Part Two of Our Interview with CM Advisor Peter Pitts

Peter Pitts is a member of our Advisory Board and the President of the Center for Medicine in the Public Interest. He is also a former FDA Associate Commissioner, advisor to the Obama administration and currently serves as an Associate Editor of the DIA journal, Therapeutic Innovation & Regulatory Science. His work has been published in New York Times, The Washington Post, Wall Street Journal, and The Economist. Peter also has a fantastic blog drugwonks.com, so if you’re not already a reader, you should definitely check it out! In part One of our interview with Peter, he spoke about a variety of topics including his take on the FDA’s expedited review program, comparing the approaches taken by the FDA and the EMA (European Medicines Agency), and his overall impression of the current state of drug development. To read Part One click here.

In Part Two, he talks about anti-infectives, pediatric trials, conditional approval, and the impact of politics on the drug development process.

Peter is a very eloquent speaker and once we got him going, we just let the tape roll and the insights fly! Make sure you visit his blog drugwonks.com and follow him on Twitter: @PeterPitts

----------------------------------------------------------------------------------------------------------------

Peter Pitts:

Anti-Infectives

In 2010, Representative Henry Waxman voiced concern about non-inferiority trials – but when he was confronted with the science he backed down. That’s a good thing. When politicians start to dabble in science, they generally get badly burned.

Today the FDA is trying to expedite reviews of anti-infectives. The need for these products and that in itself changes the benefit / risk profile. And that will allow for approvals based on less data – and in an expedited fashion.

There are multiple ways to get an important new therapy to market quicker – but that has to be based on a public health need, not a marketing strategy.

Pediatric Trials

Pediatric trials bring both public health and IP benefits, but they are hard to design, hard to recruit for, and hard to field. They’re especially important for anti-depressants and anti-psychotics. We also will be seeing more precise clinical trials in minority and genotype populations. From a perspective of companion diagnostics we’re developing more medicines for small, more precisely identifiable patient populations – clearly the wave of the present and this will continue for the foreseeable future. It’s all about personalized medicine.

The best way to address benefit/risk profile is to make sure that the right patient gets the right medicine in the right dose at the right time. That will result in more positive clinical outcomes and huge cost savings. That’s where you’re going to see the greatest increase in adaptive clinical trials, whether in children, pregnant women, certain genotypes, women, men, African-Americans, Asians, etc.

The benefit/risk profile of a product that’s proven to be more beneficial within an identifiable sub-population is a key for expedited review, because you can more precisely define who it works for and, just as importantly, who should not be using it.

Conditional Approval

As far as so-called “conditional approval” goes, I wouldn’t look for it any time soon in the US. The last time I spoke with senior members of the FDA, I heard comments like, “What does that even mean?” And, then again, do drug developers really want conditional approval? You invest a lot of time and money to get a conditional approval and then the agency decides to take the product off the market? Is that something to roll the dice on?

Unless and until the FDA can ramp up its pharmacovigilance prowess, any kind of provisional approvals will remain problematic. At the moment, the FDA doesn’t have an eye in the sky.

Political Impact

And there’s the issue of Congress politicizing the FDA process. Plan B, Avandia, Zohydro. As Mark McClellan used to say, “If people are saying we’re approving drugs too slowly, and others are saying we’re approving drugs too quickly. We must be doing something right.”

That’s my story… and I’m sticking to it!

----------------------------------------------------------------------------------------------------------------

Again make sure you visit his blog drugwonks.com and follow him on Twitter: @PeterPitts

Thanks Peter, we look forward to further collaborations in the future.