Who is in charge of granting pre-approval drug access?

Patients suffering from rare diseases or life-threatening illnesses, like cancer, can often find that there are very few treatment options available to them. For these patients, accessing an investigational drug outside of the clinical trial setting could be the only viable option. Governments and health agencies across the world recognize the importance of providing pre-approval [...]

By | 2018-08-10T04:52:35+00:00 July 4th, 2018|Expanded Access Programs, Unlicensed Medicine Access|Comments Off on Who is in charge of granting pre-approval drug access?

Should Randomized Controlled Trials remain the gold standard for testing and evaluating new drugs?

For years, Randomized Controlled Trials (RCTs) have been the gold standard for assessing the safety and efficacy of investigational new drugs. These trials are considered the most effective at overcoming bias and yielding high-quality evidence because patients are allocated at random to receive either the study drug or a comparison/control product. Patients are unaware of [...]

By | 2018-03-07T12:41:08+00:00 October 24th, 2017|Drug Manufacturers, Legislation, Unlicensed Medicine Access|Comments Off on Should Randomized Controlled Trials remain the gold standard for testing and evaluating new drugs?

FDA could lift restrictions on off-label drug promotion

The FDA has recently announced that the agency is considering loosening the restrictions on off-label drug promotion in the US. Under the current legislation, physicians can prescribe drugs to treat conditions not included on the approved drug label, a practice which has become common in oncology and pediatrics, but pharma companies are not allowed to [...]

By | 2018-03-07T12:42:55+00:00 October 20th, 2017|FDA, Legislation, Unlicensed Medicine Access|Comments Off on FDA could lift restrictions on off-label drug promotion

Gottlieb says supply issues, not FDA, to blame for limited access to investigational products

Right to Try legislation, which has already been passed in 37 states, is now being considered at the national level. The legislation, which aims to remove the FDA from the equation when granting patients access to unlicensed drugs, has been backed by both President Donald Trump and Vice President Mike Pence. After the Senate unanimously [...]

By | 2018-03-07T12:46:52+00:00 October 17th, 2017|Expanded Access Programs, FDA, Legislation, Unlicensed Medicine Access|Comments Off on Gottlieb says supply issues, not FDA, to blame for limited access to investigational products

New calls for reform of pediatric clinical trial rules

The Institute for Cancer Research (ICR) in the UK is challenging current European regulations governing clinical trials in children, claiming that the out-of-date rules are limiting pediatric patients’ ability to access new cancer treatments. Under the current EU Pediatric Regulations, which were established in 2007, drug companies can choose not to run clinical trials in [...]

By | 2018-04-03T14:50:37+00:00 March 28th, 2017|Unlicensed Medicine Access|Comments Off on New calls for reform of pediatric clinical trial rules

Early Access to Medicines Scheme (EAMS)

Earlier this month, Sanofi’s atopic dermatitis drug, dupilumab, became the latest drug to be approved for the Early Access to Medicines Scheme (EAMS) in the UK. But what exactly is the EAMS, and how do drug companies get their drugs included in this scheme? The EAMS was established in 2014 to help patients with serious [...]

By | 2018-04-03T14:51:04+00:00 March 21st, 2017|Unlicensed Medicine Access|Comments Off on Early Access to Medicines Scheme (EAMS)

Big Pharma speaking out against new off-label drug regulation

Last month, the Food and Drug Administration (FDA) made some changes to the regulatory definitions governing off-label use of drugs in the US, and pharma groups are seriously disgruntled. A final rule was released by the FDA on the 9th of January, 2017, which amends the definition of “intended use” for drugs and devices. Under [...]

By | 2018-04-03T15:11:04+00:00 March 7th, 2017|Unlicensed Medicine Access|Comments Off on Big Pharma speaking out against new off-label drug regulation

FDA considering allowing drug companies to pitch off-label drug uses in their TV ads

For most patients living in the US, turning on the TV and seeing an advertisement for a drug or pharmaceutical product is a common occurrence. In fact, these commercials have become an accepted part of daily TV viewing, and the drug industry spends billions of dollars every year on this direct-to-consumer marketing. However, visit almost [...]

By | 2018-04-03T15:15:40+00:00 February 24th, 2017|Unlicensed Medicine Access|Comments Off on FDA considering allowing drug companies to pitch off-label drug uses in their TV ads

Using off-label drugs to treat cancer

A drug is approved for market use only after a clinical trial has shown that it is safe and that it effectively treats a certain condition. Once the drug is on the market, it can then only be used to treat patients who have that same condition. If an approved drug is used to treat [...]

By | 2018-04-04T10:57:33+00:00 January 17th, 2017|Unlicensed Medicine Access|Comments Off on Using off-label drugs to treat cancer

Why is the use of unlicensed medicines in pediatrics so common?

In order for a manufacturer to sell its drug on the market, it will have to receive a valid license from the US Food and Drug Administration (FDA), or the equivalent review board in countries outside the US. This license will specify exactly how the medicine should be used and what patients are allowed to use it ...Read More

By | 2018-04-04T12:44:31+00:00 December 8th, 2016|Unlicensed Medicine Access|Comments Off on Why is the use of unlicensed medicines in pediatrics so common?