Market Place
FDA running out of funds amid shutdown; Pfizer, Lilly, AstraZeneca cut jobs
This week, politics dominates Phispers as UK braces for a no-deal Brexit and the US finds itself in the midst of the longest government shutdown in its history.
Amid this political climate, the EU pharma industry body EFPIA has prepared a list of actions that need to be taken in the event of a no-deal Brexit.
EU drug regulator EMA finally relocated from London to Amsterdam, and expects to lose 25 percent of its employees due to the relocation.
In the US, the FDA said it is running out of funds.
However, the agency has restarted food inspections and has called back hundreds of furloughed employees.
A top US lawmaker, meanwhile, launched a probe into drug pricing.
Companies like Pfizer, AstraZeneca and Eli Lilly announced job cuts.
In regulatory news, GMP violations were reported at a major Chinese drugmaker, while Indian drugmakers Lupin and Sun recalled products from the US.
FDA says it’s running out of funds; to restart food inspections despite shutdown
In the US, the ongoing government shutdown has turned out to be the longest in history and President Trump has said it could stretch on for “months or even years.”
However, the US Food and Drug Administration (FDA) has resumed food safety inspections at facilities that handle riskier products such as fresh-cut produce, seafood and soft cheeses.
FDA Commissioner Scott Gottlieb said last week he would try to recall about 10 percent of food inspectors. Gottlieb said hundreds of furloughed employees have agreed to come back and restart inspections that had stopped with the federal government shutdown that began on December 22.
Though FDA can retain more than half of its workforce thanks to application fees paid by drug and device makers, Gottlieb has cautioned that the agency has only about three weeks’ worth of funding to draw down. The agency can’t accept any new fees during the shutdown.
In a tweet, Gottlieb said: “We’ve stretched carryover drug user fees to get a longer runway should the shutdown continue, by for example sharply reducing any overhead charges to CDER/CBER. The slower burn rate gives us about five weeks left as of this week. These numbers could change.”
“We’re shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions,” he added.
The government shutdown, therefore, threatens to jeopardize highly anticipated new drugs from Janssen, Sanofi, and Novartis for depression, diabetes and multiple sclerosis, as also other potential new therapies.
EFPIA prepares list of actions that need to be taken in
event of no-deal Brexit
This week’s big news came from the UK, where Prime Minister Theresa May’s Brexit deal was rejected by 230 votes — the largest defeat for a sitting government in history.
With the UK now bracing the possibility of a no-deal Brexit, the European Federation of Pharmaceutical Industries and Association (EFPIA) said in a statement: “With the prospect of the UK leaving the European Union in a disorderly manner on 30 March 2019 without a deal, there are very real, tangible and immediate threats to patient safety and public health in both the UK and across Europe.”
The EFPIA has urged negotiators to agree on a series of actions that need to be taken to protect patients, such as the introduction of measures that will continue to recognize UK-based testing at least until it can be transferred to the EU. “It is critical that, in the event of a ‘no deal’, the EU introduces a measure that will continue to recognize UK-based testing at least until it can be transferred to the EU,” the EFPIA said.
The body has also recommended measures to enable the continued UK participation in key data sharing platforms that protect public health and medicines safety in Europe.
A “no deal” scenario presents a clear threat of disruption to the supply of medicines throughout the EU. Every month, 82 million packs of medicines move between the UK and the EU. Therefore, the EFPIA has asked for discussions between relevant authorities and the pharmaceutical sector to co-ordinate contingency plans such as putting fast track lanes or priority routes for medicines into ports and airports.
“Medicines and clinical trial materials should be temporarily exempted from any new customs and borders checks,” the body said.
EMA shifts to Amsterdam; may lose quarter staff post
relocation
The European Union Medicines Agency (EMA) finally moved from London to Amsterdam last week. The EMA’s executive director Guido Rasi was presented a pair of clogs to mark its relocation.
The EMA’s new US$ 346 million (€300 million) headquarters is currently under construction. Therefore, its 900 employees will first work out of temporary offices near the city's main train station until November.
After closely monitoring its staffers’ intentions, the agency expects to lose about 25 percent of its staff. In addition to the staffing losses, EMA said it will temporarily reduce or suspend activities in the first half of 2019 as it moves into the final phase of its physical relocation.
For instance, between February 11 and March 15, 2019, no pre-submission meetings for initial marketing authorization applications will take place. EMA will also not print or dispatch certificates for pharmaceutical products from February 25 until March 14, 2019, though companies can still submit requests during this period, which EMA will continue to process.
Pfizer lets go of researchers, Astra lays off workers in US;
Lilly cuts jobs in France
Several companies rang in the new year by announcing plant shutdowns and job cuts. First there was news from AstraZeneca which is looking to streamline its biologics production. The British drug major is closing two plants in Colorado and laying off 210 workers stationed there.
According to a Worker Readjustment and Retraining Notification Act (WARN) notice posted on the Colorado government’s website, Astra plans to close facilities in Boulder and Longmont. The shutdowns are part of a global revamp designed to make its biologics supply chain more efficient.
Second, Pfizer is cutting 150 staffers at two sites in Lake Forest (Illinois, US) and Chennai (India) and ending development of five preclinical programs. Importantly, Pfizer is taking the ax to its preclinical R&D group for biosimilars.
“We’re not exiting biosimilars or anything like that,” says the spokesperson, who emphasized that the pharma giant has three biosimilars on the market and five in mid to late-stage development.
Both the R&D groups affected by the cuts were inherited in the US$ 15 billion buyout of Hospira in 2015, which put Pfizer in the biosimilars business. Last week, Pfizer had announced it was closing down two troubled manufacturing facilities in India acquired in the Hospira acquisition.
Third, Eli Lilly is cutting 250 jobs in France as part of a ‘modernization’ effort at a plant in Fegersheim. The cuts will come through a ‘voluntary exit plan’ that Lilly will negotiate with local unions and will take place through the end of 2020, a company spokesperson said. The site produces insulins and oncology drugs and employs about 1,550 people. Recently, Boehringer Ingelheim and Sanofi had announced job cuts in France.
GMP violations at major Chinese drugmaker;
Lupin, Sun recall products from US
Qilu Tianhe Pharmaceutical, a company affiliated with the Qilu Pharmaceutical Group in China that produces APIs and finished dosage forms, was placed on Health Canada’s inspection tracker due to concerns over GMP observations made by a regulatory partner.
The firm employs over 1,500 people at its manufacturing site in Jinan City, Shandong in China. In August 2018, the company had received its first finished dosage form approval from the US FDA for the injectable combination of the antibiotics piperacillin and tazobactam.
Also placed on the Health Canada’s inspection tracker list is India’s Vital Laboratories Pvt Ltd (Plant I). The firm’s Plant II had received a warning letter from the FDA in 2017 in which the FDA had said it had cited “similar cGMP deviations at other facilities” in the firm’s network. Specifically, when FDA inspected Vital Laboratories Private Limited Plant-I (formerly known as Vital Healthcare Private Limited) in Vapi (Gujarat) in 2015, it was classified as unacceptable for drug manufacturing as a result of observations that were similar to those observed during Plant-II’s inspection.
With the FDA currently operating below full capacity due to the US government shutdown, it remains to be seen if the regulatory partner of Health Canada, which communicated the concerns, was the FDA or some other agency.
In other compliance news, a sterile injectable manufacturer in Slovakia — Unimed Pharma — failed an inspection conducted by the local Slovakian authorities as ‘critical’ deficiencies related to pharmaceutical quality management, cross-contamination management and quality assurance management were uncovered. As an outcome of the inspection, the authorities recommended restriction on the current GMP certificate issued to the site and stated that due to the nature of the non-compliance, prohibition of supplies is recommended, unless there are no alternative suppliers and there is a risk of shortage.
Indian generic manufacturers Lupin and Sun Pharma also encountered product quality issues as Lupin recalled 42 lots from the US market of Ceftriaxone for injection after the products were found to contain visual grey particulate matter in reconstituted vials. Sun Pharma also recalled three lots of Vecuronium Bromide for injection from the US market, as the product was found to contain particulate matter identified as glass.
US lawmaker launches probe into drug pricing; Teva reaches
drug pricing settlement
On Monday, Representative Elijah Cummings, a top lawmaker in the US, launched a probe into the drug industry’s pricing practices. A week back, Cummings and his fellow Democrats had introduced a legislation aimed at lowering medicine prices.
Cummings, who chairs the House Oversight Committee, sent letters to 12 drugmakers seeking information on price increases, investment in research and development, and corporate strategies to preserve market share and pricing power, his office said in a statement.
Companies such as AbbVie, Amgen, AstraZeneca, Celgene, Eli Lilly, Johnson & Johnson, Mallinckrodt, Novartis, Novo Nordisk, Pfizer, Sanofi and Teva Pharmaceutical received letters seeking information about their pricing practices.
Novo Nordisk, Amgen, Celgene and Novartis said they were reviewing the request.
Cummings’ letters focused on drugs that are the costliest to Medicare Part D, a program that helps beneficiaries of the federal health insurance for the elderly and disabled pay for self-administered medicines. They include several blockbuster drugs like AbbVie’s Humira and Johnson & Johnson’s cancer drug Imbruvica.
Meanwhile, a proposed shift in Medicare coverage for medicines administered by doctors is expected to help reduce total drug spending. However, it may also lead to higher out-of-pocket costs for some patients, a new study has said.
At present, drugs given by infusion or injection in outpatient settings are covered by Medicare Part B. In a push to curb health spending, the Trump administration has proposed moving coverage for such medicines to standalone drug plans known as Medicare Part D, which typically contract with pharmacies to fill prescriptions for consumers. Currently, Medicare Part B does not actively negotiate drug prices while plans in Part D do have negotiating power.
Drugmakers using scare tactics to ward off generics: Healthcare and government officials in the US are also concerned that the makers of the most advanced drug therapies are using scare tactics to ward off emerging generic versions of their products.
Doctors, drug companies and FDA say the companies that make costly name-brand biologic drugs, which are grown from living cells, are sowing doubt about the wisdom of switching to cheaper, unbranded versions of their medicines, even though FDA has certified them as safe and effective.
Biologics have led to breakthroughs against cancer, rheumatoid arthritis and other serious diseases. But they are hugely expensive. The campaign against those cheaper versions, known as biosimilars, could delay affordable access to a host of novel therapies.
FDA Commissioner Scott Gottlieb indicated the FDA may take action if it determines a company is deliberately misleading the public about the safety of biosimilars.
Teva reaches drug pricing settlement: Fourteen years after Illinois’ attorney general accused Teva of defrauding Medicaid with inflated pricing, the Israeli drug maker agreed to a US$ 135 million settlement with Illinois to resolve allegations of fraudulent pricing.
The settlement stems from a 2005 lawsuit Attorney General Lisa Madigan filed against Teva and 46 other pharma companies, alleging the drugmakers fraudulently published inflated average wholesale prices that went into calculating Medicaid reimbursement rates. As a result, taxpayers overpaid for Teva drugs, the suit argued.
Since filing the suit, Madigan has recovered more than US$ 436 million in settlements from various companies. Nine drugmakers are still facing litigation.
JP Morgan healthcare
meet ends with discussion on relocating out of San Francisco
The JP Morgan Healthcare Conference at the Westin St Francis hotel held during January 7 to 11 has been a hot topic of discussion in the pharma circles. Held each year in San Francisco, the meet ends up occupying all hotels, restaurants, bars and coffee shops in the six-block radius around Union Square in the city.
During the meet, the industry makes big announcements about new deals, financings and collaborations. This year saw plenty of those announcements, such as Celgene, Loxo, Adaptive, and many others. The JPM week is also a mega networking event.
However, this year, the event proved to be exceedingly expensive. Hotels charged anything between US$ 8,000 to US$ 20,000 for four nights, while also selling “time” for meetings in their lobby. Hotel Nikko, for instance, rented out tables for US$ 30 per person per hour. Food prices too hit through the ceilings. A simple egg breakfast came for US$ 28, while a cup of coffee costed US$ 21 coffee. San Francisco’s Parc 55 hotel charged every company holding an event on its property during the annual JPM meet US$ 170 for a gallon of coffee.
Even taxi companies (like Uber) and airlines made hay while the JPM meet was on.
San Francisco is already an expensive city. With everything turning super-expensive during the JPM week, many took to Twitter to vent out their angst. “Threaten to stop trading through JPM, that will have biggest impact on changing the location,” a person said on Twitter.
The location may not change though — reports say JPM has signed a contract with its investment bank and the Westin hotel for another 17 years!
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : #Phisper Infographic by SCORR MARKETING & PharmaCompass is licensed under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
