By Palmer Reuther
Stuck between a rock and a hard place, or, in this case, patients and its’ organizational mission, the Food and Drug Administration (FDA) sided with the patients. Late yesterday Dr. Douglas Throckmorton, deputy director of the FDA’s Center for Drug Evaluation and Research, announced that a liquid form of Morphine, currently unapproved by the FDA, will remain on the market in limited supply.
Dr. Douglas Throckmorton
The surprise here for some physicians and patients? Not all drugs on the market are backed by FDA approval. For a list of drugs not approved by the FDA, click here.
Reasoning behind the ruling shed light on the FDA’s more compassionate side as it agreed with hospice and other health care organizations that many terminally ill patients would face significant ”hardship” without access to this powerful pain medication.
The decision is a concession of sorts as just last month the FDA sent a letter to nine pharmaceutical companies, warning them to stop making drugs where the therapeutic benefits remain unproven.
Some many feel that this move by the FDA is more of a PR stunt to gain back waning public trust after a number of premature approvals were forced through its backlogged system, but regardless there are thousands of struggling patients that can rest a little easier today.
April 10th, 2009
By Palmer Reuther
The Wall Street Journal reported this morning that Johns Hopkins has banned free drug samples and gifts from pharmaceutical and medical device companies. To ensure that these new regulations are met, the University is restricting drug and device sales reps from patient-care areas of its hospital and clinics.
There is no huge surprise here and this trend is expected to continue as the doc-rep relations comes under increased scrutiny. It is interesting that medical device and pharma cos are being lumped together under the same regulations. Historically, pharma cos have been at the tip of the compliance spear, with similar regulations then sweeping the med device industry.
Health care compliance is a growing area of interest for those in the industry. We’ll be sure to keep an eye out for other developments in this area.
April 9th, 2009
By Rachel
The UK drug watchdog, NICE (National Institute for Clinical Excellence), was under fire again recently, this time from the Daily Mail (one of the UK’s most influential national newspapers). This time it’s not the guidance given on prescription drugs that are ‘too expensive’ for the NHS, but rather how much NICE spends on ‘spin’: “fury over drug watchdog’s £4.5m PR budget”. The article states that NICE spends £4.5m on ‘communications’ and £3.4m on assessing new medicines. However, a breakdown on what is included in the communications category is not divulged.
NICE is a hugely influential organisation. In 2006/7 it produced 21 technology appraisals, 50 interventional procedure reviews, 13 clinical guidelines and 2 sets of public health advice, all of which required extensive communication and collaboration with a large number of stakeholders, ranging from patients to healthcare professionals, public health experts and health economists. In addition to engaging stakeholders in the review processes, NICE reaches out to target audiences through a number of other communications channels to ensure there is a two-way dialogue between stakeholders and partner organisations.
It seems to me that the issue here is the balance of spend – as a public body, NICE cannot make recommendations without due consultation. It has a duty to communicate clearly and transparently with patient groups and healthcare professionals. This communication requirement cannot realistically be achieved on a shoestring budget, but neither should it be profligate in its spend.
September 12th, 2008
