are available.
2. Lenalidomide capsule: As of 11 January, 23 solutions of the drug for myelodysplastic syndrome patients were in short supply and 23 were available. Most pharmaceutical companies did not share an estimated release date, but Sun Pharma said its six solutions should be available in mid-March.
3. Lisdexamfetamine dimesylate capsule: The attention-deficit/hyperactivity drug is in short supply among 10 manufacturers because of regulatory delays, demand increases and an ingredient shortage. A majority of solutions are on allocation or in limited supply, according to the FDA.
4. Mercaptopurine tablet: Four solutions of the chemotherapy drug are in shortage, one was discontinued and another is available. The drug is used with other cancer therapies for acute lymphoblastic leukaemia and acute lymphatic leukaemia, and Mylan discontinued its 50 milligram solution in December. Two drugmakers now report four 50 milligram solutions are on back order.
5. Rho(D) immune globulin: One of the makers of the antibody, Kedrion Biopharma, has three solutions in shortage. The company said the supply issues are because of a “shortage of an active ingredient[,] manufacturing issues and plant maintenance requirements”. Four other solutions are available.
The Guardian article – NHS medicines shortage putting lives at risk, pharmacists warn (Open access)
STAT-News – Bernie Sanders proposes subpoenas of CEOs of J&J, Merck on drug prices
Becker’s Hospital Review article –
The Guardian article – The Guardian view on medicine shortages: a global issue for which Britain needs a plan (Open access)
See more from MedicalBrief archives:
Global ingredients’ shortage threatens SA medicine supply, warns Adcock
Drug shortage fears as supply chain challenges persist
US cancer drug shortages lead to rationed treatment
Penicillin shortage affects children’s antibiotics, warns Pfizer
Critical shortage of ADHD medication in US and demand rises