Peter Pitts was an associate director of public affairs at the FDA. As well as the founder and president of the RCMP, the Center for Medicine in the Public Interest.
Federal Newswire
With your background at the FDA, what insights does that give you about the industry?
Peter Pitts
I was an associate commissioner at FDA with a lot of things under my portfolio. One of the more important being the public spokesperson of the FDA in charge of the public affairs office. I understand when the FDA does things right by communications, when they do things wrong.
There are a lot of issues in terms of what the FDA hasn't done right lately that need to be cleared up there. I started and I still run the Center for Medicine of the Public Interest, which is a not for profit agency to talk about medical innovation, to tell the truth, and sometimes that truth is not pretty.
I'm also a visiting professor at the University of Paris School of Medicine, which gets me over to Europe often. It's interesting to see how Europe is dealing with many of these same issues in ways that are better than we are, and in ways that are worse. Specifically, in terms of the way they help to address innovation. When people say we should do things like they do in Europe, they really should know what they're talking about. But sometimes the way they do it in Europe is far worse than the way we approach it here.
Federal Newswire
Why is Big Pharma a target by politicians and late night comedians?
Peter Pitts
I guess there's a quick answer and there is the back up. The quick answer is it's politically convenient to look for simple answers to complex questions. The truth is that things don't happen by accident.
The reason that innovations in healthcare technology almost exclusively come from within our borders is because we like innovation. We believe in intellectual property. We incentivize it and you get what you incentivize.
There's nothing more clear cut than when you look at the Orphan Drug Act. We just passed the 40-year mark of the Orphan Drug Act, where we incentivize investment in hard to cure diseases. Since it came online 40 years ago, we have over 800 new FDA approved treatments for disease cases that never had any treatments at all. Europe doesn't do that quite as aggressively as we do.
We believe in the free market. We believe that when you free your geniuses up to do their jobs and you reward them fairly, you get miraculous cures. But people want to point to Europe and say, “well, why are drugs so much less expensive there?” The truth is, in the U.S. 80-90% of all medicines used by volume are generic drugs. Generic drugs in the U.S. are less expensive than Europe and Canada, but somehow nobody wants to talk about that.
These new miraculous patent medicines are more available to patients in the U.S. than they are anywhere else in the world. Again, this is not an accident. This is because we believe in it. We incentivize it and it happens.
Federal Newswire
What does the future look like in terms of medical progress?
Peter Pitts
Well if you we're going to mess around with intellectual property and the patent system.. [or] we're going to aggressively seize people's intellectual property and their patents… there will be no more medical innovation.
When you read about a new drug [costing] $1 million, that's a meaningless number because patients don't pay the list price. Patients pay their co-pay. Over 92% of Americans have insurance that picks up those costs.
All these initiatives aren't going to lower drug prices for patients because when patients say my drugs are too expensive, what they mean is that copay is too expensive. That's just a fact. None of these initiatives lower copays by a single penny, although they do threaten the initiatives to invest billions of dollars in health care technology and drug development.
The FDA does not approve drugs willy-nilly. Most drugs fail. So unless we give drug developers, the innovative industry, the sign that we're going to support their efforts through fair reimbursement policies and audience innovation, we end up being just like Europe, which is not where we want to go.
Federal Newswire
Why is there a disconnect between patient groups and pharma companies on the issue of addressing drug prices through the Inflation Reduction Act?
Peter Pitts
Well the Inflation Reduction Act is an enormous piece of legislation. It's got lots of things in it that I think are good. Capping and smoothing payments for people on Medicare, incredibly important. But the piece that allows the government to set prices is extremely dangerous because price controls equal choice controls.
It's true anywhere in the world where this happens. Europe, Canada, the government sets the prices, limits choices for patients. Nobody's for that.
The president says this is going to lower drug prices for Americans. Well, not for the 92% of Americans who have health care insurance. Their co-pays aren't going to be impacted by a penny. In fact, because of the weird math of American health care, co-pays might actually go up. The ability to get new or generic products at lower prices is going to be completely skewed.
There's a lack of honesty and if we don't pull together and be honest with each other, all we're going to do is start exchanging talking points and the best lobbyist wins.
Federal Newswire
Does the GOP have an idea of how to balance healthcare policy with keeping the business sector thriving?
Peter Pitts
If you would have asked me that question eight months ago, I would have said that the Republicans have no alternatives. But things have changed and now [they have] serious legislation that I hope will get passed. I think good things would happen relative to pharmacy benefit managers. You have an invisible middleman that is sucking literally hundreds of billions of dollars out of the healthcare industry that goes straight to their bottom line. No one wants to talk about it.
A couple of years ago, Mitt Romney said, “well, why don't we just do away with the middlemen and pass the savings along to the consumer?” When the Senate called a panel of pharma executives to testify, they all said that if the PBMs were zeroed out of the equation, they would lower prices and they all raised their hands when somebody on the panel asked if that was true.
Now there's legislation, and I'm hopeful that it passes. I'm optimistic. This has been driven by the GOP.
Federal Newswire
Could we see Congress return to regular order and actually pass legislation that allows the American business sector to thrive? Could we see a return to normalcy?
Peter Pitts
I think the answer to your question is, hope springs eternal. I'm certainly hopeful. It's looking at this stuff chronologically. You have to have amazing bipartisan legislation that is really evolved and moves health care forward. You had Hatch-Waxman and the Orphan Drug Act more recently. These are bipartisan pieces of legislation that have an enormous impact on health care in this country.
Am I optimistic now that we can move forward? I absolutely am. The fact that the speaker is actually talking about that, he actually has said those words, is amazing. Health care should not be political.
Federal Newswire
How much does it cost to take a drug from the laboratory to the market?
Peter Pitts
Tufts University does a regular study that answers this question, and it's about $2.2 billion to get a drug approved through the FDA. Now, that also includes the hundreds of billions of dollars that drug companies invest in products that fail, that never even get to the FDA.
On top of that, you've got the products that get to the FDA and don't get approved. After all that, you're left with various products, only about which I believe 25% of the drugs that get approved through the FDA actually end up turning a profit.
This is a high risk proposition when people say, “well these drugs make billions of dollars.” That's true. But you also have to factor in all the drugs that fail. That dwarfs the profits.
Also, look at big pharma stock prices. I don't own any health care stocks. I never have and I never will. They are not top performers, not by a long shot. Now, when you look at any big drug companies stock price, believe me, it's not on anybody's recommended list.
You have blips like COVID vaccines. But those blips, they come and they go. And drugs go off patent and they get picked up on the generic market. You have to look at the whole picture.
Federal Newswire
What is the business environment like for small pharmaceutical companies?
Peter Pitts
These days, Alzheimer's disease, gene therapies, and CRISPR technologies [are the focus], and these are high-risk propositions. [But] the government is going to make it even less likely for them to make their money back.
When you look at things like Alzheimer's disease, if we don't seriously invest and we don't allow small company thinkers to develop and evolve their technologies economically, it's going to bury us and it is going to be our own fault.
Federal Newswire
How does the public health community get back to making this is about science and not about politics?
Peter Pitts
You have to give people permission to rethink their position. One of the serious issues when it comes to COVID is that the government was very quick to point fingers at misinformation and disinformation, and rightly so. But [it should admit], “hey, we've made some serious mistakes on the communications front ourselves—we want to apologize.” When you apologize, you can move on. But when you don't, you can't.
I'll give you two good examples. President Biden at one point said that if you get vaccinated against COVID, you'll never get COVID. Of course, that's untrue. Then the White House had to explain what the president actually meant. But the damage was done. People said, “well, if the president doesn't know what he's talking about, why should I even pay attention?”
Dr. Fauci, a bright guy, a public health hero, made a lot of mistakes. I never heard one word of apology or correction out of his mouth. That's got to change. If we want people to do the right thing, we have to accept that the government made process fails. There were self-inflicted wounds and science evolves. We're all learning at the same time and moving forward.
People want to believe the FDA. People want to believe the CDC. People want to believe the president. But we have to admit that we've made mistakes.
Federal Newswire
In the future, are we going to see more public private partnerships in health care reform?
Peter Pitts
Well one of my proudest moments in government was working on the Part D benefit. I was there when the president signed the bill. I helped make that happen. I'm incredibly proud of that. When the government and private industry works together, we can accomplish amazing things.
Operation Warp Speed [to find a Covid treatment] would never have happened without that partnership. All the other issues notwithstanding, Europe doesn't do that. They believe the government can do it all. That's our leg up.
We make a lot of money doing that, and that's okay [because] we're going to save and improve hundreds of millions of lives. If we don't keep our eye on the prize, shame on us because we know what the answer is and are in it together.
