News in brief from around the world… The UK has taken steps to legalise medical cannabis and US lawmakers have passed new laws to dilute Obamacare, while Chinese regulators have sought to curb the use of potentially carcinogenic heart drugs.
⇒ The UK is set to legalise medicinal cannabis, Home Secretary Sajid Javid said on 26 July, following the hospitalisation of a young boy who was denied access to epilepsy medication last month.
Javid said that senior clinicians would be able to prescribe cannabis-based medicines to patients with an “exceptional clinical need”, while other forms of the drug will be strictly controlled and not available on prescription. He emphasised that the decision does not foreshadow legalisation for recreational use.
In a review commissioned by Javid in June, Professor Dame Sally Davies, the chief medical advisor, concluded that there is “evidence that medicinal cannabis has therapeutic benefits”. The Advisory Council on the Misuse of Drugs (ACMD) recommended that products meeting a “clear definition” of medicinal cannabis should be placed in Schedule 2 of the Misuse of Drugs Regulations 2001, allowing them to be prescribed by doctors.
On the ACMD’s advice, the Department of Health and Social Care and the Home Office will develop “additional frameworks and clinical guidelines” to ensure that such medicines “can be prescribed safely to patients but cannot be traded illicitly”.
Javid said that “recent cases involving sick children” had made it clear to him that the UK’s current position of medicinal cannabis was “not satisfactory”. On 16 June, Javid granted an emergency licence to return medicinal cannabis oil to 12-year-old Billy Caldwell – who uses it to treat life-threatening seizures – after it was confiscated by customs officials at Heathrow Airport.
⇒ China’s National Health and Family Planning Commission said (in Chinese) on 30 July that all domestic medical institutions should stop using bulk manufacturer Zhejiang Huahai Pharmaceutical’s blood and heart drug Valsarten due to an impurity – known as NDMA – that could pose cancer risks.
The regulator added that the drug – and associated data – should not be used for the diagnosis or treatment of diseases, and that medical institutions should cooperate with a recall issued earlier this month by Huahai.
Huahai said (in Chinese) that none of its other products contain NDMA and that it would continue to improve its systems in an attempt to prevent similar incidents in the future.
This follows recalls of certain products containing the drug issued earlier this month by both the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA). Based on animal studies in which the impurity was found to increase the occurrence of cancer, the US Environmental Protection Agency (EPA) has said it considers NDMA a probable human carcinogen.
⇒ The US House of Representatives has passed two additional measures watering down certain aspects of the Patient Protection and Affordable Care Act (ACA) or “Obamacare”.
The Protect Medical Innovation Act of 2017 – which passed by a vote of 283-132 on 24 July – will amend the Internal Revenue Code of 1986 to permanently repeal excise taxes imposed via the ACA on the sale of a medical device by a manufacturer, producer or importer.
Congressman Erik Paulson, who sponsored the bill, says that the tax stifles innovation, while critics argue that it doesn’t hurt consumers and its repeal will be costly.
Meanwhile, the House also passed the Increasing Access to Lower Premium Plans and Expanding Health Savings Accounts Act of 2018 by a vote of 242-176 on 25 July, amending provisions of both the Internal Revenue Code and the ACA.
The Act will redefine the definition of a qualified health plan for insurance premium tax credit and allow individuals to purchase a cheaper health insurance plan in the individual market than the ACA currently allows.
Courts and cases
⇒ The American Thoracic Society led 10 medical professional organisations in filing an amicus brief in the United States District Court for the District of Maryland on 17 July, supporting a lawsuit alleging guidance on pre-market review of tobacco products issued by the US Food and Drug Administration (FDA) is unlawful, arbitrary and capricious.
The suit, filed in March 2018, notes that the FDA issued a schedule in 2016 for conducting pre-market reviews of cigars and e-cigarettes under the Tobacco Control Act. The Trump administration later delayed the schedule, and the FDA issued guidance outlining the duties and responsibilities of tobacco manufacturers before going to market with such products.
The brief aims to show that “the FDA’s inaction is currently causing harm and will continue to cause harm” as the delay give companies “the luxury of time to amplify their marketing to children, who are the key target for candy-flavored tobacco products,” the petitioners say.