About Gerrod McDonald

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So far Gerrod McDonald has created 19 blog entries.

What patients are eligible for pre-approval drug access?

Recently approved legislation, the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017”, allows patients in the US the ability to request access to investigational drugs, without any approval or oversight from the FDA. This Right to Try law was passed in an attempt to improve upon the prior system [...]

By | 2018-08-10T04:54:47+00:00 June 27th, 2018|Expanded Access Programs, FDA|Comments Off on What patients are eligible for pre-approval drug access?

Why collect Real World Data (RWD)

Randomized controlled trials (RCTs) have long served as the gold standard for developing and assessing new drugs and devices. However, over the past couple of years, there has been a real push towards collecting and using Real World Data (RWD), rather than focusing solely on the standardized clinical trial method. RWD is any information relating [...]

By | 2018-08-10T04:56:32+00:00 June 15th, 2018|Expanded Access Programs|Comments Off on Why collect Real World Data (RWD)

FDA commissioner releases statement on Right to Try

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 [...]

By | 2018-08-10T05:02:58+00:00 June 7th, 2018|Expanded Access Programs, FDA, Legislation|Comments Off on FDA commissioner releases statement on Right to Try

NORD launches new patient initiative, RareInsights

Late last month, The National Organization for Rare Disorders (NORD) launched its new initiative, RareInsights, aimed at expanding public knowledge of rare diseases and using that knowledge to create real-world solutions for patients. NORD is one of the US’ leading non-profit organizations advocating for rare disease patients through education, funding and support for drug research [...]

By | 2018-08-10T05:07:01+00:00 June 6th, 2018|Health|Comments Off on NORD launches new patient initiative, RareInsights

Right to Try becomes law

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 [...]

By | 2018-08-10T05:11:48+00:00 May 31st, 2018|Expanded Access Programs, Legislation|Comments Off on Right to Try becomes law

Study conducted to examine how to broaden clinical trial eligibility criteria

National Right to Try legislation was passed by Congress last week in an effort to make investigational drugs more readily available to patients who have no other treatment options available to them. However, many believe this legislation will do little to help patients and have argued that regulators should focus less on passing new laws [...]

By | 2018-08-10T05:27:59+00:00 May 25th, 2018|FDA|Comments Off on Study conducted to examine how to broaden clinical trial eligibility criteria

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 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 [...]

By | 2018-08-10T05:29:59+00:00 May 22nd, 2018|Health, 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 shame [...]

By | 2018-08-10T05:32:15+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 does [...]

By | 2018-08-10T05:34:11+00:00 May 8th, 2018|FDA, Reference Listed Drug|Comments Off on FDA accepts partial responsibility for high drug prices