Last Week in Focus: Updates to our Regulatory Trackers and Explainers (23 March 2015)
Posted 23 March 2015 | By
Here at Regulatory Focus, we don't just write about the latest regulatory news and events—we keep track of them, too. Each week, we update several of our "Regulatory Trackers" and "Regulatory Explainers," all in the hopes of making it easier for you to make sense of complex regulatory developments. Make sure you didn't miss a thing by reading this at-a-glance update.
Several new bills introduced in the US Congress in the last two weeks would affect products regulated by the US Food and Drug Administration (FDA).
|Legislation and Summary||Link to Text||Executive Summary||Date Introduced|
|Infection Reduction Labeling Act||Link to Legislation||Would allow solid antimicrobial copper products to be labeled with statements regarding infection reduction properties, and exempt those products from drug and device regulations.||18 March 2015|
|Speeding Access to Already Approved Pharmaceutical Act of 2015||Link to Legislation||Would allow companies whose products are approved in the EU to request an expedited review process. FDA would review products in 90 days.||18 March 2015|
|Patient Choice Act of 2015||Link to Legislation||Allows terminally ill patients to access “adequately safe” drugs through a provisional approval pathway. Bill introduced in 2013 under same title.||16 March 2015|
|PATIENT Act of 2015||Link to Legislation||Would give some drugs an additional 24 months of marketing exclusivity if they are reformulated to be safer, more effective or more abuse-resistant.||13 March 2015|
|Saving Kids from Candy-Flavored Drugs Act||Link to Legislation||Would increase penalties for marketing scheduled drugs contained within candy or fruit-flavored substances.||12 March 2015|
|Compassionate Access, Research Expansion and Respect States Act of 2015||Link to Legislation||Would make it easier to research the medicinal properties of marijuana, and reschedule marijuana as a Class II substance under the Controlled Substances Act.||10 March 2015|
You can keep up with legislative developments by bookmarking out FDA Legislation Tracker here.
Last week, the US Food and Drug Administration (FDA) awarded its third-ever rare pediatric disease priority review voucher—an incentive meant to accelerate the development of new medicines for rare pediatric diseases.
If you aren't well-versed in the program—or if you didn't read our explainer on the vouchers—you probably wouldn't have known that FDA's third approval was a big deal. Why? It means the program's statutory sunset clause is going into effect, and FDA's voucher program will end in just one year. Read more about the voucher program and how FDA's latest approval will affect it here.
Our FDA advisory committee calendar is one of our most-updated pages on the website, with at least one update per week. This week, we updated our calendar to include more information about several upcoming meetings:
- 23 March 2015 - A Review of the Use of Sedation in Pediatric Clinical Trials
- 14 April 2015 – Cardiovascular Outcomes Trials (CVOTs) for Diabetes Drugs: AstraZeneca’s Onglyza and Kombiglyze and Takeda’s Nesina, Oseni and Kazano
- 15 April 2015 – A Review of The Medicines Company’s Cangrelor
- 29 April 2015 – A Review of Amgen's T-VEC for Melanoma
There are also details about all past FDA advisory committee meetings, including vote summaries and major topics of discussion. Read more about upcoming FDA advisory committee meetings here.
We've been keeping track of so-called "Right-to-Try" legislation for a few months now, and last week saw a flurry of activity in the space. Two states—Wyoming and Arkansas—signed legislation into law intended to make it easier for drug companies to offer their products to critically ill patients without the fear of being sued.
Several more states, including Virginia, are expected to have similar laws passed in the coming days and weeks. Read more about Right-to-Try laws in our legislation tracker here.
Miss an update? Don't worry. You can easily find all of our Regulatory Trackers, Regulatory Explainers and Regulatory Reconnaissance on our Research and Resources page. It's a one-stop page for our most-loved content.