Market Place
EMA pushes for review of all chemically synthesized APIs for nitrosamines; Trump’s order decries Pelosi’s drug policy
This week, we update you on the ongoing Republicans versus Democrats slugfest in the US over their drug pricing policy plans.
In a latest salvo, President Trump has decried the Democrats’ ‘Medicare-for-all’ proposal through an executive order.
Post the discovery of cancer-causing impurities in blood pressure drugs and ranitidine, EMA has asked for testing of all chemically synthesized APIs for nitrosamines.
The UK is working on preventing drug shortages ahead of a possible no-deal Brexit by restricting export of drugs.
South Africa-based drugmaker Aspen Pharmacare got fined in the UK for price fixing.
The USFDA said heparin supply chain is not affected by African swine fever in China.
And two Americans and a Briton bagged the Nobel Prize for medicine for discovering a molecular switch that regulates how cells adapt to fluctuating oxygen levels.
All
chemically synthesized APIs to be reviewed for nitrosamines: EMA
As concerns mount over cancer-causing impurities in commonly used antacid and blood pressure medicines, the European Medicines Agency’s human medicines committee (CHMP) requested that marketing authorization holders (MAHs) for human medicines containing chemically synthesized active substances review their medicines for the possible presence of nitrosamines and test all products at risk. The review will include all generics and over-the counter (OTC) products.
However, in view of the large number of authorized products, MAHs have been advised to use a risk-based approach and prioritize their evaluations and confirmatory testing. Companies are expected to evaluate the possibility of nitrosamines being present in their medicines within six months. In the event of nitrosamine detection, the authorities are to be informed immediately.
The EMA also issued a notice to this effect and made a questions-and-answers document available on its website.
Last week, the US Food and Drug Administration (FDA) warned against the use of a particular testing method for testing of nitrosamines in ranitidine. The agency had observed the testing method used by a third-party laboratory applies higher temperatures. The higher temperatures generated very high levels of NDMA from ranitidine products.
The FDA published the method for testing angiotensin II receptor blockers (ARBs) for nitrosamine impurities, which is not suitable for testing ranitidine because heating the sample generates NDMA.
The FDA recommended using an LC-HRMS (liquid chromatography-high resolution mass spectrometry) testing protocol to test ranitidine samples as “FDA’s LC-HRMS testing method does not use elevated temperatures and has shown the presence of much lower levels of NDMA in ranitidine medicines than reported by the third-party laboratory.”
International regulators using similar LC-MS (liquid chromatography–mass spectrometry)
testing methods “have also shown the presence of low levels of NDMA in ranitidine samples”.
Trump issues executive order that decries Democrats’ Medicare-for-all proposal
The President of United States Donald Trump continues to be in the ‘attack drug companies’ mode. In an hour-long speech at a retirement home in Florida, Trump implied that the drug industry may have been behind the recent push to open a formal impeachment investigation.
He also signed an executive order on October 3 that decried Medicare-for-all (an expansion of Medicare to cover all Americans being pushed by Democrats) and promoted private insurance’s role in Medicare.
Trump referred to the proposals put forth by Democrats as socialist and pledged to prevent them from coming to fruition. Medicare is a scheme that covers Americans aged 65 years or more.
The executive order follows measures the Trump administration rolled out in recent months to curtail drug prices and correct other problems with the country’s healthcare system. Policy experts say the efforts may slow the tide of rising drug prices.
Some provisions in the executive order are largely uncontroversial, such as improving network adequacy, expanding access to tele-health and reducing the time between drugs being approved by the FDA and their being covered by Medicare.
But the Trump administration’s explicit intent to promote Medicare Advantage, a program that allows Medicare enrollees to opt into private qualified plans, could have major implications for the current Medicare system.
Trump also suggested that drug companies were backing impeachment efforts in Washington as a way to sabotage his efforts to make prescriptions affordable. Trump also accused House Speaker Nancy Pelosi of trying to distract voters from the Democratic impeachment inquiry with promises to work with the White House on lowering drug prices.
“Nancy Pelosi just said that she is interested in lowering prescription drug prices and working on the desperately needed USMCA (United States–Mexico–Canada Agreement). She is incapable of working on either,” Trump said.
Pelosi, on the other hand, said lowering drug prices and impeachment “have nothing to do with each other.”
Trump said drugmakers would lower their prices once importation begins. He said a proposal is coming soon to lower drug prices by importing drugs from Canada and other countries and promised to allow states to import drugs from Canada.
UK
prevents drug exports ahead of a possible no-deal Brexit
The UK is working on preventing drug shortages ahead of a possible no-deal Brexit. Last week, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published a list of 24 medicines that cannot be parallel exported from the UK.
The list includes drugs like the hormone therapies estradiol and levonorgestrel, the antiviral oseltamivir, adrenaline, the blood thinner rivaroxaban and the high blood pressure medicine prazosin, among others. The country has decided to restrict these medicines from parallel export as the practice can create or worsen supply shortages.
Last week, the UK Prime Minister Boris Johnson presented a revised exit plan in a speech in Manchester at a Conservative Party conference. He said that the plan would represent the UK’s final plan to reach an agreement with the EU and that if an agreement cannot be reached, the UK would withdraw from the EU on October 31 without a deal.
“Parallel export is the practice of buying medicines already placed on the market in the UK in order to sell them in another country in the European Economic Area (EEA) where they are repackaged and relabelled in accordance with the requirements of the importing country,” Steve Oldfield, chief commercial officer of the UK’s Department of Health and Social Care, said in a letter to wholesalers.
Anyone holding a wholesale dealer licence can parallel export a medicine but in practice parallel export is undertaken by a small group of licence holders. “Sometimes the parallel export of a medicine can lead to or exacerbate supply shortages in the exporting country. Shortages of medicines can pose serious risks to patients,” he added.
If wholesale license holders supply one of the listed medicines for parallel export, the letter explains that they would be in breach of regulation 43(2), which may lead to regulatory action by the MHRA.
The Association of the British Pharmaceutical Industry has praised the move. Of the 12,300 medicines used in the UK, around 7,000 come from or via the European Union (EU).
After
Italy, Aspen fined for price fixing in the UK
Over the last three years, South Africa-based drugmaker Aspen Pharmacare has had a brush with the law over price gouging on at least two occasions.
In October 2016, Italian antitrust authorities had fined Aspen nearly US$ 5.5 million for halting supplies of several cancer drugs. And in 2017, the European Commission had opened an EU-wide probe into Aspen over the same concerns.
Last week, there was news that three pharmaceutical firms, including Aspen, colluded to increase the price of a life-saving drug purchased by the UK’s National Health Service.
In 2016, Aspen had made a deal with two other firms to keep them out of the UK market for fludrocortisone, the Competition and Markets Authority (CMA) said. The medicine is used to treat Addison’s disease (an insufficient production of certain hormones).
“This alleged illegal agreement protected Aspen’s UK monopoly in relation to the supply of the drug to the NHS and gave the firm the opportunity to increase prices by up to 1,800 per cent,” the CMA said.
The arrangement between Aspen, headquartered in South Africa, Britain’s Amilco and the Netherlands’ Tiofarma lasted from March 2016 until October 2016.
Aspen has already admitted to taking part in this agreement, but the other two firms have not. Amilco and Tiofarma now have the opportunity to respond to the CMA’s provisional findings.
The watchdog also said Aspen will pay the NHS US$ 9.8 million (£8 million) to resolve another competition issue related to the supply of fludrocortisone.
In addition, Aspen has committed to ensure that in the future there will be at least two suppliers of fludrocortisone in the UK to lower the prices available to the NHS.
Heparin
supply chain not
affected by African swine fever in
China, says FDA
The US Food and Drug Administration (FDA) has said manufacturers of the blood thinner heparin continue to report that African swine fever in China is not affecting manufacturing and distribution of the drug intended for the US market.
Recently, China struggled to contain an outbreak of African swine fever and is expected to lose about 150 million of its approximately 440 million pigs. The active pharmaceutical ingredient (API) in heparin is derived from pig intestines. Since China supplies a large portion of the API, there were concerns that the African swine fever outbreak might affect the availability of heparin.
Heparin is used in many settings, including as a treatment for heart attack patients. It is also given to patients before and after certain surgeries to prevent blood clots.
The update from FDA follows a letter sent in late July by the House Energy and Commerce Committee to FDA Acting Commissioner Ned Sharpless seeking further information on how the agency is monitoring the supply of heparin.
According to the American Society of Health-System Pharmacists (ASHP), several manufacturers have said they are experiencing shortages of heparin. For instance, ASHP said Fresenius Kabi has put heparin “on a protective allocation due to a potential shortage of raw ingredient,” while “Pfizer has heparin on shortage due to manufacturing delays.” However, some manufacturers have said they have supplies of the critical drug.
“FDA continues to be in regular contact with US heparin suppliers and manufacturers as this situation evolves,” the agency said. In 2008, there were issues with Chinese heparin manufacturers that led to the deaths of nearly 150 Americans.
Two
Americans, a Briton bag Nobel Prize for medicine
The 2019 Nobel Medicine Prize was given to two Americans and a Briton for discovering a molecular switch that regulates how cells adapt to fluctuating oxygen levels. This discovery has opened up new approaches to treating heart failure, anemia and cancer.
Thomas Perlmann, secretary of the Nobel Committee and professor of molecular development biology at the Karolinska Institute, announced the award at a ceremony in Stockholm.
William Kaelin Jr. of Boston’s Dana-Farber Cancer Institute and Harvard Medical School, Peter Ratcliffe of the University of Oxford and London’s Francis Crick Institute, and Gregg Semenza of Johns Hopkins University identified “the molecular machinery that regulates the activity of genes in response to varying levels of oxygen, … one of life’s most essential adaptive processes,” the committee said in its announcement. The discoveries have paved the way for understanding “how oxygen levels affect cell function in both health and diseases including anemia and cancer.”
The trio had also won the 2016 Lasker Award for basic medical research and will share the Nobel Prize award of around US$ 900,000 (9 million Swedish kronor).
Medicine is the first of the Nobel Prizes given each year. Last year American James Allison and Japanese Tasuku Honjo won the prize for discoveries about how to harness the immune system in cancer therapies.
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