In Focus: The Top News Stories from 2015
For RAPS’ Regulatory Focus, 2015 might simply be called: The Year of the Explainer.
With major legislation altering the inner workings of the US Food and Drug Administration (FDA), as well as new priority review voucher programs coming to fruition, RAPS’ reader interest has been spiking for longer, more in-depth articles. Without further ado, here are the top most-read articles in 2015 based on traffic statistics:
9. After Three-Year Delay, FDA Finalizes Guidance Documents on Biosimilarity
2015 has been a hallmark year for biosimilars in the US. Not only did FDA approve the US’ first biosimilar in March and add it to FDA’s “Purple Book” in April, but later that month FDA also finalized three key guidance documents that will help bring industry up to speed with the agency’s expectations for biosimilars. CDER Director Janet Woodock also in September told US senators that more guidance and approvals are coming.
8. OTC Asthma Inhaler Prepares to Return to Market, Years After Being Pulled for Environmental Problems
This story, from 2014, focuses on the only over-the-counter asthma medication sold in the US, which was later pulled from the market. The inhaler has not returned to the market since FDA’s advisory committee met in February 2014 and voted against the risk-benefit profile of the inhaler.
7. India’s Data Integrity Problems
For a quick look at all of the warning letters centered on data integrity and sent to Indian pharmaceutical manufacturers from 2013-2015, this is the story. Focus also took a deeper dive into some of the other issues with Indian manufacturers after a review of 50 Form 483s from FDA, and outlined some other outstanding warning letters for Indian companies from 2015 here, here and here.
6. How Many Drugs has FDA Approved in its Entire History? New Paper Explains
Another classic article from 2014 has come up in a major way this year, particularly as FDA approved a 19-year high number of new drugs in 2015. More than 1,500 drugs have been approved by the agency over the course of its history.
5. FDA Advisory Committee Calendar
The constantly-updated advisory committee tracker from our partners at Tarius has become the go-to source for not only when the meetings will take place, but what they’ll involve.
4. FDA Says it Discovered Problems With Generic Version of ADHD Drug Concerta
This story from 2014 offers a look at what happens when equivalency problems surface after a generic drug is approved.
3. 'Right to Try' Legislation Tracker
Since 2014, more than 20 states have now passed so-called "Right to Try" bills in the hopes of allowing terminally ill patients to access experimental—and potentially life-saving—treatments. The only problem: No one really has any evidence that the laws are working. And as Health Affairs notes, the expectations of the new laws is creating some false impressions.
2. Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers
Charts, graphics, videos and explanations for even the most novice of FDA-watchers -- this article has it all. And as the recently-passed congressional spending bill pushes back the end date for the rare pediatric disease voucher system, this (constantly updated) explainer will continue to be necessary for anyone tracking the priority review voucher programs.
1. Regulatory Explainer: The (Updated) 21st Century Cures Act
The nearly 200-page House-passed bill is currently struggling to make its way through the Senate, and now that the National Institutes of Health received a major boost in funding (to the tune of $2 billion) from the omnibus bill, there may not be a need for this massive overhaul of how FDA regulates many healthcare products. Still, the bill covers some of the most pressing issues for the industry and represents a good example of a piece of legislation that can garner support from both sides of the aisle, which is extremely rare with today’s Congress.