According to an independent report commissioned by the UK's Department of Health, the National Health Service (NHS) could save as much as £5 billion (GBP) per year by 2020 through medicines optimization and leveraging NHS buying power to save on medical devices and consumables. Improving Efficiency Last year, Health Secretary Jeremy Hunt appointed Lord Carter, member of the House of Lords (Labour) to chair the NHS Procurement and Efficiency Board. In his capacity as cha...

Pharmaceutical companies frequently find themselves sanctioned by the US Food and Drug Administration (FDA) for failing to adhere to federal good manufacturing practice (GMP) requirements. But it's an exceptionally rare occurrence to see FDA cracking down on a fellow federal government agency, as it is this week. On 4 June 2015, the National Institutes of Health (NIH) issued a statement saying it had "suspended operations" at its Pharmaceutical Development Section (PDS) ...

No healthcare product, no matter how innovative or essential, will make it to patients without regulatory approval. Every regulatory professional knows this. But there is another critically important factor involved in getting treatments to patients that you may not know as much about—a concept known as market access. The elements of market access include reimbursement and the evidence necessary to secure it from payers, pricing and coverage policy. These areas ...

The US Department of Health and Human Services (HHS) has unveiled new regulations to establish a parallel system of organ donation intended to serve patients with the human immunodeficiency virus (HIV). Background The regulations come almost a year and a half after US President Barack Obama signed into law the HIV Organ Policy Equity (HOPE) Act of 2013 . The law, passed in November 2013, modified the National Organ Transplant Act (NOTA) of 1984 by permitting HIV-p...

The cost of 12 cancer drugs could soon be capped in India if a recommendation from the country's National Pharmaceutical Pricing Authority (NPPA) is approved, The Indian Express reports. At the same time, the government is actively looking into revising its National List of Essential Medicines (NLEM) following a proposal from a parliamentary committee for price caps to be extended to all drugs two weeks ago. Background In India, the prices of drugs listed under t...

Just weeks after India's drug pricing chief was ousted, a parliamentary committee has proposed expanding price caps to all drugs. Background In India, the price of drugs listed as essential medicines is capped by the National Pharmaceutical Pricing Authority (NPPA) under the country's Drug Price Control Order (DPCO) . The amount these drugs can be sold for is indexed to average wholesale prices of similar products, and can only be increased once per year, as was th...

US Sen. Elizabeth Warren (D-MA) has unveiled plans to introduce new legislation she says will require pharmaceutical companies found guilty of regulatory and legal non-compliance to pay large fines, all in the hopes of providing a new funding stream to the National Institutes of Health (NIH). The Premise: Big Profits Come From Government In a speech at a healthcare conference on 22 January 2015, Warren—a populist Democrat whose meteoric rise to popularity has left some ...

The National Institutes of Health (NIH) is trying to simplify the oversight of complex, multi-center clinical trials through a new policy promoting the use of a single institutional review board in trials it oversees. Institutional review boards (IRB), sometimes known as ethics committees in foreign countries, are meant to ensure that clinical trial participants are treated safely and fairly in accordance with local, national and international regulations. Traditionally...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Following public criticism of its rejection of a number of expensive cancer treatments, the UK’s health cost watchdog is calling for a review of the way new medicines are adopted by the National Health Service.  In a statement released today, the National Institute for ...

This content is provided by RegLink News , publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members. Brazil’s national regulatory agency, Anvisa, has published guidance on the implementation of the country's track and trace system for drugs, the National Drug Control System (SNCM).  The guidance manual , released 18 August 2014, specifies the requirements for mandator...

The US Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) have jointly approved the first-ever product through a parallel review pilot program that seeks to accelerate the process by which device products obtain government reimbursement decisions. Background The pilot program, known as Parallel Review , was conceived in October 2011 as a way to allow companies to get their products from an investigational stage to reimbursement ...

There exists in the US a stockpile of healthcare products that, one hopes, will rarely need to be used. Known as the Strategic National Stockpile (SNS), the stockpile contains drugs and medical devices intended to be helpful in the case of a national emergency, such as an outbreak of disease, a terror attack, natural disaster or other unforeseen events. Background: The SNS Technically the “stockpile” is not a single store of products, but rather a collection of strat...