The Orphan Drug Act (ODA), which was passed in 1983 to incentivize drug development for rare diseases, has come under scrutiny in recent years. There are some within industry who claim that the program has been manipulated by drug manufacturers to maximize profits and protect niche markets for treatments for more common conditions. However, advocates in [...]
The FDA has recognized the important role that real-world evidence (RWE), i.e. evidence that is collected outside the tightly controlled clinical trial setting, can play in furthering drug development and facilitating drug approvals. In line with this, late last year, the FDA released a 40-page regulatory framework outlining how the agency plans to utilize RWE [...]
The goal of the FDA is to ensure that patients can access needed medicines in a safe and compliant manner, and the agency will support any legislation that aims to further this. As such, although the FDA was opposed to Right to Try prior to its passage earlier this year, now that it has been signed [...]
After Right to Try legislation was passed in the US earlier this year, many believe that desperate patients will now find it easier to try investigational products outside of the clinical trial setting. However, like with the FDA’s Expanded Access Program, the Right to Try law does not require companies to provide their unapproved drugs [...]
Over the past decade, regulators and healthcare authorities have become increasingly aware of the important role that patients can play in developing new medicines and getting them to market. In light of this, in new legislation in the US, the 21st Century Cures Act, which was passed in December 2016, the FDA has been charged [...]
With the Brexit leave date fast approaching, efforts are continuously being made to ensure that patient health and wellbeing remain protected, following the UK’s exit from the EU. Last month, the Secretary of State for Health and Social Care, Matt Hancock, released two letters to the pharmaceutical industry outlining recommended contingency plans for a potential ‘no-deal’ Brexit [...]
In a move that defies President Trump’s proposed budget for fiscal 2019, the Senate is gearing up to approve a $2 billion increase in funding for the National Institutes of Health (NIH). This increase has been proposed as part of the Senate’s “minibus”, which combines the Senate’s Defense bill and its Labor, Education and Health [...]
The national Right to Try bill was signed into law last month by President Donald Trump. The legislation intends to allow patients with no other treatment options available to them to try investigational drugs that have passed basic safety and efficacy studies, without requesting permission from the FDA. This offers an alternative pathway to the [...]
On Wednesday of this week, President Donald Trump signed the national Right to Try bill into law. The Senate version of the bill was cleared by the House earlier this month, after much debate and deliberation. Once it takes effect, the law promises to improve treatment access for patients across the US who cannot wait [...]
Last week, President Trump’s administration released its new drug pricing plan, which calls for more competition and negotiation as well as greater incentives to lower list prices and out-of-pocket costs for patients. However, many commentators have claimed that the plan is too lenient on big pharma, as it does not push for any real drug [...]