YourEncore Insights - Life Sciences

Peter J. Pitts

Recent Posts

Embracing Satan's PDUFA

Posted by Peter J. Pitts on 8/19/16 8:00 AM

Monday’s public meeting on the FDA’s PDUFA VI Commitment Letter was a love-fest (mostly) – but as Theresa Mullin, Director of CDER’s Office of Strategic Programs, wisely noted, “the devil is in the details." Indeed.

The meeting was in three panels: Pre-Market Review and Post-Market Safety, Regulatory Decision Tools, and Administrative Enhancements.

A few highlights and comments.

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Topics: Pharmaceutical Industry, Regulatory, FDA

Real World Evidence: Times They Are a (Slowly) Changin'

Posted by Peter J. Pitts on 8/2/16 8:50 AM

Per the FDA’s PDUFA VI "commitment letter," the agency will face some real world deadlines to advance the use of real world evidence. But, since we’re dealing with the real world, let’s get real – guidance is unlikely until the end of 2022 at the earliest. (That's the timeline agreed to via the PDUFA VI negotiations.)

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Topics: FDA

If Brexit, Whither EMA?

Posted by Peter J. Pitts on 7/14/16 9:00 AM


If Brexit, whither EMA?

Will Great Britain become like Norway and Iceland, attending committees such as the CHMP, where their views and votes are not of the same standing as those of members of the EU, or choose to follow a different route? There’s a lot at stake for the future of the MHRA and the British public health.

But what about the impact of removing MHRA expertise from EMA?

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Topics: Pharmaceutical Industry, Regulatory

Getting Real World About Outcomes Data

Posted by Peter J. Pitts on 6/1/16 1:00 PM

I’ve just returned from a cold, blustery and wet London where I attended the annual Pharma Access Leaders Forum.

But the meeting was hot.

In fact, piping hot when you consider the tectonic changes being felt in the world of healthcare technology assessment (HTA) and their implications on both patient access and innovation. And the linkages couldn’t be more profound.

Wither HTA in the EU? A key red thread through a series of potent discussions was real world evidence (aka, “outcomes data”). Head honcho HTA officials from across Europe (including England and Scotland – both still in Europe as of last report) returned again and again to the value of outcomes not just for the evolving world of Risk Sharing Agreements, but for the acceleration of reimbursement science.

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Topics: FDA, R&D

Transparency Isn't a One-Way Proposition

Posted by Peter J. Pitts on 4/13/16 11:00 AM

Transparency in medicine isn't a one-way street.

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory

FDA Gets Out In Front on Single Source Problem

Posted by Peter J. Pitts on 3/29/16 11:00 AM

National Public Radio’s Marketplace program reports:

The Food and Drug Administration recently said it’s going to prioritize any generic drug application when there’s currently just one manufacturer.

Here’s why:

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Topics: Pharmaceutical Industry, Regulatory, FDA

Understanding and Maximizing Interactions with the Califf FDA

Posted by Peter J. Pitts on 3/17/16 9:36 AM

image source: fda.gov

Does it really matter who sits in the corner office at the FDA?

Isn’t PDUFA VI already a done deal?

Can one person really change the direction of an agency that is almost entirely staffed by career civil servants?

Why bother with a new Commissioner with only one year left in the Administration?

These are all good questions, and the right answers depend on specifically who is leading the FDA.  Thanks to his recent confirmation, we now know that man is Dr. Robert Califf.

For some answers, insights, and prognostications to the questions above, I sat down with Dr. Tim Franson, Chief Medical Officer of YourEncore, to discuss what industry can expect and how to maximize future FDA interactions. 

Listen to the 40 minute discussion.  It’ll be 40-minutes well spent.

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Topics: Pharmaceutical Industry

Roundtable: Driving Down Healthcare Costs

Posted by Peter J. Pitts on 3/14/16 12:36 PM

Everybody wants to lower healthcare costs, but nobody agrees on the best way to do so. And what about those pesky unintended consequences?

I was asked by Healthcare Sales & Marketing Magazine to lead a panel of three experts on this timely/thorny topic. My co-conspirators include Ben Locwin (President, Healthcare Science Advisors), Bill Soucie (Vice President of Market Access at Xenoport), and Matt Wallach (Co-Founder and President, Veeva Systems).

As the lead-in to the the panel says, "Something needs to be done."

Read the full article to hear the panel’s take on the causes and possible cures for rising healthcare costs.

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Topics: Healthcare Costs

FDA's Abuse-Deterrent Commissioner

Posted by Peter J. Pitts on 3/4/16 9:26 AM

 

Yesterday the FDA Science Board discussed the agency’s approach to opioids.

FDA presenters included agency point-man Doug Throckmorton (Deputy Director for Regulatory Programs, CDER), Janet Woodcock (Director, CDER), Sharon Hertz (Division Director, Division of Anesthesiology, Analgesia and Addiction Products), Gerald Dal Pan (Director, Office of Surveillance and Epidemiology) – and newly confirmed FDA Commissioner Rob Califf.

Califf was there at the beginning of the meeting (expected) and stayed through the entire length of the day-long affair (unexpected). An important signal that he intends to be a hands-on leader.

I was chosen to speak during the open public comment part of the hearing, and spoke about using real-world information to provide providers and patients with information beyond the limited world of pivotal trials. Here are my brief remarks:

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Topics: Regulatory

From Snake Oil to Fish Oil: The Need for a New Approach to Off-Label Communication

Posted by Peter J. Pitts on 2/25/16 1:23 PM

As you well know, off label communications is on my short list of regulatory policy and public health issues that keep me up at night.  

Why?  There is a leadership vacuum on the topic, and absent clear leadership, federal judges are starting to dictate regulatory policy through the Amarin case and others.  If existing policy has evolved to protect the public from snake oil, the recent Amarin decision is precarious precedent for communications about fish oil – and beyond.   

To help find better solutions to this important issue, on February 18th the new Duke-Margolis Center for Health Policy held a conference titled, “Off Label Communication in 2016: Meeting Information Needs through New Policy Options.”

Those new options are detailed in an important new paper:
Policy Options for Off-Label Communication: Supporting Better Information, Better Evidence, and Better Care

I am honored to be one of the co-authors and to have had the opportunity to speak at the event. 

Just about every speaker pointed to the need for FDA leadership though bold action and … clarity.  The paper lays out what we refer to as Guiding Principles for Lasting Solutions. They are:

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Topics: Life Sciences, Pharmaceutical Industry, Regulatory