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Vermont becomes first state to pass drug importation law

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 cut 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 ...Read More

By | 2018-05-23T11:14:04+00:00 May 23rd, 2018|Legislation|Comments Off on Vermont becomes first state to pass drug importation law

FDA publishes list of branded drug companies blocking generic competition

As part of the Trump administration’s efforts to address rising drug prices in the US, the FDA has recently published a list of brand name companies which have been using delaying tactics to actively block generic drug competition. FDA commissioner, Scott Gottlieb, has claimed that the purpose of this new initiative is not to ...Read More

By | 2018-05-18T04:35:32+00:00 May 18th, 2018|FDA, Reference Listed Drug|Comments Off on FDA publishes list of branded drug companies blocking generic competition

FDA accepts partial responsibility for high drug prices

Last month, FDA commissioner, Scott Gottlieb, touched on the agency’s shortcomings which have partly contributed to rising drug prices in the US. Speaking at a pharmaceutical event for pharmacy benefit managers in Washington, Gottlieb claimed that many entities are to blame for the skyrocketing drug prices patients are now facing, but that the FDA ...Read More

By | 2018-05-08T08:56:39+00:00 May 8th, 2018|FDA, Reference Listed Drug|Comments Off on FDA accepts partial responsibility for high drug prices

RARE Act of 2018

Earlier this year, at the end of February, The Rare Disease Advancement, Research, and Education Act of 2018 (H.R.5115), or the RARE Act of 2018, was introduced into Congress. The goal of this bill is to “expand and improve the programs and activities of the Department of Health and Human Services for awareness, education, research, surveillance, ...Read More

By | 2018-04-30T15:59:17+00:00 April 19th, 2018|Legislation|Comments Off on RARE Act of 2018

Workshops held to discuss the use of Real World Evidence

The use of Real World Evidence (RWE) has expanded over the past decade. Real-world study designs are more efficient than before, sources of data collection have improved dramatically, and data analytic tools are increasingly able to comb out meaningful results. However, despite this, RWE does not yet have a clear, established role, with many companies ...Read More

By | 2018-04-30T16:01:15+00:00 April 9th, 2018|FDA|Comments Off on Workshops held to discuss the use of Real World Evidence

House of Representatives will vote again on national Right to Try bill

Last week, the US House of Representatives rejected the national Right to Try (RTT) bill, by a vote of 259-140. This bill, an earlier version of which was passed by Senate in August of last year, would allow pharma companies to make their investigational drugs available to seriously ill patients without any FDA oversight. However, the ...Read More

By | 2018-04-30T16:02:05+00:00 April 4th, 2018|Legislation|Comments Off on House of Representatives will vote again on national Right to Try bill

FDA and NORD collaborate on patient engagement initiative

In line with recently enacted legislation, including the 21st Century Cures Act, the FDA has been developing a number of programs to help bring the patient perspective to drug development and review processes. The FDA recognizes how important it is to work closely with patients and understand their individual and collective experiences in order to ...Read More

By | 2018-04-30T16:03:14+00:00 April 4th, 2018|FDA|Comments Off on FDA and NORD collaborate on patient engagement initiative

House rejects national RTT bill

On Tuesday the 13th of March, the US House of Representatives failed to pass the federal Right to Try (RTT) bill. This bill, which was passed by Senate in August of last year, would have allowed pharma companies to make their investigational drugs available to seriously ill patients without any FDA oversight. Although RTT legislation has ...Read More

By | 2018-04-30T16:03:59+00:00 April 4th, 2018|Legislation|Comments Off on House rejects national RTT bill

Letter sent to Congress supporting Right to Try

Last month, WEP Clinical posted a blog article discussing a letter sent to Congress opposing Right to Try (RTT) legislation. Those responsible for drafting and sending the letter argue that RTT will do very little to improve patient access, and will harm patient wellbeing by providing false hope. This letter gained widespread support and was signed by ...Read More

By | 2018-04-30T16:06:27+00:00 April 4th, 2018|Legislation|Comments Off on Letter sent to Congress supporting Right to Try

Rare Disease Day 2018

Today is Rare Disease Day 2018. Celebrated on the last day of February every year, Rare Disease Day aims to raise awareness about rare diseases and their impact on patients’ lives around the world. A disease is defined as rare in Europe when it affects fewer than 1 in 2000 people, and is defined as ...Read More

By | 2018-04-30T16:07:38+00:00 February 28th, 2018|Blog|Comments Off on Rare Disease Day 2018